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1a. Project Name

Ophthalmology IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2j. Business Requirements Analyst

2k. Conformance Facilitator

Stephen Chu

2l. Other Facilitators

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

Attachments

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3f. Common Names / Keywords / Aliases:

Interoperable ophthalmic information exchange, Ophthalmic FHIR resources, continuity and collaborative ophthalmic care, prior authorisation of ophthalmic treatments

3g. Lineage

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6h. Other Providers

6i. Realm

Universal

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Sep 28, 2020

7c. Co-Sponsor Approval Date

Sep 29, 2020

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



 Show Changes

Version

27

Modifier

Stephen Chu

Modify Date

Oct 05, 2020 02:51

1a. Project Name

Ophthalmology IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3f. Common Names / Keywords / Aliases:

Interoperable ophthalmic information exchange, Ophthalmic FHIR resources, continuity and collaborative ophthalmic care, prior authorisation of ophthalmic treatments

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Sep 28, 2020

7c. Co-Sponsor Approval Date

Sep 29, 2020

Version

26

Modifier

Stephen Chu

Modify Date

Oct 05, 2020 02:41

1a. Project Name

Ophthalmology FHIR IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3f. Common Names / Keywords / Aliases:

Interoperable ophthalmic information exchange, Ophthalmic FHIR resources, continuity and collaborative ophthalmic care, prior authorisation of ophthalmic treatments

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

Sep 28, 2020

7c. Co-Sponsor Approval Date

Sep 29, 2020

Version

25

Modifier

Stephen Chu

Modify Date

Oct 05, 2020 02:38

1a. Project Name

Ophthalmology FHIR IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3f. Common Names / Keywords / Aliases:

Interoperable ophthalmic information exchange, Ophthalmic FHIR resources, continuity and collaborative ophthalmic care, prior authorisation of ophthalmic treatments

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

24

Modifier

Stephen Chu

Modify Date

Oct 05, 2020 02:29

1a. Project Name

Ophthalmology FHIR IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

23

Modifier

Stephen Chu

Modify Date

Oct 05, 2020 02:27

1a. Project Name

Ophthalmology IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Implementation Guide

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

22

Modifier

Stephen Chu

Modify Date

Oct 05, 2020 02:24

1a. Project Name

Ophthalmology IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

21

Modifier

Stephen Chu

Modify Date

Sep 28, 2020 08:12

1a. Project Name

Ophthalmology IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to develop a FHIR implementation guide to support interoperable information exchanges between healthcare practitioners responsible for collaborative and shared care of patients suffering from eye disorders.
The scope of this project is constrained by a finite set of business and clinical use cases (see project page) in the ophthalmic medical domain.
The business/administrative and clinical workflow from these use cases are used to identify the business and clinical datasets and mapping the data components onto FHIR resources, where necessary, extensions to and profiles of relevant FHIR resources will be created.
The output of this process would be a FHIR implementation guide that defines/describes the profile, extension and terminology/value-set artefacts, and to provide technical and clinical guidance on their implementations to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, and other international works such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

This project will take an incremental approach to the clinical domains with retinal problems as the first set of clinical use cases to be addressed by the implementation guide.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

20

Modifier

Stephen Chu

Modify Date

Sep 28, 2020 07:58

1a. Project Name

Ophthalmology IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to take a finite set of use cases (see project page) in the ophthalmic medical domain and map workflows and clinical datasets onto FHIR resources. The output of this process would be a FHIR implementation guide that through profile, extension and value-set artefacts will provide technical and clinical guidance to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

Our objectives:
1. Support the documentation and exchange of ophthalmic data within EHRs and other healthcare technology systems with appropriate use cases.
2. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary and diverse secondary and tertiary level care and pharmacy)
3. Map the necessary ophthalmic data elements to clinical terminology standards, clinical information models (CIM), as standardized FHIR mappings for transfer of data
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

3b. Project Need

This project is principally driven by the critical needs to support effective collaborative and shared care among specialist and generalised practitioners to ensure high quality of care required by rapidly growing rates of patients suffering from eye disease, many of which are time critical, highly complex, high risk (of avoidable vision loss), which have very serious implications including economic burden and serious loss in quality of life to individuals, their families and society.
An example is diabetic retinopathy (DR), one of the world’s leading causes of vision loss. Currently, 126M people are affected globally, almost 40M of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60M will have vision-threatening disease
Currently there lack semantically interoperable data standards to support easy and effective information exchanges between healthcare providers involved in collaborative care of these patients.
The key objectives of this project is to develop a technical implementation guide on using relevant FHIR base resources, extensions/profiles to support effective and easy interoperable clinical, financial and authorisation information exchanges to enable effective:
• Collaborative/share care
• Continuity of care when patient transition from one care setting to another
• Referral exchanges, e.g. between optometrists/general practitioners and ophthalmologist, and between ophthalmologist
• Prior authorisation requests from practitioners to payers
• Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)
Technology need: -
Currently, there is no standardized ophthalmic information representation in the FHIR domain. This problem presents a number of challenges.
• Implementors may take varying approaches in FHIR representation of ophthalmic information leading to a divergence, e.g. in the declaration of datasets
• The variations may result in high implementation.
• Implementers may hold back further development due to implementation uncertainty.

Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited interoperable technology support for managing the data and/or workflows in these scenarios.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

19

Modifier

Ashley Kras

Modify Date

Sep 27, 2020 22:21

1a. Project Name

Ophthalmology IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

We have engaged the following for endorsement:
- Peak ophthalmic specialty societies (RANZCO, AAO)
- Large ophthalmic clinical registries across the globe (SSR, ICHOM, AAO’s IRIS registry)
- Ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc. eg OCULO etc)
-See below - 6g. “other stakeholders”

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Prof. Mark Gillies, Nigel Morlet, & Ashley Kras from Australia, Michael Mair from New Zealand, and James Grue from the USA (representation from at least 3 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project's main goal is to take a finite set of use cases (see project page) in the ophthalmic medical domain and map workflows and clinical datasets onto FHIR resources. The output of this process would be a FHIR implementation guide that through profile, extension and value-set artefacts will provide technical and clinical guidance to EHR and other technology providers.

This multi-stakeholder /and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The IG will target the universal realm as at least 3 countries have expressed interest in participation.

Our objectives:
1. Support the documentation and exchange of ophthalmic data within EHRs and other healthcare technology systems with appropriate use cases.
2. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary and diverse secondary and tertiary level care and pharmacy)
3. Map the necessary ophthalmic data elements to clinical terminology standards, clinical information models (CIM), as standardized FHIR mappings for transfer of data
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.

We will approach the IG development in phases, dividing the scope into disease categories, or ‘modules’. Each module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021 with a ‘retinal disease’ module for approval in the ballot, our aim is to submit new modules for approval in sequential ballot cycles.

Wherever possible, we will leverage existing FHIR profiles, extensions and value-sets, such as:
- IHE’s previous work on codifying ophthalmology for the ‘Genera Eye Evaluation ’ cCDA (GEE). (https://www.ihe.net/resources/technical_frameworks/#eyecare),
- ICHOM’s standardized health outcome datasets,
- Save Sight Institute’s registry data dictionaries.

3b. Project Need

Technology need: -
Currently, there is no standardized way to represent ophthalmic information in the FHIR domain. With the growing adoption of FHIR around the world, this presents a number of challenges.
1. Implementers may hold back further development due to implementation uncertainty.
2. Implementers may consider the cost of implementation too high without appropriate guidance.
3. Without appropriate guidance, implementors may take varying approaches leading to a divergence in the use of FHIR and particularly the declaration of datasets.

This project can lower the barrier for implementers to start or extend their current FHIR capabilities. Greater adoption and use by the major vendors will drive innovation in the sector as data becomes more accessible and integrations become more economically viable.

We have identified a number of clinical use cases where there is no or limited technology support for managing the data and/or workflows in these scenarios. These use cases are outlined below:
1. Referrals
2. Continuity of care
3. Collaborative care between practitioners
4. Prior authorization and claims (eg Da Vinci)
5. Care quality improvement through registry reporting (eg CMS in US adopting FHIR-based reporting)

Desired outcome:
Very clear clinical, business, and QA outcome requirements that ophthalmic data exchange will help support.

This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has a significant impact on humans and society. The visually impaired are stifled in their ability to contribute to the economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Our first objective is to submit the IG’s first module (Retina) for approval in the May 2021 ballot.

Prior to this, proposed deliverables and target dates are:

- PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).


-Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.


-Submit to TSC for PSS approval - deadline Friday 18th December


- First draft IG complete by 31 Jan. This would include:
Documented use cases with illustrated workflows showing use of FHIR resources
Profiles and extensions identified and documented
ValueSets and data mappings documented
Automated CI (build) setup for IG
Draft published using build
Where possible example implementations
-IG substantively complete - March 7th

-Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:

- Save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians, EHR Vendors, Quality Reporting Agencies, Standards Development Organizations (SDOs), Clinical Registries, Governments

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS, Other

6g. Other Vendors

The following major ophthalmic diagnostic imaging and EHR vendors are some of those who have already expressed interest in collaborating in this project:
-Carl Zeiss
-Heidelberg Engineering
-Optos
-EyeMD

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

18

Modifier

Mike Mair

Modify Date

Sep 17, 2020 09:29

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras, James Grue

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

This project aims to create a currency for Ophthalmology EHRs by expressing Ophthalmological data as FHIR resources and value sets. By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the universal realm, and wherever relevant will make reference to realm specific profiles (eg - US Core profiles for prior authorization as it pertains to US payers and the Australian profile realm for Medicare applications). If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016. (ref: https://www.ihe.net/resources/technical_frameworks/#eyecare)

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition we have a new era of image analysis and AI in Ophthalmology; in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

17

Modifier

Ashley Kras

Modify Date

Sep 15, 2020 20:08

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras, James Grue

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the universal realm, and wherever relevant will make reference to realm specific profiles (eg - US Core profiles for prior authorization as it pertains to US payers and the Australian profile realm for Medicare applications). If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016. (ref: https://www.ihe.net/resources/technical_frameworks/#eyecare)

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition we have a new era of image analysis and AI in Ophthalmology; in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

16

Modifier

Ashley Kras

Modify Date

Sep 15, 2020 19:20

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras, James Grue

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the universal realm, and wherever relevant will make reference to realm specific profiles (eg - US Core profiles for prior authorization as it pertains to US payers and the Australian profile realm for Medicare applications). If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016. (ref: https://www.ihe.net/resources/technical_frameworks/#eyecare)

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition, in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

15

Modifier

Ashley Kras

Modify Date

Sep 14, 2020 20:08

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras, James Grue

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the universal realm, and wherever relevant will make reference to realm specific profiles (eg - US Core profiles for prior authorization as it pertains to US payers and the Australian profile realm for Medicare applications). If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016. (ref: https://www.ihe.net/resources/technical_frameworks/#eyecare)

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition, in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

14

Modifier

Ashley Kras

Modify Date

Sep 13, 2020 22:40

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the universal realm, and wherever relevant will make reference to realm specific profiles (eg - US Core profiles for prior authorization as it pertains to US payers and the Australian profile realm for Medicare applications). If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016. (ref: https://www.ihe.net/resources/technical_frameworks/#eyecare)

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition, in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

13

Modifier

Ashley Kras

Modify Date

Sep 13, 2020 22:39

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the universal realm, and wherever relevant will make reference to realm specific profiles (eg - US Core profiles for prior authorization as it pertains to US payers and the Australian profile realm for Medicare applications). If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016.

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition, in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

12

Modifier

Ashley Kras

Modify Date

Sep 13, 2020 22:35

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the universal realm, and wherever relevant will make reference to realm specific profiles (eg - US Core profiles for prior authorization as it pertains to US payers and the Australian profile realm for Medicare applications). If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016.

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

Attachments

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition, in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

11

Modifier

Ashley Kras

Modify Date

Sep 13, 2020 21:18

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016.

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

Attachments

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition, in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September and Tuesday 15th September (US time).
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 9th.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

10

Modifier

Ashley Kras

Modify Date

Sep 13, 2020 21:01

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver
Mila Kolmogorova
Robert Medynski

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg – glaucoma, cataracts etc) that FHIR profiles will evolve.
6. Given the long project timelines alignment to changing profiles and resources will be maintained as required (e.g. provider specifications).
7. This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.
8. In parallel, the group will:
-participate in FHIR connectations
-contribute towards the development of SMART on FHIR and CDS hook applications to support the use cases
-continue to engage relevant stakeholders for contribution, endorsement and further clinical validation, such as– peak specialty societies, EHR vendors (especially those that are specialty-focused and have large market share in the ophthalmic space and therefore play a critical role in digitally capturing eyecare data)
Wherever possible, the relevant FHIR Resources will reference existing value sets (outlined in ‘list of vocabularies’; where there is a need to establish a new code system to address a particular gap identified in existing terminologies, this will be defined.

Notably, IHE’s previous work on codifying the ‘general eye exam’ (see attached document) will be referenced:

“The General Eye Evaluation (GEE) consists of two content profiles. These profiles are patient 365 visit/encounter based and define the structure of data that is collected during a patient’s general eye examination. The American Academy of Ophthalmology (AAO) has created a collection of recommended best practices for this and other aspects of eye care that it terms the Preferred Practice Patterns (PPP). The information in this document is based upon the “Comprehensive Adult Medical Eye Evaluation October 2010” PPP specification generated by the AAO. The 370 comprehensive eye examination consists of an evaluation of the physiological function and the anatomical status of the eye, visual system and its related structures.” – IHE Eye Care, Technical Framework, authored by IHE Eye Care Technical Committee, 2016.

In addition, determining data elements required will draw upon guidance from:
-ICHOM’s standardized health outcome datasets; “To unlock the potential of value-based healthcare by defining global Standard Sets of outcome measures that matter most to patients and driving adoption and reporting of these measures worldwide to create better value for all stakeholders” – https://www.ichom.org/mission/#mission
-Save Sight Institute’s registry data dictionaries; in particular, for the ‘retina module’ we will reference the dictionary used to define the robust database in the 10 year old “Fight Retinal Blindess!” project. “Critically, the dataset which underpins the nAMD registry has been endorsed by the International Consortium for Health Outcomes Measurement (ICHOM) as the preferred minimum dataset for Macular Degeneration and the FRB! system as the preferred tool to collect this data.” (https://www.savesightinstitute.org.au/research-units/save-sight-registries/fight-retinal-blindness/).

Attachments

3b. Project Need

In addition to the general benefits of facilitating a truly interoperable ecosystem for disease management for all stakeholders, it is noteworthy to highlight that in order to prevent avoidable vision loss, ophthalmic management is undergoing a fundamental paradigm shift towards decentralizing care.
This is principally driven by the unsustainably growing rates of eye disease and the current and projected increasing shortfall of specialists available and trained to meet the management needs. This supply/demand mismatch is more pronounced in the developing world.
Preventing blindness and restoring sight is not only life-changing for individuals, but also absolutely imperative from a population standpoint. The cost of not preventing avoidable blindness has significant impact on human and society. The visually impaired are stifled in their ability to contribute to economy through work, suffer a dramatically reduced quality of life, are more susceptible to developing other medical conditions and require considerable care demands from others. Therefore current and future economic burdens are driven by both direct therapeutic care and indirect care costs.
Take diabetic retinopathy (DR), one of the world’s leading causes of vision loss, for example:
Currently, 126m people are affected globally, almost 40m of whom have vision-threatening DR. By 2030, it is predicted that almost 200m will be affected, of which nearly 60m will have vision-threatening disease.

Hence, specialty societies are fostering collaborations between ophthalmologists, optometrists and primary care physicians and technological disruption is enabling remote care provision and communication in innovative ways.
For example, guidelines, referral pathways and triage thresholds have been formally co-developed for how to safely and effectively co-manage patients with chronic, sight-threatening eye disease such as glaucoma, macular degeneration and diabetic retinopathy.
In addition, in 2018 a retinal image analysis company (IDx) launched the first FDA-approved AI product (integrated software and hardware) that automates the identification of ‘referrable diabetic retinopathy.’ This aids primary care clinicians in detecting, triaging and managing a subspecialty complication of diabetes.
We have seen an accompanying proliferation of remote-monitoring tools and services (both hardware and software) digitally linking patients to and between care providers. Some examples include ipad software to perform vision testing (such as acuity and visual fields), and hardware to check intraocular pressure at home (iCare home).
In addition, the COVID-19 pandemic has particularly and significantly impacted ophthalmic, as the majority of blinding ophthalmic diseases do not require immediately urgent attention, but absolutely require regular monitoring and treatment. Notwithstanding the fact that service provision has been curbed during the pandemic, patients with chronic diseases requiring various non-urgent therapies are cancelling and delaying appointments, which has and will continue to lead to avoidable blinding and sight-impairing outcomes.
The need for interoperable systemic communication is abundantly clear today, and will continue to grow with time.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Objective: as outlined in project scope above

Overall target is to submit for May 2021 ballot for IG approval. Prior to this, proposed deliverables and target dates are:

PSS draft submit to Patient Care and EHR sponsor and co-sponsor groups for review in respective WG meetings - Monday 14th September
Review feedback from drafts and resubmit revised final PSS to aforementioned groups within 2 weeks thereafter Before PSS submission deadline for this ballot cycle - October 2nd.
Submit to TSC for PSS approval - deadline Friday 18th December
IG substantively complete - March 7th
Ballot final content submission - April 11th

3h. Project Dependencies

FHIR Resources: https://www.hl7.org/fhir/resourcelist.html
FHIR Clinical Guidelines: http://build.fhir.org/ig/HL7/cqf-recommendations/artifacts.html

Clinical guidance resources:
- save sight registry data dictionary
- IHE "general eye exam" documentation, co-sponsored by the AAO (American Academy of Ophthalmology), which has drawn upon existing ontologies to arrive at expert consensus opinion of how to abstract ophthalmic clinical concepts (all critical examination findings) into terminologies such as LOINC and SNOMED
- Utilisation of the DICOM WG-09 (ophthalmology) standards; an initiative led by the AAO addressing unique issues relating to imaging and reporting of image-based studies in ophthalmic applications. - https://www.dicomstandard.org/wgs/wg-09/

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/PC/Ophthalmology+FHIR+Project

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

Using FHIR instead.

3m. External Vocabularies

Yes

3n. List of Vocabularies

ICD9 (WHO)
ICD10 (WHO
SNOMED-CT (http://snomed.info/sct); CSIRO SNOMED browser (http://ontoserver.csiro.au/shrimp/licence.html)
LOINC (http://loinc.org)
AMA's CPT codes (http://www.ama-assn.org/go/cpt)
RxNorm (NLM - http://www.nlm.nih.gov/research/umls/rxnorm)
DICOM code definitions (https://www.dicomstandard.org/wgs/wg-09/)
ClinicalTrials.gov
Medical Device Codes (urn:iso:std:iso:11073:10101)
NCI metathesaurus (http://ncimeta.nci.nih.gov)
UCUM (http://unitsofmeasure.org)

3o. Earliest prior release and/or version to which the compatibility applies

There is no prior release.

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4

4c. FHIR Profiles Version

R4

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

No

6b. Content Already Developed

~30%

6c. Content externally developed?

Yes

6d. List Developers of Externally Developed Content

IHE (general eye exam) - as described in 'Project Scope'
Save Sight Registry (data dictionary)
ICHOM (https://www.ichom.org/standard-sets/)
Shrimp ontoserver (http://ontoserver.csiro.au/shrimp/licence.html)

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Quality Reporting Agencies, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Clinicians
Implementors
EHR Vendors

6g. Vendors

Pharmaceutical, EHR, PHR, Equipment, Health Care IT, HIS

6h. Providers

Local and State Departments of Health, Medical Imaging Service, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

9

Modifier

Ashley Kras

Modify Date

Sep 13, 2020 20:58

1a. Project Name

Ophthalmology Retina Module IG Project Scope Statement

1b. Project ID

1650

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR® R4 (HL7 Fast Healthcare Interoperability Resources, Release 4)

2a. Primary/Sponsor WG

Patient Care

2b. Co-Sponsor WG

Electronic Health Record

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Ashley Kras

2e. Other Interested Parties (and roles)

Note: peak medical societies prior to balloting submission, the following bodies have recently been engaged for endorsement, and have already expressed interest in doing so:
- peak medical societies (ophthalmic specialty)
- large ophthalmic clinical registries across the globe
- ophthalmic-focused digital platforms and companies (tele-health solutions, remote devices etc.)

2f. Modeling Facilitator

Warren Oliver

2g. Publishing Facilitator

Stephen Chu

2h. Vocabulary Facilitator

Warren Oliver

2i. Domain Expert Representative

Mark Gillies, Nigel Morlet, Michael Mair, Ashley Kras

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

Warren Oliver

3a. Project Scope

By way of background, this project scope statement proposal is compiled by a group of SMEs (ophthalmologists and optometrists) and technologists with deep experience in ophthalmic clinical data, and the clinical context in which it lives. In addition, the group benefits from its constituent’s vast and highly relevant complimentary experience within the ophthalmic world. For example, the tech lead (Warren) has led many real-world ophthalmic FHIR implementations; others hold varied roles within tech industry, global terminology standards development teams, academic clinical research institutes, as well as in clinical registry and database formation and maintenance. This collaboration organically grew out of the most recent FHIR connectathon (#24; May 2020) and has since maintained connection through weekly meetings, which have been mediated and supported by Dr. Stephen Chu (Patient Care co-chair). Integrally integrated into the group, Dr. Chu has been invaluably guiding the initiative through HL7 processes.

This multi-stakeholder and multidisciplinary project initiative aims to broaden the scope of FHIR’s real world applicability in the ophthalmic (eye diseases) domain. The overarching goal is to abstract the complete ophthalmic clinical lexicon into FHIR compatible concepts in the form of an implementation guide (IG), upon which the rapidly maturing FHIR ecosystem and community can draw. The suite of use cases outlined on the project page speak to the abundance of value to be extracted from an ‘end-to-end’ clinically validated and endorsed ophthalmology implementation guide. The project will develop, test, and pilot a health information technology system agnostic framework for viewing and sharing ophthalmic data interoperably. This will ultimately provide guidance on how to facilitate FHIR-compliant communication related to management of eye disease between clinicians (such as ophthalmologists and optometrists) and patients, as well as remote technologies, researchers and the life science industry.

Practically, the project’s will take a phased approach to IG development. The scope is divided into disease categories, or ‘modules.’ Each disease module IG submission will be use-case driven; the use cases and accompanying artefacts required will be outlined in the IG proposal. Beginning in May 2021, the aim is to submit a new module for approval in sequential ballot cycles. The initial target is ‘retinal disease’ and therefore the first milestone is to submit a comprehensive retina ‘module’ implementation guide for approval in the May 2021 ballot.

The project will:
1. Identify use cases to support the documentation and exchange of ophthalmic data (initially, retina disease focused) within EHRs and other healthcare technology systems.
2. Identify, develop and prioritize the necessary ophthalmic data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
3. Identify workflow processes required to support basic care coordination requirements particularly as they relate to the various healthcare professionals involved in caring for eye disease (eg – ophthalmologists, optometrists, primary care and pharmacy)
4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and chosen data elements.
5. The project team recognizes that through the process of developing modules for various disease (eg &