FDA expands support of artificial intelligence in medicine and drug development

Digital Health

Expanding a 2017 digital health program, the US Food and Drug Administration (FDA) is encouraging the use of artificial intelligence and other digital tools in medicine and drug development and is establishing a new incubator focused on health technology, according to a report by Meg Tirrell of CNBC.com. (https://www.cnbc.com/2018/04/26/fda-moves-to-encourage-a-i-in-medicine-drug-development.html)

According to FDA Commissioner Scott Gottlieb, who spoke at the Health Datapalooza at the end of April in Washington, “AI holds enormous promise for the future of medicine. We’re actively developing a new regulatory framework to promote innovation in this space, and support the use of AI-based technologies. 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.”

In 2017 the FDA created a pre-certification program for digital health companies, allowing certain companies that garner that status to bring digital health products to market by means of a more streamlined regulatory process. Gottlieb added that the FDA also is planning to apply that program to tools that are based on AI.

The FDA is also creating a new incubator. Named the Information Exchange and Data Transformation, or INFORMED, the incubator will enable the FDA to focus on devices that improve cancer treatment and drug development.

Gottlieb mentioned collaborations with Project Data Sphere that have the objective of using medical imaging data to create algorithms that can do a better job of classifying tumors, and with the National Cancer Institute on a joint fellowship program that aims to design “digital biomarkers” to use in drug development.

Gottlieb also said that the agency intends to determine how the public feels about the appropriate method of incorporating digital health tools designed to be used with prescription drugs. The FDA is attempting to put the finishing touches on the pre-certification program framework and anticipates that it will have it in place by the end of 2018.

Gottlieb concluded, “We share your urgency to advance this innovation in care, and we’re committed to doing our part to support its benefits to patients.”

Health Datapalooza, which according to organizers, “sits at the nexus of ideas, evidence, and execution,” enabled Federal policymakers and regulatory leaders to meet with Silicon Valley startups and the health system’s chief information officers. The organizers described Health Datapalooza as “a diverse community of big thinkers and roll-up-our-sleeves-and-get-it-done problem solvers who share a mission to liberate and use data to improve health and health care.”

The conference was created to dig into the real world experience of turning information into innovation as the challenges facing health and health care continue to evolve. Attendees discussed what works, what does not work, why, and what is coming next. Bringing together diverse and influential voices from the public and private sectors, the conference offered different viewpoints from industry leaders to policy makers, delivery systems to startups, academics to data liberators, patients to clinicians, and everything in between. Datapalooza attendees got to hear about the real-world concepts and actionable steps that they could take back to their workplace, presented by both newcomers and senior leaders with first-hand experience using data to improve health and health care.