Making Electronic Data More Available for Research and Public Health (MedMorph) Reference Architecture HL7 FHIR Implementation Guide

1a. Project Name Making Electronic Data More Available for Research and Public Health (MedMorph) Reference Architecture HL7 FHIR Implementation Guide 1b. Project ID 1611 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 Feb 20, 2020 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? No 1j. Unit of Measure 2a. Primary/Sponsor WG Public Health 2b. Co-Sponsor WG FHIR Infrastructure 2c. Co-Sponsor Level of Involvement Other Involvement. Specify details in text box below 2c. Co-Sponsor Involvement Notification of ballot-ready content for review 2c. Co-Sponsor Update Periods WGMs 2b. Co-Sponsor WG 2 Biomedical Research & Regulation 2c. Co-Sponsor Level of Involvement Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.) 2c. Co-Sponsor Involvement Potential 2c. Co-Sponsor 2 Update Periods Monthly and at WGMs. 2c. Co-Sponsor Involvement Potential 2c. Co-Sponsor 3 Update Periods WGMs 2d. Project Facilitator Nagesh Bashyam, Brett Marquard 2e. Other Interested Parties (and roles) Aaron Harris, Abigail Viall, Arunkumar Srinivasan, Brian Gugerty, John Loonsk, Laura Conn, Maria Michaels, Sameemuddin Syed, Teresa Kinley, Wendy Blumenthal Patient Care Workgroup EHR Workgroup 2f. Modeling Facilitator Brett Marquard 2g. Publishing Facilitator Nagesh Bashyam 2h. Vocabulary Facilitator Brett Marquard 2i. Domain Expert Representative Maria Michaels, 2j. Business Requirements Analyst Brian Gugerty (HCS), Wendy Blumenthal (Cancer), Aaron Harris, Abigail Viall(Hep C) 2k. Conformance Facilitator Nagesh Bashyam 2l. Other Facilitators 2m. Implementers Dynamic Content Group Epic Altarum 3a. Project Scope The goal of the MedMorph project is to develop and pilot a scalable and extensible standards-based reference architecture. This reference architecture will enable clinical data exchange with EHR systems and public health systems, specialized registries, national health care survey systems, and research information systems for multiple conditions. Initially, the reference architecture will be outlined using three priority use cases: Hepatitis C Cancer Health Care Surveys The MedMorph project will leverage, where appropriate, existing FHIR resources and profiles, CCDS and USCDI definitions, and CQL to improve patient data exchange from different EHR platforms to various receiving systems. The use of standards will help improve the timeliness and completeness of data collected by public health and research and reduce the burden on health care providers and patients. There are some overlaps in current HL7 projects such as the CDA STU Public Health electronic Initial Case Report (eICR) and FHIR Electronic Case Reporting (eCR) in HL7 PSS #136. These projects focus primarily on an 1) initial case report for reportable conditions, 2) a bidirectional communications transaction, the Reportability Response, and 3) a specification (the electronic Reporting and Surveillance Distribution (eRSD)) to help automate reporting. MedMorph will look to leverage this work and the work of the FHIR Common Reporting Framework and expand the focus to include research and chronic reporting. This FHIR implementation guide will use the US Core profiles as needed and appropriate. If this FHIR implementation guide is unable to use a US Core profile, we will work with the primary sponsoring workgroup to create new profiles or extend existing ones. The project is incremental, will evolve, and the sponsoring work group will receive regular updates. Attachments MedMorph Reference Architecture PSS.docx 3b. Project Need While FHIR IGs exist for some research and public health use cases, many have focused on a specific use case without an underlying common architecture that can help minimize efforts for both the senders and receivers of data. The combination of industry-accepted standards such as FHIR and a common architecture can bring together disparate approaches to meet the needs for specific use cases while minimizing the burden on senders and receivers of data. MedMorph seeks to develop a reference architecture that will provide a common reporting framework for public health and research use cases. Applying a common framework can address many public health initiatives, such as: Electronic case reporting Syndromic surveillance Chronic disease surveillance Public health and clinical registry reporting Healthcare surveys Additionally, developing a common Reference Architecture will limit proliferation of IGs for public health and promote configuration over proprietary implementation. The project will leverage the existing US Core FHIR profiles and will only create new profiles if existing profiles cannot meet the project requirements. 3c. Security Risk 3d. External Drivers 3e. Objectives/Deliverables and Target Dates FHIR IG: Sept 2020 Ballot 3f. Common Names / Keywords / Aliases: MedMorph 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: TBD 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies 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 Digital Bridge 6b. Content Already Developed 20 6c. Content externally developed? No 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Clinical and Public Health Laboratories, Immunization Registries, Quality Reporting Agencies, Regulatory Agency, Other 6f. Other Stakeholders Research Community 6g. Vendors Pharmaceutical, EHR, PHR, Health Care IT, Clinical Decision Support Systems, Lab 6g. Other Vendors 6h. Providers Clinical and Public Health Laboratories, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm U.S. Realm Specific 7d. US Realm Approval Date Mar 03, 2020 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Feb 20, 2020 7c. Co-Sponsor Approval Date Mar 23, 2020 7c. Co-Sponsor 2 Approval Date Mar 24, 2020 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 Mar 03, 2020 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Apr 06, 2020 7j. TSC Approval Date Apr 13, 2020