1a. Project Name

HL7 Clinical Genomics Domain Information Model(s)

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

Clinical Genomics

2d. Project Facilitator

Robert Freimuth

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

2g. Publishing Facilitator

2h. Vocabulary Facilitator

2i. Domain Expert Representative

2j. Business Requirements Analyst

2k. Conformance Facilitator

2l. Other Facilitators

2m. Implementers

3a. Project Scope

Throughout the past decade, the HL7 Clinical Genomics has been developing various artifacts (e.g., informative, DSTU and normative specifications), domain analysis models, storyboards, etc. The approved/trialed/proposed specifications are of different HL7 flavors, i.e., v3, v2, CDA and recently FHIR. These artifacts share some common view of clinical genomic data, but lack semantic alignment at the modeling level. Therefore, it is crucial to have agreed-upon Clinical Genomics Domain Information Model(s) (CG DIMs), which have the following functions:
1. The CG DIMs reflect the results of the Domain Analysis Model efforts
2. The CG DIMs serve as a single source of semantics with which all standard specifications are aligned
3. The CG DIMs are represented in an HL7 standards-independent format, e.g., plain UML
4. The CG DIMs are Universal and do not mandate binding to specific vocabularies (these bindings could be present in realm-specific versions of the actual standard specifications)


3b. Project Need

The need for this project stems from lack of Clinical Genomics Domain Information Model(s), as well as from lack of alignment across the current HL7 Clinical Genomics specifications.

3c. Security Risk


3d. External Drivers

3e. Objectives/Deliverables and Target Dates

Draft Domain Information Model [2019 07]
Comments Only Ballot [2019 09]
Normative Ballot [2021 01]

3f. Common Names / Keywords / Aliases:


3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:


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?

3m. External Vocabularies


3n. List of Vocabularies

Relevant domain vocabularies will be provided in the model as examples, but as this is not an implementation specification no formal binding is needed.

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

4a. Products

Domain Analysis Model (DAM)

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

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Create new standard

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

Comment (aka Comment-Only)

5c. Additional Ballot Info

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

The modeling done as part of this project is being coordinated with similar work done by GA4GH.

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

Clinical and Public Health Laboratories, Standards Development Organizations (SDOs)

6f. Other Stakeholders

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6g. Other Vendors

6h. Providers

Clinical and Public Health Laboratories

6h. Other Providers

6i. Realm


7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

7b. Sponsoring WG Approval Date

May 03, 2016

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

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date