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1a. Project Name

SDPi+FHIR Device Interoperability

1b. Project ID

1615

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

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

Health Care Devices

2d. Project Facilitator

Todd Cooper

2e. Other Interested Parties (and roles)

Ken Fuchs
John Garguilo
John Rhoads
Stefan Schlichting

2f. Modeling Facilitator

2g. Publishing Facilitator

2h. Vocabulary Facilitator

2i. Domain Expert Representative

David Gregorcyzk

2j. Business Requirements Analyst

2k. Conformance Facilitator

Michael Faughn

2l. Other Facilitators

2m. Implementers

Draeger Medical
IHE Devices
Philips Healthcare
OR.NET

3a. Project Scope

Application of IEEE 11073 Service-oriented Device Connectivity (SDC) standards with HL7 FHIR to support medical and health device interoperability across multiple use contexts and applications that interact with and consume information from devices. This includes regulated (medical) and non-regulated (health) devices. Software as a Medical Device (SAMD) and health apps are to be supported. Devices on FHIR implementation guides will be created and / or updated, as well as IHE Devices profiles created. Educational and similar materials will also be created as appropriate.

Attachments

3b. Project Need

Device informatics / interoperability standardization has been progressing in parallel within HL7 Devices, IHE Devices, and IEEE 11073 Standards Committee. Although these efforts are generally well coordinated, there is an increasing need to ensure strong linkages between the specifications, especially between FHIR and IEEE 11073 SDC. The latter is tailored for the most acute, medical grade device connectivity applications (e.g., operating room and ICU), including service-oriented plug-and-play and medical content reporting, alerting and external control (including closed-loop clinical apps/SAMD). FHIR supports interoperability across the broad landscape of health information exchange, including integration of device-sourced content and services. This project ensures the coordinated and cohesive development of FHIR profiles, extensions and implementation guides, as well as SDC-based IHE profiles to enable the next generation of device interoperability standardization.

3c. Security Risk

Unknown

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

Kick-off @ 2020 May WGM

3f. Common Names / Keywords / Aliases:

FHIR, SDC, IEEE 11073, device, health software, SAMD, SOA, web services

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

3j. Backwards Compatibility

No

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

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

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources, Guidance (e.g. Companion Guide, Cookbook, etc), Non Product Project - (Educ. Marketing, Elec. Services, etc.), White Paper

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

R4

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

White Paper, Implementation Guide (IG) will be created/modified

5a. White Paper Type

Balloted Informative

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

Adopted

5a. Specify external organization

HL7-IHE Gemini Project
IHE Devices
IEEE 11073 Standards Committee

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

5d. Joint Copyright

Yes

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

Yes

6a. External Project Collaboration

Materials created in this project will integrate work being advanced in IEEE 11073 standards as well as IHE profiles related to SDC connectivity, namely Service-oriented Device Point-of-care Interoperability (SDPi) profiles.

6b. Content Already Developed

50%

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

Todd Cooper

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6f. Other Stakeholders

6g. Vendors

EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS

6g. Other Vendors

6h. Providers

Emergency Services, Healthcare Institutions (hospitals, long term care, home care, mental health)

6h. Other Providers

6i. Realm

Universal

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

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



 Show Changes

Version

1

Modifier

Todd Cooper

Modify Date

May 07, 2020 20:45

1a. Project Name

SDPi+FHIR Device Interoperability

1b. Project ID

1615

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Health Care Devices

2d. Project Facilitator

Todd Cooper

2e. Other Interested Parties (and roles)

Ken Fuchs
John Garguilo
John Rhoads
Stefan Schlichting

2i. Domain Expert Representative

David Gregorcyzk

2k. Conformance Facilitator

Michael Faughn

2m. Implementers

Draeger Medical
IHE Devices
Philips Healthcare
OR.NET

3a. Project Scope

Application of IEEE 11073 Service-oriented Device Connectivity (SDC) standards with HL7 FHIR to support medical and health device interoperability across multiple use contexts and applications that interact with and consume information from devices. This includes regulated (medical) and non-regulated (health) devices. Software as a Medical Device (SAMD) and health apps are to be supported. Devices on FHIR implementation guides will be created and / or updated, as well as IHE Devices profiles created. Educational and similar materials will also be created as appropriate.

3b. Project Need

Device informatics / interoperability standardization has been progressing in parallel within HL7 Devices, IHE Devices, and IEEE 11073 Standards Committee. Although these efforts are generally well coordinated, there is an increasing need to ensure strong linkages between the specifications, especially between FHIR and IEEE 11073 SDC. The latter is tailored for the most acute, medical grade device connectivity applications (e.g., operating room and ICU), including service-oriented plug-and-play and medical content reporting, alerting and external control (including closed-loop clinical apps/SAMD). FHIR supports interoperability across the broad landscape of health information exchange, including integration of device-sourced content and services. This project ensures the coordinated and cohesive development of FHIR profiles, extensions and implementation guides, as well as SDC-based IHE profiles to enable the next generation of device interoperability standardization.

3c. Security Risk

Unknown

3e. Objectives/Deliverables and Target Dates

Kick-off @ 2020 May WGM

3f. Common Names / Keywords / Aliases:

FHIR, SDC, IEEE 11073, device, health software, SAMD, SOA, web services

3j. Backwards Compatibility

No

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources, Guidance (e.g. Companion Guide, Cookbook, etc), Non Product Project - (Educ. Marketing, Elec. Services, etc.), White Paper

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

R4

5a. Project Intent

White Paper, Implementation Guide (IG) will be created/modified

5a. White Paper Type

Balloted Informative

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

Adopted

5a. Specify external organization

HL7-IHE Gemini Project
IHE Devices
IEEE 11073 Standards Committee

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

Yes

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

Yes

6a. External Project Collaboration

Materials created in this project will integrate work being advanced in IEEE 11073 standards as well as IHE profiles related to SDC connectivity, namely Service-oriented Device Point-of-care Interoperability (SDPi) profiles.

6b. Content Already Developed

50%

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

Todd Cooper

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

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS

6h. Providers

Emergency Services, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR