A lire sur: http://www.atelier.net/en/trends/articles/e-health-existing-legislation-france-quite-adequate_425971
The penetration of connected objects into the healthcare sector will not depend so much on legislative adjustments as on developing the business model.
Interview with Marguerite Brac de La Perrière, a lawyer who is Head of the Digital Health department at the Alain Bensoussan law firm.
L'Atelier: What exactly distinguishes health data from well-being data?
Marguerite Brac de La Perrièr: The distinction between the two is in fact rather tenuous. However it is essential to make a distinction in order to decide which legislation should apply. The legislators have not specifically defined the concept of ‘personal health data’ so it’s up to the CNIL [the independent French regulatory body whose mission is to ensure that data privacy law is applied to the collection, storage, and use of personal data] to decide in each case. Precedents from CNIL rulings, plus the draft European Regulation on General Data Protection, which is due to be adopted soon, nevertheless allow data to be defined as one or the other on a case-by-case basis. Basically, personal health data is information which may reveal a health-related condition in the person concerned. Information on a person’s body weight is not deemed to be ‘personal health data’ unless it points to the fact that the patient is suffering from a definite condition – such as obesity, for example. When it comes to healthcare-related connected objects, the main issue as regards regulation is first and foremost to describe and categorise the device in order to determine the applicable legislation.
So how do you distinguish medical devices from other health-related connected objects?
Medical devices are defined in the legal provisions as “any instrument, apparatus (…) or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes.” For example, a tablet is not specifically designed for medical use, so it would not be called a ‘medical device’, but objects which might be linked to it – a tensiometer for instance – could be. In the same vein, applications and software can be defined as medical devices if they’re specifically intended for medical purposes. From a business viewpoint, you have to remember that qualifying as a medical device with the associated European Community Conformity labelling (EC) doesn’t necessarily mean that you’ll be reimbursed for it through the health insurance system. The product will only be covered by the medical insurance if it’s actually on the list of reimbursable products and services, which means that it’s subject to prior demonstration that it has a high enough ‘expected service level’, i.e. clinical usefulness. In practice, our legal framework in France does allow the use of connected objects in medical practice, although this framework might eventually be made more specific or simplified.
Have you any examples of connected objects that are covered by the health insurance system?
Health-related mobile applications –‘apps’ – which are used for remote monitoring in cases of chronic illness are enjoying a boom, but you can’t yet be reimbursed for them. And there are a lot of connected objects currently being trialled. However, remote monitoring systems for implanted pacemakers are a good example of health-related connected objects – which of course do qualify as medical devices – that are already prescribed, implanted and covered in the same way as the monitoring services provided by healthcare professionals.
What are the next steps on the legal front?
Well in fact the legal and regulatory framework currently in force in France is not a hindrance. Even though some regulatory changes might be seen as necessary, with the main aim of simplifying things, we could still see a surge in connected objects under the current legislation. We should resist our French tendency to pile on the legislation. In the meantime, the European Commission has taken matters in hand and drafted an action plan for online health, which includes clarifying the legal framework by 2020.
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Business & FinanceSeptember 13, 2013
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