Regulatory Issues



Information Blocking Enforcement on the Horizon

By Shannon Bond – Information blocking may be old news, but its enforcement is not. On September 3, 2025, the U.S. Department of Health and Human Services announced that it would be increasing resources to investigate and enforce information blocking compliance.




Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices

By Daniel Caños PhD MPH & Michelle Tarver MD PhD – Today’s health care ecosystem is generating richer and more diverse data streams, providing new opportunities to modernize how Real-World Data generates relevant and reliable Real-World Evidence. The FDA is working to provide clearer recommendations and more consistent acceptance of RWE as valid scientific evidence.