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1a. Project Name

Birth Defects DAM and FHIR IG

1b. Project ID


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

Project Services

2d. Project Facilitator

Craig Newman, Thanh Cheng

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

AbdulMalik Shakir

2g. Publishing Facilitator

Craig Newman

2h. Vocabulary Facilitator

Shu McGarvey

2i. Domain Expert Representative

2j. Business Requirements Analyst

Thanh Cheng, Mike Yaskanin

2k. Conformance Facilitator

Craig Newman

2l. Other Facilitators

2m. Implementers

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

3f. Common Names / Keywords / Aliases:

Birth Defects, Ambulatory Reporting, Hospital Reporting

3g. Lineage

Sibling of the existing birth defect reporting CDA IG

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL: and child pages

3j. Backwards Compatibility


3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?


3l. Reason for not using current V3 data types?

Not a V3/CDA project

3m. External Vocabularies


3n. List of Vocabularies


3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

Domain Analysis Model (DAM), FHIR Extensions, FHIR Implementation Guide, FHIR Profiles

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

Likely R4

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Create new standard, 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

5a. Revising Current Standard Info

5b. Project Ballot Type

Informative, STU to Normative

5c. Additional Ballot Info

DAM will be informative; IG will be STU to Normative

5d. Joint Copyright


5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.


6a. External Project Collaboration

Reporting requirements will be gathered from state and local jurisdictions and likely the CDC as well. The National Birth Defect Prevention Network is also interested in participating.

6b. Content Already Developed


6c. Content externally developed?


6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?


6f. Stakeholders


6f. Other Stakeholders

Public Health birth defect registries

6g. Vendors


6g. Other Vendors

6h. Providers

6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

May 21, 2019

7a. Management Group(s) to Review PSS


7b. Sponsoring WG Approval Date

May 16, 2019

7c. Co-Sponsor Approval Date

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

May 22, 2019

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Jun 03, 2019

7j. TSC Approval Date


  1. RE: Project ballot type: Since this project includes multiple deliverables, it should define which artifacts will be balloted at which level.

    RE: Implementers:  Only 1 is defined, the second is vague.  The STU ballot depends on two defined implementers. Approval should be contingent on discovering a second.

    RE: Project intent:  Scope includes DAM, extensions, and IG.   Project intent only states "Implementation Guide (IG) will be created/modified

  2. There's no mention of the FHIR IG conforming to the FHIR US Core profile. The question for USRSC is should it?

    1. This is a possibility but we'd need to do more investigation (presumably as part of the DAM work) to make sure US Core will work for us. Plus, there seems to be discussion on Zulip about "must support" on the US Core profiles causing problems for other use cases that want to reuse those profiles. I think out goal will be to use US Core if appropriate.

  3. US Realm also suggested that we construct a CDA to FHIR mapping once both IGs are available. This could be done but we should work with SOA and their cross-transformation project (see May 2019 ballot) and leverage their work where possible.

  4. There is a separate PSS (previously approved) that covered the creation of the CDA IG. If we find that updates to that CDA IG are required (due to issues found during DAM creation and/or FHIR IG authoring), we will update the CDA IG as part of that pre-existing PSS so that this PSS can focus solely on the DAM and FHIR IG (which are not part of any other PSS). We have removed CDA as a work product for this reason.