00:00:00
Voiceover: Hundred Days to Success. This is the podcast of G_NIUS, the Guichet national de l'innovation et des usages en e-santé around Lionel Reichardt. Meet healthcare innovators and key experts to help you succeed in your projects.

00:00:20
Lionel Reichardt: Hello everyone and welcome to the 100 Days to Success podcast in this episode we'll be talking about SLA. ANS is the Agence du Numérique en Santé. It supports the digital transformation of our healthcare system, working alongside all the players involved - health, social and medico-social, private and public, professionals and users. It operates under the aegis of the Délégation ministérielle du numérique en santé. To this end, we will be welcoming Franck Le Ouay, co-founder and Chairman of LIFEN, which offers a secure messaging service to simplify and facilitate medical communication between healthcare professionals and patients. He will tell us how and why his company worked with the Agence du Numérique en Santé. Our second guest, Mathieu Slosar, mission manager at the Agence du Numérique en Santé and referent for secure healthcare messaging, will explain how the ANS works with innovators.

00:01:10
Lionel Reichardt: Frank Le Ouay, good morning. Thank you for accepting our invitation. Can you tell us about your background and training, and the idea that led to the creation of LIFEN?

00:01:19
Franck Le Ouay: Thank you for having me here. I'm 43 years old, I'm an engineer by training and I've always had a passion for computers and algorithms. I started my career at Microsoft in the United States. I spent a few years there and then I came back to France, to Paris, to set up a first company called Criteo, which was in the online advertising sector and which developed well since it's now a Nasdaq-listed company with almost 3,000 employees worldwide. And then, five years ago, I launched LIFEN in the healthcare sector.

00:01:57
Franck Le Ouay: The starting point was to observe that in the healthcare sector, there are a lot of silos. People, players need to collaborate, to communicate effectively for the benefit of the patient and for the benefit of everyone, and it's not working well enough. And so, we have tackled this problem of medical coordination by trying to develop tools to facilitate the sending and receiving of medical documents, which is the basis of medical communication, whether between hospitals, general practitioners or patients. In general, all those involved in the healthcare system.

00:02:36
Lionel Reichardt: To develop your solution, you relied on the MSSanté trust space, designed by the Agence du numérique en santé l'ANS. How did you work with ANS?

00:02:45
Franck Le Ouay: For us, it was important, to maximize the adoption of our systems, to comply with the various regulations in force in France, whether on the question of security or exchanges, data storage. Obviously, when you work in the healthcare sector, there are a lot of regulations. It's important to understand what you're getting into, what you can and can't do. And so, naturally, we approached the ANS 5 years ago, when the project started, to understand all this. When you're just starting out, it's not easy to understand what you absolutely have to do, and what you don't. There are a lot of things that exist, but we're not sure what they are. There are a lot of things out there. In any case, we quickly decided that we had to become an MSSanté operator.

00:03:34
Franck Le Ouay: And so there you have it, we've gone through the whole process of becoming an official operator. We've also taken steps to become an accredited healthcare host, which is another type of certification. And then, we took steps to send to the DMP, so different types of steps with the ANS or other agencies.

00:03:59
Lionel Reichardt: What does this MSSanté certification consist of, a standard you can comply with? What does this certification imply and impose for a project developer?

00:04:08
Franck Le Ouay: Already, I'd like to say since we're looking a bit at what's happening in other countries and for the record, I think France has done things very well on MSSanté because already, there's a regulatory framework that's clear. And that's important, because if it's not clear, it means that players are afraid to do this or that. Digital technology in particular can be frightening, as it changes habits. So having a very clear framework that says if you do this, you're referenced, it's official, it's legal. This reassures both manufacturers and operators, so it's a very good thing. The second good thing is to have established a clear specification of what needs to be done in terms of technology, processes, etc., to be certified, and to let the entire industrial market propose solutions based on these certifications. This guarantees the interoperability and security framework proposed by the French government, which is both normal and legitimate.

00:05:15
Franck Le Ouay: And it also allows manufacturers to propose solutions, innovate and let industry play its role in the healthcare sector. It's always a bit complicated to find the barrier between what is the role of the State and what is the role of industry. And in this case, I think it's been handled rather well on MSSanté.

00:05:34
Lionel Reichardt: These repositories are proposed by the Agence du Numérique en Santé. Manufacturers have the opportunity to co-design them. There are calls for industrialists to apply. Has LIFEN participated in these calls for proposals?

00:05:46
Franck Le Ouay: Yes, it's a trend that is, again, positive. In other words, when it comes down to it, when it comes to designing standards, you have to be as close as possible to what's actually happening in the field. And so, what we're seeing is that there's a lot of consultation and debate between the agency and manufacturers like ourselves. Not just us, of course. Everyone is free to get involved in the subjects that interest them. Whether it's MSSanté, or the directory of practitioners, for example, or other subjects. There are regular calls for collaboration, so all you have to do is go to the site to get interested and take part.

00:06:40
Lionel Reichardt: There are other types of ANS open approach, such as Connectathon, what does this consist of? How can it help the ecosystem to develop better?

00:06:49
Franck Le Ouay: The principle is that when a standard is dictated, in practice, afterwards, there may be lots of little adjustments to be made depending on the software and it's important that we can test from start to finish software A which implements the standard, software B which also implements it and do they manage to talk to each other? There's already a nice aspect to organizing these events, bringing together the whole industry, but it's really about provoking exchanges, making sure that we don't just implement a standard in theory, but that we verify that it works in practice from end to end with the various players in the field. So, this was organized for biology last year, and I believe that other events of this type will be organized in the future. And here again, I think it's a pretty good initiative.

00:07:42
Lionel Reichardt: Back to MSSanté, LIFEN is a certified operator. What does this certification mean for you?

00:07:48
Franck Le Ouay: We're going to comply with a framework that is both technical on the technologies we use, on what they call the MSSanté trust space. There is a set of rules to respect, which are normal. There is a set of process rules. We have to make sure that, for example, when we create an MSSanté address for a practitioner, we verify the identity of these practitioners. Here again, it's a matter of course, but it's part of the processes to be put in place. There's a framework in place that we have to respect on a daily basis. And then, there are typically exchange committees between operators, which are organized twice a year, to enable dialogue between the field, the operators who, on a daily basis, develop solutions and are in contact with practitioners, and the agency. It's this type of meeting that has enabled and continues to enable the MSSanté trust space framework to evolve. Typically, not long ago we added the entire medico-social sphere, which wasn't initially present, and I think this was done thanks, in particular, to feedback from manufacturers who said, there's a strong demand, we need to modify the framework to enable this.

00:09:12
Lionel Reichardt: MSSanté is a repository. It's also a certain number of necessary certificates. What does this involve administratively? Does it take a lot of time?

00:09:21
Franck Le Ouay: That's something we would have liked. But I don't think it's part of ANS's mission. The ANS's role is to establish standards and to say whether or not you comply, whether you respect the standards. But unfortunately, they're not going to push one manufacturer over another on a commercial basis. You can't expect that from the ANS, it's not their role. They're not an outsourced sales agency. They will promote the standard, but not promote your solution that implements the standard.

00:09:59
Lionel Reichardt: The ANS also has a role in informing and training the digital healthcare ecosystem, whether it's institutions or manufacturers. These include webinars and e-learning modules. Have you used these services to train your teams or customers?

00:10:11
Franck Le Ouay: In fact, we regularly have to request certificates for establishments, whether on an MSSanté or on the DMP. These certificates are issued by the ANS. This is perhaps a point for improvement. The time needed to obtain a certificate is relatively long. We've had cases where it's taken seven months to get a certificate, which is quite a long time. What could be improved is both the timeframe, and ultimately the interaction we can have with the Agency on this type of process and even others, which is that in fact, we have an online questionnaire, we make the request and then afterwards, it's complicated to know a little where the request stands and why it's blocked, et cetera.

00:10:56
Franck Le Ouay: So, I think we'd benefit from perhaps having named interlocutors, people we can contact to try to understand a little where requests are at. Because if it's taking a long time, it's often because there's a blockage somewhere and so we can maybe help unblock things if necessary.

00:11:23
Lionel Reichardt: You're asking questions about how to work with ANS, the Agence du Numérique en Santé. Elements of an answer with Mathieu Slosar, mission manager at ANS. Hello Mathieu. Can you tell us about your background and training?

00:11:33
Mathieu Slosar: Hello everyone! Indeed, I've been mission manager at ANS for three years now. I trained as an engineer in health information technology at Polytech Grenoble. I then did a lot of work in telemedicine as a project manager before joining the ANS, as MSSanté referent, in particular for the deployment of secure health messaging systems. Today, the Agence du Numérique en Santé has three main missions. The first, a regulatory role, is to promote and develop the standards that will guide e-health in France. These are technical and organizational guidelines. It also has a role in building projects, with the development of several e-health tools, notably the MSSanté port, which we'll be talking about, and finally, a role in deploying and supporting regions to deploy these guidelines and tools so that they serve the greatest number of people. As part of the ANS, I'm involved in these last two missions as a project manager in the Parc division, the stakeholder support and customer relations division, where I'm in charge of the deployment of MSSanté, one of the services supported by the Agency, as well as this link with the regions, where we answer questions, push for news, push for new deployment methods and new advances that the ANS may have produced.

00:13:05
Lionel Reichardt: What are the methods for working with ANS? There are several methods for working with us. In any case, for me, what I'm pushing, which is what's at the core of my conviction about my work with ANS, is that we're always open to working with outside players. It's not a vault where we produce, we're not interested in the outside world. In any case, that's not how I see it. I think it's interesting to be able to exchange views with players at any time, whether it's very early on in the project, to get some information, or even at the very beginning of the launch for technical or organizational questions on the agency's point of view, on different tools, or even afterwards, in evaluation too. It's interesting to get feedback from the field on the added value or how users feel about a new service.

00:13:56
Mathieu Slosar: What you need to know about MSSanté is that it can be a relatively long process, we can come back to that, indeed, but there are plenty of ways to contact us, to see a little as an entrepreneur, industrialist, newcomer on the subject of health or who is more particularly interested in health data exchanges, there are several ways to work with us. I'm thinking in particular of the fact that there are several ways of interfacing with the MSSanté trust space. It's an MSSanté trusted space, not a secure health messaging service. In France, there are 200 secure health messaging services that are compatible with the MSSanté system. As I was saying, this system is not a messaging service, it's an interoperability system between messaging services. The idea is that, before MSSanté was created in 2014, there were several secure health messaging systems that couldn't communicate with each other. It's a bit as if, in traditional messaging, Gmail and Yahoo couldn't communicate with each other. This posed real difficulties for information sharing and exchange between all professionals. So, we built this MSSanté service, this interoperability repository on which operators contract with the ANS to offer a compatible service and which enables all owners of an MSSanté mailbox from any operator, from any industrial or regional service or other, to be able to exchange with anyone in the MSSanté trust space.

00:15:38
Lionel Reichardt: What questions should we ask ourselves when we want to join the MSSanté trust space?

00:15:44
Mathieu Slosar: There's a first question you have to ask yourself, which is what does my service, my solution want to do? What do I want to offer my users? Do I want to offer MSSanté mailboxes to my users? Or do I simply want to interface with my users' existing mailboxes? And to answer this question, as I was saying, you need to look at the organizational model of your solution, i.e. who exchanges what, with whom, how and how often? In other words, when? It's important to stipulate this organizational model, these flows, and then know exactly what you want to do with the trust space. Basically, once you've answered this question, it's much simpler to position the MSSanté bricks where they need to be. If ever the solution is intended more as a messaging client that will interface with various existing MSSanté boxes, then there are already existing repositories for interfacing.

00:17:00
Mathieu Slosar: Same if, on the other hand, the interest is perhaps to have your own MSSanté boxes for interfacing reasons or solution reasons or market positioning reasons, it's more interesting to be your own operator or in any case, to have boxes. At that point, you can either contract with the ANS to become an operator, or go through an existing operator. There are around forty manufacturers offering existing MSSanté messaging services. It's important to remember that the timing may be slightly different. In other words, to become an operator, it may take a few weeks, or even a few months to several months, depending on the existing technical architecture, if you're already a health data host, and so on. On the other hand, going through an existing third-party operator can be much quicker. You'll need to check the list of operators we update on our mssante.fr website.

00:18:00
Mathieu Slosar: The important point I'd also like to come back to is that we're in a secure messaging system. It's a trusted space that enables exchanges between professionals, whether they're healthcare professionals or medico-social professionals, and soon with users, patients like you and me. But we're not talking about an unsecured system with application boxes that can be used to send anything and everything from anyone into the trusted space. It's important to remember that each box is the responsibility of a healthcare professional, so it's worth taking an interest in the solution's organizational and deployment model, to make sure that it's in line with the trusted space. As far as technical standards are concerned, we're using SMTPS standards, etc. There's nothing complicated about that. On the other hand, it's the organization of the solution that really needs attention. That's why we're well aware that switching from a non-secure to a secure messaging system can raise a number of questions, things that are sometimes difficult to get to grips with. We've put in place a lot of support for what we call new industrialists or, soon, new entrepreneurs who want to join the trusted space. Basically, all they have to do is contact us via our various communication flows, or via the MSSanté customer service, which is the e-mail address monserviceclient.mssante@esante.gouv.fr, and we can then set in motion what we call support for new industrialists. There's a 15-minute preliminary discussion to understand your needs. And then, during an hour-long exchange, you'll have three ANS experts, whether technical, organizational or even legal experts, depending on the case, who will enable you, based precisely on these input elements, this organizational model of what you do, your positioning, the players who will be exchanging, to guide you between the different solutions, either interfacing with existing solutions, or becoming an operator, or going through a third-party operator depending on your schedule too. This is an important element that could guide you. You can contact us at any time during the project. Of course, the more mature the project, the easier it is for us to position ourselves. And above all, we like to hear from you afterwards, to see how you're getting on. It's always gratifying to know that through the support we've been able to provide, through our exchanges too, we're trying to get close enough to your questions and problems. It also helps us to design future reference systems to make things easier for everyone. We like to hear how things went. Did you get to do the project you wanted to do, and so on. We won't necessarily be experts in all areas of e-health. We'll be MSSanté experts, but that may open the door to other questions. We'll be able to guide you through the agency at that level.

00:20:53
Lionel Reichardt: Frank Le Ouay, good news for LIFEN the G_NIUS solution, the Guichet National de l'Innovation des Usages en e-Santé, which is there to guide project developers on regulations, funding, the status of proposed solutions, has been launched. If such a platform had existed five years ago, what services would have helped you grow faster and more efficiently?

00:21:16
Franck Le Ouay: I think it's fairly recent, so we, unfortunately, five years ago, did it differently. But there too, I think it's a rather good approach to want to train the widest possible body of industrialists, of people in the standards and the various norms in force. So it's a rather good approach. I think it would also be useful to clarify, what should who do? Finally, as a manufacturer, we ask ourselves the question, there's such and such a standard, such and such a certification, is it really necessary for me to do this, yes or no? Sometimes, it's not very clear. If these platforms could also help guide manufacturers as to what they really need to do and what they don't, that would be really useful.

00:22:16
Lionel Reichardt: Concluding Franck Le Ouay, what advice would you give to a project owner starting out in healthcare innovation today who would like to work with ANS?

00:22:23
Franck Le Ouay: Many things. First, give yourself the time to do it right because all these things take time. Getting certified can take five, six months, or even longer. So don't react in a hurry. I'm also thinking of taking part in the debates they organize, and trying to co-construct the reference systems or specifications with them, if they're being debated. I don't think you should hesitate to do so. They're very receptive to that, and I think it can help everyone. What's next? You have to take the standards, take the guides that are proposed and implement them, that's following the guidelines. What's required is relatively simple. You just have to take the time to do it properly. There's no particular difficulty if you have the will to do it, it's possible for everyone.

00:23:27
Lionel Reichardt: Our episode is coming to an end. Thank you for listening to us. We thank our two guests for their availability, and you for listening. Feel free to subscribe to the podcast on the platforms. We look forward to seeing you soon for a new episode of 100 Days to Success.

00:23:45
Voiceover: 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.