SMART Health Cards: Vaccination & Testing Implementation Guide

1a. Project Name SMART Health Cards: Vaccination & Testing Implementation Guide 1b. Project ID 1694 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 Public Health 2b. Co-Sponsor WG Patient Empowerment 2c. Co-Sponsor Level of Involvement Other Involvement. Specify details in text box below 2c. Co-Sponsor Involvement updated at least at each WGM 2b. Co-Sponsor WG 2 Orders & Observations 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballot 2d. Project Facilitator Max Masnick 2e. Other Interested Parties (and roles) Vocabulary CIC Pharmacy PIE BR&R CBCP 2f. Modeling Facilitator Mark Kramer 2g. Publishing Facilitator Max Masnick, Paul Denning 2h. Vocabulary Facilitator Carmela Couderc 2i. Domain Expert Representative Christian Hay (GS1); Andrew S. Kanter, MD MPH FACMI FAMIA (Director, Columbia International eHealth Laboratory) 2j. Business Requirements Analyst 2k. Conformance Facilitator Yunwei Wang 2l. Other Facilitators 2m. Implementers Epic, Cerner, The Commons Project, Sorsix, Atter Pathology Services, Jack Nathan Health 3a. Project Scope As part of the response to COVID-19, a coalition of health and technology leaders has created the Vaccination Credential Initiative (VCI; https://vaccinationcredential.org/). VCI’s goal is to provide a trusted and verifiable copy of vaccination records, or other COVID-related laboratory test results. This will be accomplished by using the SMART Health Cards framework (https://smarthealth.cards/), which works with both digital and paper workflows. The SMART Health Cards framework does not specify the clinical content contained within. The purpose of the proposed FHIR Implementation Guide is to do just this: describe the contents of a FHIR Bundle that is contained within a Health Card. The development of this IG is part of the VCI working group (n.b. that this is not a HL7 Work Group), which includes representatives from EHR vendors, large health systems, testing laboratories, and technology companies. We are working closely with experts from these organizations to inform the content and structure of the IG. The resulting product of this effort will be a FHIR IG that Issuers of Health Cards can use to build and validate their implementation, and Verifiers of Health Cards can use to design their verification process. This IG will examine how both US Core and International Patient Summary (IPS) IGs can be leveraged to create SMART Health Cards. Given the needs to have the FHIR bundle fit on a QR Code, we expect data minimization to exclude information that is not relevant to the use cases for SHC. Attachments 3b. Project Need There is a pressing public health need to empower individuals with a convenient, standardized, equitable access to COVID-19 vaccination and testing status. The Vaccination Credential Initiative is a community-driven approach that uses the SMART Health Cards specification to solve this problem. The goal of this IG is to facilitate and coordinate inclusion of key clinical data related to COVID (and other infectious diseases) by implementers of the SMART Health Cards framework. This is necessary to achieve the goal of a trusted and verifiable copy of vaccination records, or other COVID-related laboratory test results. 3c. Security Risk No 3d. External Drivers The timeline for this work is driven by the real-world need described above. Given the extraordinary circumstances of the COVID-19 pandemic, we are moving as quickly as possible to make a stable version of this Implementation Guide available to implementers; this will likely occur soon (by the end of March 2021) out of band with the typical HL7 balloting workflow. 3e. Objectives/Deliverables and Target Dates September 2021 Ballot 3f. Common Names / Keywords / Aliases: vaccination credentials, vaccination yellow card, vaccine yellow card 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/display/PHWG/SMART+Health+Cards+-+Vaccination+and+Testing+IG+Project+Page 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies CVX LOINC SNOMED GTIN GLN ICD-11 ATC Australian Immunisation Register (AIR) MVX https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.3380 https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.114222.4.5.293 http://terminology.hl7.org/CodeSystem/v3-ActReason http://terminology.hl7.org/CodeSystem/v2-0163 http://terminology.hl7.org/CodeSystem/v3-ActSite http://terminology.hl7.org/CodeSystem/v2-0162 https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.3287 https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.3288 https://cts.nlm.nih.gov/fhir/valueset/2.16.840.1.113762.1.4.1114.9 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? FHIR R4 4c. FHIR Profiles Version 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? 5a. Externally developed IG is to be (select one) 5a. Specify external organization This IG is being created as part of the Vaccination Credential Initiative. 5a. Revising Current Standard Info 5b. Project Ballot Type STU to Normative 5c. Additional Ballot Info We will work with HL7 and our sponsoring WG to determine what approach to ballot type makes the most sense. 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 This IG is being created as part of the Vaccination Credential Initiative. 6b. Content Already Developed 80% 6c. Content externally developed? Yes 6d. List Developers of Externally Developed Content Content was developed by the Vaccination Credential Initiative (https://vci.org). A current build of the IG is available at http://build.fhir.org/ig/dvci/vaccine-credential-ig/branches/main/ 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Clinical and Public Health Laboratories, Immunization Registries, Regulatory Agency, Payors, Other 6f. Other Stakeholders Patients 6g. Vendors EHR, PHR, Health Care IT, 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 Universal 7d. US Realm Approval Date Apr 20, 2021 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Apr 01, 2021 7c. Co-Sponsor Approval Date Apr 08, 2021 7c. Co-Sponsor 2 Approval Date Apr 22, 2021 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 Apr 07, 2021 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date Apr 30, 2021 7i. Steering Division Approval Date Apr 19, 2021 7j. TSC Approval Date Jun 07, 2021