What FDA Expects From Medical Device Cybersecurity Efforts

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By Jae Kim and Raymond Williams (April 27, 2022, 5:17 PM EDT) — In recent years, the threat of cybersecurity attacks has evolved in the minds of the public and regulators from a theoretical novelty to a tangible reality. There have been numerous institutions in various industries coming under attacks by malicious actors, sometimes resulting in data breaches and significant monetary penalties.

In the health care sector, cybersecurity incidents can have an adverse clinical impact on patients, particularly if personal medical devices or interconnected medical devices are rendered inoperable or become compromised.

On April 8, the U.S. Food and Drug Administration issued a new draft guidance on cybersecurity, “Cybersecurity in Medical Devices: Quality System…

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