The Commission’s DG CONNECT published a Green Paper on mHealth and a Staff Working Document on the existing EU legal framework applicable to lifestyle and wellbeing apps in early May. The purpose of the consultation was to receive the views of all the stakeholders involved in mHealth including regional and national authorities, health professionals, carers, health practitioners, medical associations, consumers, users of mHealth apps, patients and their associations, developers and many other commercial actors.

The consultation questions focused largely on deployment and uptake, as well as on achieving cost savings and market factors. One of the suggestions made by EPHA is to broaden the focus and gather evidence on mHealth’s concrete impact on health outcomes, practicability and digital inclusion before embarking on large-scale implementation initiatives. Overall, there needs to be a good balance between social and economic objectives to ensure that mHealth’s future implementation does not only benefit individuals who already have a range of other quality healthcare options at their disposal. There also needs to be clarification of the applicable legal framework in cases where mHealth solutions fall into the ’grey zone’ between medical devices / in vitro medical devices and other categories, as well as due to convergence of technology, as it is important to avoid legal gaps to guarantee patient safety and quality of care.

The consultation response was also informed by the EPHA Briefing on mHealth released in 2013 prior to the observed increase in interest regarding mHealth policy options.

EPHA response - key points

In its mHealth consultation response, EPHA continues to elaborate a number of the points addressed in the EPHA-led eHealth Stakeholder Group report on Health Inequalities and eHealth published in April 2014, which also touched upon mHealth. The principal question explored is how innovation can be both profitable in economic terms - both for health systems and industry - while at the same time ensuring that the vision of ’Including Everyone’, which was recommended in the high-level eHealth Task Force report, can become a reality.

A number of the most important points, drawn from the 23 questions of the consultation, are summarised below:

  • There needs to be a distinction between solutions that involve entry and processing of sensitive personal health data and those that do not. For the latter group, no specific additional security safeguards may be required. Solutions that depend on collecting personal health data should be subject to the provisions contained in the current and revised Data Protection, e-Privacy and other applicable legislation;
  • mHealth developers should apply ’data protection by design’
  • The right balance should be struck between privacy and user-friendliness so that privacy does not become a barrier to using technology; mHealth should learn from other sectors (e.g., banking). Cloud computing should provide better protection and security of data, and the possibility to have ‘private’ and ‘open’ environments;
  • A common, international language of consent should be developed that can be understood by users worldwide. This could involve standard ‘badges’ or icons that refer to consent for processing certain categories of data and certain purposes;
  • In order to realise the potential of ‘Big Data’ in practice, the development of specific security standards for mHealth may be necessary in order to successfully deploy solutions for (public) health research purposes;
  • Research should clarify what types of apps are on the market and what purposes they serve; research is also required on mHealth’s effects on prevention and health promotion;
  • Good practices, guidelines and experiences should be shared between Member States and at EU level;
  • The Transatlantic Trade and Investment Partnership (TTIP) and other trade agreements should not impose unfavourable regulatory conditions and lower standards in data protection and patient safety;
  • There should be no competition between mHealth and traditional healthcare provision;
  • Ethical and legal concerns over usability, quality, safety, data protection and efficacy must be tackled as a priority;
  • Apps and other mHealth solutions should be integrated more actively into the health system and their use should be coupled with professional guidance, feedback and follow-up by mHealth-trained healthcare professionals.
  • Digital health literacy must be fostered amongst all users to ensure that nobody is left behind.

Next steps

Following the summer break, EPHA will continue to raise and discuss eHealth and mHealth related concerns with the Commission and the eHealth Stakeholder Group, provided that EPHA’s mandate on the group will be renewed.

The impact of new technology on healthcare reform and the implications for end users is also an issue that will be discussed with the newly elected MEPs as part of EPHA’s advocacy work in the health systems area.

Moreover, EPHA is currently involved in a project with industry and NGO partners which will develop and test a health literacy tool for use by healthcare professionals working with migrant mothers in Europe, taking the form of a smartphone app. The solution specifically uses drawings to overcome language and cultural barriers often faced by migrants and facilitate better patient-healthcare professionals interaction. Such a tool would be particularly valuable given that migrants experience important barriers when it comes to accessing healthcare in Europe, partly related to language, resulting in lower health literacy and a disproportionate burden of disease. Lack of meaningful, culturally relevant health information and knowledge pertaining to accessing preventive services also contribute to the deterioration in health status of immigrants over time.

Last modified on July 25 2014.