The FDA is making an effort to increase medical device interoperability, but their current plan for achieving that objective isn’t comprehensive enough, according to a group of healthcare CIOs and IT executives.
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The College of Healthcare Information Management Executives (CHIME) wrote a letter on behalf of its 1,800 health IT executive members to the FDA. The CHIME letter was a response to the FDA’s draft guidance on using medical devices to safely exchange patient data. In the letter, CHIME made it known that it fully supports the FDA’s goal of achieving more medical device interoperability, but expressed skepticism that the recommendations previously issued by the FDA will seamlessly facilitate improved medical device interoperability.
The CHIME letter indicates that even though CHIME members sometimes purchase new software and devices — which are supposedly interoperable — they struggle to connect the new software and devices with their existing systems without the help of a third party.
The following is a list of some of the advice CHIME gave to the FDA as it continues to develop its medical device interoperability policies:
- The FDA should work with ONC, device manufacturers and healthcare providers to establish a defined set of interoperability regulations for medical devices.
- The FDA should also collaborate with ONC to better define interoperability and to certify application programming interfaces.
- Manufacturers should be mandated to annually complete a risk assessment on their devices.
- The FDA should align its interoperability regulations with its existing cybersecurity guidance.
The FDA’s stance on medical device security should be fresh in the minds of device manufacturers, especially since the government agency released a draft guidance on the topic earlier this year. In its release, the FDA stated that all connected medical devices have some cybersecurity vulnerabilities. The FDA urged developers to be aware of the performance of their devices even after they are released and sold so they can help preserve high quality patient care.