Ophthalmology IG Project Scope Statement

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