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Medical Devices / Regulatory Affairs / Postmarket Safety

AHA Urges Greater FDA Cybersecurity Oversight of Devicemakers

Dec. 18, 2017
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The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the FDA.

Representing nearly 5,000 healthcare organizations, the association called on the FDA to increase its oversight of the medical device industry and to ease the “substantial and unsustainable” regulatory burden on hospitals and health systems.

More FDA oversight is especially needed with regard to updating and patching devices as new threats emerge, as well as efforts to improve transparency and the dissemination of key information regarding device software during cyberattacks, AHA said.

The association pointed to the upwards 200,000 computers across more than 150 countries that were victims of the WannaCry ransomware attack earlier this year.

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