CHIME wants 'assurance' of med device interoperability

The College of Healthcare Information Management Executives (CHIME) believes that, when it comes to medical device interoperability, not enough is being done to ensure such tools can connect with their electronic health record systems.

In comments responding to the U.S. Food and Drug Administration's draft guidance for medical device interoperability published in January, CHIME says providers often will purchase systems in which vendors tout interoperability, only to find out after the money has been spent that third-party software is needed to enhance connectivity. The organization is calling for the agency to require, rather than recommend, greater transparency on the part of developers, as well as collaboration with the Office of the National Coordinator for Health IT to create both a "baseline set" of interoperability standards for devices and a "more robust" definition of interoperability.

"Data formats and transmission protocols vary across devices, pediatric or for adults; yet providers need a uniform set of standard," CHIME says. "Having this would go a long way to furthering interoperability."

CHIME also calls on the FDA to require medical device developers to conduct yearly risk assessments on their devices. "Provides are required under HIPAA, and as part of the Meaningful Use requirements, to conduct a risk analysis," it says. "On the other hand, device manufacturers are under no obligation to perform these risk assessments, which are only 'suggested' activities."

Other recommendations CHIME has for the FDA include:

  • Synchronize efforts with other federal agencies in applying risk management principles
  • Ensure alignment between the FDA's cybersecurity guidance for device manufacturers and the interoperability guidance
  • Work with ONC to have them certify APIs
  • Create a central, online database that includes key functionality of devices

In the draft guidance, FDA calls on device manufacturers to design systems with interoperability as an objective. It also says that vendors must conduct appropriate performance testing and risk management activities, in addition to specifying functional, performance and interface characteristics publicly.

Last summer, Michael Johns, M.D., and William Stead, M.D., both of the Center for Medical Interoperability, called the current lack of interoperability between medical devices and other healthcare IT tools a safety dilemma and an ethical issue.

To learn more:
- read CHIME's comments (.pdf)

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