On 14-16 April 2015, the “Fifth National Congress” organized by Società Italiana di Telemedicina e Sanità Elettronica took place. During the congress have been discussed and analyzed several issues and matters related to the impact on consumers’ health of the “health and lifestyle apps” and the proper qualification of medical apps from a legal standpoint.
As a matter of fact, currently in Italy (as well as in EU) it is quite difficult to ascertain whether the so-called “health apps” or mobile health (“mHealth“), provided by mobile devices’ manufacturers as services/software, might be qualified as “medical devices”, according to the definition provided for by art. 1, para 2, let. a) of Legislative Decree no. 46/1997 (the “Decree”), which implemented in Italy the EEC Directive 93/42 of 14 June 1993 concerning medical devices.
The lack of certainty in the qualification of the health-related apps as “medical devices”, is due , in first instance, to the fact that, currently, neither the European Commission nor the Italian Health Ministry have released any official public available guideline on the assessment/qualification of such apps as “medical devices”, pursuant to the relevant definitions provided for by the Decree and for by the Directive mentioned above.
The above, despite of the fact that the mHealth apps are becoming increasingly popular.
To date, only in the United States the Food and Drug Administration (“FDA”) published in September 2013 a Guidance on Mobile Medical Applications, (amended on 9 February 2015) to provide its guidelines about the apps, related to the health and intended to be used on mobile platforms. The FDA clarified that it intends to apply its “regulatory oversight” on a subset of mobile medical apps that present a greater risk to patients’ safety if they do not properly work as intended by the manufacturer.
Given the expanding spread of mobile apps that offer healthcare services, on 10 April 2014 the European Commission published a Green Paper. Namely the European Commission launched a public consultation on eleven issues related to the uptake of mHealth in the EU (including the data protection and the security of health data and the “state of play” of the applicable EU legal framework).
In this respect, in the Green Paper the EU Commission already anticipated the current and potential benefits of mHealth apps (i.e. “More efficient and sustainable healthcare” and “More empowered patients” ), as well as the potential risks related thereto (i.e. “Data protection, including security of health data”).
A “Summary Report on the Public Consultation results” has been published on 12 January 2015 on the website:https://ec.europa.eu/digital-agenda/en/news/mhealth-europe-preparing-ground-consultation-results-published-today.
It has been announced that m-Health will be one of the key topics of the EU agenda of eHealth Week in Riga in May 2015.
The European and Italian legal framework should therefore be constantly monitored, taking into account the future development related to the discussion that will take place in Riga.
Going back to the Italian scenario, it is important to highlight that the Regional Commission on Medical Devices of Emilia Romagnastressed in 2013 the importance of the introduction of a guideline for the proper legal qualification of the “health apps”, anticipating the issues and aspects announced in the Green Paper by the European Commission.
However as mentioned above, the “medical apps” are attracting the attention of several operators and Authorities.
To this end, we would point out that the Italian Health Ministry has announced the implementation of a project for the introduction, by the end of 2015, of an obligation for the manufacturers to notify and register medical app in the “information system” of the Ministry – that already includes the database of medical devices available in Italy. A specific section of the register of the Ministry will be created and it will be accessible by consumers/patients also.
Finally, also the Italian Data Protection Authority has recently published the results of a survey concerning the compliance of the medical apps with the Italian data protection legal framework. The survey highlights that the users are not duly informed nor protected and unable to provide their informed and free consent to the processing of their data, which, in the case at hand, are often “sensitive” since they might disclose “health and sex life” of the data subject (see art. 4 (1) let d) Legislative Decree no 196/2003).