Applications that use AI and machine learning (ML) have a unique dependence on data, said the FDA’s Digital Health Center of Excellence Acting Deputy Director MiRa Jacobs at Tuesday’s open forum held by the Alliance for a Stronger FDA.

And the FDA’s role, Jacobs said, “is to fully understand the source of the data, determine if any bias has been created during the collection of this data, and ensure there are no safety risks to the patient.”

While the Digital Health Center of Excellence is focused on defining policy related to medical devices and products that rely on AI/ML and cultivating educational resources for stakeholders, the agency is also interested in AI/ML in two significant ways — what it can mean to the FDA and its work and what it means for the products the agency regulates.

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