A new era for eHealth in the EU

August 2018 | EXPERT BRIEFING | SECTOR ANALYSIS

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On 20 April 2018, Andrus Ansip, the current vice president of the European Commission for the Digital Single Market (DSM), stated in a blog post: “Digital technology can help: to increase efficiency, bring innovation, improve people’s quality of life as well as encourage healthy living”. A number of European Union (EU) initiatives are being deployed to promote eHealth solutions to improve people’s health, including the ‘Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society’, which was adopted by the Commission on 25 April 2018. However, significant potential barriers, including privacy concerns, still cloud the full deployment of such solutions.

Background

For some years, digital innovation in the health sector has been the subject of many discussions and policy initiatives, as part of the EU DSM strategy. Such discussions and initiatives date back to 2004 when the first EU eHealth action plan was adopted. Since then, legislative and policy initiatives have continued, both at EU and Member State level.

In Belgium, for example, a legislative proposal on the compulsory use of electronic prescriptions is currently being discussed in parliament. Also, in April 2018, the pharmaceutical industry launched the new ‘e-PIL’ pilot project in Belgian and Luxembourg hospitals, with the support of the Belgian and Luxembourg national competent authorities and after obtaining a derogation from the Commission. This pilot project aims at replacing paper versions of patient information leaflets with electronic versions.

At EU level, the eHealth action plan 2012-2020 was adopted in 2012 with the aim of providing a roadmap to EU Member States and addressing barriers to the interoperability and implementation of eHealth systems in the EU.

Potential concerns

As recognised by the eHealth action plan 2012-2020, the eHealth objectives of the EU are hindered by a number of challenges, such as a lack of awareness and trust in eHealth tools and services among patients, citizens and healthcare professionals, high start-up costs involved in setting up eHealth systems, inadequate or fragmented legal frameworks (for example, a lack of reimbursement schemes for eHealth services) and lack of interoperability between eHealth systems.

In this regard, privacy concerns are particularly significant. The EU General Data Protection Regulation (GDPR), which became applicable on 25 May 2018 and which provides a uniform set of data protection rules across the EU, constitutes indisputably a new rising challenge for the development of eHealth solutions. Under the GDPR, health data may only be processed in limited circumstances, such as where a data subject has provided its explicit consent to such processing, and the processing of health data must follow general data protection principles, for example data accuracy or data minimisation. Any data collected through digital health solutions, including wearables, apps, devices and others, will necessarily encompass health-related data and therefore potentially raise privacy and cyber security concerns. Under the GDPR, companies are now faced with unprecedented high fines for breaches of data privacy rules which can reach up to €20m, or up to 4 percent of a company’s total worldwide annual turnover.

Latest developments

With an eye toward future developments, the Commission adopted the long-awaited ‘Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society’ on 25 April 2018, following the review of stakeholders’ comments submitted as part of a public consultation on the transformation of health and care in the DSM carried out by the Commission between July and October 2017.

The Communication highlights the new opportunities offered by eHealth to prevent diseases, meet patients’ needs, address shortages in healthcare staff, secure equal access to high-quality healthcare and maintain sustainable healthcare systems across the EU. The Communication emphasises that eHealth can benefit people and healthcare systems as well as the economy, which is an accomplishment identified by the Commission as a ‘triple win’. In order to implement these new eHealth opportunities, the Commission calls on Member States to transform their national healthcare systems. Indeed, the Communication acknowledges that such healthcare systems need to be reformed and must incorporate innovative solutions in order to become more resilient, accessible and effective, and cope with future challenges.

Most importantly, the Communication sets out the Commission’s action plan which revolves around three main pillars: (i) ensuring citizens’ secure access and sharing of health data cross-border; (ii) sharing data and infrastructure to improve research, diagnosis and personalised treatment; and (iii) empowering individuals and person-focused care through digital services.

The Commission’s action plan seeks more in particular to (i) enable the cross-border exchange of electronic health records by establishing a ‘European electronic health record exchange format’; (ii) support the cross-border exchange of ePrescriptions and electronic patient summaries; (iii) develop mechanisms to support the sharing of medical information and resources for the purposes of research and disease prevention; and (iv) encourage in general the coordination and collaboration between national healthcare authorities. According to the Commission, the first exchange of ePrescriptions and electronic patient summaries are expected to start in 2018 in eight or nine Member States with around 22 Member States to follow by 2020.

With this action plan, the Commission aims to ensure faster diagnosis, personalised treatment and better health outcomes. This objective reflects the need expressed by 93 percent of the respondents to the public consultation that citizens must be able to manage their own health data.

The Communication also refers to wearables and mobile health (mHealth) apps, which are currently on the rise. mHealth is recognised as a way to allow citizens to monitor their everyday health. Evidently, according to the Commission’s ‘Eurobarometer’ survey published in 2017, more than half of EU citizens want online access to their medical and health records. The Communication notes that health data collected by mHealth apps can boost research and contribute to disease prevention and improved treatment in the future. Of course, the development of mHealth apps depends largely on access and sharing of personal data. As large amounts of sensitive personal data are likely to be collected and processed by mHealth devices and apps, security remains the preliminary concern. In that respect, the Communication recognises that data protection rules and principles constitute core elements in accomplishing the proposed actions. This was also recognised during the public consultation where privacy breaches (66 percent) and cyber security concerns (54.4 percent) were identified as the main restrictions to data sharing.

The Commission proposal for Horizon Europe

The Commission is expected to support eHealth through funding from the ‘Horizon 2020’ and the ‘Third Health Program’. Notably, the Commission published on 7 June 2018 its proposal for the next research and innovation programme (Horizon Europe) laying down the EU budget from 2021 to 2027 that will succeed Horizon 2020.

The Commission initiative for linking genomic databases

In the context of these new developments, in April 2018 the Commission also launched an EU initiative for linking genomic databases across EU Member States’ borders. Up until now, 14 EU Member States have joined this initiative by signing a declaration to collaborate on the secure cross-border access to genomic information (Bulgaria was the 14th Member State to join). Characterised as a ‘game changer’ by the Commission, the sharing of genomic data “will improve understanding and prevention of disease, allowing for more personalised treatments (and targeted drug prescription), in particular for rare diseases, cancer and brain related diseases”.

Conclusion

Emerging technologies have certainly given rise to new policy, legal, regulatory and business challenges; but they are also providing promising avenues for improved health and treatment in the EU. It is the Commission’s stated intention to continue to support digital health in the next few years and to assist the restructuring of national health systems through funding and actions that sustain cooperation and exchange of best practices between EU Member States.

Clearly, although certain initiatives have been put in place to make eHealth a reality in and across EU Member States, the EU is currently facing a challenge in developing and strengthening eHealth solutions in a uniform and consistent manner. Such a challenge can result in opportunities for healthcare, health systems, the economy, individual citizens and the healthcare industry, and bring about important changes to national healthcare systems. As illustrated by the ‘e-PIL’ pilot scheme, there is room for the industry to dynamically respond and grasp the new promising opportunities emerging as a result of digitisation. However, the legal and regulatory issues revolving around eHealth are still complex, new and risky, especially with regard to the protection of sensitive health data and a delicate balancing exercise needs to take place to ensure that these disruptive new technologies evolve at the same pace as the legal and regulatory framework that applies to them in the EU. This is no mean feat because the pace of technology is much faster than the pace of the law.

Cristiana Spontoni is a partner and Elinor Pecsteen and Katerina Skouteli are associates, at Jones Day. Ms Spontoni can be contacted on +32 2 645 14 48 or by email: cspontoni@jonesday.com. Ms Pecsteen can be contacted on +32 2 645 14 11 or by email: epecsteen@jonesday.com. Ms Skouteli can be contacted on +32 2 645 11 47 or by email: kskouteli@jonesday.com.

Cristiana Spontoni, Elinor Pecsteen and Katerina Skouteli

Jones Day