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Digital Health

Aligning Regulatory and HTA Strategies of Digital Health Technologies to Reduce Duplication of Effort and Resources

Friday, May 8, 2026
12:30 - 13:30 WEST
Location: Auditorium 1
Learning Level: Intermediate
Description: In the EU, regulatory and Health Technology Assessment (HTA) pathways for medical devices serve distinct mandates. Regulation is harmonized and enables market access across the European Economic Area via CE marking, while HTA remains largely national and heterogeneous. The new HTA Regulation introduces Joint Clinical Assessments (JCAs) across Member States for medicines and certain high-risk devices, but most low-risk devices will not be within scope in the near term. Although regulation and HTA are designed for different purposes, there are convergent evidence needs and shared data elements that could benefit both processes, yet information exchange between authorities is limited. We examine low-risk digital health technologies (DHTs), unlikely to be included in JCAs but representing a large cohort that must still navigate both regulatory and HTA expectations. Manufacturers commonly approach these as separate, sequential steps, rebuilding dossiers and running studies that satisfy one gatekeeper but not the other. The result is duplicated effort, inefficiency, and missed opportunities to design evidence that serves both.

In the form of an interactive and mixed panel spanning experts from regulation, HTA, and health economics, we explore two questions:

1. System-level alignment: Could authorities improve interaction between regulatory and HTA pathways for low-risk DHTs, and if so, what is practically achievable now versus longer-horizon policy options?
2. Manufacturer-led alignment: Regardless of policy change, can companies “plan once”, defining shared endpoints and analyses to build a single-source, modular evidence package that serves both CE marking and national HTA, without compromising either mandate?

Learning Objectives:

  • Upon completion, participants will be able to differentiate EU regulatory and national HTA mandates for low-risk DHTs and explain the implications for evidence generation and submission strategy.
  • Upon completion, participants will be able to assess the desirability and feasibility of system-level alignment mechanisms from different perspectives.
  • Upon completion, participants will identify where convergence has already been attempted (policy/authority vs. manufacturer) and extract actionable takeaways for low-risk DHTs.