Digital Health Technologies: Therapeutic Applications

Covers prescription digital therapeutic software (Software as a Medical Device/SaMD)—including standalone therapeutic apps or software integral to medical devices—intended to treat medical conditions such as panic disorder, PTSD and other therapeutic indications. Coverage is limited to products with final governmental/FDA marketing clearance or approval (De Novo, 510(k), or PMA), prescribed by a licensed provider, supported by evidence of improved net health outcomes and real‑world usability, and HIPAA‑compliant; general wellness apps, software that only stores/transmits data, technologies without required approvals/evidence, and specified products like Freespira and NightWare are excluded.

"Software intended for therapeutic use that meets the definition of 'Software as a medical device' (intended for a medical purpose and not part of a hardware medical device or solely for storing/tra..."