Wanted: clear assessment criteria for digital health technologies
Assessing digital tools is essential, but should not be a barrier to access. Amid a range of initiatives at a national and EU level, a MedTech Forum session explores solutions that could unlock the full potential of a fast-moving field.
Imagine a start-up develops a new technology that helps patients to manage their health in a way that was not possible before. Once they are ready to take their product to market, they come and ask your advice ‒ you work in the health sector, you probably know how it works. Right?
So, where should they begin? How do they navigate the assessment process? What about procurement or reimbursement? Is the German system the same as the Irish system? How about Spain or Poland?
The answer is not so simple, but there are several ongoing initiatives that aim to make things smoother.
Dedicated framework for digital health
Digital technologies have enormous potential to transform personal health and bring new efficiencies to our health systems. Understanding their full value and impact in various care settings is essential to their adoption.
However, we know that the uptake of digital innovation in healthcare is mixed. There are differences between countries across Europe, and within national health systems.
One of the explanations for this is the lack of dedicated frameworks for assessing digital health technologies. There are no standardised evaluation methods to address the uncertainty that may be associated with some new digital technologies, and too few financial pathways to enable payment for digital innovation.
The problem is not so much a lack of effort as a lack of coordination, harmonisation and certainty. In recent years, there have been positive signs, including national proposals for assessment frameworks, sometimes linked to reimbursement, and a drive towards pan-European evaluation.
Where are we now?
Europe must create ecosystems that favour timely access to digital health innovations. However, at the moment, there is a wide range of assessment frameworks across Europe. This is a significant barrier, especially to smaller players.
Where frameworks exist, they are often not sufficiently comprehensive to cover the full spectrum of innovative health solutions coming to market. This leaves us with a fragmented landscape where several assessment processes may apply. In addition, the interplay between various EU rules ‒ the Medical Device Regulation/In Vitro Diagnostic Regulation, Health Technology Assessment (HTAR) and the AI Act, for example ‒ is not yet clear.
You can see why our hypothetical start-up might feel like they are trying to solve a Rubik’s cube for the first time. They may even redirect their efforts to developing consumer technologies or to other sectors, or they may take their solutions to another market. In which case, we have a lose-lose situation: health systems and patients miss out on a potentially valuable product, while the company and the EU economy pass up a new opportunity for growth.
Solving the problem together
In developing a framework that is sufficiently inclusive and flexible enough to adapt to an evolving field, stakeholders must collaborate. The good news is that there are already two European projects that bring together knowledge and expertise to find solutions, while national HTA bodies, academics, companies and health professionals are working together to take down barriers.
At The MedTech Forum, we will hear from experts and initiatives seeking to advance a more coherent digital single market for health technologies in Europe.
ASSESS-DHT brings together 14 partners from 7 countries with a view to increasing the adoption of trustworthy and effective digital health technologies across Europe. Its focus is on developing robust and harmonised methodologies for HTA of digital tools in health.
EDiHTA is devising a ready-to-use European HTA framework for digital health technologies in Europe. A 16-member consortium, drawn from 10 countries, will pilot its framework in several hospitals to demonstrate its value.
These are hugely promising initiatives and it will be fascinating to hear their vision for the future and to discuss how these two projects complement one another. There will also be an opportunity to gauge the response of HTA bodies, payers, physicians and industry.
Let’s hope that, together, we can come up with a clearer answer to give to future innovators exploring the health technology market. Developing game-changing technologies and bringing them to market may never be easy, but we should collaborate to make it as simple as possible.
