FDA announces digital health services pilot 

The Food and Drug Administration announced Dec. 5 that it will launch the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO, an initiative aimed to promote access to certain digital health devices. The voluntary pilot is being launched in conjunction with the Centers for Medicare & Medicaid Services Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions Model announced Dec. 1. The ACCESS Model is designed for providers offering technology-supported care to patients with Original Medicare for managing common chronic conditions. Under the TEMPO pilot, participating digital device manufacturers would offer devices intended to provide care covered by the ACCESS program and would collect, monitor and report real-world performance data. The FDA also said that under the pilot, participating manufacturers could request that the agency exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance. The FDA will collect statements of interest for participation in the pilot beginning in January. The FDA said it expects to select up to 10 manufacturers in each of the four clinical use areas of the ACCESS Model for participation in the TEMPO pilot.   
 
The AHA recently provided comments to the FDA in response to a request for information on measuring and evaluating real-world performance of artificial intelligence-enabled medical devices, calling for policy frameworks balancing flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety.