00:00:00
G_NIUS : 100 days to success. This is the podcast from G_NIUS, the Guichet national de l'innovation et des usages en e-santé, featuring Lionel Reichardt. Meet healthcare innovators and key experts to help you succeed in your projects.

00:00:20
Lionel Reichardt: Hello everyone! You're listening to 100 Days to Success, the podcast aimed at innovators and entrepreneurs in digital healthcare, but also at anyone curious about this field. This podcast is produced by G_NIUS, the Guichet national de l'innovation et des usages en e-santé. For this episode devoted to the place of ethics in digital health, I'm pleased to welcome Dr. Mélodie Bernaux, project director at DNS, the delegation for digital health within the French Ministry of Health and Prevention. Mélodie Bernaux Hello.

00:00:56
Dr Mélodie Bernaux: Hello!

00:00:57
Lionel Reichardt: Ethics is a fundamental pillar of France's digital health strategy. Could you begin by defining the concept of Ethics in Healthcare? And why is it important to make it a priority as part of the digital shift in healthcare?

00:01:09
Dr Mélodie Bernaux: Ethics is first and foremost medical ethics, for us healthcare professionals in the healthcare field. It begins with the Hippocratic Oath, which sets out the main principles of medical ethics and makes them explicit. These are justice, autonomy, beneficence and non-maleficence. And when we began to see the rise of digital health care, the DNS, which was not yet the DNS, decided that we needed an ethics of these practices, that we needed to think about how to implement these practices ethically. So we tried to think about the ethics of digital health.

00:01:54
Dr Mélodie Bernaux: Digital health ethics would mean a digital health tool that's accessible to all, that's easy to use. So accessible to all, fair, equitable, easy to use, autonomous, respectful of people's choices and wishes, and responsible. And in this case, we've tried to draw on the thread of eco-responsibility. It's clear that all these principles apply to several dimensions. We're thinking immediately of data with digital, integrity, data confidentiality, reliability that can take on ethical dimensions, systems that must be secure, explainable, usable by all.

00:02:34
Dr Mélodie Bernaux: And then, of course, there's the top one, which is the users, so the users who need to understand, this applies to both patients and healthcare professionals who are going to use digital healthcare. Respect the patient's autonomy, respect the healthcare professional's decision and always maintain a human and empathetic relationship between caregiver and patient. And so, if we bring all this together as part of the digital health roadmap.

00:03:05
Dr Mélodie Bernaux: Laura Létourneau and Dominique Pon, who really wanted to develop the uses of digital health within a framework of humanist values, wanted to create the digital health ethics unit within the DNS and posed ethics as you've no doubt already seen the digital health house, which enables the digital health strategy and roadmap to be presented and ethics, is one of the fundamental pillars of this digital health house along with the other two pillars which are security and interoperability.

00:03:42
Dr Mélodie Bernaux: This digital health ethic has one objective, which is to base the digital shift in health on this framework of humanist values, to help structure uses, to also provide safeguards, to set limits and ultimately, to give meaning to the deployment of e-health in France for patients, for healthcare professionals and in fact for all users of the healthcare system, to develop the confidence they will have in digital health. And we know that it's if we develop trust that we'll enable people to create uses and develop uses of digital.

00:04:23
Dr Mélodie Bernaux: So, there's a logic maybe it was in medical ethics. It's a very conceptual thing. And in our digital health ethics, we really wanted to apply it in an operational and concrete way, with the aim of developing uses and enabling patients and citizens to become fully involved in their own health. Because this is something you've heard a lot about in the roadmap.

00:04:46
Lionel Reichardt: That's clear. We can clearly see the place of ethics in this house, which often represents this roadmap for healthcare. This roadmap is very French. And yet, at the start of 2022, France has taken over the presidency of the European Union. For the first half of 2022, it has made healthcare development one of its priorities, with a particular commitment to developing a European ethical framework for digital healthcare. In fact, the European principles for digital health ethics were published in January 2022. First question before we present them. How did you go about drawing up these principles and getting all European countries to adhere to them? Do they even have the same vision, the same maturity on these ethical issues?

00:05:30
Dr Mélodie Bernaux: As part of the French presidency of the European Union, President Emmanuel Macron wanted to emphasize the strength, I believe, the relaunch and the sense of belonging to the European Union. This sense of belonging to the European Union is based on a framework of humanist European values, which of course logically includes ethics. Similarly, the European Commission has long been planning a data strategy, and as part of its data strategy, to propose a regulation for a European health data area, a proposal it made in May, and so with the arrival of the French presidency of the European Union, the DNS, we said to ourselves "we're going to have to prepare the way for the negotiation of this text on the European health data area".

00:06:19
Dr Mélodie Bernaux: As I was saying earlier, for this European health data area to be a success, there must be uses, and for there to be uses, all citizens must have confidence. And this trust can only be achieved through the development of this ethical framework. Over the past three years, as part of the Digital Health Ethics Unit, a great deal of work has been carried out, in particular by Brigitte Seroussi, to develop the ethics of digital health, with reports on the use of artificial intelligence in health, the eco-responsibility of digital health and all the referencing evaluation criteria for my health space. We drew on all this work to formalize sixteen principles within the framework of the ethical dimension with which we are familiar. And we proposed these principles in December, even before the start of the French presidency of the European Union, to the member states of the *e-Elf* Network, which brings together the DNSs of all the member states of the European Union. And very quickly in fact, within four weeks, it was obvious for all the member states to validate these principles, so much so that they represented values that we all shared and subscribed to very quickly.

00:07:41
Dr Mélodie Bernaux: On January 26, at the very start of the EFP these principles were adopted. And then, a little more in-depth work began, as we started working with all the member states to build a common vision of these principles. Ethical principles are a phrase, and it's important to spell them out and understand them in the same way, even if we wanted them to be self-explanatory, self-evident and very clear in English and French. For the time being, we needed to dig a little deeper into what was implied by these principles, and try to identify usage in the different member states.

00:08:26
Lionel Reichardt: There are sixteen of these European principles for digital health ethics. As you mentioned, they are grouped into the four major dimensions you mentioned in your introduction. Can you give us a quick overview? And are they legally binding? Could they be?

00:08:42
Dr Mélodie Bernaux: All right. I'll start by presenting them to you. So the first dimension is to place digital health within a framework of humanist values, which we take to be four principles: digital health complements and optimizes the principles of health. Face-to-face healthcare practices. People are informed of the benefits and limits of digital health. People are informed about how digital health services work, and can easily configure their interactions with these tools.

00:09:11
Dr Mélodie Bernaux: Fourth principle for this dimension when artificial intelligence is implemented, the utmost has been done to ensure that it is explicable and free from discriminatory bias. The aim of this dimension is to apply to digital healthcare the principles of free decision, self-determination and consent found in all healthcare practices, and to ensure that the relationship between caregiver and patient remains empathetic and humanistic. The second dimension is to give people control over digital technology and their health data. With four principles.

00:09:43
Dr Mélodie Bernaux: Once again, people have an active role in shaping European and national digital and health data frameworks. People can easily and reliably retrieve their health data in a commonly used format. People can easily obtain information on how their health data has been or can be accessed and for what purpose. And people can easily and reliably give access to their health data and exercise their rights, including their right to object, where applicable.

00:10:12
Dr Mélodie Bernaux: This dimension is designed to give users control over their healthcare data. It's not ethical not to have easy access to health data. It's unethical not to be able to access your health data when you're abroad. And it's not ethical for the RGPP for health data not to be applied in exactly the same way in all EU member states. So, it's really on these aspects that this dimension focuses.

00:10:41
Dr Mélodie Bernaux: We have a third dimension which is developed inclusive digital health. Digital health services are accessible to everyone, including people with disabilities or low literacy levels. Digital health services are intuitive and easy to use. People have access to digital health training, and digital health services offer human assistance when needed. The idea of this third dimension is autonomy and to enable everyone to access and benefit from all the advances in digital health without needing a third party and without needing an intermediary, or if they do need one, not to be faced with new digital tools that would not enable them to benefit from digital.

00:11:30
Dr Mélodie Bernaux: And the fourth dimension, it's about responsibilities, it's about implementing eco-responsible digital health. This is perhaps the dimension that has the most. The most innovative and the one that most surprised our European neighbors. We're pioneers in France in this area, and we have four principles. The environmental impact of digital healthcare is identified and measured. Digital health services are developed in compliance with best ecodesign practices. Reuse and recycling of healthcare IT equipment are provided for, and digital healthcare players are committed to reducing their ecological footprint.

00:12:07
Dr Mélodie Bernaux: Today, these principles, if they are articulated, if they have links with certain European Union legislation. None of them is legally binding. It's the soft law of soft law. On the other hand, we know that the Commission reread its entire proposal for a regulation on a European health data area before publishing the text, to ensure that it respected ethical principles. So we really find ourselves infused throughout the proposal with these principles, and that was really the whole point of adopting them.

00:12:39
Lionel Reichardt: Super, it's very clear. To conclude, Dr Bernaux for the digital health innovators and entrepreneurs listening, why should they care about ethics and these European principles that have been put in place?

00:12:53
Dr Mélodie Bernaux: Simply for the reason we've been talking about throughout our exchange, which is that ethics are the guarantors of individual trust, and without trust, you can't develop uses. And if you don't have usage, you don't have innovation, you don't have the development of digital health. So I think that's what makes it interesting.

00:13:22
Lionel Reichardt: That couldn't be clearer. Mélodie Bernaux Thank you very much. Our episode is coming to an end. Thank you for listening. We'd also like to thank our guest for his availability. Don't hesitate to subscribe to the podcast on your listening platforms. We look forward to seeing you soon for a new episode of 100 Days to Success.

00:13:43
G_NIUS: Those who are making e-health today and tomorrow are on the G_NIUS podcast and all the solutions to succeed are on gnius.esante.gouv.fr.