Transmitting Patient Vital Signs from Medical Devices 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
Final
Production
Rating 3
No
Free
Yes
Implementation Specification
Final
Production
Rating 3
No
Free
Yes
Implementation Specification
Final
Production
Rating 3
No
Free
Yes
Limitations, Dependencies, and Preconditions for Consideration Applicable Value Set(s) and Starter Set(s)
  • IHE-PCD, Continua and ITU refer to the IEEE 11073-10101 standard for its nomenclature.
  • The following specific IHE-PCD profiles that best meet this interoperability need include:
    • IHE-PCD (Patient Care Device Profiles) - Alert Communication Management (ACM)

    • IHE-PCD (Patient Care Device Profiles) - Device Enterprise Communication (DEC)

    • IHE-PCD (Patient Care Device Profiles) - Implantable Device – Cardiac Observation (IDCO)

    • IHE-PCD (Patient Care Device Profiles) - Point-of-Care Infusion Verification (PIV)

    • IHE-PCD (Patient Care Device Profiles) - Rosetta Terminology Mapping (RTM)

  • The Regenstreif LOINC/IEEE Medical Device Code Mapping Table  allows enterprise information systems (i.e. ""Other information Systems/Technologies") to process vital signs and combine those observations with other types of information; it bridges the semantic map between IEEE 11073 10101 conformant medical devices and certified health IT or aligned information systems that use LOINC already for laboratory reports, document taxonomies, standard forms, questionnaires, assessments, social determinants, and screeners. 
  • FDA  cybersecurity recommendations for medical device manufacturers.  
  • Design Considerations and FDA Pre-Market Submission Recommendations for Interoperable Medical Devices.
  • See IHE projects in the Interoperability Proving Ground.
  • Feedback requested

Comment

Section I I – N Transmitting Patient Vital Signs from Medical de

Please make the following changes:

1.Please add a new row “Implementation Specification” with Standard Implementation/Specification named “Continua Design Guidelines”. The remaining fields are the same as for IHE-PCD in the row above.

2.Please add a new row “Implementation Specification” with Standard Implementation/Specification named “ITU H.810, H.811, H.812, H.12.5 and H.813”. The remaining fields are the same as for IHE-PCD in the row above.

3.Within Dependencies for Consideration field, please change the first bullet to IHE-PCD, Continua and ITU IEEE 11073-10101 standard for its nomenclature.