[Tribune] What governance for smart health connected health?

[ad_1]

Pierre Simon is the ex-president of the telemedicine company SFT Antel and published a book "Telemedicine, challenges and practices" on October 19, 2015. Expert in e-health, he holds a blog on the subject, where he notably advocates close collaboration between doctors and startups so that the products sold comply with data confidentiality, patient safety and the organization of care. Here, he gives us a forum on the state of smart health connected health in France and abroad and the various types of governance associated with it.

The issue of governance of smart health connected health and telemedicine comes up regularly in the debates and symposia devoted to these themes. The most fervent supporters of "centralized" governance are digital industrialists and start-ups and certain institutions, including the CNOM, which believes that the state must regulate any trend towards the uberization of smart health connected health.

The first national priority telemedicine plan, voted by the Council of Ministers in June 2011, was governed by the State (Ministry of Health) represented within the health regions by the ARS (Regional Health Agencies). This governance, both state and decentralized, worked well for the projects selected in the regional telemedicine plans (2012-17). Should a higher level of governance be created, above that of the ARS, to develop a national strategy for telemedicine and smart health connected health?

Let’s first try to contribute to the answer by looking at what types of governance are in place among our European and North American neighbors and how effective they are.

What about abroad?

In decentralized unitary states like Norway and Denmark, governance of smart health connected health and telemedicine has been entrusted to university hospitals : Odense University Hospital in Denmark and Tromsö University Hospital in Norway. In these two countries, there are only localized telemedicine and smart health connected health programs, responding to specific needs to improve access to care: northern and western Norway and southern Denmark.

The role of university hospitals in the governance of telehealth in Quebec is also illustrated by the 4 RUIS (Integrated University Health Network) which are headed by the CHUs of Montreal, McGill, Laval and Quebec. The Quebec government funds these RUISs for care, particularly those delivered by telehealth. However, not all RUIS have the same development of telehealth, the most important being that led by the McGill University Hospital which has within its RUIS responsibility for care for the Inuit populations of the Canadian Far North.

In federal states like Germany and Spain, local governments manage the development of smart health connected health. There is no national program and the development of telemedicine is very uneven from one region to another. So in Spain, telemedicine is especially developed in Catalonia, Galicia and Andalusia. Likewise in Germany, there is no national program. Thetelemedicine is not developed in all länders. Only three länders (Badr-Wurtemberg, Bavaria, Berlin) have a very structured program in telemedicine, with an essentially hospital development. This is also the case in other Canadian provinces where the development of telemedicine is the direct responsibility of the governments of these provinces (ministries of health).

When there is centralization of organization and management by the State, as in the United Kingdom and the Netherlands, governance is entrusted to a national state agency. In these centralizing countries, like France, telemedicine is part of a national program with fairly mixed results : the UK having trouble developing its program " 3millionlives", While the Netherlands has a program of telemedicine services (as Portavita) which is a real success, still in full development, and which has been the subject of an industrial-liberal healthcare professionals and hospital co-construction.

And in France ?

France has done fairly well with its priority telemedicine program over the past five years thanks to the establishment in January 2011 of a strategic steering committee, centralized governance (see the image below), and decentralized operational management (ARS). It is therefore inaccurate to suggest that the first strategic telemedicine plan would not have had governance….

The French demand for a governance of smart health connected health rests above all on the legitimate desire of the industrial environment to obtain a sustainability of the market of smart health connected health objects and medical devices, and put an end to what some people wrongly call " a clearly immature sector in France (Jean-Yves Paillé, La Tribune du 17/06/2016). The smart health connected health market would know " development difficulties due to insufficient demand from the French population, a framework of trust for health professionals (to be reinforced) so that they prescribe smart health connected health objects ”.

The model of the smart health connected health market in the United States is often taken as a reference by medico-economic commentators from the French media, especially in the study Accenture published in 2015. Is "American" medicine possible in France? We do not think so and most French health professionals do not want it. France has a tradition of clinical medicine that the United States never had. Our country can develop smart health connected health and telemedicine without having to copy the American model. It is also striking to note that many other European countries have a similar approach, in particular those which have a Bismarkian type health system..

So what would be the missions of ideal governance to perpetuate the market of smart health connected health and telemedicine?

This governance should be able to influence the industrial supplier of smart health connected health objects and medical devices, facilitate their use by the citizen or the patient and facilitate their prescription by the medical health professional.

• Influence the industrial supplier of smart health connected health objects and medical devices

No one disputes that we are faced with an excessive production of smart health connected health objects. Some would say it was a real tsunami. More than 100 million smart health connected health devices around the world today and only less than 300 approved today by the FDA in the USA. This bubble may explode in a while.

The market for smart health connected “wellness” objects can hardly be regulated by a health authority. It is generally part of the classic commercial offer and the regulation is done by itself with regard to "gadget" objects whose commercial life is generally short.

There are smart health connected health objects which, without being medical devices, have a health interest in the primary prevention of certain chronic diseases. We think in particular of all these objects allowing the citizen to measure his daily physical activity, his caloric consumption, the evolution of his weight, etc. It's the " quantified self ”. These objects, when well designed, can be real "coaches" for the citizen who wants to control his health risk factors. There are also all these smart health connected objects that can be useful for maintaining a person's autonomy, re-educating certain movements or improving certain handicaps (serious games).

These objects could be prescribed by health professionals as part of a preventive action against certain risk factors or certain disabilities.. A multidisciplinary working group was set up at the Ministry of Health in 2015 (WG 28) to study the labeling conditions, without resorting to CE marking, which would allow health professionals to prescribe them. The conclusions of WG 28 are expected by the end of 2016, hoping that proposals will be made at the time of the LFSS 2017.

Health professionals are in favor of prescribing certain smart health connected health objects, but wish to be involved in their construction, if they are the ones who must be the prescribers. The new governance could favor this industrial-professional healthcare (medical learned societies) co-construction of smart health connected health objects. The current caution of healthcare professionals, in addition to the legal obstacles to be removed, is mainly based on the difficulty of recognizing reliable and secure objects from those who are not. A co-construction of such objects would be able to create a better climate of confidence among health professionals.

• Facilitate their use by the citizen or the patient

The use of certain smart health connected objects for the well-being of the citizen, such as those who measure weekly physical activity, the caloric amount of food, or those that accompany smoking cessation or alcohol consumption, for the primary prevention of the risk of chronic diseases, such as diabetes type 2 linked in large part to overweight, chronic hypertension favored by a diet too rich in salt and excess alcohol, respiratory failure secondary to post-smoking COPD… etc.

Theuse of these objects should be able to be recommended by healthcare professionals (the pharmacist may have an essential role in collaboration with the primary care physician), provided that a health authority has previously given these products a label guaranteeing their reliability and the security of the data they collect and deliver. Financial support, in part or in full (means Review), could then be ensured within the framework of vast prevention programs initiated by complementary health or compulsory health insurance.

The use of CE marked medical devices should be reserved for patients having a proven and advanced chronic disease, whose medical telesurveillance at health home provides a real medical service in terms of morbidity and mortality reduction, demonstrated by scientific studies published in peer-reviewed journals. These telemonitoring medical devices, built with algorithms, are prescribed by healthcare professionals who take full responsibility (safety of results). These devices, which will have the CE label, will be registered on the LPPR. As part of the experimentation art.36 of the LFSS 2014, 4 chronic diseases, of which the patients benefit from an ALD, were taken into account (chronic heart failure, chronic kidney failure dialyzed or transplanted, chronic respiratory failure with assistance respiratory and insulin-treated diabetes complex). The proposals for financing by health insurance, both from the manufacturer or from the service provider for products registered with the LPPR, as well as from health professionals who will provide medical remote monitoring will very soon be subject to an order from the Minister of the health.

In this field of medical telesurveillance at health home for advanced chronic diseases, often responsible for avoidable hospitalizations, France is rather innovative compared to other European countries, especially in the funding model it offers.

The role of users and patients in the choice of smart health connected health objects is essential and must be taken into account. Several user and patient associations are now involved in " living lab » chronic diseases and thus want to assess the quality of use of smart health connected health objects. The co-construction of smart health connected health objects should take into account the opinions of the "e-patient".

Finally, the development of these modes of health home care by telemonitoring systems will be all the easier since medical health professionals have been associated with the construction of the algorithms. This is the position supported by the French telemedicine company (SFT-Antel).

• Facilitate their prescription by the medical health professional

We saw it before, the medical health professional will prescribe certain smart health connected health objects and medical devices when the responsibility he engages in is clearly identified. France has gone further in medical liability law than most other European countries. The role of the pharmacist must also be better defined because the latest health laws (July 2009, January 2016) give him a responsibility in supporting patients with chronic diseases. Can he be a prescriber of smart health connected wellness objects? The question deserves to be debated. The pharmacist has his place in the primary care path in collaboration with other health professionals, the treating physician having legal and regulatory responsibility for the coordination of this care path.

smart health connected health objects and medical devices can be integrated into telemedicine practices. The national priority telemedicine program of June 2011 enabled the development of teleconsultation and tele-expertise in various situations where there was a need to improve access to care.. The next five-year telemedicine development plan could be devoted to the health home care of patients with advanced chronic diseases by medical telemonitoring. The prevention of hospitalizations and emergency visits should have a significant impact on hospital expenditure. But it will take several years to demonstrate this.

In summary, France wishes to innovate in a centralized governance of the development of smart health connected health in order to perpetuate the market for smart health connected objects and medical devices. The chances of success necessarily go through close collaboration between public authorities, industrialists and start-ups of smart health connected health, representatives of users and patients and representatives of medical and non-medical health professionals. If such governance were to be put in place in 2017, it would really be a purely French innovation, because very few countries have made such a central choice to develop smart health connected health and telemedicine. Success in Europe or on the North American continent is mainly linked to very decentralized governance or very small countries. But can it be otherwise in the land of Jacobinism?

[ad_2]

AB SMART HEALTH health home & BUILDING REVIEW