Health IT Pulse

Oct 7 2014   5:00PM GMT

FDA’s plans through 2018 include postmarket surveillance reform

Alex Delvecchio Alex Delvecchio Profile: Alex Delvecchio

Tags:
cybersecurity
FDA
medical device security
medical devices

The FDA offered a glance into its future that envisions improvements to current methods of enforcing health IT safety. Regulators plan to continue their migration from passive to active monitoring of postmarket surveillance of FDA-regulated devices. In the FDA’s Strategic Priorities document, which details the agency’s outlook through 2018, it calls this action a “major part of our mission to protect public health.”

The strategy document mentions the FDA’s Sentinel Initiative as an example of an active system, one that allows the FDA to track adverse events involving regulated devices. With The Sentinel Initiative system, FDA users can pull data and reports from technology such as EHRs and administrative databases to measure potential safety issues, while maintaining patient privacy. The agency hopes to increase use of this system to monitor medical device safety concerns that may call for regulatory intervention.

In a separate announcement, the FDA moved closer to realizing some of its medical device security goals by releasing guidance that discloses cybersecurity issues that developers should address before submitting a device to the agency for premarket approval. The “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” guidance makes recommendations that providers test and document device performance to avoid purposeful or accidental inference with devices, and ensure medical devices “uphold information confidentiality, integrity, and availability.”

In addition to its postmarket surveillance, the FDA’s strategy document also shared the agency’s plans to improve product development tools to help decrease the costs and time it takes to create a medical device. This falls under its larger mission to increase regulatory capacity to effectively assess FDA-regulated products at a pace that accommodates new developments to “ensure that the United States remains a leader in innovation.”

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