211 separate responses from public authorities, healthcare providers, patients' organisations and web entrepreneurs, inside and outside the EU, gave feedback on eleven issues related to the uptake of mHealth in the EU. While recent statistics confirm that national and EU funding initiatives are bearing fruit and that Europe is set to become the largest market by 2018, responses indicated that more remains to be done so that EU entrepreneurs can effectively access this booming market.
- 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.
The Commission will, in the course of 2015, discuss with stakeholders the options for policy actions (legislation, self- or co-regulation, policy guidelines, etc.).
A series of actions to support mHealth deployment are already foreseen under Horizon 2020 and will be taken into account in future work programmes. mHealth will be one of the key topics on the agenda of eHealth Week in Riga in May 2015.
The public consultation on mHealth was open from 10th April until 10th July 2014. It invited stakeholders to provide their views on 11 issues related to the uptake of mHealth in the EU. These were: data protection, including security of health data; big data; state of play of the applicable EU legal framework; patient safety and transparency of information; mHealth role in healthcare systems and equal access; interoperability; reimbursement models; liability; research &innovation; international cooperation; and access of web entrepreneurs to the mHealth market.
Of the 211 responses received, 71% were provided by organisations and 29% by individuals. Responses were received from industry, national and regional authorities, health professionals, the research community, non-governmental organisations and patient associations.
Figure 1: Distribution of responses by sector and type of the organisation
The largest number of responses came from Belgium (47), the United Kingdom (26), Germany (20) and France (19). The Commission received 19 replies from outside the EU, including 8 from the United States.
Figure 2: Country distribution of responses
mHealth is an emerging part of eHealth, where Information & Communication Technologies are used to improve health products, services and processes. It is a promising area to supplement the traditional delivery of healthcare. It includes applications which
- perform measurements (e.g. of glucose levels)
- complement medical devices (e.g. helping in the delivery of insulin by transmitting control signals to the pump from a mobile platform)
- remind patients they should take their medication
- provide recommendations (e.g. meditating techniques) to improve users' overall health & wellbeing
Published in 2012, the Commission's eHealth Action Plan 2012-2020 already recognised the current and potential benefits of mobile health apps, as well as potential associated risks, and announced this Green Paper on mHealth.
The Green Paper was accompanied by a Staff Working Document to raise app developers' awareness of EU rules on data protection, medical devices (helping them determine whether such legislation applies to their apps or not) and consumer directives.
Find the summary report and all the responses here