Devices
Anesthesia (Archived)Mission
To coordinate and facilitate the integration of health care devices to ensure interoperability and harmonization of data within healthcare entities by:
- Establishing standardized version 2.x and version 3 content to support health care device interoperability at the enterprise level
- Harmonizing device data models between HL7 and other organizations including ISO/IEEE 11073
- Harmonizing and coordinating device terminology usage within HL7 components
- Harmonizing and coordinating device data messaging and interchange syntax
- Working with the FHIR project to create device related resources consistently with existing device standards, domain information models, and domain use cases and context.
- Support revision and harmonization of the Clinical and Laboratory Standards Institute (CLSI ) Point of Care Test (POCT) and laboratory automation standards
- General coordination and harmonization between HL7 and other national and international organizations involved in health care device informatics and interoperability
- Engaging the device informatics ecosystem to participate in standards development efforts including medical device manufacturers, information integrators, and data consumers.
The committee has relationships with the following organizations:
- IEEE Engineering in Medicine and Biology Society (EMBS) 11073 Working Group for Medical Device Communication and IEEE Standards Association.
- Clinical and Laboratory Standards Institute (CLSI) POCT Consensus Committee and Laboratory Automation and Informatics Consensus Committee
- World Health Organization eHealth Standardization Coordination Group (WHO eHSCG)
- Integrating the Healthcare Enterprise Patient Care Devices Domain (IHE PCD)
- Health Information and Management Systems Society (HIMSS)
- FDA Center for Devices and Radiological Health (CDRH)
- American College of Clinical Engineering (ACCE)
- Personal Connected Health Alliance / Continua Health Alliance
- ISO TC 215 Health Informatics – Systems and Device Interoperability (WG 2)
- U.S. National Institute for Standards and Technology (NIST) Medical Device Communications Test Project
- Joint ISO/TC 215 - IEC/SC 62A WG - Medical IT Risk Management
- CEN TC 251 WG IV Health Informatics
- Association for the Advancement of Medical Instrumentation (AAMI)
- AAMI/UL Joint Committee 2800
- ISO/TC 121/SC4 Anaesthetic and Respiratory Equipment
- CDISC
- Heart Rhythm Society (HRS)
- OR.NET
- ICEAlliance
- Regenstreif Institute
- MDPnP Medical Device “Plug-and-Play” Interoperability Program
This group was formerly (pre-2005) known as LAPOCT.
Charter
Work Products and Contributions to HL7 Processes
The work products pursued by the WG, often in coordination with the HL7 internal and external groups identified, include the following:
- Support implementation and maintenance of the HL7 (v2.x) observation reporting
- HL7 (v3) observation reporting
- Implantable Devices - Cardiac (IDC) messaging and support terminology
- Response to any issues arising regarding v2.x Chapter 13 (Lab Automation)
- Terminological and structural representation support for device data in the products of other HL7 working group products (e.g. Anesthesia)
- Support revision of RCRIM Annotated-ECG related standard components
- Support revision of POCT related standard components
- Support FHIR device-related resource definitions
The Work Group will develop specifications using the principles and language of the Services Aware Interoperability Framework (SAIF) Canonical Definition (CD) and the restrictions and specializations of?the HL7 SAIF Implementation Guide (IG) to ensure traceability from conceptual to logical to implementable specifications.? When submitting artifacts or methodology to the HL7 SAIF IG the Work Group will develop this content in compliance with the principles and language of the SAIF CD.
Excluded from the scope are:
- Imaging-related data (e.g., from DICOM enabled systems) except insofar as DICOM, the Imaging Integration WG and this DEV WG jointly deem appropriate;
- Point-of-care device interoperability that is within the scope of the ISO/IEEE 11073 standards, except as jointly deemed appropriate by ISO TC215 WG2, IEEE EMBS 11073, CEN TC251 WGIV and this DEV WG
- Patient care (esp. vital signs) data not communicated from devices, except as the Patient Care WG and this DEV WG jointly deem appropriate
- Devices that do not have communications capability (or where that capability is limited only to self identification), e.g. orthopaedic implant, etc.
Formal Relationships With Other HL7 Groups
This Work Group works closely with the following groups:
- Anesthesia
- Orders and Observations
- Conformance & Guidance for Implementation/Testing (CGIT)
- Patient Care
- Structured Documents
- Vocabulary
- Regulated Clinical Research Information Management
- Patient Safety
- Mobile Health
- Fast Healthcare Interoperability Resources (FHIR)
- Clinical Quality Information (CQI) Work Group
Formal Relationship With Groups Outside of HL7
The committee has formal relationships, with the approval of the HL7 Board in accordance with Policy and Procedures, with the following organizations:
- IEEE Engineering in Medicine and Biology Society (EMBS) 11073 Working Group for Medical Device Communication.
- Clinical and Laboratory Standards Institute (CLSI - formerly NCCLS) POCT Area Committee and Laboratory Automation Area Committee
Date of Last Revision
September 19, 2022