EDiHTA consortium is developing the first framework for evaluating digital health technologies. Will Europe have a blueprint for implementing telemedicine solutions, mobile health applications, and AI systems? ICT&Health interviewed Dr. Iga Lipska, Chairwoman of the Board of the Health Policy Institute and one of the members of the EDiHTA consortium.
Why HTA for e-health solutions, and what is the timeline for EDiHTA?
The four-year EDiHTA project, which kicked off on January 1, 2024, is a scientific research initiative funded by the European Union's Horizon program. Our consortium builds on its experience evaluating traditional medical technologies, such as drugs, medical devices, surgical operations, and organizational solutions.
In essence, our goal is to apply the Health Technology Assessment (HTA) approach to digital technologies. While developing a framework to evaluate e-health solutions, we aim to include factors typically overlooked in traditional HTA, such as the environmental impact and the organization of healthcare delivery. HTA generally focuses on clinical and economic perspectives, as well as ethical considerations, and these will remain important for digital technologies. However, additional domains unique to digital solutions will also be crucial.
Luckily, we already have guidelines to follow that have been implemented in several Member States. Another example to consider is the Joint Clinical Assessment (JCAs) for Oncology Drugs and Advanced Therapies at the European level, starting on January 12, 2025.
Where do you start working on the guidelines?
Given the broad and diverse nature of the field, we began by reviewing existing methodologies and defining digital technologies. EDiHTA aims to cover a wide range of digital innovations, including telemedicine, mobile health apps, and AI-driven technologies. AI, in particular, presents a challenge due to its dynamic and evolving applications, with many technologies overlapping—such as medical robots that incorporate AI, robotics, and telemedicine elements or wearables for which telemedicine, health apps, and AI tools can potentially be incorporated.
Our goal is to develop guidelines that help hospitals and ambulatory healthcare facilities navigate these new technologies and implement those that positively impact patient outcomes. Since many of these technologies are publicly funded, resources must be used efficiently.
It’s also important to mention that EDiHTA is one of two ongoing projects under the EU’s HORIZON program, which is focused on creating European frameworks for evaluating digital health technologies. Thus, we are collaborating closely with the ASSESS DHT consortium to ensure our efforts are complementary.
Who makes up the EDiHTA consortium?
The consortium comprises 16 partners from 11 countries (10 EU countries and the UK). This diversity of partners allows us to draw on experiences from different health systems, creating a universal framework for digital technology assessment.
We have planned six pilot projects in different countries, divided into three groups. Each group is responsible for evaluating different technologies: telemedicine, mobile applications, and AI systems. This is important since we want the HTA framework for digital technologies to be implementable across the European Union. Recruitment for some additional pilots will be announced competitively in 2025. We have four years and a budget of 8 million euros to complete the project.
Where did the idea of developing a digital health technology assessment model come from?
It arose from the consortium partners' prior experiences and their collaborations in various international forums, including Health Technology Assessment International (HTAi). It wasn’t a sudden realization; instead, the concept evolved over time as digital technologies for healthcare advanced.
Stakeholders across the system—patients, medical entities, research centers, and digital solution providers—have been grappling for years with the question of how to rationally implement new technologies for maximum benefit. The need to find answers has only become more pressing since technological transformation has accelerated. When generative artificial intelligence emerged in 2022, it became clear that guidelines were urgently needed at the EU level, no matter how challenging the task.
Before submitting our project proposal to the EU call, we met several times online and twice in person to establish the consortium and finalize ideas for EDiHTA. Competition was extreme; nine projects were submitted, and only two were funded.
Digital technologies hold immense potential to improve healthcare quality and accessibility. Mobile apps, for instance, can help manage chronic diseases, monitor patients' health in real-time, and offer personalized care. They can also optimize processes in medical facilities, leading to cost savings and increased efficiency. But before we can harness their full potential, we need to determine which of them will bring benefits.
Will the guidelines be implemented throughout the European Union one day?
It’s difficult to predict how these guidelines will be adopted across the EU at this early stage. However, we hope that EDiHTA will contribute to the development of solutions similar to the EU HTA regulation for cancer drugs and advanced therapies (ATMPs). It took almost 20 years to establish a legal framework for joint clinical assessments for medicines at the European level. This experience provides a strong foundation for applying similar principles to digital solutions.
I remain optimistic: When the AI regulation initiative was introduced, many doubted it would succeed. Yet today, we have the EU AI Act. One of the biggest challenges for EDiHTA is the rapid pace of technological development. It’s hard to predict what solutions will emerge tomorrow.
The consortium is fully aware of the magnitude of the challenge. We have significant HTA experience and have recognized that digital technologies require a more flexible approach. Evaluations must consider difficult-to-measure effects, such as the impact on health systems and society. It's also crucial that digital health solutions comply with current regulations and ethical standards. There are already many guidelines and initiatives we can build upon, such as Germany’s DiGA fast-track for mobile health apps or France’s PECAN.
Our goal is simple: to ensure digital technologies are implemented effectively and safely, minimizing risks. This is a challenge we must face, as digital technologies are sophisticated AI-based applications where risks are more complex to assess immediately.
While drugs have known side effects, digital health solutions like AI often carry unknown risks. Yet, many digital solutions with significant potential aren't widely used due to the lack of guidelines regarding implementation. For example, mobile apps for mental health could help address the shortage of psychologists and psychiatrists. However, they also come with risks, which must be carefully analyzed to assess the benefit-risk ratio.
Personally, I also hope that this framework for evaluating digital health technologies will pave the way for their reimbursement, making them more accessible to patients. Since digital innovations show clinical benefits similar to drug– and non–drug technologies, they should be incorporated into healthcare systems.
What plans does the consortium have for the coming months?
We are currently focused on reviewing existing solutions for assessing digital technologies and thus collaborating with various agencies to gather as much information as possible. One of our partners is Spain’s AQuAS (Agency for Health Quality and Assessment of Catalonia), based in Barcelona. The literature review will be completed by the fall of 2024. The next step is to begin designing frameworks, which will be consulted with key stakeholders, including patients, HTA agencies, decision-makers as Ministries of Health, and digital technology developers.
