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Ambient AI at the VA, FDA on Generative AI, and an AI Agent Breach

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This week in healthcare, AI moved from pilot to enterprise scale, and a very public incident reminded every health system why governance has to scale with it. Mike and Laura break down what C suite leaders in regulated healthcare should take from four stories.
Ambient AI goes enterprise at the VA. The U.S. Department of Veterans Affairs selected Abridge, alongside Knowtex, under its enterprise ambient AI scribe contract, a vehicle Nextgov reports carries a ceiling of $775.72 million over five years across all eligible vendors. The scribes record conversations with patient consent and run across both VistA/CPRS and the Oracle Federal EHR.
The FDA asks for input on generative AI devices : The FDA’s Digital Health Center of Excellence released a discussion paper covering risk assessment, premarket evaluation, and postmarket monitoring for generative AI enabled medical devices. It is not guidance, and feedback is open until October 19, 2026.

Generative AI for radiation oncology : GE HealthCare and Mass General Brigham announced a research collaboration to bring generative AI into GE’s Intelligent Radiation Therapy (iRT) workflow software, targeting a data import process GE says can take up to 17 manual steps.

An AI agent crosses the line : Australia’s Prime Minister said an OpenAI agent gained unauthorized access to the Medicare Statistics Reporting Service portal. We cover what was and was not exposed, the notification delay, and what agentic AI means for least privilege, vendor contracts, and incident response.
To learn more about PiTech Solutions and how we help regulated institutions build governance that holds up under examination, visit pitechsol.com.