Health technology assessment (HTA) is a difficult task in drug development, medical device innovation and digital health solutions. To support this task, the European HTA Regulation came into force in January 2022 and will apply in January 2025. For certain companies in the medical devices and pharmaceutical industries, this is an anticipated change, as they now need to adjust to their health. Technology assessment documents for country-specific regulatory agencies.
Article 23 of the HTAR foresees the voluntary cooperation of HTA bodies in various member states. To date, there is still a lack of common and harmonized methodological guidance for digital health technologies. By 2028, Europe Electronic Invest in health technology (EDiHTA) The project aims to establish a framework dedicated to digital health technology.
Digital health regulatory activity to date
To create an overview of the insights and framework needed for digital health, the European Task Force on the Harmonized Assessment of Digital Medical Devices (DMD) (Task Force EU task force) has been established in 2022. “The aim is to create a blueprint at European level for assessment Fruzsina Mezei, health economist and coordinator of the DMD Task Force at EIT Health explained.
In 2024, the EDiHTA Project was launched to address the issue of standardization of digital health technology assessment. The EDiHTA project represents an EU investment totaling 8 million euros; it will be implemented through cooperation between 16 partners from 10 European countries and is expected to last 4 years.
Why is this important and what can we expect?
Steven Vandeput, advisor to Digital MedTech and Services & Technologies Home Assistance in Belgium, said initiatives such as EDiHTA bring clarity to open questions around regulation of the digital health industry.
“Harmonizing and clarifying digital health assessment processes, taking into account their specific nature, is the path towards a common approach in all EU countries for technology providers to know… what to do (e.g. what evidence to bring to the table) and, of course, be able to reuse it everywhere instead of copying it or being forced to provide other data and evidence everywhere,” Vandeput said. However, based on the current EU Task Force, he cautioned that different consortia should be mindful of each other so as not to make different recommendations and cause confusion. industry, authorities and assessment agencies.
Marco Marchetti, head of the Health Technology Assessment Executive Unit at the Italian National Agency for Regional Health Care Services (AGENAS) and co-chair of the HTA Member Country Coordination Group (HTACG), participated in both mentioned initiatives. EDiHTA, an EU project that is part of a broader EU strategy, builds on and complements the foundations laid by the EU Task Force, he said. The task force plans to conclude operations as originally planned next year, while EDiHTA is scheduled for completion in 2028.
Taking all this into account, the question remains: Will EDiHTA, once finalized, 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 related to digital therapeutics? Should these regulations be adapted to the findings made by EDiHTA?
Marchetti said it’s difficult to predict how different countries will act when it comes to changing laws. “What I can say is that at European level we are trying to standardize and harmonize the approach and the assessment process,” he said. “This is in the interest of HTA agencies, of the new HTA regulations.”
Some digital medical devices fall under the Medical Devices Regulations (MDR) and are classified as Class 2b and Class 3, which have specific regulatory requirements and also fall under the HTAR. But many digital solutions do not fall into these categories.
“However, there is an awareness that these digital solutions have a huge impact on public health and that we also need evaluation criteria for those solutions,” Marchetti added.
The EDiHTA project will be presented at the HIMSS 2024 European Medical Conference & Exhibition.
Marco Marchetti, head of the Health Technology Assessment Executive Unit at the Italian National Agency for Regional Health Care Services (AGENAS) and co-chair of the HTA Member Country Coordination (HTACG) led by HTAR founded, will speak at the Innovation Forum at HIMSS 2024 European Medical Conference & Exhibition, scheduled to take place from 29-31 May 2024 in Rome. Learn more and register
