The Journal of mHealth Vol 3 Issue 1 (Feb/Mar 2016) | Page 29

The Changing Landscape in mHealth and eHealth No one can deny that patient care has become a major public policy concern, nor can anyone reasonably question the impact of inefficient healthcare systems on the economy. It is estimated, for example, that chronic diseases across Europe may lead to 718 billion EUR in lost wages in 20173. Opinion polls tell us that healthcare is consistently valued as a key priority for citizens across Europe, but the reality is that we are no longer able to afford to finance them in their current configuration4. Our healthcare systems that we successfully democratised in the last century have now become our most urgent patients. Recently, there has been a significant rise in the awareness of the consumer wellness market and its possible impact on healthy lifestyles. Of the total 185 million patients who can potentially benefit from mHealth, 141 million patients could improve their lifestyle to some extent through improving how they manage their medical conditions5. For out-patient care situations, mobile-enabled patient support programmes and health data collection for the remote monitoring of chronic illnesses, are offering patients and their care providers new ways of dealing with diseases. For example, providing patients who have chronic illnesses with ITC-enhanced healthcare services and people with personal fitness and wellness tools to help achieve a healthy lifestyle are at two ends of a service spectrum, but they are all part of the healthcare industries ongoing digital transformation. While the healthcare industry is at the early stages of this evolution, empowering patients through simple-to-use and easily deployable preventive services provides the possibility to significantly help resolve parts of the crisis in healthcare. The impact of regulation Existing regulations are one of the key hurdles for mHealth development. Regulatory frameworks for mHealth policy issues, or any form of digital healthcare, are manifold and inextricably intertwined. Of course, regulatory reform is not simple, particularly when it comes to healthcare. Three particularly challenging areas that require a coordinated EU response concern: »» Safety and privacy concerns »» Interoperability (of health information systems) »» Standards (common interfaces and formats) The security of data and the protection of privacy are fundamental issues for digital healthcare innovators, practitioners, legislators and patients. As such, the new European Data Protection Regulation that is expected to go into effect in 2016 will be a welcome development for organisations involved in data processing for scientific research and public health reasons. If, however, data protection is the foundation of the digital healthcare market, interoperability issues constitute its cornerstone. At a European level, there is an almost nonexistence of regulatory frameworks addressing interoperability issues. This will continue to hinder the sustainability and scalability of mHealth solutions, both within national borders but also in the context of transnational or cross-border healthcare. On the other hand, standards and interoperability are key enablers for the scaling up of key digital healthcare services, which, in turn, can help to improve the quality and efficiency of care. While the healthcare industry and industrial consortia have developed some standards, new systems still tend to be bespoke, provided by a single manufa