Skip to end of metadata
Go to start of metadata





1a. Project Name

Reaffirm HL7 Version 3 Standard: Implantable Device Cardiac - Follow-up Device Summary, Release 2

1b. Project ID

1362

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

Oct 23, 2019

1f. Name of standard being reaffirmed

HL7 Version 3 Standard: Implantable Device Cardiac - Follow-up Device Summary, Release 2

1g. Project Artifact Information

A project artifact is balloting Normative (no STU) (this includes reaffirmations)

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

Orders & Observations

2b. Co-Sponsor WG

Health Care Devices

2d. Project Facilitator

Lorraine Constable

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

The therapeutic devices domain comprises the models, messages, and other artifacts that are needed to support messaging related to therapy delivery and observations made by a medical device.
Currently, the scope has been focused only on implantable cardiac devices (pacemakers, defibrillators, etc.).
This message is related to the follow-up of an Implantable Cardiac Device (pacemaker, defibrillator, etc.) that will contain a subset of device observations, current device therapy settings and device diagnostic information.

Attachments

3b. Project Need

To enable a standardized device report format to be used across the (Implantable Device Cardiac) IDC sector.
Users: IDC industry and cardiologists/cardiac technicians.

3c. Security Risk

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

The earliest ballot cycle the TSC will allow - either Feb2020 or May 2020

3f. Common Names / Keywords / Aliases:

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=41

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

Yes

3n. List of Vocabularies

Uses IEEE 11073-10103 standardised IDC terminology

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

4a. Products

V2 Messages - Clinical, 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

reaffirmation

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

6f. Other Stakeholders

6g. Vendors

Health Care IT

6g. Other Vendors

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 24, 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

Nov 07, 2019

7j. TSC Approval Date