Health regulators sharpen AI and digital care oversight

During July and early August 2026, U.S., EU and UK regulators advanced digital health and AI oversight across privacy, device regulation, fraud enforcement and liability. In the U.S., the FTC sued Hims & Hers Health over alleged deceptive subscription practices and undisclosed health data sharing with ad platforms, while Access DX Laboratory, its former CEO and a Florida businessman agreed to pay a combined $36.4 million to resolve False Claims Act allegations tied to unnecessary genetic testing and kickbacks.

The Senate HELP Committee approved S. 3097 to extend HIPAA-like protections to wellness data held by digital health companies outside HIPAA, and Sen. Mark Warner released an AI framework with bills covering consumer-facing AI agents and pre-deployment safety testing. FDA’s Digital Health Center of Excellence also sought input on a risk-based, “competency-based” approach for generative AI-enabled medical devices, with comments due by October 19, 2026.

EU and UK activity centered on implementation. The EU adopted the Digital Omnibus on AI to amend the AI Act, industry groups pushed for trusted testing environments, and health technology assessment officials issued principles for using AI in Joint Clinical Assessment dossiers. In the UK, MHRA guidance clarified when ambient voice products and digital mental health technologies qualify as medical devices, while AI Airlock case studies highlighted qualification, intended purpose and lifecycle management challenges.