Digital health solutions are breaking new ground in healthcare and offer value to patients, medical staff and healthcare systems alike – but who pays? Social security is the obvious answer, but it will only reimburse certified and approved solutions with proven results. However, demonstrating the impact of digital health technologies, which is radically different from that of traditional treatments such as drugs, is a challenge.

Drugs change biology, but digital health solutions change the behaviour of people. How do we measure that?

“Drugs change biology, but digital health solutions change the behaviour of people. How do we measure that?” asked Professor Jochen Klucken, Chair of Digital Medicine at the University of Luxembourg, when speaking at the European Digital Healthtech Conference in Luxembourg on 14-15 May 2024. “What type of data is needed?”

Proving the value of digital health

Panel discussion on good practices for reimbursement at the European Digital Healthtech ConferenceEuropean countries wanting to adopt digital health solutions to enhance their healthcare systems are now grappling with these questions. Several countries are working on systems for evaluating solutions and giving them green light for reimbursement.

One example is the German fast-track process for digital health applications. The country uses 14 measurable and quantifiable types of evidence, such as the facilitated access to care, patient safety, health literacy and the coping with illness-related difficulties in everyday life. “This way of taking patient-relevant improvement into account is very innovative,” stated Professor Klucken.

Belgium has implemented a new reimbursement scheme for mobile medical applications, which allows up to three years of temporary reimbursement of new devices that still need to be further proven. “This gives companies more time to gather clinical evidence,” said Ulla Cahay, Policy Officer at Belgium’s National Institute for Health and Disability.

European approach

While these and similar initiatives are welcomed by the healthtech community, a coherent approach to the clinical validation and reimbursement of digital technologies within the EU is still missing. Requirements and regulations vary between countries, which is particularly challenging for startups.

While organisational benefits might not be transferrable between different countries, clinical evidence should be valid in a similar context.

“We can’t conduct the same type of multi-country studies that big pharma companies do,” said Mihael Jakovac, Head of Market Access at German-based Kranus Health, and called for improved opportunities to transfer results from one country to another. “While organisational benefits might not be transferrable, clinical evidence should be valid in a similar context,” he pointed out.

The EU’s Health Technology Assessment (HTA), which is intended to provide policy makers with evidence-based information and facilitate reimbursement decisions, is a step in this direction. “We are moving towards an integrated assessment for improved decision making, but there is no uniform approach yet,” said Marco Marchetti, Director HTA Department at Italy’s National Agency for Regional Healthcare and Co-Chair of the HTA Member State Coordination Group. “It takes time, but the speed of the process is increasing.”

Good practice for digital health companies: How to succeed

The road towards certification and reimbursement of digital health technologies crosses a lot of uncharted territory, and there is not yet any tried and tested direct route to success. The European Digital Healthtech Conference panellists shared their best pieces of advice.

  • Know your market

Healthtech companies working on multiple European markets must be aware of the specific needs of each country. “When it comes to reimbursement, there is no such thing as one European healthcare market,” Mr Jakovac pointed out.

  • Understand different requirements

Each country has its own legal framework, and in some cases, requirements exceed common EU standards such as the GDPR (General Data Protection Regulation). Digital solutions may also have to be interoperable with IT systems that differ between countries and regions.

  • Avoid the country lock-in effect

Once a solution has been adapted to the requirements of one country, it is not always easy to transfer it to another one. “You need to have a European-wide outlook,” said Stefan Bartosch, CEO of German Medical Valley Digital Health Application Center (dmac). “Luxembourg is a good platform to reach different markets.”

  • Be aware that processes are constantly evolving

As most of the processes put in place to assess digital health solutions are new, the competent authorities are still learning. “Every time we go to see the regulator, they have learnt new things about what they need,” said Mr Jakovac. “This gives us the opportunity to make suggestions, but it also creates some uncertainty.”

  • Keep the need for financing and commercialisation in mind

Clinical validation takes time and is costly. “You need a good shareholder setup and considerable funds,” said Mr Bartosch. He also underlined the need for companies to include marketing and sales experts in their teams. “Even if you get the approval for reimbursement, you still need to fight for your clients on the market. Many companies fail to understand the importance of this.”

The development of a smooth validation and adoption process for digital health technologies in Europe still requires work. The stakeholders participating at the European Digital Healthtech Conference pinpointed the challenges to take into account, shedding light on the next steps to be taken.

Photo credits: Luxinnovation/Sophie Margue