7 December 2015
mHealth: What’s (h)appening?
Today we live in times of cost-reduction, budget-constraints and an increased demand of efficiency. The European Commission (EC) has estimated that, without new approaches, average healthcare spending could rise from 7 to 9 per cent of GDP by 2060.
However, there is untapped potential in the innovation brought forward by mHealth, which can help make significant savings in healthcare expenditure. mHealth refers to the use of software applications on portable electronic devices to provide health services and manage patient information. According to recent PWC studies 99 billion euros could be saved in healthcare costs in 2017 if the adoption of mHealth were to be fully encouraged and mHealth could contribute 93 billion euros to the total EU GDP in 2017. A study from the Boston Consultancy Group, based on pilot-projects in Nordic countries, shows mHealth could generate a 50-60% reduction in hospital stays and could reduce overall elderly care expenditure by 25%.
How does mHealth do it? The possibilities offered through mHealth range from a first aid kit manual telling someone what to do when confronted with a serious injury to a monitoring instrument for diabetes patients. mHealth can already help an asthma patient manage their condition and in the near future, mHealth may be able to diagnose someone who has malaria without the use of a blood sample. From measuring blood pressure to sending data to the doctor, mHealth possibilities are almost infinite.
mHealth has the possibility to completely revolutionise the way that healthcare systems function, how patients monitor their conditions, and healthcare professionals perform their jobs. These enormous possibilities can be tapped into not only in the healthcare sector, but by tech companies, app creators, and mobile phone operators across sectors. Yet it is the legal framework for mHealth that will determine how big the economic gains and cost-savings will be. If there is no encouragement for mHealth, the economic gains and cost-savings will be relatively small. If mHealth is encouraged, the gains will be huge.
What is the legal framework for mHealth today? Currently the Medical Devices Directive applies to medical technology, but will soon be replaced by the Regulation on Medical Devices. It seems, however, that the transition between the Directive and the new Regulation will not have a lot of effect on mHealth. Medical software (e.g. software in mammography) will automatically be regulated by the new legislation. However ‘standalone software’, such as in apps, must have a medical purpose
to be regulated by the new Regulation on Medical Devices. The distinction between medical purpose
and non-medical purpose
is not one that is easily made, leading the Commission to issue its Guidelines on the Qualification and Classification of standalone software used in Healthcare.
The legal context doesn’t end there. Of course mHealth produces data, uses data, and transfers data. This is now regulated by the EU Data Protection Directive, the ePrivacy Directive and the Directive on radio equipment and telecommunications terminal equipment. But this is all due to change rapidly with the European Commission’s Digital Single Market strategy.
In the framework of the Digital Single Market the general Data Protection Regulation is undergoing a review (trilogue anticipated to end in December). There will be an additional review in the first half of 2016 of the special rules applying to electronic communications services (ePrivacy Directive); the European free flow of data initiative will tackle restrictions on the free movement of data for reasons other than the protection of personal data within the EU. Yet as Shadow Rapporteur for the Data Protection Directive, Marju Lauristin (S&D, ET), stated during a November workshop of the ENVI Committee, even with the anticipated legal framework, “There are still open questions that will have to be further discussed, particularly on eHealth. For example, will an app developer need to work directly with authorities in all 28 Member States?”
With such questions in mind, the Commission will continue to address the emerging issues of ownership, interoperability, usability, and access to data.
It is clear that the appropriate use of data will be the biggest issue for the future implementation of mHealth. This is illustrated by the opinion of the European Data Protection Supervisor – an independent supervisory authority that ensures the European institutions and bodies respect the right to privacy and data protection in mHealth – in stating key challenges as, for example, the definition of health data
, accountability for data processing
, and the use of big data
There is certainly much work to be done around mHealth, and the anticipated Code of Conduct on mHealth should provide insight on next steps. Created in April 2015 and facilitated by the Commission, the stakeholder group drafting the Code intends to foster trust among consumers that use healthcare apps while creating legal certainty for app-developers by identifying the conditions under which they are allowed to process health data.
One thing is sure, mHealth is moving at national level, EU-level and worldwide. Does Europe want to go with the flow or stay behind? Considering that the EU wants to be an eZone for eEntrepreneurs while keeping its healthcare systems sustainable, mHealth seems like a viable path. Combining both goals, mHealth presents opportunities for growth of the knowledge economy and sustainability of healthcare systems.
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