EDiHTA - European Digital Health Technology Assessment framework

Description

From 2024 to 2028, researchers at the Norwegian Center for E-health Research (NSE) will engage in the EU-funded project EDiHTA, where NSE holds the primary responsibility for a specific work package (WP2). In collaboration with Det Norske Veritas (DNV) and other project partners, NSE will analyse how the EU policy on the European Health Data Space (EHDS) will impact the evolving European HTA framework that includes digital health technology (DHTs).

Why do we need EDiHTA?

Health systems worldwide face the task of providing high-quality services while facing numerous challenges, including a shortage of healthcare workers, demographic changes, complex legislation, and constrained financial resources. Moreover, the expectations of patients, governments and society at large are constantly evolving.

Digital health technologies (DHTs), such as mobile health apps, telemedicine, and artificial intelligence, hold immense promise for improving the quality of healthcare and making European healthcare systems more sustainable. To fully harness this potential, a European HTA framework tailored to the development, testing, and implementation of DHTs in healthcare, is required.

What can EDiHTA offer?

EDiHTA's vision is to create a flexible, inclusive, validated, and innovative framework for the assessment of DHTs. This framework will be interactive, user-friendly, and it will be informed by the input of relevant stakeholders such as patients, hospitals, regulators, HTA bodies, and technology developers.

The digital HTA framework will be validated through pilot projects conducted in real healthcare environments at several major European hospitals, in collaboration with European technology providers.

EDiHTA's ultimate goal is to deliver a comprehensive framework for evaluating healthcare services. This framework will integrate existing assessment domains and methods with new and innovative approaches. This allows it to be used as a basis for decision-making across various levels, from healthcare professionals to national and international decision-makers.

NSE's role in EDIHTA:

NSE leads the work package WP2, Data security and privacy policy requirements for EDiHTA, collaborating closely with Det Norske Veritas (DNV).

We will analyse EU policies concerning EHDS to identify data security and privacy policy requirements that the EDiHTA framework must comply with.

Additionally, we will map and compare the different countries' governance structures related to the implementation of EHDS. The results of this work package will establish a solid foundation for decision-making in subsequent work packages, particularly in WP3 and WP4, responsible for designing and developing the new HTA framework. The changes in rules and opportunities related to the secondary use of data may necessitate the integration of include new perspectives and questions into traditional HTA validation processes.

NSE will also contribute to all the other work packages in the project. A digital tool will be developed for use in HTA validation processes after the project’s completion.

Method

To ensure that EDiHTA reflects a wide range of perspectives, this project will engage stakeholders from various sectors, including HTA and regulatory authorities, patient interest groups, non-governmental organisations, and private sector representatives. Stakeholder involvement will span various levels, from providing information and seeking consultation, to participation throughout the development process.

The project will adopt an open innovation process to foster external contributions, raise awareness of EDiHTA within the European life science ecosystem, and effectively capture the needs of the European market.