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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 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, Theodore Leng from the USA at a minimum (representation from at least 2 countries)

2j. Business Requirements Analyst

2k. Conformance Facilitator

Stephen Chu

2l. Other Facilitators

2m. Implementers

The growing list of participating and contributing industry stakeholders include, but are not limited to:

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

Heidelberg Engineering
Carl Zeiss Meditech
Medisoft

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’. Beginning with fundamental ophthalmic Resource profiling of observations / procedures / conditions etc, initial endeavours will focus on specialty-specific extensions. Thereafter, a 'modular,' use-case approach will be taken, that addresses the FHIR profiles relevant to one subspecialty at a time.

The aim is to test prototypes of fundamental ophthalmic profiles in the May 2021 connectathon. The primary focus will be to validate critical FHIR profiles that are necessary to enable use case interoperability problems to be addressed. This will involve engagement and participation from relevant industry stakeholders and ultimately demonstrate the IG capabilities. Thereafter, the intention is to submit the IG for review and approval in the September 2021 ballot. Following this initial proof of concept / prototype, the project's aim is to increase the maturity and breadth of IG artefacts, expand its scope, deepen stakeholder engagement, increase the practical functionality of validation and thereby iteratively refine the IG through participation in sequential connectathons and submissions for approval in subsequent 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 fundamental +/- 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 before the May 2021 connectathon. The goal is for this to include:

- documented use cases with illustrated workflows showing use of FHIR resources
- specialty-specific profiles and extensions identified and documented (eg - laterality) as
ValueSets with data mappings
- automated CI (build) setup for IG
- draft published using FHIR build
- where possible example implementations

- Technical connectathon participation: May 2021
- IG substantively complete: July 25, 2021
- Ballot final content submission: August 8, 2021

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

Oct 14, 2020

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Nov 23, 2020

7j. TSC Approval Date

Nov 30, 2020


Version

35

Modifier

Ashley Kras

Modify Date

Apr 19, 2021 09:49

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, Theodore Leng from the USA at a minimum (representation from at least 2 countries)

2k. Conformance Facilitator

Stephen Chu

2m. Implementers

The growing list of participating and contributing industry stakeholders include, but are not limited to:

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

Heidelberg Engineering
Carl Zeiss Meditech
Medisoft

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’. Beginning with fundamental ophthalmic Resource profiling of observations / procedures / conditions etc, initial endeavours will focus on specialty-specific extensions. Thereafter, a 'modular,' use-case approach will be taken, that addresses the FHIR profiles relevant to one subspecialty at a time.

The aim is to test prototypes of fundamental ophthalmic profiles in the May 2021 connectathon. The primary focus will be to validate critical FHIR profiles that are necessary to enable use case interoperability problems to be addressed. This will involve engagement and participation from relevant industry stakeholders and ultimately demonstrate the IG capabilities. Thereafter, the intention is to submit the IG for review and approval in the September 2021 ballot. Following this initial proof of concept / prototype, the project's aim is to increase the maturity and breadth of IG artefacts, expand its scope, deepen stakeholder engagement, increase the practical functionality of validation and thereby iteratively refine the IG through participation in sequential connectathons and submissions for approval in subsequent 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 fundamental +/- 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 before the May 2021 connectathon. The goal is for this to include:

- documented use cases with illustrated workflows showing use of FHIR resources
- specialty-specific profiles and extensions identified and documented (eg - laterality) as
ValueSets with data mappings
- automated CI (build) setup for IG
- draft published using FHIR build
- where possible example implementations

- Technical connectathon participation: May 2021
- IG substantively complete: July 25, 2021
- Ballot final content submission: August 8, 2021

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

7f. FMG Approval Date

Oct 14, 2020

7i. Steering Division Approval Date

Nov 23, 2020

7j. TSC Approval Date

Nov 30, 2020

Version

34

Modifier

Stephen Chu

Modify Date

Apr 18, 2021 00:35

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

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

In addition, multiple EHRs vendors have expressed interested in implementation and will be participating in the January technical connectathon, as will diagnostic device manufacturers.

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’. Beginning with fundamental ophthalmic Resource profiling of observations / procedures / conditions etc, initial endeavours will focus on specialty-specific extensions. Thereafter, a 'modular,' use-case approach will be taken, that addresses the FHIR profiles relevant to one subspecialty at a time.

The aim is to test prototypes of fundamental ophthalmic profiles in the May 2021 connectathon. The primary focus will be to validate critical FHIR profiles that are necessary to enable use case interoperability problems to be addressed. This will involve engagement and participation from relevant industry stakeholders and ultimately demonstrate the IG capabilities. Thereafter, the intention is to submit the IG for review and approval in the September 2021 ballot. Following this initial proof of concept / prototype, the project's aim is to increase the maturity and breadth of IG artefacts, expand its scope, deepen stakeholder engagement, increase the practical functionality of validation and thereby iteratively refine the IG through participation in sequential connectathons and submissions for approval in subsequent 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 fundamental +/- 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

- Technical connectathon participation: May 2021
- IG substantively complete: July 25, 2021
- Ballot final content submission: August 8, 2021

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

7f. FMG Approval Date

Oct 14, 2020

7i. Steering Division Approval Date

Nov 23, 2020

7j. TSC Approval Date

Nov 30, 2020

Version

33

Modifier

Stephen Chu

Modify Date

Apr 18, 2021 00:26

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

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

In addition, multiple EHRs vendors have expressed interested in implementation and will be participating in the January technical connectathon, as will diagnostic device manufacturers.

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’. Beginning with fundamental ophthalmic Resource profiling of observations / procedures / conditions etc, initial endeavours will focus on specialty-specific extensions. Thereafter, a 'modular,' use-case approach will be taken, that addresses the FHIR profiles relevant to one subspecialty at a time.

The aim is to test prototypes of fundamental ophthalmic profiles in the May 2021 connectathon. The primary focus will be to validate critical FHIR profiles that are necessary to enable use case interoperability problems to be addressed. This will involve engagement and participation from relevant industry stakeholders and ultimately demonstrate the IG capabilities. Thereafter, the intention is to submit the IG for review and approval in the September 2021 ballot. Following this initial proof of concept / prototype, the project's aim is to increase the maturity and breadth of IG artefacts, expand its scope, deepen stakeholder engagement, increase the practical functionality of validation and thereby iteratively refine the IG through participation in sequential connectathons and submissions for approval in subsequent 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 fundamental +/- 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

7f. FMG Approval Date

Oct 14, 2020

7i. Steering Division Approval Date

Nov 23, 2020

7j. TSC Approval Date

Nov 30, 2020

Version

32

Modifier

Ashley Kras

Modify Date

Apr 15, 2021 12:54

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

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

In addition, multiple EHRs vendors have expressed interested in implementation and will be participating in the January technical connectathon, as will diagnostic device manufacturers.

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’. Beginning with fundamental ophthalmic Resource profiling of observations / procedures / conditions etc, initial endeavours will focus on specialty-specific extensions. Thereafter, a 'modular,' use-case approach will be taken, that addresses the FHIR profiles relevant to one subspecialty at a time.

The aim is to test prototypes of fundamental ophthalmic profiles in the May 2021 connectathon. The primary focus will be to validate critical FHIR profiles that are necessary to enable use case interoperability problems to be addressed. This will involve engagement and participation from relevant industry stakeholders and ultimately demonstrate the IG capabilities. Thereafter, the intention is to submit the IG for review and approval in the September 2021 ballot. Following this initial proof of concept / prototype, the project's aim is to increase the maturity and breadth of IG artefacts, expand its scope, deepen stakeholder engagement, increase the practical functionality of validation and thereby iteratively refine the IG through participation in sequential connectathons and submissions for approval in subsequent 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 fundamental +/- 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

7f. FMG Approval Date

Oct 14, 2020

7i. Steering Division Approval Date

Nov 23, 2020

7j. TSC Approval Date

Nov 30, 2020

Version

31

Modifier

Anne Wizauer

Modify Date

Dec 10, 2020 16:31

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

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

In addition, multiple EHRs vendors have expressed interested in implementation and will be participating in the January technical connectathon, as will diagnostic device manufacturers.

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

7f. FMG Approval Date

Oct 14, 2020

7i. Steering Division Approval Date

Nov 23, 2020

7j. TSC Approval Date

Nov 30, 2020

Version

30

Modifier

Anne Wizauer

Modify Date

Nov 24, 2020 20:46

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

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

In addition, multiple EHRs vendors have expressed interested in implementation and will be participating in the January technical connectathon, as will diagnostic device manufacturers.

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

7f. FMG Approval Date

Oct 14, 2020

7i. Steering Division Approval Date

Nov 23, 2020

Version

29

Modifier

Ashley Kras

Modify Date

Nov 12, 2020 16:15

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

Oculo (ophthalmic tele-health company - https://connect.oculo.com.au/)
Save Sight Registry (http://savesightregistries.org/)
Verana Health (real-world evidence company, managing large clinical databases - https://www.veranahealth.com/)

In addition, multiple EHRs vendors have expressed interested in implementation and will be participating in the January technical connectathon, as will diagnostic device manufacturers.

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

7f. FMG Approval Date

Oct 14, 2020

Version

28

Modifier

Melva Peters

Modify Date

Nov 09, 2020 15:28

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

7f. FMG Approval Date

Oct 14, 2020

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