EU green paper on mHealth – VERY IMPORTANT

This week the European Commission published its green paper on mHealth previously announced in the eHealth Action Plan 2012-2020, kicking off a broad stakeholder consultation on existing barriers and issues related to mHealth deployment and helping to identify the right way forward to unlock mHealth potential. To accompany it, a very short video by Neelie Kroes is available. An accompanying short (10 page) paper by the EC on the current legal position for people using health & wellbeing apps is also well worth a read. Finally, to complete the set, the EC has produced an mHealth infographic as well.

Responses to the Green Paper are required to the European Commission by 3rd July at the latest.

In view of the potential for mHealth to benefit everyone if correctly regulated and supported, all readers are urged to respond, either individually or collectively via an industry body (eg DHACA – see below), or both.

The document, at only 19 pages long, is hugely impressive, making an excellent case for mHealth and identifying those areas where responses from stakeholders will be most valuable. mHealth is uncontroversially defined as: “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices”

There is clearly sensitivity about the role of mHealth, with statements such as “In this respect, mHealth is not intended to replace healthcare professionals who remain central to providing healthcare but rather is considered to be a supportive tool for the management and provision of healthcare” although that does not stop the recognition that changes will be needed to the way care is delivered:

Estimates show that the use of tablet computers and other mobile devices could help healthcare professionals and paramedic staff save up to 30% of their time spent on accessing and analysing information….More medical and care interventions could be done remotely or by the patients themselves, guided by monitoring and reporting systems, reducing hospitalisation….The shift towards patient-centric care may require the re-design of existing infrastructures and healthcare organisations, currently organised around healthcare professionals.

Big data gets an honourable mention too.

At Page 7, the document moves to eliciting responses. Each section has a preamble, followed by questions. The first such covers data protection & security:

  1. Which specific security safeguards in mHealth solutions could help to prevent unnecessary and unauthorised processing of health data in an mHealth context?
  2. How could app developers best implement the principles of “data minimisation” and of “data protection by design, and “data protection by default” in mHealth apps? (Note reference is given as to where these terms are defined)

Next up is big data, where the preamble makes the key point that data cannot retrospectively be analysed in this fashion “if the patient did not expressly permit his personal data to be used for research purposes at the time he was asked for his consent.”:

  1. What measures are needed to fully realise the potential of mHealth generated “Big Data” in the EU whilst complying with legal and ethical requirements?

After that comes applicable EU legal framework:

  1. Are safety and performance requirements of lifestyle and wellbeing apps adequately covered by the current EU legal framework?
  2. Is there a need to strengthen the enforcement of EU legislation applicable to mHealth by competent authorities and courts; if yes, why and how?

For patient safety and transparency of information, which to me is perhaps the most important section of all, dealing as it does with efficacy and safety, the questions are:

  1. What good practices exist to better inform end-users about the quality and safety of mHealth solutions (e.g. certification schemes)?
  2. Which policy action should be taken, if any, to ensure/verify the efficacy of mHealth solutions?
  3. How to ensure the safe use of mHealth solutions for citizens assessing their health and wellbeing?

Under mHealth role in healthcare systems and equal access, the questions are:

  1. Do you have evidence on the uptake of mHealth solutions within EU’s healthcare systems?
  2. What good practices exist in the organisation of healthcare to maximise the use of mHealth for higher quality care (e.g. clinical guidelines for use of mHealth)?
  3. Do you have evidence of the contribution that mHealth could make to constrain or curb healthcare costs in the EU?
  4. What policy action could be appropriate at EU, as well as at national, level to support equal access and accessibility to healthcare via mHealth?

On interoperability, the questions are:

  1. What, if anything, do you think should be done, in addition to the proposed actions of the eHealth Action Plan 2012-2020, in order to increase interoperability of mHealth solutions?
  2. Do you think there is a need to work on ensuring interoperability of mHealth applications with Electronic Health Records? And if yes by whom and how?

For reimbursement, the questions are:

  1. Which mHealth services are reimbursed in the EU Member States you operate in and to what extent?
  2. What good practice do you know of that supports refund of mHealth services (e.g. payer-reimbursement model, fee-for-a service model, other)? Please give evidence.

On the key area of liability, the preamble is disappointingly short as it’s only when you work through some cases that you realise how potentially serious the issue of liability could be, the one question is:

  1. What recommendations should be made to mHealth manufacturers and healthcare professionals to help them mitigate the risks posed by the use and prescription of mHealth solutions?

The section on research and innovation in mHealth begins with the rather extravagant statement that “Diet, exercise and other wellness apps are wildly popular with consumers” and asks the questions:

  1. Could you provide specific topics for EU level research & innovation and deployment priorities for mHealth?
  2. How do you think satellite applications based on EU navigation systems (EGNOS and Galileo) can help the deployment of innovative mHealth solutions?

The penultimate section on international cooperation poses the questions:

  1. Which issues should be tackled (as a priority) in the context of international cooperation to increase mHealth deployment and how?
  2. Which good practice in other major markets (e.g. US and Asia) could be implemented in the EU to boost mHealth deployment?

The final section, entitled access of web entrepreneurs to the mHealth market poses the questions:

  1. Is it a problem for web entrepreneurs to access the mHealth market? If yes, what challenges do they face? How can these be tackled and by whom?
  2. If needed, how could the Commission stimulate industry and entrepreneurs involvement in mHealth, e.g. through initiatives such as “Startup Europe” or the European Innovation Partnership on Active and Healthy Ageing?

Within the Digital Health & Care Alliance (DHACA), we will be attending events in Brussels and elsewhere on the topic and involving our members as much as they want in drawing up a response. This will include a one day members-only event, probably in late May, to work through all the questions. Membership of DHACA remains completely free so come and join us…and contribute!

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