ARTICLE SUMMARY:
In this week’s Pathways Picks: CMS opens a door for digital therapeutics; EU formally enacts the AI Act, and lays out timelines for EUDAMED mandates; World Health Organization launches a global device database; FDA’s device center details a recent reorganization; and more from the US and Europe.
Digital Health Picks
Milestones in reimbursement and AI oversight:
Reimbursement door opens for digital therapeutics. CMS for the first time says it will reimburse directly for FDA-authorized standalone mental health software. The agency included the policy in its 2025 Physician Fee Schedule proposed rule, posted July 10, following a push from industry advocates and lawmakers. The proposal has limitations, but digital therapeutics advocates suggest it sets a positive precedent for a field that has up until now run into a brick wall with Medicare. For more details in Market Pathways see: “CMS Opens New Reimbursement Avenue for Digital Therapeutics.”
