Thomas Maddox, MD, MSc, vice president of Digital Products and Innovation for BJC HealthCare and a professor in the Cardiovascular Division, has been appointed to the inaugural FDA Digital Health Advisory Committee. The committee will advise the Commissioner of the Food and Drug Administration on digital health technologies (DHT’s) and guide on policies and regulations for their use. The first meeting was held in late November 2024 and focused on generative artificial intelligence (GenAI) and its use in healthcare.
“The committee discussed best practices in training and validation of GenAI models for use in healthcare, ensuring that sufficient evidence exists for their effectiveness and safety,” said Dr. Maddox. “We also recommended continuous monitoring of the use of GenAI models in clinical practice to ensure quality outcomes for care teams and hospitals.”
The recommendations will help guide development of regulations governing GenAI in healthcare. During the meeting, FDA Commission Robert Califf noted that many clinicians across the country had expressed concern that the technology was being adopted more for financial considerations than due to improvements in patient care quality. Already the FDA has approved an estimated 900 clinical AI algorithms, with cardiology having the second highest number of AI approvals. Dr. Maddox is considered a national expert on DHT’s and has discussed the future of AI and other technology advances at national cardiology and digital health conferences.