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Food and Drug Administration Adds AAMI Cybersecurity Guidance to Recognized Consensus Standards Database Ready to Announce with Confidence?

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PHG Philips is mentioned as one of the companies whose representatives were involved in the development of AAMI's cybersecurity guidance for AI/ML-enabled medical devices. The article does not provide specific sentiment towards Philips' stock performance or business operations.

Food and Drug Administration Adds AAMI Cybersecurity Guidance to Recognized Consensus Standards Database Ready to Announce with Confidence? Arlington, Virginia--(Newsfile Corp. - March 24, 2026) - The Food and Drug Administration (FDA) recently added the Association for the Advancement of Medical Instrumentation's primary guidance document on cybersecurity for artificial intelligence (AI) or machine learning (ML)-enabled medical devices to its database of recognized consensus standards.

AAMI CR515:2025; Cybersecurity considerations unique to machine learning-enabled medical devices was released in 2025 to fill existing gaps in industry guidance. Produced by AAMI's Artificial Intelligence Committee, at the time chaired by Dr. Jesse Ehrenfeld and Pat Baird of Philips, the guidance addresses cybersecurity threats that can arise from or during data collection, product design, product deployment, product use, and maintenance of AI or ML-enabled medical devices.

In recognition of the issue's urgency, the Artificial Intelligence Committee chose to produce an AAMI consensus report (CR) as opposed to a more lengthy technical information report (TIR) or standard. AAMI consensus reports are developed specifically to provide concise, prompt, and practical guidance on narrowly focused topics of high importance to the health technology community. In the case of CR515, the rapid development and emergence of AI and ML-enabled cybersecurity threats necessitated the speedy production of a consensus report rather than a TIR or consensus standard.

FDA's full recognition of CR515 is a major milestone for AAMI's impact in the AI sphere. Matt Williams, AAMI Vice President of Standards, said, "FDA's recognition of CR515 is a welcome validation not just of AAMI's efforts to produce a guidance document that meets the moment, but of our mission to support the safe and effective use of health technology for new and legacy medical devices alike."

Other AAMI-Affiliated Standards Recognized by FDA

The FDA also added a cluster of ISO guidance documents related to anesthesiology and cardiovascular health to its recognized consensus standards database.

International Secretariat and U.S. TAG administered by AAMI:

U.S. TAG administered by AAMI:

Contact:

Daniel Visnovsky

DVisnovsky@aami.org

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289622

Source: Association for the Advancement of Medical Instrumentation

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