FDA’s Stance on AI-Enabled Medical Devices Signals Intensified Scrutiny
The Food and Drug Administration’s (FDA) recent draft guidance on artificial intelligence-enabled medical devices indicates a growing regulatory emphasis on these technologies. Dr. Scott Schell, chief medical officer at IT consulting firm Cognizant, highlighted the significance of this guidance in an interview with Information Security Media Group.
“I think the timeliness of this draft guidance is very important because it signals that the agency is now ready to embrace some of the unique characteristics about AI that differ from other software-based health tech,” Schell stated regarding the FDA’s move.
The draft guidance, issued during the final days of the Biden administration, addresses concerns that impact developers and manufacturers of medical devices incorporating machine learning, deep learning, and neural networks, as well as other AI types. (See: FDA Warns of Cyber Risks in Guidance for AI-Enabled Devices).
“This is a good opportunity to focus on decision-making versus decision-support capabilities, because clinicians are not ready to let the AI make the decision to basically invoke the next care action for their patients.”
Schell emphasized the importance of heeding the draft guidance, stating, “If you’re in this space and you have IP or innovation around this kind of med tech, then you really need to be thinking about every stage of design data systems, integration, testing and validation. And all of this should be conducted in the context of this draft guidance.”
In an audio interview (see audio link below), Schell discussed the potential impact of multi-agentic AI in healthcare, HIPAA-related concerns about AI-enabled medical devices and how open-source AI technology from Chinese firm DeepSeek is unlikely to be promptly integrated into the U.S. healthcare sector.
Dr. Schell, a senior executive, surgeon, and healthcare futurist, brings over 30 years of industry expertise. His experience encompasses leadership roles in developing extensive population health and predictive analytics platforms at Alere, Cleveland Clinic, and UPMC. He has launched and sold five healthcare startups and served as a managing partner for a private equity firm focused on digital health.
