EDiHTA - EIT Health

EDiHTA: The first European Digital Health Technology Assessment framework

The challenge

 

Health systems worldwide are under constant pressure to provide high-quality services. Digital health technologies (DHTs) can be game changers in improving the quality of healthcare services, but existing Health Technology Assessment (HTA) methodologies are unable to capture the real added value of DHTs. DHTs are expected to improve both the quality and delivery of healthcare services for European countries while ensuring the sustainability of Europe’s healthcare systems. DHTs are also able to collect real-world data and evidence relevant for decision makers. However, the implementation of DHTs implies new methodological challenges to the standardisation of assessment criteria.

EDiHTA will be the first flexible, inclusive, validated and ready-for-use European HTA framework reaching Technology Readiness Level (TRL) 6-7, allowing the assessment of different DHTs (e.g. telemedicine, mobile Apps, AI) at different TRLs, territorial levels (national, regional and local) and perspectives (e.g. payer, society, hospital). All relevant stakeholders will contribute to its design, development and validation. The digital framework will be piloted in real healthcare settings in 5 major European hospitals and through an open piloting scheme with European DHT developers.

EIT Health's role

EIT Health is leading on two areas:

  1. Implementation and validation of the EDiHTA framework with pilots;
  2. The effective use, uptake and exploitation of the EDiHTA framework.

1. Implementation and validation:

In order to test and validate the EDiHTA framework and to assess the usability of the EDiHTA digital platform, 2 different phases of piloting and framework are planned. This will be applied to different categories of DHTs (telemedicine, mobile App and AI-supported DHTs) to assess performance and user experience. This will be achieved through the following steps:

  • Define a protocol for common data collection and analysis methods to be used across pilot sites;
  • Perform and analyse results from pilot sites selected within the consortium partners: a first selection of candidates for the first pilot phase has been already being performed among partners to cover all kinds of DHTs with different TRL;
  • Perform and analyse results from a second pilot action of sites selected through an open call to DHT developers within the European ecosystem by the EIT Health;
  • Provide recommendations for the finalisation of the EDiHTA framework and the digital platform. EIT Health is in charge of the design and implementation of the open pilots.

2. Effective use and uptake

In order to facilitate the successful uptake, use and exploitation of the EDiHTA framework, educational activities will be performed that will continue after the project end. This will be achieved through the following steps:

  • Develop educational material and modules on the EDiHTA framework;
  • Conduct stakeholder training seminars;
  • Exploit the commercial and non-commercial opportunities of the EDiHTA framework to relevant stakeholders interested in the further use and uptake of results;
  • Define standards and benchmarks for future DHT assessments by HTA agencies, regulatory bodies and others;
  • Create a governance and business model for EDiHTA (an agreement on the ownership of the framework, either in its entity or its elements – content and digital solution – will be agreed).

EIT Health is in charge of the creation of educational materials and the online platform modules and the set-up of the stakeholder training webinars and seminars.

Objectives

The principles of EDiHTA are to:
1. Promote a holistic approach involving all stakeholders for consensus building at national and European levels;
2. Define a common terminology, harmonise and enrich existing HTA frameworks and create an open repository with frameworks, guides, articles and HTA methodologies;
3. Optimise assessment processes along the DHT life cycle;
4. Follow a multi-stakeholder, multi-domain and modular approach;
5. Co-create EDiHTA solutions;
6. Provide a validated and ready-for-use digital HTA framework for DHTs.

The overall goal of EDiHTA is to deliver a fit-for-purpose HTA framework for DHTs that integrates existing assessment domains and methods with new ones in order to inform decision-making. An innovative first of its kind, the HTA framework-platform will be developed to allow HTA assessments to be performed digitally in a standardised format that will be customised according to the type and lifecycle stage of the DHT and decision-making process at the macro (policy), meso (management providers) and micro (clinicians) levels.

Project partners

The multidisciplinary EDiHTA consortium brings together 18 partners from 10 European countries with key expertise in HTA research.

Partners

Learn more

Contact Us

Marie Anson

EDiHTA Project Coordinator & Programme Lead at EIT Health France