Bradley Merrill Thompson

Healthcare professionals other than physicians, dentists and veterinarians who have prescribing authority under state law can order prescription digital therapeutics. That could improve access, especially to devices that treat mental health conditions.

As the agency's workload swells with the weight of a public health emergency, digital health companies on a timeline should consider whether their products truly warrant a regulatory submission, writes Epstein Becker & Green's Bradley Merrill Thompson.

Epstein Becker & Green's Bradley Merrill Thompson describes the agency's current trajectory for regulation of patient-facing and provider-facing telehealth products that incorporate AI.

Epstein Becker & Green's Bradley Merrill Thompson explains why the FDA PreCert Program's built-in subjectivity and bias toward established entities should worry the healthcare and medical technology industry.

Ironically, the agency that goes after companies for false and misleading claims is making them about its own policies.

While key details are still missing, the picture that's emerging is surprisingly restrictive

Epstein Becker & Green's Bradley Merrill Thompson says the FDA's much-touted program is riddled with unseen costs and unanswered questions.