1c. Is Your Project an Investigative Project (aka PSS-Lite)?
1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?
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
2d. Project Facilitator
Craig Newman, Thanh Cheng
2e. Other Interested Parties (and roles)
2f. Modeling Facilitator
2g. Publishing Facilitator
2h. Vocabulary Facilitator
2i. Domain Expert Representative
2j. Business Requirements Analyst
Thanh Cheng, Mike Yaskanin
2k. Conformance Facilitator
2l. Other Facilitators
State of Michigan
Henry Ford Health System
3a. Project Scope
This project will be performed in several stages, some of which may happen concurrently. Any products (DAM, implementation guides, etc) will be officially balloted through HL7.
○ Phase 1 will being with an existing analysis of data requirements in the state of Michigan and expand to collect reporting requirements from the CDC and as many jurisdictions as possible to create a comprehensive birth defect reporting domain analysis model (DAM). This part of the project will also document use cases jurisdictions have beyond the existing ambulatory and hospital reporting use cases.
○ Phase 2 will focus on developing FHIR specifications for exchanging birth defect content between providers and registries. This will allow trading partners to select the format that works best for them. A variety of different FHIR workflows (messaging, SMART apps, RESTful services, etc) will be considered. US Core profiles will be used in the FHIR IG. If phase 1 indicates the US Core profiles are not appropriate to use, we will clearly document the need to diverge from US Core. This phase will also include updating the existing CDA IG if gaps are found during the creation of the DAM.
○ Phase 3 will investigate data exchanges beyond the initial reporting of birth defects. This could include responses from registries back to providers requesting more information or offering treatment guidance and additional resources. The use of a FHIR subscription model where a registry subscribes to receive updates on specific patients of interest as new data is collected could also be explored. Other areas of investigation that come up during the earlier phases may also be investigated.
3b. Project Need
Over 40 jurisdictions in the United States have a birth defect registry. To date, a CDA implementation guide for reporting birth defects has been developed based on input from the CDC and 14 jurisdictions, but it is largely based on requirements and workflows gathered several years ago. While the CDA IG has been HL7 balloted, the data model underlying it has not. From experience with case reporting, we know that some EHR vendors prefer to implement FHIR IGs rather than CDA IGs. Before embarking on the development of a FHIR IG, we need to develop a broadly based domain analysis model (DAM) and perform a gap analysis between the DAM and the CDA IG. We will then develop one or more FHIR IGs, ensuring that consistent content and vocabularies are define regardless of the product family selected for use.
3c. Security Risk
3d. External Drivers
3e. Objectives/Deliverables and Target Dates
This PSS will cover the first 2 phases. If Phases 3 look like it will produce ballotable material then an additional PSS will be developed and submitted.
Phase 1 - Birth Defect DAM
Prepare and submit HL7 Project Scope Statement - May-Aug 2019
Gather input from Jurisdictions and prepare DAM - July 2019-March 2020
Ballot Informative DAM - May 2020*
Complete ballot reconciliation - September 2020
Publish DAM October 2020
*Because of the timing of the HL7 ballot periods in 2020, it may be possible to make the January/February 2020 ballot cycle which would accelerate the reconciliation and publishing timelines.
Phase 2 - Birth Defect FHIR IG
Prepare FHIR IG (and if necessary) update the existing CDA IG - January-Aug 2020
Ballot STU IG - September 2020
Complete ballot reconciliation - January 2021
Publish IG(s) - February 2021