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1a. Project Name

Regulated Product Submission R2 (Reaffirmation)

1b. Project ID

1577

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

HL7 Version 3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2

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 Decision Support

2d. Project Facilitator

Mark Gray

2e. Other Interested Parties (and roles)

ICH M8 - eCTD Regulatory and Industry Parties

2f. Modeling Facilitator

Marti Velezis

2g. Publishing Facilitator

Marti Velezis

2h. Vocabulary Facilitator

2i. Domain Expert Representative

Mark Gray

2j. Business Requirements Analyst

Marti Velezis

2k. Conformance Facilitator

2l. Other Facilitators

2m. Implementers

3a. Project Scope

Reaffirmation Ballot - no changes to standard

Attachments

3b. Project Need

Reaffirmation of the standard

3c. Security Risk

No

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

No changes to ballot content.
submit for reaffirmation May 2020 Ballot
reconciliation at the May WGM
and publishing thereafter

3f. Common Names / Keywords / Aliases:

RPS, Regulated Product Submission

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/pages/viewpage.action?pageId=66923135

3j. Backwards Compatibility

Yes

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

Yes

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

3m. External Vocabularies

No

3n. List of Vocabularies

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

4a. Products

V3 Messages - Clinical

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

Reaffirmation of a 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

Normative (no STU)

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

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, Regulatory Agency

6f. Other Stakeholders

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

Other Regulated Products (e.g., devices, foods, etc)

6h. Providers

6h. Other Providers

6i. Realm

Universal

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

7b. Sponsoring WG Approval Date

Oct 01, 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

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Oct 14, 2019

7j. TSC Approval Date