Navigating Health Technology Assessment (HTA) ​Expectations for Digital Measure Approval

Why is this important?​

Accelerating and widening access to safe, effective and innovative health technologies that bring value to patients and the healthcare system is essential for improving health outcomes, reducing disparities, and ensuring sustainable, patient-centered care in an increasingly complex and resource-constrained healthcare environment.

What are the challenges?

Technology and Regulatory Complexity

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What is the solution?​

Collaboratively develop a clear roadmap for evidence generation to support submissions and acceptance from regulators and HTA bodies.​

Build and implement relevant, robust and reliable digital measures for drug development & clinical care.​

Avoid unnecessary duplication in regulatory and HTA processes by profiling the different requirements and developing a consensus-based framework for a patient-centered, DHT-derived endpoints.​

Improve time to market and acceptance of innovative health technologies by using validated DHTs.

The NICE Advice Pilot Mission​

Mission members (interested parties) will select a use case to serve as a proof of concept on how:​

• The DEEP TSP (device-agnostic target solution profile) can support the selected HTA framework and highlight evidence gaps.​
• The DEEP framework (Stack Model) can enable evidence generation in a standardized way.​
• The DEEP Stack Model can be used to provide relevant, robust and reliable patient-centered, digital measures for regulatory and HTA acceptance.
  

What is the scope and timelines?

Q1 to Q4 2026

Scope:

1) Simulation Workshop

2) Case Study Generation 

3) Evaluation and Proof of Concept

4) Submit to NICE

5) Review Outcomes

How can mission members benefit?​

• Clarify stakeholder needs: Explore interactions between clinical trial sponsors, DHT developers, regulators, notified bodies and HTA bodies.​
• Learn from professionals: Gain insights on the HTA body perspective on DHT-derived endpoints.​
• Test innovative tools: Learn the DEEP framework and experience the lifecycle of digital measures from development to acceptance and beyond.

Join DEEP and other sponsors on this mission to take the right steps towards successful HTA interactions!

Interested in joining this mission or need more information? Contact us.

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