Medical Device Communication to Other Information Systems/Technologies

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Type Standard / Implementation Specification Standards Process Maturity Implementation Maturity Adoption Level Federally required Cost Test Tool Availability
Implementation Specification
ITU H.810, H.811, H.812, and H.813
Final
Production
 Rating 1
No
Free
Yes
Limitations, Dependencies, and Preconditions for Consideration Applicable Value Set(s) and Starter Set(s)

These ITU standards are Continua Design Guidelines, developed to provide a suite of open industry standards and specifications that provide several means to end-to-end interoperability between personal medical devices and health information systems.  Unrestricted access to the implementation specification: http://www.pchalliance.org/continua-design-guidelines 
  • System Authentication  -  The information and process necessary to authenticate the systems involved
  • User Details -  identifies the end user who is accessing the data
  • User Role – identifies the role asserted by the individual initiating the transaction.
  • Purpose of Use - Identifies the purpose for the transaction.

Comment

Submitted by mkirwan@pchall… on 2017-11-20

Section:III-A Push Communication of Vital Signs from Medical Dev

HIMSS and PCHAlliance encourages the Need inclusion of medical device-related data sets, typically aligned with the IEEE 11073 nomenclature, which go beyond device identification attributes currently contained in the CCDE list to include vital signs measurements and other physiological data.

HIMSS and PCHAlliance recommends ONC leads the joint efforts of advancing medical devices interoperability for patient-centered care. The key pieces such as human factors/usability engineering, service-oriented architecture design and implementation, communication testing and facilitator for integration that ONC could orchestrate with are listed as follows:

•         HL7 has a work committee, Health Care Devices to coordinate and facilitate the integration of health care devices to ensure interoperability and harmonization of data within healthcare entities.

•         IEEE 11073-20701, Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding that defines the architecture for service-oriented distributed PoC medical devices and medical IT system.

•         FDA has CDRH Human Factors team for Human Factors and Medical Devices

•         NIST Medical Device Communication Testing – test tool update, joint IEEE/HL7 May WG meeting @ San Diego, CA