FDA Launches Digital Health Incubator
FDA commissioner Scott Gottlieb says the agency has launched its INFORMED (Information Exchange and Data Transformation) internal data science incubator that will initially focus on the conduct of regulatory science research in areas related to health technology and advanced analytics related to cancer. Speaking 4/26 at the Academy Health 2018 Health Datapalooza conference, Gottlieb cited INFORMED as one of the agency accomplishments in carrying out its Digital Health Innovation Action Plan.
Among the ongoing INFORMED projects, he said, are collaborations with Project Data Sphere, a nonprofit open access cancer data repository, aimed at developing algorithms for classification of tumor dynamics using medical imaging data.
FDA is also launching a new premarket digital safety program, according to Gottlieb, that enables a unified data standard for meeting electronic reporting requirements under the expedited safety reporting regulations of an IND application. “This new program will initially involve the FDA Oncology Center of Excellence and the agency’s drugs and biologics Centers,” he reported. He indicated that workflow mapping shows that medical reviewers spend a lot of time on administrative and file management tasks rather than on signal detection and medical review. He said a recent successful agency pilot was aimed at developing and demonstrating the feasibility of a data submission process where premarket safety reports are transmitted to FDA as data sets that can be easily visualized and analyzed. “We believe that the new digital framework can significantly improve the efficiency and accuracy of the premarket safety submission and review process, saving hundreds of review hours every month when the program is fully implemented,” Gottlieb said.
Other initiatives he described included a new policy that streamlines the path for digital health products that contain several functions, some of which are not subject to FDA oversight. And he covered advances that have been made on the CDRH precertification pilot program.
“Today, I’m announcing that we’ll expand the opportunities to use digital health tools as part of drug development and, in the process, enable new innovation to improve patient care,” Gottlieb said. “Given the falling costs and increasing quality of ubiquitous smart devices, developers can find new ways to use cloud-based services and tools to support patient health and support more effective treatments, tailored to a patient’s needs and preferences. To help expand the potential for digital health to address these possibilities, we’ll be advancing a policy framework in this area through new guidance. And we’ll be seeing public input on the right approach to incorporating software that’s designed to be used with prescription drugs.”