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

00:00:21
Lionel Reichardt: Hello everyone and welcome to the hundred days to success podcast aimed at innovators and entrepreneurs in digital healthcare, but also anyone curious about the field. In this episode, we'll be talking about integrating ethics into the construction of an innovative healthcare solution. To this end, we welcome Paul-Louis Belletante, founder and CEO of BETTERISE, a digital healthcare services platform. We also welcome Brigitte Seroussi, university professor, hospital practitioner at APHP and head of the ethics unit of the ministerial delegation for digital health.

00:01:00
Lionel Reichardt: Paul-Louis Belletante Hello and thank you for sharing your experience with us. Could you first tell us about your training and background?

00:01:08
Paul Louis Belletante: I come from a business engineering background. I quickly turned to entrepreneurship at the start of my professional career. I've had the chance to create several companies in the digital sector and I turned to the world of healthcare, to the world of digital healthcare in 2013, with the creation of BETTERISE.

00:01:26
Lionel Reichardt: You run Société BETTERISE, a company founded in 2013. Can you introduce it to us?

00:01:32
Paul Louis Belletante: BETTERISE is a company that publishes solutions enabling caregivers to treat their patients remotely. We offer a wide range of solutions that enable doctors and nurses to monitor their patients remotely, detect possible complications in their patients and, above all, support their patients remotely in better understanding their treatment, better understanding their illness and, above all, helping them to understand what they need to do on a daily basis to live better.

00:02:02
Lionel Reichardt: So you're a digital healthcare company in the medical sector. Ethics is a very important component. How do you define ethics on a daily basis?

00:02:12
Paul Louis Belletante: For me, ethics is all about actions rather than words. I'm insisting on this because we're in a world of digital health where there can't be many startups evolving. Ethics is often used as a rhetorical flourish, but there isn't much action behind it. Healthcare is a very special field in which to do business. Because healthcare, of course, has patients at the end of the line, and ethics has to be an integral part of all the company's procedures for developing a product. Ethics is not just a label. Ethics is not just a posture. Ethics must be infused into every single one of the company's procedures, whether they be HR procedures, sales management procedures, development procedures, testing procedures, or the day-to-day management of the company. Without ethics, there is no digital healthcare, because without ethics, we put patients at risk.

00:03:15
Lionel Reichardt: When and how did you integrate ethics into your project?

00:03:18
Paul Louis Belletante: So we've really had two parts at BETTERISE. We had a first part from 2013 to 2017 when we chose to have customers rather than raise funds to find financing. We tended to focus on wellbeing, primary prevention and wellness. At the time, ethics were important to us. But we tried to do things well, in line with the various texts we were familiar with at the time. But our priority was above all to deliver to our customers, mainly in the insurance world. In 2017, we were able to make a real turn towards the medical world because our experience had been in the world of primary prevention and we chose to do it all over again. We started from scratch. We rebuilt our entire technical platform, we took over all our procedures. All this was simply to comply with current regulations. You know, there comes a time in a company's life when you step back and say, here's where you want to be in three years' time. We realized in 2017 that if we wanted to be ready to offer digital care in 2020, and we're there now, there were regulations to follow. The RGPD, of course, as far as data processing was concerned, and obviously also the European Regulation on Medical Devices, which came out in 2017 on the basis of this regulation, which comes into force next May. These regulations always take time to come into force. We have taken over all our companies' procedures in terms of development, design, sales management and supplier management. We've internalized a lot of things, and we've completely redeveloped our services to make sure we're offering the highest quality services to caregivers and, ultimately, to patients.

00:05:10
Lionel Reichardt: How does ethics play out in your team today? Are they standards to be respected, values to be shared?

00:05:17
Lionel Reichardt: What's important to see in ethics is that very often when we talk to people, ethics remain rather vague. So it's important to define what ethics is. For us, ethics means doing everything we can to respect patients and ensure their safety. This is how we can then offer services that will enable them to improve their health, because today, we're really involved in the manufacture of genuine medical devices certified by the NSM, which have clinical claims backed up by clinical assessments and which have clinical benefits such as life extension that are recognized and claimed. When we have these promises, many people say yes, but actually, how do you do it? What's the framework? Do you use labels or anything? Once again, our answer is quite simple: we don't need any specific label. Today, European regulations are extraordinarily clear and precise. They're very simple to follow, and these regulations are often based on standards, international standards, ISO standards that you just have to - note the quotation marks - "follow" to be sure that all your company's procedures comply with international expectations, international regulatory requirements. To this end, we have sought certification. We are ISO 13 485 certified for quality in the design, distribution and deployment of medical devices. So we have certifications. We have our products certified as medical devices by notified bodies and as such, we can effectively claim these clinical benefits and we can guarantee our partners, our customers, that these services are reliable, are secure and above all will respect the patient, will respect patient safety and will effectively enable caregivers to care for patients remotely.

00:07:13
Lionel Reichardt: Ethics is mostly about the patient and the data. What is ethical data management for a company in the digital health sector?

00:07:21
Paul Louis Belletante: First of all, it's to ensure that data processing has only one primary goal, and that is the primary goal of improving the patient's health or enabling caregivers to better care for their patient. The main data processing must be done around this. If you change course and say to yourself I'm actually storing a lot of data so I can then resell it to base my business model on it, you're deviating from your core mission.

00:07:49
Paul Louis Belletante: One thing that must remain ingrained in the minds of all our employees is that we do all this to improve patients' health. Therefore, any processing - and I insist on this - that has to be done around patient data, must serve this main purpose. Any other processing must not be authorized, must not be, must not be conceived within the company, or in any case studied with the utmost caution, and must never take us away from our goal, because afterwards, if we make digital health services to harvest data and then sell it, that's quite different from making digital health services to care for patients. So, indeed, data processing is extraordinarily important. This processing is highly regulated by the RGPD in particular, and as such, I'm sorry to come back to certifications and regulatory monitoring, but everything is very precisely set out in the legal texts on this data processing part, what we have the right to do with health data. I also invite all those working on these subjects to consult the French Public Health Code, in particular, which sets out a lot of things, and of course, all the documentation available on G_NIUS or any other tool we use. A lot has been written. Entrepreneurs in the healthcare world are not left alone. It's something we're fighting against. Everything is written down, everything is framed and everything is extremely clear. It's extremely clear what you're allowed to do and what you're not allowed to do. You just have to follow it, and if you add on top of that this notion that only the patient's interest comes first, you're pretty much guaranteed to do things right.

00:09:26
Lionel Reichardt: You're wondering how to integrate ethics into the construction of innovative healthcare solutions. Brigitte Seroussi, university professor, hospital practitioner at APHP and head of the ethics unit of the Délégation ministérielle au numérique en santé of the French Ministry of Health and Prevention, provides some answers. Good morning, and thank you for sharing your views on the subject of ethics. First of all, what is the ethics cell of the delegation for digital health?

00:09:59
Brigitte Séroussi: The ultimate aim of this digital health ethics unit is to ensure that the digital shift in healthcare takes place within an ethical framework, meaning that it's not just about digital tools and services. The idea is to integrate ethics into practices, and to do so as far upstream as possible. So, ultimately, the idea is to develop methods and tools that will measure the ethics of digital health, bearing in mind that the definition of digital health ethics can be said to be the intersection of the benefits of medical ethics and the benefits of digital technology, leaving aside the risks of digital technology. The benefits of medical ethics are autonomy, justice, beneficence and non-maleficence. The risks of digital technology, we may see. The benefits, we know, are the quality of care, better coordination of players, and the risks. In the end, it's all the things that come with digital technology, especially when it comes to data. But if the information and the journey for the coordination of care, it can also pose a problem for patients and also healthcare professionals to know how far the journey is in the hands of whom it travels. The idea is to propose pragmatic safeguards to measure this, to be transparent about these safeguards and to generate trust among all the players in the ecosystem.

00:11:32
Lionel Reichardt: You've effectively defined these notions of ethics in healthcare. How do you then integrate them into an innovative project?

00:11:38
Brigitte Séroussi: Within this digital health unit, we have a number of working groups, including one on this very subject. Its title is "Ethics by Design". It is led by David Gruson. The aim is to propose a guide to best practices for integrating the ethical dimension into solutions as far upstream as possible, since it's by design. So, in fact, we have proposed a segmentation into four, four headings of the construction of a health link solution, with the part, data collection and processing, construction of an algorithm, evaluation of the algorithmic and preparation for production launch, and finally, at the level of these four headings. The idea is to question, because ethics is essentially about questioning. For example, when it comes to data collection, we'll ask ourselves whether you've chosen the right data to best represent the target population, i.e. whether the data in your analysis population corresponds to the target population on which you want to apply the AI solution you're developing. We've heard a lot that AI is racist, especially healthcare AI, because in the end, the analysis population is not representative of the target population on which the solution is to be used. And then, there's something else too, there's more ethics, there's going to be, are we really in line with the purpose? Are we using the right data to serve the purpose of the AI solution? Do we have too much data? Do we have the right data? So there are all these questions. And then, there's also the fact of involving all the players who will be affected by the solution, in particular patients and healthcare professionals, in a scientific and ethical council right from the start of construction, which will ultimately enable us to accompany the various stages of their construction. And then, there are lots of other elements which are the subject of this best practice guide and which we're going to publish fairly quickly precisely to be able to have lines of questioning at each stage of the construction of the AI solution

00:13:56
Lionel Reichardt: Does this notion of ethics resonate with the question of democracy in healthcare.

00:14:01
Brigitte Séroussi: So yes, of course, since what I was saying earlier is that patients need to be on board when it comes to choices and decisions. So, what I understand is that your question is aimed, for example, at this scientific and ethical council, but also at AI solutions. It's true that the principle of medical ethics, which is autonomy, will focus in particular on decision-making autonomy. And what's important is that the decision-making autonomy of the healthcare professional is preserved. That's what article 11 of the bioethics bill stipulates. It's the human guarantee. Where does this leave healthcare democracy? It's because we owe patients an explanation. First of all, we owe it to them to inform them that this artificial intelligence tool has been used to help healthcare professionals make the best possible decisions about patient care. So it's this transparency that's important to bear in mind. But beyond transparency, there is also a duty to inform and explain. So, start-ups and industrial publishers of healthcare-related solutions need to bear in mind that when they develop a solution, they need to be able to explain what it does. Now, explaining what it does isn't always easy, but in any case, you have to explain what can be explained and identify the area that can't be explained, so as to be totally transparent. Today's AI solutions often use massive data to learn algorithms that can discriminate between mammograms with cancer and mammograms without, or between solutions that are more likely to favor certain types of treatment over others. Some things can be explained, because the methods developed include variables that appear to be important in the decision. But there are also things that are not explicable, and this explicability is due to the patient at the time of the decision. It is also due to the healthcare professionals so that they can construct their own and finally transmit it as a recommendation to their patient.

00:16:32
Lionel Reichardt: Ethics can be seen as a constraint for project developers. But what are the benefits and opportunities for an innovative project?

00:16:40
Brigitte Séroussi: I don't agree with you that it's a constraint. I think it's an opportunity, and that's how solution developers should see it. In any case, it may seem like a constraint in the short term, because these are things that have to be integrated into the solution-building process. But in the long term, it's a win-win situation. And I believe that having ethical safeguards is absolutely not a brake on innovation, and it's a real winner in the long term. In other words, this solution will find its audience, it will find its users, precisely because it will have ethics integrated into its approach.

00:17:24
Lionel Reichardt: We're back with you. Paul-Louis Belletante, head of BETTERISE, Brigitte Séroussi also that we've just heard that ethics is born of questioning. What was this questioning for you? How did you respond? Who were you with?

00:17:39
Paul Louis Belletante: We're supported by people whose job it is. Precisely, this respect for regulatory requirements. I'm sorry, but I really must insist on respecting these regulatory requirements, because it really helps us frame this debate. Ethics means doing the right thing to do the right thing, and there are regulations based on standards. So, if you're accompanied by competent people who respect these standards, they'll help you ask yourself the right questions: am I allowed to do that? Can I do that? What's the best way to do this as part of a continuous improvement process? In other words, digital health cannot be treated like any other subject. You really have to ask yourself the right questions, and say to yourself, I really have to ask a question that may seem very simplistic, but I think it's one that many people in the digital health market have forgotten: do I have the right to do this? Do I have the right to market this product? Now, far be it from me to criticize this market because we're a player in it, and we know how complicated it is. But I find that there are far too many entrepreneurs or companies who are not sufficiently aware of these issues of regulatory compliance. It's quite frightening, because it's a real risk for their company, but also for patients. Today, particularly with remote monitoring solutions, when you have data processing that will help a doctor diagnose a patient, when I say data processing, I'm not talking about artificial intelligence or anything else. I'm just talking about analyzing data to bring up a little orange or red sticker next to a piece of data, so that the doctor's attention is focused on that particular piece of data. You're considered a tool that will help a doctor diagnose, so you're considered a medical device, and you have to go and get these medical device certifications. If you don't, you simply don't have the right to practice. The right questions to ask yourself are these ones, you absolutely need to be accompanied on these questions effectively, because it's something that's quite consequential to digest

00:19:53
Paul Louis Belletante: But the question is not is there an alternative to this, no, not at all. Ask the right questions, do you have the right to do so? Get help to make sure you can do it or not. The answers are pretty binary. These days, we hear a lot on the market about yes, but there is tolerance. There is no tolerance. There's no tolerance in terms of regulations, and even less tolerance in terms of health regulations. So, yes, you need support, because if you don't, you're going to make products that don't have the right to be marketed. And controls are beginning to intensify, and that's very good for the market, because there are plenty of players doing things right. Controls will intensify. Watch out for the backlash from the regulatory bodies, who will be auditing a good number of solutions that don't currently comply with these regulatory requirements. So, if we want to be ethical in healthcare, let's start by complying with regulatory requirements.

00:20:45
Lionel Reichardt: Are ethics, precisely, compliance?

00:20:47
Paul Louis Belletante: Compliance is part of ethics. Afterwards, you have two ways of following this, that is, you can do your job as a companion of these minimums. I respect the rules and then, finally, I make files that will be passed on to the organizations and that's enough. I think that ethics, if I may say so, is compliance plus humanity, in other words, you do things well and then you add a layer of humanity by saying, in the end, I'm only doing this to look after people, to enable others to look after people, and so I always put myself in the patient's shoes. I add a human layer to this regulatory layer. And for me, that's what ethics is all about. Why are you involved in digital healthcare? It's because, in the end, it's the most beautiful of all missions. Some people say yes, but it's also a market where there's a lot of value. Yes, it's a good thing there's value, because if a society doesn't give value to everything that helps to improve the health of all the citizens of a country or a planet, then the world is walking on its head. But there are a lot of sectors that are much simpler to undertake than healthcare. I think that if we enter the healthcare field, it's because we want to do things. In the end, we want to improve the condition of all citizens, and that means improving the human condition and supporting people. I think that ethics is obviously a good layer of compliance and then a good dose of humor.

00:22:23
Lionel Reichardt: If it's human and if it's a value, how do you make sure it's shared within a team? Do you have a working group? Do you hold regular meetings? Do you take it into account in your recruitment?

00:22:34
Paul Louis Belletante: This is indeed a point that needs to be addressed. It's not the simplest point, but then again, the human element changes everything. In other words, the compliance framework is framed by our procedures. These procedures are audited regularly. These procedures are certified, so employees have to follow them. It's a daily job to present the procedures to them, to ensure that they are respected, and to make sure that all the company's actions are carried out in accordance with the announced procedures. It's a job, I'll call it a bit of a classic, of setting the company's framework. Then, there's always the human side of things, which takes place on a daily basis, in every exchange, every e-mail, every phone call with one of our employees. We never accept any deviation in our thinking, in our reflections, in the thoughts exchanged in meetings, which might lead us to think at some point that the company's primary interest is not the patient who uses one of our services, but the patient who comes first. So, this really happens on a day-to-day basis, through daily comments to employees and in recruitment. It also happens through this feeling of, sorry I'm going to talk about feeling, but because we're in the human by these exchanges and by saying is this person in front of me carries good values.

00:24:11
Paul Louis Belletante: Beyond the CV, you need to talk to the person you're going to recruit. Ask the right questions, not necessarily about their training or what they've done, but how they see things. When you present your job, how does she react? And if this person has that little human touch, if this person has that desire to do things well, and you can feel whether it's just window-dressing or whether it's a real value rooted in the person. It's a good person. And if the skills do indeed go with it, it's a good person to recruit.

00:24:46
Lionel Reichardt: Should this ethic be embodied in an ethics committee or a scientific committee?

00:24:50
Paul Louis Belletante: Actually, you always have to surround yourself. You always have to look for information. I'll come back to G_NIUS again, sorry, but that's also the point of these episodes. There's a lot of information. There's a lot of people available on the market today, whether it's from private organizations, whether it's from the Ministry, the digital health delegations, the Agence du numérique en santé, G_NIUS and so on. Etc. Who are ready to answer your questions, who are ready to build this e-health market with you. It means never hesitating to surround yourself with the right people and to seek out the right information. Then, of course, it's about surrounding yourself. And first and foremost, surround yourself with doctors, surround yourself with caregivers who manage ethics in a certain way in their day-to-day work. So, yes, a scientific advisory board is essential because, obviously, you need to be accompanied by doctors who have been there for decades, who have patients in front of them and who are constantly reframing you, telling you to be careful, there are patients in front of you, you're not just behind your computer making services for the sake of communication, no, you're making services that really have an impact on the patient's health. So you can't do just anything. Generally speaking, the professors and doctors with whom we work, and we work with a certain number of them in general, are quick to give you a framework on these subjects, and that's a good thing. And I'd like to add, and this is where I find digital health fascinating, that there is a double dialogue, i.e. today, in a hospital corridor, things are happening in real life that are not even authorized in terms of digital health. I'll take as a witness dialogues between doctors in a corridor on a patient case to find the best solution, to find the best diagnosis, to find the best treatment.

00:26:42
Paul Louis Belletante: These are things that are done in a natural way because these people there respect the patient and will never think ill of the patient. They won't use all their discussions to harm patients. When you go digital, when you add a digital tool to these discussions, to this reflection between doctors, you have to add security measures as regards data, as regards confidentiality, as regards data processing. And that's where, paradoxically, you're the one who manages to force caregivers to use tools following certain authentication and identification rules, telling them to be careful, because once your discussions are digitized, once what you say about a patient is transformed into digital data, this digital data can harm patients. So we have to protect them. So, we have to put in place security measures that are defined and, once again, PGSIS is defined in the French Public Health Code, which is quite interesting because, in the end, we start talking to doctors and these doctors frame us by saying, be careful, we can't do just anything, there are patients at the end or at the end of the race often, it's us who find ourselves talking to these doctors and putting constraints on them by saying yes, but in the digital world, there are also these constraints that apply. But once again, it's the exchange that allows us to create beautiful things, and it's extraordinarily enriching. In other words, professors of medicine, doctors and engineers together manage to create services that meet regulatory requirements. that correspond to a high degree of ethics and that have more of a positive impact on patient health.

00:28:24
Lionel Reichardt: Paul-Louis Belletante, to conclude, what advice would you give to a project leader who needs to integrate ICT into his innovative healthcare project?

00:28:32
Paul Louis Belletante: First of all from the start, to feel surrounded, I mean to feel surrounded. As I said, there are a lot of resources available so that an entrepreneur can launch a digital health project knowing fairly quickly and precisely what is possible and what is not. For me, this is the basis once again. There's no point in going off half-cocked with prototypes or things that don't take into account the specific nature of healthcare and regulatory requirements. You need to have a good idea of what you want to do, and immediately confront this idea with different people, and different texts, to be sure that this idea can be successful, and then, on this basis, go ahead and talk to caregivers, doctors and nurses who will help you design your solutions and help you deploy them. A digital healthcare solution is not designed to be discussed on the Internet or at conferences. It's meant to be in hospital corridors, and it's meant to be used by patients. So, by all means, by all means, by all means, the most important thing is to walk the corridors of hospitals when you can, talk to patients, talk to carers and if you do that, if an entrepreneur, really infuses himself with the world of healthcare. If an entrepreneur checks at every moment that what he's doing is authorized within the regulatory requirements afterwards, if you have a good execution of the project, there's nothing stopping you from setting up a good service that's going to help patients live their health better.

00:30:16
Paul Louis Belletante: And then we'll have to find a business model. But I think that's for another episode, another podcast. I'd also like to add that ethics shouldn't be seen as a constraint, as something that's going to bother us throughout our entrepreneurial life. It's the sine qua none condition for ensuring that your project can then be taken up by caregivers, or marketed at all. If you build a service, if you manufacture a medical device that doesn't meet regulatory requirements, you'll never get far. So that's the first issue. It's not a constraint, it's an obligation. And I take issue with all those who say yes, but you have to respect innovation. We mustn't over-regulate innovation, not in healthcare. In healthcare, we have no choice but to comply with regulations, and it's perfectly possible to innovate while respecting regulatory constraints. But entrepreneurship is all about creating within constraints. If there were no constraints, or if everything were easy, entrepreneurship would be very easy. Entrepreneurship means creating something within the constraints you have. So regulation is not a constraint, it's an obligation. But there are two extremely positive points. Firstly, these regulations help you to do things right. Are you in any way responsible for these medical devices? Still, you can be more or less sure that once you've complied with the regulatory constraints and requirements, your service is fit to be marketed. You can already be reassured, and secondly, I'd like to finish on a hopeful note: following regulations is also an extraordinary way of differentiating yourself in a market where there are so many players, and where a very large number of players today, unfortunately, deal with compliance with regulatory requirements, I don't think in the right way, when you talk to a healthcare establishment, when you talk to an ARS, a region, a ministry, the fact of arriving by saying we're certified, we have medical devices that are class 1, class 2A certified with the NS gives credibility to your discourse and a good number of players are really starting to tell you, that's why I'm really insisting for all those who undertake this market. Everyone is realizing that this is indeed an obligation, and all companies involved in digital e-health, who haven't yet considered the importance of regulatory requirements, should really look into the matter, because firstly, they have no choice, and secondly, in doing so, there's really going to be a premium on companies in this market who are totally compliant with regulatory requirements.

00:33:19
Lionel Reichardt: Paul-Louis Belletante Thank you for this insight. Our episode is coming to an end. Thank you for listening. We'd like to thank our two guests for their availability, and you for listening. Don't hesitate to subscribe to the podcast on your listening platforms. We look forward to seeing you soon for a new episode of "one hundred days to success".

00:33:40
Voice-over: Those who make healthcare today and tomorrow are on the G_NIUS podcast and all the solutions for success are on gnius.esante.gouv.fr