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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 13-113
Standard
IEEE Std 11073-20601-2019
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
Scope/Abstract
Within the context of the ISO/IEEE 11073 personal health device standard family, this standard defines an optimized exchange protocol and modeling techniques to be used by implementers of personal health devices to create interoperability between device types and vendors. This standard establishes a common framework for an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices, like weigh-scales, fitness trackers, activity monitors, treadmills, etc., and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes). Interoperability between these types of devices is key to communicating this data to interested parties including healthcare providers, custodians, and family members, enabling people to be better-informed participants in the management of their health.

This standard is relevant to all medical devices and personal health products which claim interoperability with other networked entities and is being recognized on its scientific and technical merit because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Relevant guidance:

1. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.

2. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 2005.

3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff: issued September 2019

4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019.

5. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff , issued October 2014

6. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005

7. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff , issued December 2016


FDA Technical Contact
 Maria Isabel Tejero Del Rio
  FDA/OC/CDRH/OPEQ/OHTIII/
  301-796-5322
  Isabel.Tejero@fda.hhs.gov
Standards Development Organization
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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