New EU assessment framework for digital health on the way?

Health technology assessment (HTA) is a huge task in drug development, medical device innovation and digital healthcare solutions. To assist you with this task, the European HTA regulation came into force in January 2022 and will apply in January 2025. For some players in the medical device and pharmaceutical industries, this is a long-awaited change as they currently have to adapt their health technology assessment documentation to different country-specific regulatory authorities .

Article 23 of HTAR provides for voluntary cooperation of HTA agencies in many Member States. To date, there is a lack of shared and harmonized methodological guidelines for digital health technologies. In 2028, the European Digital Health Technology Assessment (The EDiHTA) project aims to establish a framework specifically for digital health technologies.

Digital health regulation activities to date

To create an overview of the necessary insights and frameworks for digital health, the European Task Force for Harmonized Evaluation of Digital Medical Devices (DMDs) (EU Task Force) was launched in 2022. “The aim was to create a blueprint at European level for assessment procedures and methodologies for digital medical devices and to encourage voluntary commitment to the use of a common HTA framework,” explains Fruzsina Mezei, health economist and DMD, out. Taskforce coordinator at EIT Health.

In 2024, the EDiHTA A project was launched to address the standardization of digital health technology assessment. The EDiHTA project represents an EU investment totaling EUR 8 million; It will be implemented through collaboration between 16 partners from 10 European countries and is expected to cover a period of four years.

Why is this important and what can we expect?

Steven Vandeput, advisor for Digital MedTech and Services & Technologies Home Assistance in Belgium, says initiatives such as EDiHTA bring clarity to the open questions surrounding the regulation of the digital healthcare sector.

“Harmonizing and clarifying digital health assessment procedures, taking into account their specific nature, is the best way to achieve a common approach across EU countries so that technology providers know… what to do (e.g. what evidence to Discuss). the table) and can of course reuse it everywhere instead of duplicating it or being obliged to provide different data and evidence everywhere,” says Vandeput. However, in light of the existing EU task force, he warns that different consortia should take each other into account so that they do not come up with different recommendations and create confusion among industry, authorities and evaluation bodies.

Marco Marchetti, Head of the Health Technology Assessment Operational Unit at the Italian National Agency for Regional Healthcare Services (AGENAS) and Co-Chair of the HTA Member State Coordination Group (HTACG), has been involved in both aforementioned initiatives. EDiHTA, an EU project that is part of the wider EU strategy, builds on and complements the foundation laid by the EU Task Force, he says. The task force plans to complete the originally planned activities within a year, while EDiHTA is expected to be ready in 2028.

Taking all this into account, the question remains: once finalized, will EDiHTA have an impact on existing digital technology regulations, such as Digital Health Applications (DiGA) in Germany and Prize en Charge Anticipée Numerique des Dispositifs Médicaux ( PECAN) in France regarding digital therapies? ? Will these regulations have to adapt to the findings of EDiHTA?

Marchetti says it is difficult to predict how different countries will act on legal changes. “What I can say is that at European level we are trying to standardize and harmonize the approach and the evaluation process,” he says. “This is in the interest of the HTA authorities and the new HTA regulations.”

Some digital health devices fall under the Medical Device Regulation (MDR) and are classified as Class 2b and Class 3, which have specific regulatory requirements and are also subject to HTAR. But many digital solutions do not fall into these classes.

“However, there is a realization that these digital solutions have a huge impact on public health, and we need to have evaluation criteria for that too,” Marchetti adds.

The EDiHTA project will be presented at the 2024 HIMSS European Health Conference and Exhibition.

Marco Marchetti, Head of the Operational Unit Health Technology Assessment at the Italian National Agency for Regional Healthcare Services (AGENAS) and Co-Chair of the HTA Member State Coordination (HTACG), set up by the HTAR, will speak at the Innovation Forum at the 2024 HIMSS European Health Conference & Exhibition, scheduled for May 29-31, 2024 in Rome. More information and registration