FDA releases FAQs on new requirements for medical devices vulnerable to cybersecurity threats

Mar 30, 2023 - 03:08 PM
Artificial Intelligence can support health care leaders, but it’s not a complete solution, expert says. A clinician holding a tablet using artificial intelligence to evaluate medical data.

Effective today under the Consolidated Appropriations Act of 2023, medical devices seeking approval from the Food and Drug Administration must meet certain cybersecurity requirements if they connect to the internet and contain software and technological characteristics vulnerable to cybersecurity threats. See the FDA FAQs for more on the requirements.

Related News Articles

Headline
Medical device supplier says cyber incident is disrupting some operations
Boston Scientific, a large supplier of medical devices, said in an Aug. 26 statement posted on its website that on Aug. 25 it “identified a cybersecurity…
Headline
MyChart warns of phishing schemes using fraudulent emails, other messages 
Epic’s MyChart has shared examples from potential phishing schemes observed as recently this month that include email messages linking to a fake MyChart…
Headline
Advisory warns of active cyber threats to programmable logic controllers 
The National Security Agency and other federal agencies released a joint advisory Aug. 18 warning of active cyber threats to Siemens S7 Series programmable…
Headline
Agencies issue update on Medusa ransomware activity
A joint advisory released Aug. 19 by the FBI, Cybersecurity and Infrastructure Security Agency, and the Department of Health and Human Services provides…
Headline
FDA seeks feedback on potential regulatory approaches for generative AI-enabled medical devices
The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial…
Headline
HHS seeks comments on collection of customer feedback for national health information exchange network
The Department of Health and Human Services Aug. 14 released a request for comments through the Office of the National Coordinator for Health IT on a proposed…