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The Food and Drug Administration is making moves to encourage the use of artificial intelligence and other digital tools in medicine and drug development, expanding a program it announced last year around digital health and establishing a new incubator focused on health technology.
"AI holds enormous promise for the future of medicine," FDA Commissioner Scott Gottlieb said in prepared remarks for the Health Datapalooza conference Thursday in Washington. "We're actively developing a new regulatory framework to promote innovation in this space, and support the use of AI-based technologies."
The agency established its pre-certification program for digital health companies last year, enabling certain firms that obtain that status to bring digital health products to market through a more streamlined regulatory process. Gottlieb said the regulatory agency will look to apply that program to tools based on AI as well.
"We expect to see an increasing number of AI-based submissions in the coming years, starting with medical imaging devices, and we're working with experts in the field," Gottlieb said.
As part of the agency's new incubator, which is called the Information Exchange and Data Transformation, or INFORMED, the FDA will focus on tools to improve cancer treatment and drug development.
The regulator cited collaborations with Project Data Sphere that aim to use medical imaging data to develop algorithms that can better classify tumors, and with the National Cancer Institute on a joint fellowship program to design "digital biomarkers" to use in drug development.
Gottlieb also said the agency will seek public input on the right way to incorporate digital health tools designed to be used with prescription drugs, and is fine-tuning the pre-certification program framework, and hopes to have that in place by the end of this year.
"We share your urgency to advance this innovation in care," Gottlieb said. "And we're committed to doing our part to support its benefits to patients."