Government Agencies Seek Feedback on the Future of Interoperability


Posted March 5, 2019

A consortium of federal government agencies is asking industry, academia, and non-governmental organizations for innovative ideas “to solve the interoperability issues between medical devices, data, and platforms" with the intention of improving patient safety and care.

This request for information (RFI) was published by the Networking and Information Technology Research and Development (NITRD) Program’s Health Information Technology Research and Development Interagency Working Group. NITRD is a $5 billion multidisciplinary program consisting of 21 member agencies working to advance networking and IT capabilities that is managed by the National Science and Technology Council.

NITRD envisions a future where people hospitalized with serious injuries or illness have medical device additions and changes automatically recorded in their electronic health record with “no deficit in patient safety, loss in data fidelity, or data security as the patient transitions across the continuum of care.” The group also wants to bring about “seamless” swaps between devices of different venders, “autonomous capabilities,” “real-time systems interactions,” and more.

The RFI is seeking feedback on how to create sustained interoperability by asking participants the following questions:

  • What is your vision for addressing interoperability issues between medical devices, data, and platforms? How would this plan to create interoperable systems address your key use cases and pain points?
  • Who are the relevant parties and their contributions to your interoperability solution?
  • What are the challenges and impediments to making interoperability happen? How might these issues be addressed and by whom?
  • Is the federal vision for a medical device, data, and platform interoperability end state outlined in the RFI viable? Please explain why you have reached the conclusion that you have.

Responses to these questions will be used to help determine next steps in addressing federal efforts in the interoperability of data, platforms, and medical devices, according to the RFI. Feedback can be submitted at www.FederalRegister.gov until March 15. NITRD also anticipates hosting a conference this summer to allow for additional discussion on the topic.

“The interoperability of medical devices sounds like such a simple idea but, in reality, it is quite complex and equally critically important in all aspects of the cycle of patient care,” said Wil Vargas, director of standards at AAMI. “AAMI is excited to provide feedback in response to this RFI to advance the discussion.”

The RFI relates to the work of several AAMI standards committees that are developing documents focused on medical device interoperability, including:

  • AAMI/UL 2800-1/Ed.1, Standard for safety for medical device interoperability (published)
  • AAMI 2700-1/Ed. 1, Medical Devices and Medical Systems – Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) – Part 1: General requirements and conceptual model (under revision)
  • AAMI SW92/Ed. 1, Integrated Clinical System: Patient Controlled Analgesia (PCA) (in development)
  • AAMI SW95/Ed. 1, Requirements for the forensic (black box) data logger for an integrated clinical environment (ICE) for medical devices and medical systems — Basic safety and essential performance of the patient-centric ICE for medical devices (in development)
  • AAMI TIR75/Ed. 1, Factors to consider when multi-vendor devices interact via an electronic interface (in development)