Over three years, the French Ministry of Health has converted an e-health roadmap into e-health services for its citizens and a robust data-sharing infrastructure. The transformation continues with fast-track market access for digital therapeutics and aspiration for cross-Europe clinical evaluation of health apps.
Five Pillars of the Digital Shift
“2022 is a breakthrough year for digital health in France. We are coming to the end of our flagship three-year e-health roadmap. And there is much to celebrate. We’ve managed to create an ecosystem that will be the soil for the growth of innovations in healthcare,” said Isabelle Zablit-Schmitz, eHealth Europe & International Director at the French Ministry of Health in an interview for The Sidebar.
The “Accelerating the eHealth shift” strategy announced in 2019 aims to cover all citizens with Shared Medical Records, enabling them to access digital health services through My Health Space (Mon espace santé), a platform also available on smartphones.
Another achievement is the development of a framework for sharing health data within the national health system and among other European countries.
It has a broader context – data exchange within the long-awaited European Health Data Space. Contributing to the European Health Data Space ambition is at the top of the deliverables during the French Presidency in the EU Council.
Decreasing Ambitions, Favoring Improvements
“With the e-health roadmap, we are catching up with basics like e-prescriptions, patient records, infrastructure, and digital governance. In the meantime, we are speeding up by introducing a €650 million program to support early-stage start-ups, accelerate research, enhance education, and upscale innovation,” highlights Isabelle Zablit-Schmitz.
Unlike many other European countries sinking in increasingly expensive and endless digital health mega-projects, the French Ministry of Health skipped ambitions in favor of incremental advancements. For example, e-prescriptions were first designed with no structured data as opposed to a complex data exchange system. It’s not perfect, but it’s a part of a long journey and brings small benefits from the start.
“Long-term e-health projects usually don’t work well. People change, technologies and priorities evolve, ecosystems develop, digital transformation sets new directions. Only the strategy remains static. After a few years, it’s already outdated, and the implementation often fails,” notes Zablit-Schmitz. “So we used to set values like ethics and goals like interoperability then followed up with single and efficient projects that fit together and provide tangible outcomes for citizens.”
The health and social sector will also benefit from another €600 million within the Post-COVID Recovery & Resilience Plan. Part of the budget will be spent on the European convergence.
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Prescription Apps in France and the Domino Effect Across Europe
The fast-track access for digital health applications announced last year by President Emmanuel Macron is also taking shape. The French approach follows Germany’s legislation (DiGA) introduced in December 2019. The shortlist of requirements for the digital apps ranked as digital therapeutics included, among others, data interoperability, CE mark, and demonstrated clinical benefits to the users.
The app providers will have the opportunity to opt for fast-track market access. It assumes a one-year transition period during which the app can already be prescribed by a physician and reimbursed by a payer.
Isabelle Zablit-Schmitz reveals that the intentions are the same – removing barriers for safe and beneficial solutions in healthcare. However, the implementation will be customized to the specifics of the national health market. The Ministry of Health is currently working on a regulation to be presented soon.
“Part of the journey toward prescribable apps is collaborating with other European countries interested in DiGA-like legislation. While chairing the EU Presidency in the first half of 2022, we think some parts of the fast-track path might already be implemented at the European level. One of the examples is a joint approach to the clinical evaluation of health apps.”
It could be an opportunity for Europe to catch up, support innovation in healthcare, and become an attractive destination for digital health start-ups. Especially since, due to different reimbursement policies and health systems, pan-European DiGA-like legislation is very challenging.
One Space for Health Data
When asked about the one top priority of the French Presidency in the EU Council, Isabelle Zablit-Schmitz answers quickly: regulation in the European Health Data Space (EHDS). EHDS is seen as one of the critical building blocks of the future of health in Europe. However, it’s also a must because European companies lack the data to enhance the research and development of AI algorithms and new digital services.
According to Isabelle Zablit-Schmitz, a prerequisite for the EHDS legislation is European ethical principles for digital health in Europe, so all EU countries share a common baseline on health data processing and commitments to the citizens. It’s a lesson learned from the COVID-19 pandemic and the discussions around novel solutions like contact tracking and the EU Digital COVID Certificate.
France’s agility in moving digital transformation forward is as simple as it is effective. It lies in the outcome-oriented digitalization in healthcare, openness to adapt innovative legislation that proved its value in other countries, and willingness to bring the best part of it to the EU level.
“The intention is to simplify the life of citizens, health professionals and the operations of authorities and innovators,” concludes Zablit-Schmitz. And she really knows what she’s talking about. She herself was the founder of a start-up.
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About the author
Artur Olesch is a Berlin-based freelance journalist and correspondent for digital health-related topics.