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G_NIUS: 100 days to success. This is the podcast of 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.

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Lionel Reichardt: Hello everyone. You're listening to 100 Days to Success, the podcast aimed at innovators and entrepreneurs in the digital health sector, as well as anyone curious about this field. This podcast is produced by G_NIUS, the French national e-health innovation and usage portal. For this episode devoted to the referencing of digital health services in Mon espace santé, I'm pleased to welcome Jean-Marc Chevilley, Project Director in charge of the Mon espace santé service catalog at DNS, the French Ministry of Health and Prevention's ministerial delegation for digital health. Jean-Marc Chevilley Hello.

00:00:59
Jean-Marc Chevilley: Hello everyone.

00:01:00
Lionel Reichardt: So you're in charge of the service catalog for my health space action number sixteen of the roadmap for digital health. How does the digital services catalog fit into the house symbolizing this roadmap for digital health?

00:01:11
Jean-Marc Chevilley: Actually, the service catalog is a bit like the house itself, since the foundations of the house are there to provide all the base services, everything that will enable information to circulate securely and ethically, of course. You know how attached we are to these ethical issues. And now we can build the house, which has several sections. One of the rooms is my health space.

00:01:42
Jean-Marc Chevilley: You'll find your calendar, a messaging system and the application catalog, which is something completely innovative, because in this catalog, you'll find referenced services, whether private or public, free or paid, which will bring uses to the user, to patients, citizens, which we all are, who will be able to manipulate data or simply find advice on diet, sleep, well-being, or more complicated things where we can find the content of connected devices, glucometers for example, or hospitalization documents. So we're talking about something that's very broad, very wide-ranging, and that's designed to accompany the user throughout their entire journey.

00:02:34
Lionel Reichardt: In 2019, the law relating to the organization and transformation of the healthcare system created an article L1111-13-1 exactly in the Public Health Code that defines the criteria for referencing digital services and tools in my health space. What are these criteria and why was it important to frame this referencing and how is it organized today?

00:02:56
Jean-Marc Chevilley: It's important to point this out. To reference applications, you need a certain number of requirements. I'd even say more than criteria. These are requirements that publishers will have to meet, and so they're going to meet these requirements through very precise criteria that we've defined, by providing proof if necessary. And these requirements will include a whole range of ethical issues, from medical content to artificial intelligence. Of course, there are also safety issues. Security is essential for data protection and for the protection of users more generally.

00:03:35
Jean-Marc Chevilley: Anything to do with interoperability. We talked about data circulation, but to circulate data, you have to be sure of the data formats. So we're going to check the conformity of formats, of a report, of a biological analysis, of a constant to make sure that it can then be exchanged with other applications and find uses for it. We're also looking at the RGPD, where we're going to make sure that data is being processed for the right purpose. Once again, we're dealing with extremely sensitive issues. Beyond holding the data, there's the question of the purpose.

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Jean-Marc Chevilley: And that's being addressed through the RGPD. We have four major bases that we'll be investigating with public authority teams. And for some of them, we're going to ask for proof, since we're in an environment of trust. But trust does not exclude control. And this typically applies to editorial content. When it comes to ethics, we're going to ask for the people who produce this content to tighten their belts, to make sure it's of high quality. To illustrate the point. We have hundreds of criteria, so of course I'm not going to list all the criteria and all the proof. But that's the logic behind it.

00:04:44
Lionel Reichardt: And precisely, afterwards, in terms of organization, in terms of stages, how is this referencing organized?

00:04:50
Jean-Marc Chevilley: There are several stages. In total, there are five. But I'll just mention the main ones. The first stage is what we call verification of compliance with the doctrine. Every year, we update the digital health doctrine, which is not just technical. As we said, we update it as necessary. And the publishers who once again commit to this approach, whether private or public, will have to demonstrate their maturity in relation to the doctrine. And how they ensure compliance. This will be done with the INES teams and INES experts in a tool called Convergence, where we'll simply answer questions to ensure compliance with the doctrine and therefore the maturity of the software or service.

00:05:40
Jean-Marc Chevilley: A quick aside when we talk about application, it's in the broadest sense. They're not just applications in the sense of a download or a store. But the same applies to websites. We refer to all types of applications and services. Parenthesis closed. And so, once we've verified this compliance, we turn to GIE Sesam-Vitale, which will examine the applications. And to process the files, we'll provide them with an extraction of the verification carried out in Convergence, as well as a whole host of administrative information, which will then enable us to get into the technical part.

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Jean-Marc Chevilley: And this technical part, we're going to make sure the APIs work properly. This is what we call the APIs in our technical jargon, which will enable the publishers' solutions to communicate with my health space. So, we're in the process of examining the application. And once the file has been examined, the rapporteur summarizes it and presents it to the commission, which gives its opinion. And once the commission has given its opinion, the Minister will be able to accept the referral to my health space. We'll talk about the commission for a few minutes.

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Jean-Marc Chevilley: The commission is an independent body that was notified, not long ago through a decree. The commission will include two citizens. And why two citizens? Because citizens are at the heart of the project. They helped us draw up my health space as part of the citizen's committee. So they're part of the commission that will judge the admissibility of the applications. We'll find a representative from user associations. We'll find a representative for ethical issues, RGPD, data purposes. A representative of healthcare players. A doctor, for example, someone who will be more concerned with technical aspects, and who will therefore judge interoperability and security issues that will have been examined by INES.

00:07:43
Jean-Marc Chevilley: And finally someone from the economic sector who will simply provide an opinion on the meaning of the solution in terms of value proposition, but in the broadest sense. So these people will meet at least once a month, will receive the files in advance, and will give an impartial opinion, which will lead to referencing. And it's very important to underline this. It's not the Ministry that will decide, it's this commission that will be followed by the Minister's signature.

00:08:20
Lionel Reichardt: Thank you very much for these items. You mentioned it a little while ago, but what services and uses do you think will be referenced and available in the catalog of services in my health space?

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Jean-Marc Chevilley: Of all orders, we have a few in mind. But what we really hope is that we'll discover some and be surprised. But the idea is really to go from well-being to care, and to accompany the user when he's simply well, to the patient. When we're talking about health, we're going to find support for the simplest things, such as nutrition, sports medicine, wellbeing and meditation. A whole host of uses that will accompany the user, some of which we already use in our personal lives. We're going to consolidate all this after another type of application linked to connected devices, whether medical or not. A bathroom scale that needs to send back data every day, a connected glucometer for diabetes monitoring, everything that will revolve around remote monitoring, which is a current topic.

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Jean-Marc Chevilley: So here, we're on connected devices that are going to report vitals. We'll also have data on appointment scheduling. We're going to find slots that will enable users to make appointments. I mentioned the diary in my health space, which will enable users to keep track of their appointments. Then there are more medical documents, such as reports, hospitalization reports and operation reports. The visit, I come back to my sports doctor, the certificate to be able to practice the sport in competition and so on. So you see, there are several granularities and several types of data. And depending on this type of data, we're going to have ethical requirements, security requirements to be able to manipulate them, exchange them with my health space.

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Lionel Reichardt: To conclude, Jean-Marc chevilley, I'm an entrepreneur, an innovator in digital health, I have a service that I want to have listed in the catalog of my health space. What advice can you give me?

00:10:29
Jean-Marc Chevilley: The first G_NIUS board. In G_NIUS, you'll find all the information you need on both the course and the content. And above all, a step-by-step guide to help you decide if you're interested. Because if you're only offering a service to professionals today, you're not concerned. We'll be concerned at a later stage, as part of the package of services for professionals. Another project on which we're making progress, but not today, is the referencing of my health space. Once we've done this in G_NIUS, we know where we stand, we go to Convergence.

00:11:02
Jean-Marc Chevilley: Of course, before going to convergence, we download the doctrine to familiarize ourselves with it. You go to convergence, check your maturity in relation to the doctrine. Then you go to the portal and submit your application. So there's a request for pre-referencing, or at least a preliminary request with some information that enables you to enter the circuit. We then transmit the convergence results, complete the application and follow the process. On a routine basis, this should take between two and three months, depending on the type of solution and its maturity. It's obviously an order of magnitude that allows us to position ourselves a little in relation to an investment logic and therefore to the moment when we want to be referenced.

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Lionel Reichardt: Jean-Marc chevilley, thank you very much. You'll find a lot of information on G_NIUS, the national e-health innovation and use portal (I'll call you back at gnius-sante.gouv.fr), including information on how to register your services in my health space. This concludes our episode. Thank you for listening. Our thanks again to our guest for his availability. Don't hesitate to subscribe to the podcast on our listening platforms. We look forward to seeing you soon for a new episode of 100 Days to Success.

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