There is already a considerable body of legislation and regulations governing the use of connected objects and digital tools in the medical sphere, but many companies selling them are unaware of the rules or do not really understand what they ought to do in order to comply.

[Health 2.0] Still Insufficient Clarity on m-Health Regulation
An increasingly frequent sales argument for connected objects or software applications is their usefulness on the medical front. Ranging from connected bracelets that measure your physical exercise to alarm clocks which monitor your sleep patterns, the well-being and lifestyle management aspect, from a physical point of view, has become a major component in firms’ advertising of the everyday items they make and sell. However, while the digital health-related argument might well be a decisive factor in helping to penetrate the market, it can also turn out to be extremely expensive if your device does not conform to the strict and precise descriptions set out in European Union legislation governing medical equipment. At a session entitled ‘The m-Health Regulatory Landscape in Europe’ during the recent Health 2.0 event held in London on 17-19 November, the healthcare experts speaking reminded the audience that a regulatory framework for medical tools does exist in current European legislation.

CE labelling

Speakers pointed out that the healthcare sector is regulated by both national and EU bodies. This is very much the case for m-Health applications, which combine the basic issue of medical risk with requirements on patient data privacy. As defined in existing legal provisions, the term ‘medical device’ encompasses a very broad range of product types, from a computer and electrocardiogram equipment through to the software package used. If a connected object or app is in any way linked to medical use, the manufacturer/publisher must now apply for a European Conformity (CE) label, which involves being subjected to a far more exhaustive risk assessment. As far as the data is concerned, "[...] point number one for the legislation is that non-authorised personnel are forbidden to process medical data,” explained Céline Deswartes, Policy Officer for iHealth and Well-Being at the European Commission’s department for Communications, Networks, Content & Technology (DG CONNECT). There are exemptions, the main one being when the person concerned gives his/her explicit consent. However, such consent goes beyond simply ticking a box: the company must explain in detail how it intends to use the data and the purpose to which it will be put. Then, once a device is deemed to be a medical tool, a second question arises as to whether a patient/user will be reimbursed for its cost under the national health system in a given country as an integral part of his/her treatment.

Assistance in navigating the legislative waters

“We hope that incorporating the right to reimbursement will open the way to fast penetration of these tools into national health systems,” underlined Céline Deswartes. Moreover, if an application is reimbursable in the patient’s home country, when s/he is treated in another EU member state, the cost should also be reimbursed for the same amount by the host state. However, the main problem facing m-Health players is that although relevant legislation does exist, it is dispersed under various different headings – healthcare legislation, regulations governing electronic equipment and rules on consumer goods – which can make it extremely difficult for companies to understand the different steps that have to be followed and the label(s) that need to be obtained. The European Commission is promising to bring out a Green Paper early in 2014 to help clarify m-Health legislation and the EU has already set up some support structures for entrepreneurs. "The EU has put in place a number of support networks to foster innovation in the medical sector,” pointed out Céline Deswartes. These include the Enterprise Europe Network, whose offices provide pro bono advice and support to help small and medium enterprises and startups through the maze of EU Regulations, Directives and Decisions that affect their business.
By Quentin Capelle