The FDA has anchored a new hub for digital medicine: the Digital Health Center of Excellence (DHCoE) under its Center for Devices and Radiological Health (CDRH). The move signals a full‑throttle commitment to making digital‑health technologies, from AI‑powered diagnostics to wearable health apps and Software as a Medical Device (SaMD), safe, effective, and widely accessible.
DHCoE will serve as a one‑stop resource for innovators, healthcare providers, regulators and patients alike. It offers regulatory‑science expertise, policy guidance, technological support (including cybersecurity, real‑world evidence and AI/ML oversight), and helps navigate the complex regulatory pathways for digital tools.
Key areas of DHCoE’s work include coordinating regulatory review support, publishing guidance on digital health and medical-software regulation, fostering partnerships and building a “Network of Digital Health Experts” — a pool of vetted specialists ready to help with device‑software evaluation, cybersecurity, real‑world data analysis and clinical validation.
By streamlining oversight and regulatory support, DHCoE aims to accelerate access to cutting‑edge digital health solutions — but with a focus on safety, effectiveness, and consistent standards. Its launch may well transform how medical devices and digital health apps reach patients, potentially reshaping care delivery with more innovation and fewer regulatory bottlenecks.
