Regulatory Issues

Big Companies Position Themselves for Payday From $50B Federal Rural Health Fund

By Sarah Jane Tribble – Tory Starr is worried about the people who get medical care at Open Door Community Health Centers along California’s North Coast. “They’re the folks that work at restaurants. They’re the teacher’s aides,” said Starr, a registered nurse who became Open Door’s chief executive more than six years ago. Those patients, he said, are “really the heart and soul of rural America.”

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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.