The FDA has released an update to its plan to monitor medical devices, which includes the use of electronic health records and mobile applications.
The original plan, called "Strengthening Our National System for Medical Device Postmarket Surveillance," was issued in September 2012. Following the release of the report, the FDA held a series of public meetings and accepted comments on its website to garner stakeholder feedback. The update incorporates the public input it received.
The FDA plans to create a unique device identification number for each medical device product, and it plans to develop interoperability between EHRs and registries that store medical device data. It will also create a mobile app to help providers report adverse events.
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The original plan, called "Strengthening Our National System for Medical Device Postmarket Surveillance," was issued in September 2012. Following the release of the report, the FDA held a series of public meetings and accepted comments on its website to garner stakeholder feedback. The update incorporates the public input it received.
The FDA plans to create a unique device identification number for each medical device product, and it plans to develop interoperability between EHRs and registries that store medical device data. It will also create a mobile app to help providers report adverse events.
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