Digital medical devices (DMDs), ranging from medical-grade health apps on your smartphone to wearable sensors on your shoes, will play a pivotal role in shaping the future of healthcare. Many of these innovative tools already enable health data collection and contribute to medical research. However, the real aim is to develop, validate and give access to DMDs that support clinical decision, empower patients and improve their quality of life. To this end, the Digital Medicine group at the Luxembourg Centre for Systems Biomedicine (LCSB) and the Centre Hospitalier de Luxembourg (CHL) studies the existing challenges – from ensuring digital adoption by patients and healthcare professionals, to building an evidence-based regulatory framework – to contribute to the digital transformation of healthcare in Europe.
Many digital medical devices start as research prototypes designed to collect data from patients for scientific studies. “When it comes to research, digital devices are clearly supporting precision medicine with better data from patients, but we need to go further and ensure they also provide value to each healthcare professional and the patients they are treating,” explains Prof. Jochen Klucken, FNR PEARL Chair for Digital Medicine and head of the Digital Medicine group at the LCSB and the CHL. His multidisciplinary team combines the expertise of computer scientists, medical engineers, clinicians and socio-economic specialists to define how to improve the design, implementation and utilisation of DMDs and related health technologies.
Ensuring inclusive and user-centred design of DMDs
As one main research focus, the team investigates the patients’ perspective on using DMDs that relies on patients’ willingness to adopt digital tools. Dr Ivana Paccoud, post-doctoral researcher in the group, conducted surveys on the topic. While her findings, published in the journal Frontiers in Neurology, reveal an eagerness to use DMDs and share personal health data, they also highlight that opinions and preferences vary depending on age, level of education and disease severity. “For example, older participants and patients with a more advanced disease voiced concerns regarding their ability to handle digital technologies,” details Dr Paccoud. “They are often the ones who stand to benefit the most from innovative devices but only if their specific needs are considered from the very beginning of DMD development. Our study underscores the critical importance of systematically incorporating patients’ perspectives to ensure effective design and deployment of DMDs for personalised care.”
Offering opportunities to increase digital literacy in populations at the highest risk of being digitally excluded and guaranteeing equal access to technology will be crucial in ensuring that the use of DMDs in healthcare mitigates rather than exacerbates health inequities. Ensuring inclusive and user-centred design of DMDs is only the beginning. A regulatory framework is also needed to integrate these new technologies into the existing healthcare systems.
A fragmented European landscape in need of harmonisation
This is where the European Taskforce for Harmonised Evaluation of DMDs comes into play. Created in 2022 to help build a common roadmap for DMDs, the taskforce has recently presented two new tools, in an article published in npj Digital Medicine, that will contribute to the coordinated implementation of digital healthcare in Europe. “These are part of a classification system for digital medical devices that will help us to better assess their benefits and facilitate their integration into healthcare procedures and services,” underlines Prof. Klucken, member and rapporteur of the European taskforce.
While the use of digital devices by patients or healthcare providers is already increasing, few EU Member States have institutionalised assessment frameworks of DMDs in place. Furthermore, the existing frameworks differ between countries, resulting in inconsistencies and a fragmented European landscape when it comes to access and reimbursement of DMDs. “Take for example France and Germany, they use different methodologies and don’t evaluate the same elements, meaning decision-making in terms of reimbursement can also vary,” explains Dr Magali Boers, co-lead of the first work package of the taskforce who works on digital health at the Ministry of Health and Social Security. “We have seen this with Deprexis® and Hellobetter®, two devices for digital therapy, so called “digital therapeutics”, that have been evaluated by these two countries. While both are now reimbursed in Germany, they are not in France.” This illustrates the importance of the work conducted by the taskforce: A harmonised approach to DMDs assessment is essential to ensure that valuable technologies can be integrated across the European Union, while being adapted to the needs of each country’s healthcare system.
A toolbox to better assess digital medical devices
To help build this regulatory framework, the taskforce has developed a classification grid and an evidence matrix for DMDs. These tools are based on existing national guidelines, a survey of Health Technology Assessment (HTA) practices in nine countries, consensus meetings and workshops. “When a company wants to bring a new medication to the market, there are rules defined by the European Medicines Agency and a process to follow, with a clear definition of development studies and clinical validation trials,” details Prof. Jochen Klucken. “This concept of evidence-based medicine and the related HTA procedures are just starting to be defined for DMDs in some European countries and abroad. The classification grid and evidence matrix are the first steps to make sure that we develop devices that are both safe and effective, and that we only reimburse DMDs that provide validated clinical evidence, ideally harmonised in all European countries.”
The new grid creates a comprehensive taxonomy allowing the classification of DMDs according to their specificities: Is the device intended for patients or healthcare providers? Is it meant as a tool for prevention or as diagnostic aid? Will it empower the patient directly with better information and coaching modules? Will it support the clinical decision and management tasks of healthcare professionals through telemonitoring functions or will it directly treat the patient as a digital therapeutic? By answering these questions, the classification grid allows in turn to define what is required to properly assess each device. From clinical safety and efficacy to ethical considerations and IT security, the evidence matrix lists the different aspects to consider during the scientific development and assessments of DMDs.
Building a common approach
Together the classification grid and the evidence matrix aim to assess the value of innovation in the broad field of digital health technologies, and to inform decision-making processes on the inclusion of DMDs in healthcare systems. They offer a common reference that European countries can apply to build a national framework harmonised with their EU neighbours. They are also useful for DMD creators as they provide a list of specifications to be considered when developing a new device, when planning clinical studies for feasibility, validity confirmation, or reimbursement related purposes.
“Our work within the taskforce has brought together many actors seeking to advance the integration of DMDs in the healthcare systems. It has also contributed to raising awareness regarding the importance of developing specific DMD regulatory and HTA pathways at national and European levels,” concludes Prof. Jochen Klucken. “We hope that these tools will become the first building blocks in the construction of a common approach to DMDs assessment in Europe, fostering the integration in national healthcare pathways of devices which have demonstrated real value for patients and healthcare providers.”
—
References:
- Ivana Paccoud et al, Patient perspectives on the use of digital medical devices and health data for AI-driven personalised medicine in Parkinson’s Disease, Frontiers in Neurology, December 2024
- Magali Boers et al., Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape, npj digital medicine, 24 May 2025.
Created in 2022, the European Taskforce for Harmonised Evaluation of DMDs is comprised of over twenty members from the academic sector, policy makers, national competent authorities and HTA agency representatives from EU countries such as Austria, Belgium, Finland, France, Germany, Italy, Luxembourg, and Spain. It is chaired by the Ministerial Digital Health delegation of the French Ministry of Health and Prevention and co-ordinated by EIT Health. It is operating through and supported by contributors of other European Ministries of Health and agencies competent in the field of DMD evaluation.