Health technology assessment (HTA) is a formidable task across drug development, medical device innovation, and digital health solutions. To help with this task, the European HTA Regulation entered into force in January 2022 and will apply in January 2025. For some medical device and pharmaceutical industry players, this is a heavily anticipated change, since at the moment, they need to adapt their health technology assessment documentation to different country-specific regulatory bodies.

Article 23 of HTAR does foresee voluntary cooperation of HTA agencies in many member states. Until now, there has been a lack of shared and harmonised methodological guidance for digital health technologies. By 2028, the European Digital Health Technology Assessment (EDiHTA) Project aims to establish a framework specifically for digital health technologies.

Digital health regulation activities to date

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

In 2024, the EDiHTA Project was launched to address standardisation of digital health technology assessment. The EDiHTA Project represents an EU investment totaling 8 million euros; it will be carried out through collaboration among 16 partners from 10 European countries and is scheduled to span four years.

Why does this matter 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 around the regulation of the digital health industry.

"Harmonising and clarifying assessment procedures for digital health, taking into account their specific nature, is the way to go to have a common approach in all EU countries so that tech providers know ... what to do (e.g., which evidence to bring to the table) and, of course, can reuse this everywhere instead of duplicating it or being obliged to deliver everywhere different data and proofs," Vandeput says. However, in light of the existing EU Task Force, he warns that different consortia should be mindful of each other, so they don't end up with different recommendations and add confusion to industry, authorities and evaluation bodies.

Marco Marchetti, head of the Health Technology Assessment Operational Unit at the Italian National Agency for Regional Health Care Services (AGENAS) and co-chair of the HTA Member State Coordination Group (HTACG), has been involved in both mentioned initiatives. EDiHTA, an EU project that is part of the broader EU strategy, builds on and complements the groundwork that the EU Task Force laid, he says. The taskforce plans to conclude its original planned activities within the next year, while EDiHTA is scheduled to be finished by 2028.

Taking all this into account, the question remains: Will EDiHTA, once finalised, impact existing digital technology regulations such as Digital Health Applications (DiGA) in Germany and Prise en Charge Anticipée Numerique des Dispositifs Médicaux (PECAN) in France in regard to digital therapeutics? Will these regulations have to adapt to the findings brought by EDiHTA?

Marchetti says it's hard to predict how different countries will act in terms of legislative change. "What I can say is that at the European level, we are trying to standardise and harmonise the approach and evaluation process," he says. "This is in the interest of HTA bodies, of new HTA regulation."

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

"However, there is the awareness that these digital solutions have a huge impact on public health, and we need to have evaluation criteria for those as well," Marchetti adds.

EDiHTA Project will be presented at the 2024 HIMSS European Health Conference & Exhibition.

Marco Marchetti, head of Health Technology Assessment Operational Unit at the Italian National Agency for Regional Health Care Services (AGENAS) and co-chair of HTA Member State Coordination (HTACG) set up by the HTAR, will speak at the Innovation Forum at the 2024 HIMSS European Health Conference & Exhibition, which is scheduled for 29-31 May 2024 in Rome. Learn more and register