regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
12/13/2023
/ Acquisitions ,
Antitrust Division ,
Biden Administration ,
Competition ,
Enforcement ,
Federal Trade Commission (FTC) ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform
The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more
3/30/2023
/ Advertising ,
Breach Notification Rule ,
Civil Monetary Penalty ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Technology ,
HIPAA Privacy Rule ,
Medical Devices ,
OCR ,
PHI ,
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