Good practices and innovations in e-health

March 06, 2020

No more doubts possible, the e-health market is exploding, smart health connected health objects are developing at high speed. Practitioners have noticed this, more and more French people are using them and are very favorable to the development of these tools. As patients take charge of their health, how can they find their way in this exponential choice of smart health connected health objects? Furthermore, what should be the role of the medical profession in the face of these innovations? Elements of answers in our article:

 

Validation of doctors, a prerequisite for safety and reliability

We expect 50 billion smart health connected objects on the planet for 2020, a colossal figure! Among them, there are an increasing number of objects dedicated to health: watches, pill organizers, scales, smart health connected objects that analyze the quality of our sleep… Faced with this growing market, how can we be sure that these smart health connected health objects provide us with good information ? To date, there is no label or certification to justify the reliability of these objects. However, it is essential for its users that these tools be developed in partnership with professionals or healthcare establishments.

The enhancement by the manufacturer of the quality approach implemented with health professionals constitutes an element of reassurance for the user, which may be subject to verification. Another important point to understand: as soon as a smart health connected solution intervenes in the accompaniment of a pathology (in prevention, in treatment, in diagnosis …), it must be declared by the manufacturer as a Medical Device. This typology of smart health connected health object implies compliance with quality requirements to be distributed within the European Union.

Finally, sites like the Guide to smart health connected Health offer assessments of smart health connected health objects. For our site, Doctor Marc Labrunee, Physical Doctor and Rehabilitation, is responsible for the evaluation protocol for each object. It tests the reliability of the tools with a panel of patients and assigns them a score based on objective evaluation criteria which appears on the site to guide each user in their choice.

smart health connected objects: a repository of good practices to adopt

The French High Authority for Health (HAS) defines rules and establishes a guide to 101 good practices to support innovation projects in Health, and promote the development of secure, high-quality applications and smart health connected objects. The HAS confirms the importance of delivering health information produced by health professionals or competent professional bodies.

The data collected must be analyzed by scientifically guaranteed calculation algorithms and interpreted by a competent professional. All of these good practices are categorized into 5 areas (User information, Health content, Technical container, Safety and reliability, Use and use), and each of the criteria is evaluated according to criticality levels. Very clearly, this standard established by HAS constitutes for manufacturers the “bible” of quality requirements.

Clinical validation of medical devices: a new European regulation

On May 26, 2020, the new European regulations relating to medical devices will come into force. It will tighten current requirements, and will in particular require the creators of these high-risk devices to conduct clinical trials to prove their reliability and safety. These innovations will be classified by risk level for the patient or the healthcare professional.

The mandatory CE marking is reinforced to justify compliance. smart health connected health (telemedicine, smart health connected objects, health applications, etc.) represents great potential for the medicine of tomorrow and is gradually becoming part of the patient care process. To meet this challenge, smart health connected health objects must meet minimum quality standards, and be based on scientific validations adapted to the purposes of use.

About good practices in terms of smart health connected health objects, we interviewed Alexandra Lafontaine, CEO of Ludocare: companion-smart health connected robots for children with chronic diseases.

How was Ludocare born?

Ludocare are smart health connected robots to help patients take their medication in a fun way. Our solution was born out of an observation: The World Health Organization (WHO) estimates that almost 50% of the treatments prescribed in the world are little or badly followed by patients suffering from chronic diseases. As a reminder, chronic diseases are pathologies with which the patient is affected throughout his life that cannot be cured.

These diseases are controlled and managed with daily and multiple fund treatments. We all have in mind for example: diabetes, asthma or even heart failure. In a few figures in France, this affects around 20 million people and represents a total budget of € 95 billion / year for health insurance.

The main problem is not due to the ineffectiveness of the treatments, but to the fact that these treatments are not taken: this is called lack of adherence.

There are several reasons for this, including:

  • Oblivion;

  • rejection of the disease;

  • the tiredness ;

  • the complexity of the arrangements;

  • the heaviness of prescriptions…

This has major impacts: on patients' health in the first place, on their quality of life as well as that of their families and on health systems.

In France alone, expenses due to non-compliance are estimated at 9 billion euros per year! We consider that it is necessary to go beyond the observance until the therapeutic adhesion and for that it is mainly a question of education and this from a very young age. The patient must be given the capacity to be independent and responsible, whatever their age. Thanks to complete and fun solutions: this is what we do with our smart health connected companions: JOE and LEO

What is the role of health professionals in the development of your smart health connected objects?

The development of our solutions was done in a collaborative and participative mode both with healthcare professionals as well as with parents and children. We carried out reflection and co-construction workshops to fully understand and comprehensively identify all of the stakeholders' needs. We systematically validate our hypotheses with our customers, patients and doctors before confirming and launching developments. We create solutions dedicated to patients and their families, who are in a better position than us to tell us what they need.

We launched a Review campaign in 2018 which brought us a lot and allowed us to make the design modifications recommended by families.

Of course at the medical level we have a scientific committee made up in particular of a pulmonologist, Dr Marc Sapène also president of the Asthma and Allergies association, as well as a pneumo-allergist, Dr Madiha Ellaffi former director of the Center of Resources and Skills for Cystic Fibrosis. Their role is to support us and allow us to benefit from their professional experience in contact with patients on a daily basis.

You will soon launch a clinical study, for what reasons? And what does it consist of?

Indeed we are going to set up an observational clinical study which will extend over 12 months. The objective of this study is to provide proof of the usefulness of our systems in the context of a rigorous and independent evaluation. It consists in setting up our devices in a population of patients selected by investigative doctors who ensure their medical follow-up throughout the study. At the end of the observation period, several parameters and indicators are assessed to meet the objective of the study. It is the normal evaluation procedure for drugs, medical devices and smart health connected health devices. These studies are the subject of scientific publications within the medical world.

To guarantee the independence of the results, we collaborate with a third party organization called Contact Research Organization which will execute the implementation and follow-up of the entire study. Our objectives are to demonstrate the impact of our solutions on improving the quality of life of families as well as on the evolution of the level of therapeutic education of patients. This will allow us in a second step to approach complementary organizations and social security.