Annunciata la pubblicazione del Green Paper on mHealth

28 Marzo 2014


La vice-presidente della Commissione europea, Neelie Kroes, annuncia che il prossimo 9 aprile sarà pubblicato il Green Paper su mHealth (mobile health). Il documento sarà sottoposto alla consultazione pubblica fino al 2 Luglio.

Il Green Paper affronterà:

– lo stato dell’arte in materia di mhealth negli Stati membri;

– il ruolo del mhealth in sanità;

– questioni giuridiche rilevanti (protezione dati personali, protezione dei diritti dei pazienti);

– una mappatura dell’attuale framework normativo;

– punti critici da affrontare per promuovere lo sviluppo del mHealth;

– policy da adottare.


Di seguito si riporta il comunicato stampa.


On 9 April, the European Commission will publish a Green Paper on mobile health (mHealth). This discussion document launches a public consultation which will run until 2 July 2014.

mHealth covers medical and public health practice supported by mobile devices – such as smartphones, tablets and other wireless devices – including lifestyle and wellbeing applications connecting to medical devices and sensors. It is an emerging part of eHealth where Information and Communication Technologies are used to improve health products, services and processes.

The Commission wants inputs and ideas on what should be done to solve several issues in mHealth – such as data protection and users trust, patient safety, contribution to high quality healthcare – and at what level (EU, national, regional).

Along with the Green Paper, the European Commission will also give guidance to app developers through a Staff Working Document analysing the existing EU legal framework applicable to lifestyle and wellbeing apps.

The background:

mHealth is a rapidly developing field, which can improve the quality of healthcare and make it more efficient by supporting healthcare professionals in treating patients and easing continuity of care. Estimates show that the use of mobile devices could help healthcare professionals save up to 30% of their time spent on accessing and analysing information. Technologies like remote monitoring solutions can also give patients a bigger role in healthcare and can keep them living independently in their own home environment.

However, despite this potential, the uptake of mHealth remains limited in EU countries and healthcare authorities may need more evidence before they implement mHealth at a wider scale.

Other barriers include:

  • The consequent lack of compliance and transparency may prevent users from trusting these apps and hinder the development of the market.
  • A low level of knowledge among app developers of the legal requirements applicable to lifestyle and well-being apps.

The Staff Working Document that the Commission will issue along with the Green Paper, will raise app developers’ awareness of the EU rules in data protection, medical devices (helping them determine whether such legislation applies to their apps or not) and consumer directives.

The Green Paper on mHealth was announced in the eHealth Action Plan 2012-2020, where the European Commission recognised the current and potential benefits of mobile health apps, as well as potential associated risks.