FDA Commissioner Scott Gottlieb, MD, discussed the agency's evolving approach to digital health regulation during Academy Health's Health Datapalooza conference in Washington, D.C., April 26.
Dr. Gottlieb dedicated a portion of his speech to artificial intelligence, which he called "one of the most promising digital health tools," and noted AI technologies hold the potential to improve the early detection of various diseases.
In April, the FDA approved IDx-DR, a medical device that uses AI to detect diabetic retinopathy, an eye disease. The tool represents the first FDA-authorized medical device that provides a screening decision without needing a specialist to interpret the results.
"We're actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies," Dr. Gottlieb said during his speech.
The regulatory framework will likely expand upon the agency's Pre-Cert for Software Pilot Program, which the FDA launched in July 2017. Under the pilot, the FDA reviews digital health developers for pre-certification rather than evaluating their individual products.
"As we apply our Pre-Cert program, where we focus on a firm's underlying quality, we'll account for one of the greatest benefits of machine learning — that it can continue to learn and improve as it is used," Dr. Gottlieb said. "Employing the Pre-Cert approach to AI may allow a firm to make certain minor changes to its devices without having to make submissions each time."
Dr. Gottlieb added the FDA will work with AI experts as it develops its regulatory framework — including those outside of the healthcare sector.
"This includes AI experts with prior experience in sectors like finance that are already widely using AI platforms for fraud detection," he said. "As we develop our own policies, we want to understand how these technologies can be validated, and how patients and providers can be confident that they're reliable, unbiased and will help improve health outcomes."