The Food and Drug Administration (FDA) recently released draft guidance on artificial intelligence (AI)-enabled medical devices, signaling an increase in regulatory oversight in this evolving field. Dr. Scott Schell, the chief medical officer at IT consulting firm Cognizant, emphasized that although the guidance is non-binding, it represents a pivotal shift in how the FDA approaches the unique attributes of AI technologies compared to traditional software-based health technologies. This was discussed in an interview published by Information Security Media Group.
Issued toward the end of the Biden administration, the FDA’s draft guidance encompasses various considerations for pre-market and lifecycle management specifically tailored for developers and manufacturers of medical devices that utilize advanced software functions such as machine learning, deep learning, and neural networks. Dr. Schell noted that this document challenges the medical community to rethink the relationships between AI technologies and clinical decision-making, highlighting that healthcare professionals remain cautious about allowing AI to autonomously direct patient care actions.
Historically, the FDA’s draft guidance serves as a meaningful indicator of expected permanent regulations. Dr. Schell remarked that stakeholders in the medical technology sector must closely examine each phase of designing data systems, from integration to testing and validation, in light of this draft guidance. He believes that adapting to these considerations should not pose significant challenges, as they align with existing practices already seen in the industry.
In an accompanying audio interview, Dr. Schell elaborated on several pertinent topics relevant to healthcare and cybersecurity concerns, including innovative uses of multi-agent AI and the implications of HIPAA compliance for AI-integrated medical devices. He also discussed the limited prospects for the open-source AI technology from Chinese firm DeepSeek making its way into the U.S. healthcare landscape in the near future, citing regulatory barriers and security concerns as significant factors.
Dr. Schell boasts over 30 years of experience across healthcare, biotechnology, and technology sectors, both domestically and internationally. His background includes leadership roles in the development and deployment of large-scale population health and predictive analytics initiatives at respected institutions such as Alere, Cleveland Clinic, and UPMC. Furthermore, he has successfully founded and exited five healthcare startups and held a managing partnership in a private equity firm with a focus on digital health innovations.
