A decision by the Food and Drug Administration to recognize a set of voluntary, industry-developed interoperability standards should make it easier for technology developers to gain 510(k) clearance for new medical devices – including smartphone accessories – that follow such standards.
In its annual update to its list of accepted consensus standards for premarket reviews of medical devices, issued last week, the FDA included several items related to data exchange. Among the standards now accepted are ISO and IEEE specifications related to point-of-care and personal medical device communication for such categories as weight scales, thermometers, pulse oximeters, glucose meters, simple electrocardiographs and other devices that are increasingly being linked to smartphones and home monitoring stations.
The FDA also added standards for risk management of medical devices connected to wireless networks.
“This is the first time to my knowledge the FDA has recognized standards for interoperability,” Mary Logan, president of the Association for the Advancement of Medical Instrumentation (AAMI), told MobiHealthNews.
The AAMI and the FDA last year jointly convened a summit on medical device interoperability. A few months later, the agency and the trade group issued a report in which they said healthcare organizations needed to start paying closer attention to all the data being generated by connected medical devices. Keep reading>>