by Joana Abreu, Editor and Jean Monnet Module eUjust Coordinator
Digital Single Market appears as the common good to be achieved, in the political level, in the European Union which was also embraced by all its Member States, since national and European political agents understood new ICT tools changed the way the world works and how people relate to each other. Furthermore, its establishment allowed overcoming gaps that were appearing between national efforts on digitalization of their internal sectors, particularly when there was a need to make those sectors transnational, by connecting them in a cross-border dimension.
The path to make European efforts on digital domains more effective was to firstly modernise public services, by resorting to ICT tools – that would make them, and especially their relations with individuals, simpler and more flexible. Digitalization of public services was, then, approached through the lens of interoperability – method adopted in order to link national administrations amongst themselves and with European institutions.
Interoperability was proclaimed in the ISA2 Programme through article 1 (1) of the Decision 2015/2240: “[t]his Decision establishes, for 2016-2020, a programme on interoperability solutions and common frameworks for European public administrations, businesses and citizens (‘the ISA2 programme’)”. In this sense, a new paramount was born: the one of e-Government.
In order to meet e-Government goals, European and national agents have made particular efforts to develop other secondary public interests, that would rely on Public Administrations to concretize, implement and regulate them.
eHealth was one of them.
It becomes of great importance to address this topic as much has been said on eHealth relating to malpractice liability, for instance, but there is still much to say on public law domain and, particularly, on what concerns European Union law.
The European Commission has been trying to answer the goal of “enabling the digital transformation of health and care in the Digital Single Market”, as declared in its Communication of 25th April 2018[i], by resorting to new ICT tools to provide citizens access to health services of high quality. If the Commission already advanced citizens were entitled to digital services – which included eHealth – without being discontinued throughout Europe, that European institution also acknowledged particularly the use of interoperable means: “[t]he Commission will launch an integrated standardisation plan to identify and define key priorities for standardisation with a focus on the technologies and domains that are deemed to be critical to the Digital Single Market, including essential sectoral interoperability and standards in areas such as health (telemedicine, m-health)”[ii]. In the aftermath of these explanations, the European Commission published the Mid-Term Review on the implementation of the Digital Single Market Strategy[iii], aiming at “a connected Digital Single Market for all”, where it understood “[d]igital technologies can help improve people’s health and address systemic challenges for healthcare systems”. For those purposes, several measures were recognised as 1) promoting “citizens’ secure access to electronic health records and the possibility to share it across borders and the use of e-prescriptions”; 2) “supporting data infrastructure, to advance research, disease prevention and personalised health and care in key areas including rare, infectious and complex diseases”; and 3) “facilitating feedback and interaction between patients and healthcare providers, to support prevention and citizen empowerment as well as quality and patient-centred care, focusing on chronic diseases and on the better understanding of the outcomes of healthcare systems”. A public consultation was conducted – from 20th July to 12th October 2017 – which answers pointed out the need to promote “better interoperability through open exchange formats” [COM(2018) 233 final].
In fact, there is a sensitivity healthcare services must be rethought since ageing, multimorbidity, health workforce shortages and the rising of preventable diseases and infectious diseases (due to increased resistance to antibiotics and new and re-emerging pathogens) are serious challenges posed to healthcare systems as we know them that lead to public spending elevation on Member States which is not tending to decrease. Therefore, main aims under eHealth are to diminish public spending while better services are being provided. As perceived by the European Commission, “[d]igital solutions for health and care can increase the well-being of millions of citizens and radically change the way health and care services are delivered to patients, if designed purposefully and implemented in a cost-effective way”.
The European Union – relying on data analysis and artificial intelligence – tried to conceive and test new approaches on healthcare in order to ease faster diagnoses. Directive 2011/24/EU, on the application of patients’ rights in cross-border healthcare, already made a favourable path on settling an eHealth framework: based on facilitating cooperation and exchange of information among Member States, a voluntary network to connect national authorities responsible for eHealth was predicted [article 14 (1)], namely by resorting to interoperable applications [article 14 (2) (a)]. It has to fulfil data protection demands as expressively stated in article 14 (2) (3rd paragraph).
Therefore, there is a clear aim of establishing eHealth in the European Union and interoperability was the chosen method to achieve it.
In order to illustrate this, the European Commission published a brochure in August 2019 concerning “research and innovation of ICT for health, wellbeing and ageing: an overview”[iv]. In it, this institution highlights funded projects on eHealth domains. Between them, it also pays particular attention to eHealth interoperability and cross-border eHealth. In fact, addressing interoperability in this area, it stresses interoperability means the ability of systems and organizations to work together (“inter-operate”). Therefore, in this context, publicizes some projects as following:
- PHArA-ON, which aims at establishing interoperable platforms to support European ageing population;
- Smart4Health, which aims at enabling a entered system of electronic medical records on the European Union to potentiate personalized healthcare, particularly being citizen-focused;
- InteropEHRate, which allows electronic health records’ interoperability, authorized and “mediated by the citizen”, that will lead to a cross-border interoperability between medical records and research and development (R&D) apps.
Furthermore, based on the Organization for Economic Co-operation and Development (OECD) and the European Union’s joint publication “Health at a glance” of 2018[v], we can also understand it pays attention to how interoperability can improve healthcare results and can determine a revision of public policies on those matters.
In order to promote “the resilience of health systems”, both OECD and the European Union understood these need to answer “more efficiently to changing healthcare needs driven by demographic changes” and to explore “more fully the potential of new digital technologies to strengthen prevention and care” so a patient-centred approach could be reached.
In fact, ICT tools are perceived both by OECD and the European Union as a way to congregate better services while promoting healthcare systems’ financial sustainability and empowering patients on how they are able to access their health data even in a cross-border scenario.
In order to achieve that, OECD and the European Union underlined the role of electronic medical records and electronic prescriptions (ePrescribing) which can only be achieved by establishing a digitized infrastructure of information to assure the timely and trustworthy exchange of medical information. It would also operate as a database to researchers and to scientific approaches on the matter.
But they also underline the vital role of internet on engaging patients in preventing techniques. In fact, through digital tools, patients could access medical data and interact with health providers in an easier way. Notwithstanding, special data (concerning health and biometric data of patients), which would be used and available, has to be strongly protected and this worry should become an effective “political priority” since the regulation dynamics are difficult to achieve and not everyone is able to tell the difference between wrong and right information when it comes to health issues.
For all that was said, administrative interoperability is already acknowledged as the way forward despite some difficulties that are being experienced on its technical domain (technical interoperability) and some privacy issues that are still being addressed on this eHealth phenomenon.
As it was addressed by us in the past, the promotion of interoperable platforms and databases can lead to better public services and to minimize different treatment and approaches between Member States, promoting further integration by allowing citizens (and patients) to better understand their surroundings and the proceedings they are involved in. However, it has a hidden face that must be recalled: data treated by interoperable means has to be protected through the lens of the highest standard of fundamental rights’ protection as aimed in the European Union.
As interoperable means try to connect national public services, economic agents and data subjects, they also rely on European institutions’ engagement, as they will be mainly responsible for hosting and / or coordinating those platforms and databases or will, at least, will be linked to them. Therefore, there are two legal acts that must be read in articulation – both GDPR (Regulation N.o 2016/679) and Regulation N.o 2018/1725. In fact, when those issues relating technical interoperability are surpassed, both data protection Regulations will be called upon with particular focus on the fact that main data to be treated is going to be defined as sensitive data (which treatment has to be based on, respectively, articles 9 of GDPR and 10 of Regulation 2018/1725).
For this reason, digital literacy should also be a reality, particularly focusing on patients that must be aware about the improvements digital platforms and databases can bring to shift the path of healthcare systems but also to make them aware of the risks associated to the sharing of their data for eHealth purposes.
This becomes significantly relevant since this bet on interoperable means on eHealth comes associated to a change on the teleology of healthcare systems as we know them, which aims at promoting prevention despite treatment; on concentrating on people well-being instead of concentrating on the disease. For this reason, there is a need of trans-sectorial articulation between public services (national and European, not only on health matters but also on R&D matters), private agents (providers of healthcare and ICT services) and individuals (patients), in an interoperable approach.
Despite GDPR and Regulation 2018/1725 being able to establish a regulatory framework on data protection, which will also be capable of securing those health data that will be treated, by predicting ways of articulation between national and European regulatory agents, we perceive a problem that needs to be tackled: in fact, these regulatory solutions are only thought in the sense of promoting personal data protection. However, as there is an aim of accomplishing also a shift on the path taken to maintain a trustworthy healthcare system – eventually promoting a change on its teleology –, it would be useful to create a mechanism that would also engage health regulatory entities. In fact, these national and European authorities have particular sensitivity in health domains that cannot be overlooked in the process and data protection regulators have another point of view to approach the question that cannot also be overlooked. Therefore, a mechanism of engagement and cross-fertilization would be very useful, not only to deploy and develop eHealth aims and goals, but also to be maintained in the future when health matters and ICT solutions will be working alongside, and specific problems will start to appear.
These are preliminary sensitivities on eHealth matters which we understand will take the political, legislative and administrative agendas in the following years, not only in the European Union but also in its Member States.
[i] For further development, see European Commission, Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society, Brussels, 25.4.2018, COM(2018) 233 final, in https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52018DC0233&from=EN [access: 25.10.2019].
[ii] For further development, see European Commission, Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on a Digital Single Market Strategy for Europe, Brussels, 6.5.2015, COM(2015) 192 final, in https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015DC0192&from=EN [access: 25.10.2019].
[iii] For further development, see European Commission, Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the Mid-Term Review on the implementation of a Digital Single Market Strategy – a connected Digital Single Market for all, Brussels, 10.5.2017, COM(2017) 228 final, in https://eur-lex.europa.eu/resource.html?uri=cellar:a4215207-362b-11e7-a08e-01aa75ed71a1.0001.02/DOC_1&format=PDF [access: 25.10.2019].
[iv] See, for further development, European Commission, Research and innovation in the field of ICT for health, wellbeing and ageing: an overview, in https://ec.europa.eu/information_society/newsroom/image/document/2019-33/health_ageing_projects_list_2019_6BC92EFF-90F3-8A94-09FBFA3C4DFD150E_61321.pdf [access: 25.10.2019].
[v] See, for further development and insight, OECD and European Union (European Commission), Health at a glance: Europe 2018 – State of health in the EU cycle, OECD Publishing, Paris, February 2019, in https://doi.org/10.1787/health_glance_eur-2018-en [access: 25.10.2019].
Pictures credits: Mri magnetic… by jarmoluk.