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France and Germany: Towards a Common Strategy on Digital Health

12/10/2022

France and Germany: Towards a Common Strategy on Digital Health

Healthcare Europe

Author

Florence Verzelen

Executive Vice President, Dassault Systèmes

Author

Otmar D. Wiestler

President of the Helmholtz Association

This paper is the result of collaborative reflections between Institut Montaigne and the Gemeinnützige Hertie-Stiftung, which brings together French and German decision-makers and experts to define common priorities for building a self-confident and forward-looking Europe.

Every day, our societies produce massive quantities of health-related data. From administrative healthcare data generated by public and private insurers to clinical data extracted from medical records, pharmacies, medical examination reports, medical registries, clinical trials or genomic data, our healthcare system is digitalized from every angle.

This acceleration of data production has been facilitated by the rise of new digital health technologies, developed by public and private actors and used by stakeholders, from patients to healthcare professionals. Data can be utilized to advance various fields such as prevention, remote monitoring, telemedicine, information exchange, or the development of personalized medicine strategies. However, responsible data handling is a key prerequisite for user confidence in these tools. Confidentiality and anonymity are essential at a time when multinational technology companies are relying on them in the development of their current and future algorithms.

In Europe, the use of such technology in the healthcare sector still has a long way to go. Digital technologies are still under-used in French and German healthcare sectors, even though they are essential in improving the efficiency, quality and safety of our healthcare system while ensuring the involvement of patients in their care. Moreover, they are required for biomedical innovations and contribute to the creation of a strong health tech ecosystem within the EU. For these technologies to be "usable" at the European level, we need to create an environment where they can safely and effectively be made available.

Deploying e-health to make our healthcare systems better and more efficient

Telemedicine and remote patient monitoring have both become all the more crucial as a result of the societal changes induced by the pandemic. However, after transforming many other fields, this dynamic digital revolution is having difficulties making its way into the world of healthcare.

Telemedicine and remote patient monitoring have both become all the more crucial as a result of the societal changes induced by the pandemic.

This slowdown is the result of several obstacles. Firstly, barriers remain to sharing and using health data; it is heavily protected. Healthcare practitioners still use telemedicine too hesitantly, and the low level of acculturation to this new practice does not allow for automation and real efficiency of this new scheme. Secondly, we are witnessing a lack of funding initiatives for health-related startups; projects are encouraged, but only to a certain extent, and the outcome rarely sees the light of day.

On the public policy side, the governance framework for health innovations is too fragmented and the evaluation structure remains inadequate for new digital health solutions. For example, in the United States, the Food and Drug Administration (FDA) plans to allow new medical devices to enter the market in just two weeks using data. In Europe in contrast, this process requires several years.

However, some Franco-German organizations want to set an example and encourage digital dynamics in this sector, which has become almost sovereign. In France, the Délégation du Numérique en Santé (Digital Health Delegation), which is attached to the Ministry of Health, has established an ambitious roadmap for the deployment of digital health solutions. This delegation oversees the implementation of digital health transformation projects everywhere in France, from local GP practices to hospitals.

In Germany, the Digital Care Act (DVG), adopted by the parliament in November 2019, has expanded the authorized use of health data and telemedicine to all medical consultations. Under this development, the digitalization of healthcare has made a significant breakthrough in Germany. Many medical areas are now covered: screening, prevention, diagnosis, treatment, and care of the elderly. In addition, many policymakers strongly wish for the national health insurance fund to reimburse digital healthcare applications.

Collecting and harmonizing health data to enable its proper use

A data-driven healthcare system has immense potential for disease detection and prevention. This relates to predictive medicine, which allows for more accurate identification of at-risk individuals through a greater comprehensive understanding of human health and disease, including the interactions between genetic determinants, other predispositions, and lifestyle and environmental determinants of health.

Predictive medicine also allows us to monitor the spread of communicable and non-communicable diseases, coupled with a better ability to anticipate crises and epidemics.

Preventive medicine, on the other hand, combines prevention strategies and targeted interventions through public and private actors promoting a healthy lifestyle and thus improving disease prevention. This paves the way for more agile forms of supervision of the supply and demand of health-related needs in the population, allowing for greater agility and adaptability. Lowering the costs of treatment and thus access to all and guaranteeing the sovereignty of the EU are objectives that can be achieved in this way.

Lowering the costs of treatment and thus access to all and guaranteeing the sovereignty of the EU are objectives that can be achieved in this way.

In France, the Health Data Hub has been launched with the objective of collecting and assembling data in order to make French health data accessible to clinical and medical research and to improve patient care. It has taken the lead in a European consortium called for the future deployment of the European Health Data Space.

Germany, on the other hand, has opted for the creation of a data bank to house data for medical research. Starting in 2023, Germans will be able to share their personal health data with scientists. They will be free to choose whether this data will be anonymized. In addition, the "Health Innovation Hub" was established in 2019 to put digital solutions into practice and obtain information about their use. In addition, the BMG (German Ministry of Health) has launched an innovation forum called "Digital Health 2025" with the aim of creating a space for the structured exchange of ideas. Experts from different areas of the healthcare system cooperate in this forum to create a common vision.

Recommendations to improve the current health data landscape:

Review our main regulatory tools (certifications, authorizations, payment conditions, etc.) in order to identify potential benefits of analyses of this data. This concerns targeted prevention mechanisms, quality-based payment, support for care teams, the information provided to citizens on care and patient quality, or the collection of information on patient satisfaction.

Consolidate the current data and analytics expertise and resources of the various agencies involved in the broader health domain (and ministries of health), forming a development pathway to create critical mass and superior resources and offer attractive career paths for talent to attract and retain the necessary expertise. It is also possible to encourage public-private collaborations between the various players in this rich but still insufficiently connected ecosystem (health agencies, artificial intelligence research teams, start-ups, SMEs and health and technology manufacturers, etc.).

Encourage public actors as well as private actors who are supported by the public sector to commit to promoting virtual collaboration platforms that allow partners to work together on common projects such as how to define priority therapeutic areas, involve the relevant patient associations, train health professionals in these issues, etc.

Data protection and privacy as a fundamental value at the European level

Public opinion is still hesitant when it comes to the use of personal data for medical progress. In this case, the confidence of Europeans in health data usage depends as much on the potential of the new technologies as it does on anonymization, the ethics of data use, and the medical usefulness of the proposed solutions. A national and European ethical and technical doctrine must be developed to impose itself on international players wishing to operate in the European market.

Thus, in order to reconcile innovation and ethical respect for individuals, several paths are possible. Germany and France must work together to ensure that the proposed European Health Data Space safeguards health data security and ethical sharing based on patient consent while allowing for effective data exploitation for innovation purposes. Any delay in the implementation of EHDS is detrimental.

It is imperative that our two countries help the European Union create its own standards, such as an ethical and quality label for systems involving AI.

It is imperative that our two countries help the European Union create its own standards, such as an ethical and quality label for systems involving AI, to cite one example. This policy, geared toward both the creation of new digital actors and the animation of a network, will allow for the creation of an ecosystem in line with European values, based on certification and mutual trust. The incoming European Health Data Space will provide an ideal platform for the application of this strategy.

In France, the digital health space (Mon Espace Santé) will allow patients to authorize their data collection. A desirable strategy would be to open it up to trusted third parties while respecting the patient's consent to allow automatic analysis of the data, particularly by artificial intelligence.

In the same vein, the regulatory framework for medical data in France needs to be made more flexible. The French currently can only request the deletion or rectification of their health data if it is inaccurate or outdated, unlike in Germany, where this request does not require any such justification. Relaxing this regulation would allow for greater security of data, but also for more data to be captured.

Finally, adding case studies that demonstrate the value of sharing and using health data for both health professionals and the general public is of critical importance. For example, the creation of an observatory on the uses of health data, managed by members of civil society (patient associations, doctors' federations, etc.) could be valuable in explaining and demonstrating the use of health data for research, patient monitoring, improved care, etc. on a regular basis. Priority therapeutic areas that are visible to the general public could be highlighted (oncology, pediatrics, Covid-19). In France, the Health Data Hub has created a citizens' department dedicated to these issues, with training and promotion of patients' associations in the various governance bodies linked to the management and collection of data.

Turning the industrial health sector into a European Champion

Healthcare is a key economic sector for France. There are roughly 2.7 million healthcare workers in France, and the total healthcare expenditure in 2020 was €209.2 billion. It also creates growth: the health sector generates wealth not only in the field of health industries and technologies but also increasingly in digital technology applied to health, a field that is expected to grow exponentially in the coming years with the right support from actors in the public sector. The value creation potential of e-health in France is estimated to be between €16 and €22 billion per year.

Healthcare is also a prominent area in Germany. In 2020, the country's healthcare expenditure amounted to €411 billion and the German healthcare sector employed 5.7 million people, almost three times as many as France. In addition, the country has the second-largest medical technology sector in the world, behind the United States. In 2020, this industry generated €34 billion. A study predicts that medical technology companies will reach a turnover of 15 billion euros in 2028 from digital products and services alone. Today, this figure is €3.3 billion. The number of start-ups in the healthcare field is also noteworthy, and it increases every year.

The health sector must be considered a major economic area, creating wealth and growth directly and indirectly.

Based on these figures, the health sector must be considered a major economic area, creating wealth and growth directly and indirectly (jobs, investments, trade balance).

In addition, it is imperative to implement healthcare policies that can integrate a logic of investment and evaluation of the return on investment, the aim being to build a long-term vision of our healthcare system in which all the public and private plates are aligned toward a common objective: the creation of value for patients and for the healthcare system as a whole.

The choice of a therapeutic area as a reference for good practice in the deployment of digital technology and the use of health data

A final aspect of data in health to be apprehended is the use of data and AI.

In France, the Contrat Stratégique de Filière (2019) contains a program relating to AI in health that aims to create, in conjunction with the Health Data Hub, a tool for global leadership. On the public policy side, many centralized plans for the fight against various diseases allow for the implementation of indicators for effective evaluation, such as the Plans Cancer. The third Cancer Plan (running until 2019) was announced in 2014 with four axes: cure, preserve the quality of life, invest in prevention and research, and optimize management and organizations.

France has also promoted the use of digital twins in a project with 8 Hospital-University Institute (Institut Hospitalo-Universitaires, IHU) to accelerate research and improve physician practices.

The update of the 2018 German National AI strategy highlights healthcare as a priority area.

In 2019, the German Ministry of Education and Research launched a 10-year cancer strategy (National Decade Against Cancer) aimed at increasing the cancer research budget, establishing long-term infrastructures (National Center for Tumor Diseases with various sites), and improving the quality of cancer care and prevention programs.

The update of the 2018 German National AI strategy highlights healthcare as a priority area, citing policy initiatives such as a funding program for "Digital innovations for the improvement of patient-centered care in the healthcare system".

Considering this, the establishment of a dashboard for the health sector to drive national digital health initiatives seems like a critically useful tool.

A joint initiative in this challenging field coordinated by France and Germany can serve as the basis for a Pan-European action in digital health at a later stage.

Recommendations based on existing projects

Central to the objective of turning the healthcare system into a European champion are joint ventures between European countries. By combining the financial firepower and the technological and scientific abilities of different countries, joint ventures can help create more complete, innovative and valuable healthcare solutions. The transnational nature of these solutions will facilitate their penetration into various markets, both in Europe and outside of the bloc. One such example is the Centre of Excellence in Digital Health and Personalised Medicine (CLINNOVA), a joint venture between healthcare actors in Luxemburg, Germany, France and Denmark.

CLINNOVA's ambition is to create a cross-border health database designed to improve diagnosis accuracy and quality of patient care. Led by the Luxembourg Institute of Health (LIH), it seeks to create a network of hospitals that span across Luxemburg, Germany's Baden-Württemberg land, and France's Grand Est Region with the ultimate objective of creating a GDPR-compliant European Valley of data and AI for health. The hospitals in this network would pool their resources in terms of data and analytics to create a French-German-Luxemburgish data platform that offers data in both quality and sufficient quantity in order to develop AI software that can benefit both the practitioner and the patient, such as diagnostic assistance and prescribing aids. This project will begin with a focus on treating Multiple Sclerosis, Inflammatory Bowel Disease and Rheumatoid arthritis. This initiative is aligned with the objectives of the European Health Data Space, as it will help to develop standards for the exchange, interoperability and organization of data and thus facilitate research and development on a European scale, which ultimately stands to benefit all companies in the digital health sector.

Primary sources

Institut Montaigne, E-santé : augmentons la dose, juin 2020
Institut Montaigne, Filière santé : gagnons la course à l’innovation

France

Europe and International

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