Mobile Health in the EU
The European Commission published a Green Paper on mobile Health (mHealth) in
April 2014. mHealth is an emerging and rapidly developing field which has the
potential to play an important role in the transformation of the delivery and personal
empowerment of healthcare, as well as its evidence-base and future research. The
Green Paper focuses on the existing barriers and issues related to mHealth
deployment and seeks to identify how to unlock its potential. This briefing outlines
the main mHealth issues arising and seeks views to contribute to a formal response.
By mobile Health the Commission means ‘medical and public health practice
supported by mobile devices, such as phones, patient monitoring devices, personal
digital assistants and other wireless devices’. This also includes apps that may
connect to medical devices or sensors as well as personal guidance systems.
Key points
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The European Commission has published a Green Paper on mobile Health
The Green Paper launches a broad stakeholder consultation on the existing
barriers and issues related to mHealth deployment in Europe and seeks help
in identifying how to unlock its potential
The issues raised cover a range of important areas such as: data protection,
big data, legal, patient safety, access, interoperability, reimbursement, liability,
research and international cooperation
The results of the consultation will determine whether the European
Commission takes future steps to support mHealth deployment more widely
The NHS European Office is seeking NHS views to enable it to respond to the
EU Green Paper consultation
The potential for mHealth
mHealth could prove to be a key tool in enabling healthcare systems – including the
NHS – to tackle the challenges of an ageing population and increased budgetary
pressure. In particular, it can have a role in increasing prevention, empowering
patients and ensuring a more efficient, and therefore sustainable, healthcare system.
The EU’s mHealth market will reach an estimated $6.9bn in 2017, with savings
across Europe’s healthcare systems of c$99bn. Remote monitoring treatment
solutions constitute almost 60% of the total eHealth deployments, with solutions that
increase the efficiency of the healthcare workforce and systems making up c15%,
alongside health and wellbeing apps. The market for mobile apps has developed
very rapidly, with individuals or small companies accounting for over 64%.
Giving views on the issues at stake
The Green Paper identifies several important issues which affect the deployment of
mHealth across Europe and seeks the associated views of stakeholders through a
series of questions. The issues and questions are listed in Annex I. If you would like
to comment on any of the twenty questions asked please enter directly in the box
and respond to Michael.wood@nhsconfed.org by Monday 23 June 2014.
Annex I - The issues at stake
Data Protection
The rapid deployment of the mHealth sector raises concerns about the appropriate
processing of the data collected through apps or solutions by individuals, developers,
health professionals, advertising companies, public authorities etc. Consumers have
expressed concern about unwanted sharing with third parties, whether intentionally
or otherwise, and mHealth solutions should contain specific and suitable security
safeguards. The forthcoming revisions to EU Data Protection law will be important.
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?
Big Data
mHealth can facilitate the mining of large amounts of health data, which can be used
in research or for the development of more advanced mechanisms for early
detection and prevention. This data mining must, though, be undertaken in
compliance with legal requirements for the protection of personal data.
3) What measures are needed to fully realise the potential of mHealth generated ‘big
data’ in the EU whilst complying with legal and ethical requirements?
EU Legal Framework
The rise of mHealth is blurring the distinction between traditional provision of clinical
care and self-administration of care and wellbeing, with different actors seeking
clarity on their roles and responsibilities in the value chain of mobile health.
4) Are safety and performance requirements of lifestyle and wellbeing apps
adequately covered by the current EU legal framework?
5) Is there a need to strengthen the enforcement of EU legislation applicable to
mHealth by competent authorities and courts? If yes, why and how?
Patient Safety and Transparency of Information
Over 97,000 mHealth apps are currently available globally, across multiple platforms.
Given their variety, consumers, patients or healthcare professionals may find it
difficult to choose the right mHealth solution or app. A lack of trust in these solutions
is apparent, with some not functioning as expected, not properly tested or even
endangering people’s safety. Safety could be demonstrated by using safety
standards, specific quality labels or certification schemes (e.g. Health Apps library).
6) What good practices exist to better inform end-users about the quality and safety
of mHealth solutions (e.g. certification schemes)?
7) Which policy action should be taken, if any, to ensure/verify the efficacy of
mHealth solutions?
8) How to ensure the safe use of mHealth solutions for citizens assessing their
health and wellbeing?
Role of mHealth in Healthcare Systems
mHealth could be a significant tool in ensuring the sustainability of healthcare
systems. In particular, it can have a role in keeping patients out of hospital and in
enabling patients in rural areas or with disabilities to have greater access to
healthcare. The use of mHealth is still well below its full potential though, with a lack
of widespread evidence of its successful use.
9) Do you have evidence on the uptake of mHealth solutions within EU healthcare
systems?
10) 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)?
11) Do you have evidence of the contribution that mHealth could make to constrain
or curb healthcare costs in the EU?
12) What policy action could be appropriate at EU, as well as national, level to
support equal access and accessibility to healthcare via mHealth?
Interoperability
The absence of standards that mandate interoperability between mHealth solutions
and devices impedes innovation and economies of scale. In particular, the app
market is dominated by individuals and SMEs who may not have the necessary
resources for legal advice or knowledge of multi-layered standardization activities,
making the slow uptake of interoperability standards problematic. The issues related
to interoperability are a mix of semantic, technical, organisational and legal.
13) What, if anything, do you think should be done in order to increase
interoperability of mHealth solutions?
14) Do you think there is a need to work on ensuring interoperability of mHealth
applications with Electronic Health Records? If yes, by whom and how?
Reimbursement
The lack of innovative and adequate refund models is a major obstacle to
mainstreaming mHealth solutions within healthcare systems. Some incentive
systems are being established, locally and nationally, to improve people’s health
through behavioural change, though some national legislations still insist that a
medical act can only be performed in the presence of both the patient and the
doctor. Key issues remain over whether and how users pay for the mHealth solutions
and how to incentivise healthcare professionals to use them.
15) Which mHealth services are reimbursed in your home country and to what
extent?
16) What good practice do you know of that supports the refund of mHealth
services?
Liability
The number of actors involved means identifying potential liability arising from the
use of an mHealth solution is complex. The range of means by which patient health
can be damaged could for example include: a defective device, a wrong diagnosis,
IT error, user error etc. There may therefore be a need for greater legal clarity on the
liability risks that these actors may face in designing and using mHealth solutions.
17) 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?
Research and Innovation
There is a need to invest more in research and innovation in mHealth to support the
development of more advanced and innovative solutions while ensuring a high
degree of efficacy and reliability as well as secure processing. Horizon 2020, the
EU’s flagship research and innovation funding programme, will be an important
funder of mHealth going forward.
18) Could you provide specific topics for EU-level research and innovation and
deployment priorities for mHealth?
International Cooperation
Considering mHealth’s cross-border dimension and its potential contribution to
sustainable healthcare systems and the economy, stronger support is needed for
more regulatory convergence in the field and the exchange of good practice
internationally.
19) Which good practice in other major markets (e.g. US and Asia) could be
implemented in the EU to boost mHealth deployment?
Access of Web Entrepreneurs to the mHealth Market
The capacity for web entrepreneurs to enter the mHealth market is a key driver for
the successful uptake of mHealth and the strength of European industry. The EU has
already committed to support networking and training for web entrepreneurs and to
offer legal, financial and technical advice.
20) How could the European Commission stimulate industry and entrepreneurs’
involvement in mHealth?
Please enter any comments you have in the associated box and respond directly to
Michael.wood@nhsconfed.org by Monday 23 June 2014. Thank you for your time.