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Digital health

Cutting-edge research, a State serving as regulator and accelerator, high ethical standards and a buoyant ecosystem for therapeutic and organizational innovations. These are the pillars on which France’s e-health policy is founded. With artificial intelligence (AI) having swept into all areas of healthcare, the key challenges and issues are constantly changing. In a co-constructive approach, public and private stakeholders are increasingly working together to deliver tangible benefits to patients, users and healthcare professionals.

“Putting digital technology to work for  health.” This is the principle threaded throughout the 2023-2027 Digital Healthcare Roadmap, presented by the Government in May 2023. There are great aspirations  to make France a leader in innovation and attract talents in e-health, and  building up a true digital health industry at the same time. “We are committed to this purpose with a firm collective resolve, in the service of our values and ethics, which form a “’third European way’ between the USA and China, capable of sparking the trust essential to the development of digital uses and improved health,”  said François Braun, Minister for Health and Prevention, convinced that “progress achieved in e-health, in particular in telemedicine and telemonitoring, is truly an equalizing force in the field of healthcare, in particular for the  more remote areas.” The structuring of an ecosystem devoted to research, care and innovation must be such that it addresses the challenges of population ageing, the increase in chronic diseases and access to healthcare. By 2030, healthcare will be resolutely digital, with medical care that is more predictive and preventive. 

The digital technology revolution is already underway in a wide range of fields: namely, e-health with information systems, the Mon espace santé (1) digital health record or digital solutions for the care pathway; telehealth with remote consultations, remote monitoring, remote medicine, remote expertise, mobile applications and connected devices; AI image analysis and health data exploitation (big data and data mining) all made possible by interoperability.

The introduction of telemonitoring into common law, at the start of 2023, and the early financial coverage provided for digital medical devices are two key signals. These two decisions have made France the first European country to reimburse medical telemonitoring solutions that offer a clinical benefit or improve the organization of care. A further sign of the sector’s dynamism came with the impressive fundraising events held in the first quarter of 2023, for French startups, such as Iktos, that specializes in artificial intelligence dedicated to the discovery of effective new chemical molecules in the framework of drug research (€15.5 million), Inato that provides a platform for pharmaceutical groups and hospital centers, in order to facilitate the recruitment of patients for clinical trials  (€12.6 million) or, for instance, Kiro that develops AI solutions to interpret biological analysis reports.

“The financial resources being devoted to the deployment of digital healthcare and cybersecurity are substantial. There is a real and quite exemplary momentum in Europe, in terms of innovation and acceleration strategy,”  emphasized Annie Prévot, Director of France’s eHealth Agency (ANS), a public interest grouping that establishes the framework, foundations and major e-health programs to speed up the digital transformation of the health system.

“The government has put more than €2 billion on the table for digital healthcare. There is real support from the public authorities to speed up the deployment of ‘Mon espace santé’. Today, the ambition is to ensure that all our innovations can reach  patients and professionals alike, with major implications in terms of distribution and use. France boasts outstanding strengths, with its internationally recognized healthcare system, the breadth of its public and private hospital network, its network of independent professionals and its training programs,” said Jérôme Leleu, E-health expert, Founder & CEO of Interaction Healthcare and Simforhealth, a company specialized in digital health simulation, which is currently implementing a program of international expansion. 

The creation of the Agency for Innovation in Healthcare (AIS) in late  2022 is one of the measures provided for in the 2030 Health Innovation Plan, the health-related component of France 2030, with the aim of facilitating and driving access to innovations in health care for patients and professionals.“This final objective guides our undertakings and our work – we steer and co-ordinate the huge investments set aside for it, €7.5 billion, with priorities identified in the areas of bioproduction and biodrugs, emerging infectious diseases and CBRN threats, digital health and innovative medical devices,” explained Lise Alter, General Director of the AIS. The support we offer to companies is tailored to the major challenges they face: access to markets, scaling up or off-label uses, when the healthcare system does not have a place for the solution. The AIS has in particular initiated a pilot plan on public procurement designed to introduce buyers to innovations and thus enable them to distribute them. It is expected to soon take up quarters on the PariSanté Campus.

This world-class training, research, innovation and entrepreneurship hub brings together five public operators on the 20,000 sq m facility south of Paris (InsermUniversité Paris Sciences & LettresInriaHealth Data HubAgence du Numérique en santé) and a very large number of private-sector partners in research, innovation and care. Over 1,300 players (including 80 startups, major private players from health industries and services) are already working together in this digital healthcare Silicon Valley that will be transferred to another site in 2028-2029: the former military teaching hospital in Val-de-Grâce. “In order to build up the synergies in the ecosystem, we have created thematic ties between startups, researchers, students, manufacturers and institutions around central topics such as imaging, artificial intelligence and interoperability. We are also initiating support programs, aimed at both scientific and entrepreneurial players” said Professor Antoine Tesnière, Director of PariSanté Campus. An initial program has been launched to develop prevention using digital tools, also supported by BPI France and benefiting from €100 million in funding.

On the research front, the emphasis is currently on bringing the various areas of expertise together. Officially launched in June 2023, the Digital Health Priority Research Program and Infrastructure (PEPR) is jointly backed by the Inserm and Inria. With a 7-year budget of €60 million, its aim is to position France as the European leader in digital health innovation. Two major areas of research have been chosen: gaining so-called “multi-scale” biological and medical data (i.e. in space, on scales ranging from DNA to population monitoring, for example, but also in time, ranging from a few milliseconds to several decades) for each patient and, based on the processing of such data, building  the most comprehensive personalized and scalable digital representation possible of the said patient (digital twin).

From robotics-assisted surgical operations to  digital twins of  organs, smart prosthetics, remote monitoring of heart failure patients, digitized follow-up for cancer patients, implanted medical devices for diabetics and beyond… Artificial Intelligence (IA) and its algorithms are increasingly being used by healthcare professionals and stakeholders in the medico-social sector. However, the necessary trust remains to be built.

 “One of the major challenges for digital health is ensuring that not only the professionals working in the health system, but also patients and users take ownership of the system,” said Dr. Jacques Lucas, former Chairman of the French eHealth Agency (ANS).  With Mon espace santé, patients become empowered. They will have access to all their health reports, which will improve the quality and speed of care. However, a number of issues still  need to be ironed out and much needs to be done to gain everybody’s trust, with clear, fair and appropriate information, truly  involving all the players in the ecosystem. It is essential that patients be unidentifiable by anyone viewing their health profile..”

PariSanté Campus is also intent on involve citizens in the ethical debate on digital health, in France but, above all, across Europe. The right balance still needs to be struck, in order to establish frameworks without slowing down innovation transfer. “We cannot adopt a mindset that pits regulation against innovation. In other words, we need a framework that is agile and flexible enough, given  the speed of innovation,” said Professor Tesnière.

Special attention is being paid to enabling human and collegial supervision of AI solutions. “Over time, healthcare professionals may need to use AI as an obligation of means, for example to refine a diagnosis. However,  responsibility for that decision lies with  the doctors or other professionals,” said Jacques Lucas, who points to the important role of France on these ethical topics. Ethik-IA a citizen and academic initiative aimed at securing   human supervision of healthcare algorithms, championed the concept of Human Guarantee in the use of AI and digital health, which is now recognized in the draft European regulations on AI. In May 2023, it launched Europe’s first integrated digital healthcare offer with a human- guaranteed AI use, in partnership with Medin +, one of the leaders in teleradiology.   

The cornerstone in the development of digital technology in healthcare, the ANS has published the Doctrine on Digital in Healthcare  (4th edition in 2023). This reference framework for digital services and the exchange and sharing of health data is aimed at healthcare facilities, Regional Support Consortia for the Development of E-health (GRADeS), to publishers and to professionals in the healthcare or medico-social sectors. “We are also working on the issues of cybersecurity and interoperability of outpatient/hospital software in order to improve the quality of care and the sharing of healthcare data,” pointed out Annie Prévot, who is closely monitoring regulatory harmonization at the European level.  From 2025 onwards, the ANS will have the power impose financial penalties on digital health companies that fail to adhere to the various standards published by the ANS. A soon-to-be published standard on teleconsultation will, for example, set out the rules on the confidentiality of exchanges between patients and their healthcare professionals.  Software publishers must also provide any healthcare professional with the ability to block the sending of information to the Mon espace santé electronic health record. 

“Making France the global leader in precision medicine based on digital pathology”. Such is the aim of Owkin, a biotech company that specializes in AI applied to medical research, which launched the French consortium PortrAIt, in collaboration with Gustave Roussy and Unicancer.  With a budget of €33 million, financed by France 2030 and operated by Bpifrance and the European Union, PortrAlt aims to position France as leader in the use of AI applied to digital pathology. The tools created through this research platform will speed up the work of pathologists working to detect the presence of certain biomarkers or predict patient outcomes, in order to ultimately improve cancer management.

Most of the 25 award-winning businesses at FrenchTech 2030 working in the area of health, have deployed internationally. Here are just a few examples:  Tree Frog, France’s fast-growing biotech market leader, wants to put cellular therapy in different therapeutic fields within reach of millions of patients, via its breakthrough technology, C-Stem. Implicity, which provides telemonitoring for almost 80,000 patients  suffering from cardiovascular diseases in the USA and Europe, aims to become the global leader in preventive cardiology thanks to its R&D in artificial intelligence and data science.  Lastly, , Tribun Health, a company that is designing digitized slide management software and transforming cancer diagnostics, targets primarily the USA and Scandinavian and UK markets. Virtual reality in the area of health is another buoyant market. HypnoVR, a leader in digital therapies aimed at reducing pain and anxiety, is for instance speeding up the commercial deployment of its medical hypnosis solution in France and throughout Europe. One of the great aspirations  of ParisSanté Campus is to make the connected healthcare ecosystem shine internationally. In order to develop both its export and attractiveness, it first had to analyze the models used beyond its borders, in Europe, China and the USA. The second stage consisted of determining the key strategic issues internationally and creating operational strategies and cross-border collaborations, in Europe, North America, Israel, the Asia-Pacific zone and the Africa zone. “Our aim is to support startups that are interested in exporting to foreign markets and to host programs and foreign investments or foreign startups that are looking to come to France, with an anchoring point at the PariSanté Campus,” said Antoine Tesnière. At the 2023 BIO International Convention in Boston, he was able to showcase PariSanté Campus’ international approach thanks to the teams at Business France Santé and Business France North America. “Having  centralized everything for our foreign contacts gives  us with a high degree of visibility and clarity. There are few ecosystems that are as extensive, while also being located on a single site.”  Europe is of course the first arena in which French excellence shines. A large number of events were hosted in France during the French Presidency of the European Union. PariSanté Campus has also instituted  collaborative agreements with structures that support the dynamics of all the European Member States, in such a way as to form bilateral strategies. “We took part in an initial Franco-Swedish incubator, which has produced its first graduating class made up of startups from both countries,” said Antoine Tesnière. “We are in very advanced discussions with Germany on regulatory topics and  are very regularly visited by different delegations from the Member States to outline avenues for  collaboration.” All of this is taking place against a backdrop of digital sovereignty for which Europe is instituting ever more regulations, with a regulation on AI, one on health data and the implementation of pilot programs for health data warehouses. These past few years, France has been rising up through the ranks of innovative startups and foreign investments in Europe.

(1)   which is intended to enable better health monitoring and personalized prevention for all