Health Care Devices

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Mission

To facilitate the integration of health care device information at the enterprise level 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

·         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

 

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. Generation of Anesthesia Standards (GAS))

·         Support revision of RCRIM Annotated-ECG related standard components

·         Support revision of POCT related standard components

 

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 WG7, 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, inhaler, etc.

Formal Relationships With Other HL7 Groups

This Work Group works closely with the following groups:

·         Generation of Anesthesia Standards

·         Orders and Observations

·         Patient Care

·         Structured Documents

·         Vocabulary

·         Regulated Clinical Research Information Management

·         Patient Safety

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

 

 This group was formerly (pre-2005) known as LAPOCT.

Decision Making Practices

Decision Making Practices

Date of Last Revision

January 20, 2010