Green Paper on mHealth: now online the consultation results

January 12, 2015


The Commission has finally published the results of the public consultation on mHealth launched thorugh the Green Paper in April 2014.


According to the Summary Report, 211 responses were received.


In brief:

◦    “97 respondents believe that strong privacy and security tools (such as data encryption and authentication mechanisms) are needed to build users’ trust. Half of the respondents called for a strengthened enforcement of data protection and the rules applicable to mHealth devices.

◦    Nearly half of the respondents ask for more patient safety and transparency of information, by means of certification schemes or quality labelling of lifestyle and wellbeing apps. Nevertheless, some warn against the risks of over-regulation.

◦    Web entrepreneurs consider it difficult to access the market due to the lack of a clear regulatory framework, interoperability and common quality criteria.

◦    71 respondents think performance and safety requirements and liability rules applicable to lifestyle and wellbeing apps should be clarified, through legislation, self-regulation or guidance.

◦    A fifth of respondents believe more evidence is needed on the cost-effectiveness of mHealth. 21 respondents referred to specific studies and projects which have demonstrated efficiency gains. For example, according to one study, trials in the Nordic countries have shown that mHealth could generate a 50-60% reduction in hospital nights and re-hospitalization for patients with Chronic Obstructive Pulmonary Disease. The same study estimates that mHealth could reduce overall elderly care expenditure by 25%.

Respondents also suggested that:

◦    EU and national actions should ensure interoperability of mHealth solutions with Electronic Health Records (EHRs) for continuity of care and for research purposes.

◦    Greater emphasis should be put on actions to promote open standards and the use of the common open architecture or open Application Programming Interfaces.

◦    Health professionals, care-givers and users should be actively involved in co-designing mHealth solutions”.


In the course of 2015, the Commission will discuss with the stakeholders the proposed suggestions in order to adopt further actions in this sector.


You can download each contribution here