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G_NIUS: Hundred Days to Success. This is the podcast of G_NIUS, the Guichet national de l'innovation et des usages en e-santé. With Lionel Richard, meet e-health 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 digital healthcare, but also at 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 digital health acceleration strategy, I'm pleased to welcome David Sainati, pharmacist, project director at DNS, the Ministerial Delegation for Digital Health within the Ministry of Health and Prevention, and inter-ministerial coordinator for the digital health acceleration strategy. David Sainati, hello.

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David Sainati : Hello.

00:01:01
Lionel Reichardt: First of all, could you remind us of the genesis and ambitions of the digital health acceleration strategy?

00:01:07
David Sainati : The digital health acceleration strategy is first and foremost an interministerial strategy. It's important to stress this. This is the first time that we've had the opportunity to have a digital health strategy backed by all the ministries involved. The Ministry of Higher Education, Research and Innovation, the Ministry of the Economy, Finance and Recovery, the Ministry of Health and Prevention, and the General Secretariat for Investment, one of the Prime Minister's departments.

00:01:28
David Sainati : This acceleration strategy is a unique opportunity to position France as a leader in digital healthcare. It is also in line with the momentum of the digital health roadmap, which is being driven by the ministerial delegation for digital health and amplified by the [inaudible 00:01:42- 00:01:42] of digital health. This acceleration strategy has a budget of 650 million euros. It was announced by the French President last June and officially launched by the ministers concerned in October. This strategy is truly a unique opportunity. It's an alignment of planets with all the national digital health plans, which really is an opportunity for our sector to emerge, our digital health sector in France.

00:02:08
Lionel Reichardt: Effectively, you mention 35 recommendations. What exactly is this digital health acceleration strategy roadmap and what resources have been allocated?

00:02:17
David Sainati : The digital health acceleration strategy, effectively, comprises 35 actions in five axes for a total of 650 million euros. These five areas are broken down as follows. There is training, research, maturation, evaluation and large-scale deployment. These areas are kinetic in nature, following project leaders throughout the life of their project. First of all, training. This is a very important action for us. Training is one of our priorities. We want to train more healthcare professionals, paramedical and medico-social staff.

00:02:54
David Sainati : That makes a total of 210,000 students who will be trained in digital health by the end of the acceleration strategy by adding digital health modules to their initial training courses. We will therefore be funding higher education establishments so that they can carry out this training under the right conditions. We are also going to fund higher education establishments to create more training courses for digital health engineers, lawyers in digital health law, but also experts in medical device regulation and quality, where we know that there is strong tension on the market today for these professions and where companies are finding it hard to recruit.

00:03:29
David Sainati : Another major focus of the strategy is research, with a dedicated research budget of 60 million euros and a research program to be launched shortly. The third axis is maturation, where a number of themes have been prioritized to support innovation in these sectors, notably medical imaging. With a budget of 100 million euros in the form of innovation grants, which will be allocated to consortium or single-partner projects in these sectors, where France can rapidly position itself and take market share. In mental health too, where digital technology can really improve both prevention and care, as well as working conditions in mental health facilities.

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David Sainati : Digital medical devices, which are one of our priorities, and the accessibility of telehealth. The strategy's fourth priority is evaluation and experimentation, with a call for projects worth 100 million euros over five years. Twenty million euros per year will be allocated to co-financing the clinical evaluation of digital medical devices, which will co-finance all the clinical trials carried out on these devices, in order to enhance their value and demonstrate their medical or medico-economic benefits.

00:04:35
David Sainati : Another ambitious call for projects is the experimental call for projects, which aims to create 30 places by the end of the strategy where innovators will be able to test their solutions in real-life conditions. And lastly, deployment, with G_NIUS of course, our one-stop shop that makes life easier for entrepreneurs, but also an ambitious action within the framework of the Social Security Finance Act 2022, called anticipated access, which aims to facilitate coverage, access to reimbursements for digital medical devices.

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Lionel Reichardt: So, effectively, we see a multitude of actions that are planned to enable the acceleration of digital health and the development of uses through the validation and appropriation of this digital health. How in particular does this digital health acceleration strategy impact the entrepreneurial health innovators for whom this podcast is made?

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David Sainati : As part of this strategy, we've made sure to study the lifeline of project holders, digital health projects in order to identify their difficulties and respond to them in the simplest way possible. It's true that sometimes it's complicated. We don't have the answer to everything, and we're not magicians. Nonetheless, we have identified a number of bottlenecks, particularly in the area of digital medical devices, which are the cornerstone of our acceleration strategy. We have identified a number of actions, notably in the area of RRD. I spoke to you about the innovation grants we're putting in place in priority areas - imaging, mental health, telehealth - to support project leaders' RRD.

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David Sainati : Then, we support these digital medical devices in their CE marking with grants that will co-finance support for the constitution of these CE markings, these dossiers. We also provide support for clinical evaluation. I spoke to you about the Clinical Evaluation call for projects, which aims to co-finance and subsidize clinical trials carried out on digital medical devices. So, you can see that the RRD, CE markings, evaluation, reimbursement, we have taken the various stages of these project carriers and we try to respond with these strategies to make their lives easier and give the market more legibility.

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Lionel Reichardt: Rightly, when talking about these innovative entrepreneurs in digital health, you are at the initiative within DNS of the G_NIUS platform you mentioned earlier. This is the Guichet national de l'innovation et des usages en e-santé, which hosts this podcast, as well as all the information on digital health to make life easier for innovative entrepreneurs. Two years after its creation, what do you think of this initiative and what are the next steps?

00:07:01
David Sainati : Effectively, G_NIUS is a great initiative, also itself inter-ministerial and inter-agency, since it was created with the various partners from the Ministry of Health, but also the Ministry of the Economy where we wanted to make life easier for entrepreneurs, as you say. As a former entrepreneur, this project was particularly close to my heart, because it's sometimes difficult - and when I say sometimes, that's an understatement - to find one's way around the digital health ecosystem, the regulations and the financing available. So, G_NIUS is a platform that is developing iteratively.

00:07:33
David Sainati : We didn't aim for perfection from the outset, quite the contrary, but we co-designed it with all the players, entrepreneurs, innovators of all kinds, clusters, competitiveness clusters, to ensure that these services met their needs. We've launched services around regulations, around financing, around ecosystem identification with guided pathways that make life easier. In particular, I'd like to emphasize a guided path that's very topical, which is the guided path to facilitate the referencing of digital services in the catalog of services in my health space, which is open and to which you can apply.

00:08:06
David Sainati : New services will be launched very soon with guided pathways, particularly on digital medical devices. I've just presented the lifeline with the different actions of the strategy that specifically supports these project leaders. We're going to help them through what we know to be a complex regulatory and market access process. We're also going to make life easier for entrepreneurs when it comes to accessing funding, with a search engine that will be able to collate all the calls for projects that are currently available from the various national structures that support innovators.

00:08:39
David Sainati : It's sometimes hard to find your way around. All strategy actions will be available on G_NIUS and are evolving. All news and e-health events linked to our regional partners are also relayed on G_NIUS, the podcast, the LinkedIn page. And we're also going to do more communication to raise awareness of G_NIUS, which is now our one-year challenge. A branding challenge to ensure that entrepreneurs know about G_NIUS and get the G_NIUS reflex before contacting the relevant agencies or ministries to ask questions that they'll be able to find answers to easily and in two clicks on our platform.

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Lionel Reichardt: To conclude, and in order to spread the word about this digital health acceleration strategy, you've embarked on a Tour de France that runs, I believe, until summer 2022 in several cities. Can you tell us a little about it? What are you up to? What are the next locations and dates?

00:09:28
David Sainati : Effectively, this Tour de France is a major one for us and we really wanted to do it quickly. The health crisis didn't allow us, when we were building the digital health acceleration strategy, to go out and meet project leaders, to meet them in person. We met them via videoconferencing, but that wasn't enough for us. We really wanted to go out and meet them in the territories, to gather their problems, adapt certain actions in the strategy if necessary, and promote calls for projects and current or future actions.

00:09:59
David Sainati : So, nine dates are planned throughout France and the French overseas territories, with dates in Paris, Montpellier, Grenoble, Bordeaux, Nice, Lille, Rennes, Strasbourg and Saint-Denis de la Réunion, where in each of these locations we are working with regional partners to identify themes of interest. Themes that illustrate the strategy's actions, but also themes that showcase the region and its innovators. At each stage, we hold a round-table discussion which is broadcast by videoconference, without an audience in general, and you can find the information on G_NIUS to sign up for these videoconferences. But then we meet the players on the ground. We're going to meet the companies that are driving digital innovation in healthcare on the ground.

00:10:44
Lionel Reichardt: So it's simple, just go to G_NIUS. You'll find all the information you need about this Tour de France and, more generally, about digital health and the digital health acceleration strategy. David Sainati, thank you. Our episode is coming to an end. Thank you for listening. We'd like to thank our guest once again 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.

00:11:18
G_NIUS: Those who make healthcare today and tomorrow are on the G_NIUS podcast and all the solutions to succeed are on G_NIUS.esanté.gouv.fr.