Digital Therapeutics Regulatory Changes Transform Healthcare in 2025
Washington, Wednesday, 12 November 2025.
Evolving regulations for digital therapeutics in the US and EU are reshaping healthcare, emphasizing patient safety, compliance, and market access, driving technology-driven care advancements.
Regulatory Landscape in the US and EU
In the United States, the regulatory framework for digital therapeutics (DTx) is primarily shaped by the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). The FDA’s Digital Health Centre of Excellence plays a pivotal role in regulating Software as a Medical Device (SaMD), which includes digital therapeutics aimed at treating, diagnosing, or preventing diseases [1]. Concurrently, CMS has reformed its coding systems, introducing new CPT® and HCPCS codes to facilitate reimbursement for digital therapeutics and remote monitoring technologies [2]. In the European Union, the Medical Device Regulation 2017/745 and the upcoming Artificial Intelligence Act classify AI-based medical devices as high-risk, necessitating compliance with stringent safety and performance requirements [1]. These regulations aim to streamline the approval process and ensure patient safety across the region.
Impact on Healthcare Delivery
The integration of digital therapeutics into healthcare systems is transforming care delivery by enhancing treatment options and enabling remote monitoring and personalized care. Studies funded by the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) indicate that digital therapeutics can reduce hospital readmissions and lower total care costs by 10-15% in chronic disease management [3]. This shift towards technology-driven solutions is evident in Germany’s DiGA and France’s PECAN frameworks, which allow prescribable digital health apps to be reimbursed under statutory insurance, thus encouraging broader adoption [4]. These advancements reflect a significant move towards value-based care models that reward outcomes rather than the volume of services provided [2].
Reimbursement Challenges and Opportunities
Despite the regulatory advancements, reimbursement for digital therapeutics remains uneven and often contingent on demonstrating clinical and economic value within specific jurisdictions. In the United States, the Access to Prescription Digital Therapeutics Act (H.R. 1458) aims to create a dedicated Medicare benefit category for prescription digital therapeutics, establishing parity with pharmaceuticals [5]. This legislative effort reflects a broader trend towards integrating digital health solutions into traditional reimbursement models. Meanwhile, the European market faces challenges related to harmonizing reimbursement pathways across member states, with initiatives like the NICE Evidence Standards Framework and Early Value Assessment pathway in the UK supporting early market access [4].
Future Directions and Innovations
As digital therapeutics continue to evolve, the next few years will be critical for their mainstream adoption. Pending legislation and policy developments are expected to expand reimbursement codes and promote high-performing digital therapeutics to permanent CPT® and HCPCS categories by 2027 [5]. Additionally, the ongoing real-world evidence (RWE) studies funded by NIH and AHRQ will provide crucial data to support these transitions, ensuring that digital interventions meet the efficacy and safety standards required for broader clinical use [3]. With these frameworks in place, digital therapeutics are poised to become integral components of personalized medicine, offering tailored interventions based on individual patient data and preferences.