EUROPEAN COMMISSION Brussels, 25.4.2018 COM(2018) 233 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EMPTY on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society {SWD(2018) 126 final}



1. Policy context: health and care in a digitising world The recent report on the State of Health in the EU concluded that only by fundamentally rethinking our health and care systems can we ensure that they remain fit-for-purpose. This means systems which aim to continue to promote health, prevent disease and provide patient-centred care that meets citizens' needs. Health and care systems require reforms and innovative solutions to become more resilient, accessible and effective in providing quality care to European citizens. Europe's health and care systems face serious challenges. These are ageing, multi-morbidity, health workforce shortages, and the rising burden of preventable non-communicable diseases caused by risk factors such as tobacco, alcohol, and obesity, and other diseases including neuro-degenerative and rare diseases. We are also seeing a growing threat from infectious diseases due to increased resistance to antibiotics and new or re-emerging pathogens. Public spending on health and long-term care is steadily rising in EU Member States and is expected to continue to do so. Digital 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. Digitisation can support the continuity of care across borders, an important aspect for those who spend time abroad for business or leisure purposes. Digitisation can also help to promote health and prevent disease, including in the work place. It can support the reform of health systems and their transition to new care models, centred on people’s needs and enable a shift from hospital-centred systems to more community-based and integrated care structures. Digital tools can translate scientific knowledge into helping citizens remain in good health, thus helping to ensure that they do not turn into patients. They also have the potential to enable a better use of health data in research and innovation to support personalised healthcare, better health interventions and more effective health and social care systems. Data is a key enabler for digital transformation. Health data may be available in various forms; it is not managed in the same way in all EU Member States or within national health systems. It is often not even available to the patients themselves or to public authorities, medical professionals or researchers to help them develop and deliver better diagnosis, treatment or personalised care. Even where it exists, health data often depends on technologies that are not interoperable, thus hindering its wide use. Because of this, health systems lack key information to optimise their services, and providers find it hard to build economies of scale to offer efficient digital health and care solutions and to support cross-border use of health services. As a result, citizens cannot yet fully benefit from the digital single market in this area. Market fragmentation and lack of interoperability across health systems stand in the way of an integrated approach to disease prevention, care and cure better geared to people's needs. The EU is developing strong approaches in high performance computing, data analytics and artificial intelligence, which can help design and test new healthcare products, provide faster diagnosis and better treatments. But succeding in these endeavours depends on the availability of vast amounts of high quality data and appropriate regulatory frameworks that will safeguard the rights of the individual and society as well as stimulating innovation. As the report on the State of Health in the EU concluded, the use of patient-centred health data is still under-developed across the EU. The organisation and delivery of health and social care are the responsibility of the Member States. In some Member States, particularly those with (federal) regional systems, regional authorities are responsible for financing and providing healthcare. Nevertheless, in accordance with the Treaty on the Functioning of the European Union, the Commission can promote public health and the prevention of disease and support cooperation between the Member States, for example, to improve the complementarity of their health services cross-border. The Commission can also take action to stimulate innovation, economic growth and the development of the Single Market in close coordination with Member States. Health and care authorities across Europe face common challenges, which can be best addressed jointly. To this end, the Commission has been working with the Member States, regional authorities and other stakeholders to tap into the potential of innovative solutions, such as digital technologies and data analytics, and in doing so assist Member States in pursuing the reforms of their health and care systems. The Commission provides its support through funding and actions that promote policy cooperation and exchange of good practice. EU funding supports research and innovation in digital health and care solutions, notably through the Horizon 2020 programme. It also supports the building of infrastructure for cross-border exchange of patient summaries and electronic prescriptions, with funding from the Connecting Europe Facility programme. The Directive on patients' rights in cross-border healthcare established the eHealth network to advance the interoperability of eHealth solutions. EU legislation on medical devices, data protection, electronic identification and security of network and information systems offers a range of opportunities to facilitate the responsible use of digital technologies in health and care. Cooperation structures have also been developed; for example, the European Innovation Partnership on Active and Healthy Ageing, the Active and Assisted Living Joint Programme, and public-private partnerships such as the Innovative Medicines Initiative and the Electronic Components and Systems for European Leadership. Regional and national smart specialisation strategies also play a central role in the development of stronger regional ecosystems around the healthcare domain. Since 2004, two eHealth Action Plans have provided a framework for policy action for the Member States and the Commission, and the eHealth Stakeholders Group has played an important role. 2. Need for further EU action To date, the uptake of digital solutions for health and care remains slow and varies greatly across Member States and regions. Further action at EU level is crucial to accelerate the meaningful use of digital solutions in public health and healthcare in Europe. In its mid-term review on the implementation of the digital single market strategy the Commission set out its intention to take further action in three areas: Øcitizens' secure access to and sharing of health data across borders; Øbetter data to advance research, disease prevention and personalised health and care; Ødigital tools for citizen empowerment and person-centred care. For this purpose, the Commission carried out a public consultation. The responses to the consultation largely recognised the need for further work, identifying important challenges that prevent digital health and care solutions from being adopted across the EU and underserve people's needs. These refer to areas such as access to health data, diversity of Electronic Health Records, lack of technical interoperability and access to digital health services. The consultation also identified concerns specific to the electronic sharing of data, namely the risk of privacy breaches, cybersecurity risks and the quality and reliability of data.

On the scope of future EU actions, respondents gave priority to: ·the development of EU-wide standards for data quality, reliability and cybersecurity; ·EU-wide standardisation of electronic health records; and ·better interoperability through open exchange formats. On 8 December 2017, the Council adopted Conclusions, inviting Member States and the Commission to work together on a range of issues and seize the potential of digital technologies in health and care. The Conclusions also call specifically for the implementation in the health sector of existing EU legislation on the protection of personal data, electronic identification and information security. The present Communication sets out how the EU can help meet the objectives of these Council Conclusions. It proposes to build the necessary cooperation and infrastructure across the EU and in doing so help Member States to fulfil their political commitment in these areas. The proposed actions also support the Commission's commitment to deliver on the Sustainable Development Goals on healthy lives and well-being for all at all ages and the principles of the European Pillar of Social Rights. The vision outlined in this Communication is to promote health, prevent and control disease, help address patients' unmet needs and make it easier for citizens to have equal access to high quality care through the meaningful use of digital innovations. It will also strengthen the resilience and sustainability of Europe’s health and care systems. By helping to maximise the potential of the digital internal market with a wider deployment of digital products and services in health and care, the proposed actions also aim to stimulate growth and promote the European industry in the domain. 3. Citizens' secure access to and sharing of health data Citizens have the right to access and share their health data. When it enters into application on 25 May 2018, the General Data Protection Regulation will put citizens in control of the use of their personal data including health data. The public consultation confirmed that a majority of respondents would like to have more access to their health data. They would also like to share the data for their treatment or for research, if appropriate guarantees are in place. Technology should ensure that this is the case with infrastructure that is built in conformity with data protection rules. However, at present, many citizens in Europe have limited electronic access to data about their own health. The data is often untraceable and scattered in different places. This may impact adversely on diagnosis, treatment and follow-up; for example, when a person is abroad and their medical information is not accessible. Moreover, incompatible formats and standards in electronic health record systems continue to be used across the EU. In essence, citizens should have secure access, anywhere in the EU, to a comprehensive electronic record of their health data. Citizens should remain in control of and be able to share their health data securely with authorised parties (for medical treatment, preventive services, research or for any other purpose they deem appropriate). This should be irrespective of where the data is located and in line with data protection legislation. Unauthorised access should be prevented. Current efforts to exchange patient data across borders in the EU rely on the voluntary cooperation of health authorities to connect to the eHealth digital service infrastructure, which is supported by the Connecting Europe Facility (Broadband and Information and Communication Technologies) programme and uses the guidelines agreed by the eHealth network for the governance, establishment and operation of the eHealth digital service infrastructure. Currently, this exchange is limited to patient summaries and ePrescriptions, and does not cover electronic health records. These two use cases of patient data exchanges are planned to start in 2018 between 8 - 9 Member States, with around 22 Member States expected to join the exchange by 2020. Therefore, as the system is now moving into the operational phase, the Commission sees a need to gradually extend these two use cases to also cover the interoperability of Member states' electronic health record systems by supporting the development and adoption of a European electronic health record exchange format. There is also a clear case to develop further effective methods for enabling the use of medical information for public health and research and to develop common identification and authentication measures, as laid down in Article 14(2) of Directive 2011/24/EU. Such changes will require reviewing the management and functioning of the eHealth network to ensure appropriate governance of the eHealth digital service infrastructure and its financial basis. It will also necessitate, in agreement with the eHealth network, extending the current scope of the eHealth digital service infrastructure itself. Developing specifications for a European electronic health record exchange format should be based on open standards and build on appropriate technical expertise, taking into account the potential use of data for research and other purposes. Additionally, the Commission intends to monitor the cross-border interoperability of electronic health record systems and, once in place, the adoption of the European electronic health record exchange format across the EU. Moreover, the Commission intends to identify incentives for adopting the open European electronic health record exchange format widely across the EU and explore other measures to tackle any practices that result in the lack of interoperability, thus hindering the digital single market in this area. The Commission also plans to encourage approaches already developed in some Member States and regions to establish interoperable systems. The Commission will monitor the implementation of the General Data Protection Regulation and the Regulation on electronic identification and trust services for electronic transactions in the internal market with regard to health. The recently proposed rules on certification for cybersecurity requirements may, once adopted, also be factored in the system. Here, account should be taken of emerging technologies such as blockchain, innovative identity management mechanisms, and certification mechanism for secure solutions in line with the cybersecurity Communication and the provisions of the General Data Protection Regulation, in particular, on security, data breach and notification requirements. The Commission intends to mobilise funding from the Connecting Europe Facility and Horizon 2020 programmes for the European electronic health record exchange format and the further development of the eHealth digital service infrastructure. Health authorities can explore a targeted use of EU financing instruments, such as the European Structural and Investment Funds and the European Fund for Strategic Investments, for the deployment of interoperable electronic health records at national and regional level which enable citizens (and authorised third parties) to access their personal health data. Additional funding for this might also be considered under the next EU multi-annual financial framework.

The Commission will: ·Review Commission Implementing Decision 2011/890 pursuant to Article 14 of the Directive on patients’ rights in cross-border healthcare, in order to clarify the role of the eHealth Network in the governance of the eHealth digital service infrastructure and its operational requirements, as well as to improve the interoperability of patient data and access by the citizen. ·Adopt a Commission recommendation on the technical specifications for a European electronic health record exchange format, while monitoring implementation of relevant EU legislation and considering other measures in the future if needed. Such specifications should also address citizens' access to electronic health records and aspects related to the implementation of appropriate data protection safeguards and security of patient health data in compliance with the General Data Protection Regulation. ·Further support the eHealth Digital Service Infrastructure to enable new services for people, such as exchange of electronic health records using the specifications of the European electronic health record exchange format, and the use of the data for public health and research. ·Mobilise funds from the Connecting Europe Facility (Broadband and Information and Communication Technologies) and Horizon 2020 programmes within the current envelopes, and consider further support from the next multi-annual financial framework, to encourage further collaboration between Member States and between regions on the cross-border exchange of health data and its possible expansion (notably to full electronic health records and other new services). 4. Better data to promote research, disease prevention and personalised health and care Personalised medicine is an emerging approach that uses data generated by new technologies to better understand the characteristics of an individual and deliver the right care to the right person at the right time. New technologies enable a wider use of genomic and other information (such as molecular profiling, diagnostic imaging, environmental and lifestyle data) to help doctors and scientists better understand disease and how to better predict, prevent, diagnose and treat. Several national and regional initiatives already support the pooling of genomic and other health data to advance research and personalised medicine. We need to better coordinate these existing initiatives to reach the necessary critical mass at EU level and match similar initiatives in other world regions. Significant breakthroughs can be achieved by linking Europe's fragmented resources through secure cross-border digital infrastructures, while ensuring full compliance with data protection legislation and ethical principles. Ensuring interoperable standards for genomic and other data is also critical for an effective sharing of datasets. Linking resources and using common standards will improve the accessibility, sharing and use of health data to improve understanding of health and disease. This will also make it possible to better anticipate disease outbreaks, speed up diagnosis and develop better preventive and treatment measures, and monitor the effectiveness and possible undesired effects of such measures. European coordinated action in this field can bring tangible benefits for citizens and health systems in the EU, making it possible to tackle major health challenges such as cancer or brain disease, epidemics of infectious disease, or rare diseases (where half the new cases are found in children). Coordinated EU action in this area also responds to the Council Conclusions on personalised medicine, which called on the Commission to help achieve the potential of "Big Data". The Commission intends to support the pooling of the EU's data resources and to facilitate their use for research and health policy. It will do this in line with data protection requirements, and building on the European High Performance Computing initiative and the European Open Science Cloud infrastructure. The aim is to connect national initiatives with European networks of scientific and clinical expertise, such as the International Consortium for Personalised Medicine, the European Reference Networks, the European Research Infrastructures, the Human Brain Project and other relevant initiatives. This will help European research and industry remain at the forefront, bringing new personalised medical solutions to the market. Any initiatives in this area should take full account of EU policy and technological developments in the field of cybersecurity, 5G, the Internet of Things, the European Cloud Initiative and EU policy on healthcare products, i.e. pharmaceuticals, medical devices, advanced therapies and health technology assessments. The Commission intends step up coordination between authorities across the EU to implement the secure exchange of genomic and other health data in order to advance research and personalised medicine. By combining sequenced genomic data and other medical data, physicians and researchers can get a better picture of disease in a particular individual and determine the most appropriate treatment for that individual. This should be based on a transparent system of governance, with the aim of linking national and regional banks of "-omics" data, biobanks and other registries across the EU. The initial goal of this coordination is to provide access to at least 1 million sequenced genomes in the EU by 2022, and then to a larger prospective population-based cohort (beyond sequenced genomes) of at least 10 million people by 2025. This will integrate molecular profiling, diagnostic imaging, lifestyle (in particular risk factors); microbiological genomics and environmental data as well as links to electronic health records. It will also build on "digital patient" predictive approaches based on computer modelling, simulations and artificial intelligence. Ultimately, it will help to lay the foundation for developing a reference map (atlas) of all human cells, with a view to analyse human tissues and organs by state-of-the-art methodologies, and to compare and understand changes during disease. It is paramount to agree on technical specifications for access and exchange of health data for research and public health purposes, addressing, for example, health data collection, storage, compression, processing and access across the EU. This effort will build upon the ongoing work of standardisation bodies, national initiatives and initiatives by health professional societies, considering, among other things, the link with electronic health records. The Commission also intends to test specific practical applications of cross-border health data exchange for research and health policy to improve treatment, diagnosis and prevention of diseases, initially focusing on the following pilot areas: ·faster diagnosis and better treatment of rare diseases for the almost 30 million people in the EU affected by one of the 5000-8000 life threatening or chronically debilitating rare diseases; ·better anticipation of epidemics and EU-wide identification of cross-border infectious threats; and ·use of "real world data" (collected outside formal clinical trials) by healthcare professionals, public authorities and industry to ensure that healthcare products, innovative technologies and therapies meet patient's needs and lead to favourable health outcomes.

These pilot actions will aim to bring together appropriate programmes, initiatives and actors, both at EU and national level. This includes research programmes, the European Surveillance System for infectious disease surveillance, medical expertise and work of the European Reference Networks, the European Platform for Rare Diseases Registration, and the global rare diseases information repository (Orphanet) within the framework of the planned European Joint Programme Co-fund on Rare Diseases. The pilot actions will be developed with clinical associations, national competent authorities, health technology assessment bodies, research infrastructures, industry, the Innovative Medicines Initiative and relevant EU agencies. Beyond these initial pilot areas, others may also be considered, notably focusing on cancer or neurodegenerative diseases (establishing links with appropriate initiatives such as the Human Brain Project). These activities will increase the quality of data, standardise data collection, promote interoperability of European disease registries (such as the cancer and rare disease registries supported by the Joint Research Centre) and advance the analysis of data using of high performance computing and modelling. In this way, a critical mass of usable data will support vital knowledge generation and help improve prevention, diagnosis and treatment of patients. Furthermore, the Commission will explore with scientific representatives and clinical groups how best to stimulate demand for data aggregation, addressing incentives and concerns, such as safeguarding data protection compliance, for the further processing of health data. Resources will be mobilised through the EU research programme Horizon 2020, including the Innovative Medicines Initiative, the third "Health" programme, and the Connecting Europe Facility (Broadband and Information and Communication Technologies). Additional support from the Member States will be encouraged to allow the pilots to reach their full potential. Additional funding for this might be considered also under the next EU multi-annual financial framework to more closely link existing European resources to a world-leading health data and computation infrastructure able to effectively support scientific research and personalised medicine. The Commission will, while ensuring full compliance with data protection legislation and ethical principles: ·Set up a mechanism for the voluntary coordination of authorities and other stakeholders to share data and infrastructure for prevention and personalised medicine research. This includes a European network on genomics, and seeking to link also with ongoing '-omics' and human cell mapping initiatives. ·Support the development of technical specifications for secure access and cross-border exchange of genomic and other health datasets within the internal market for research purposes. This is to facilitate interoperability of relevant registries and databases in support of personalised medicine research. ·Launch pilot actions, pooling data and resources across the EU, to demonstrate the benefits of advancing research, disease prevention, personalised medicine, health technology assessment, as well as clinical and regulatory decision making; and ·Support all the above by mobilising funds from Horizon 2020 and the Connecting Europe Facility (Broadband and Information and Communication Technologies),) within the current envelopes, and consider further support from the next multi-annual financial framework. 5. Digital tools for citizen empowerment and for person-centred care The ageing of the population together with the growing burden of chronic conditions and multi-morbidity are steadily increasing demand for health and care. This means health and social care systems have to develop a different approach to enable more effective care delivery and to confront the complexity of different services which patients are now expected to navigate. That is why it is widely recognised that health systems need to shift from treatment to health promotion and disease prevention, from a focus on disease to a focus on well-being and individuals, and from service fragmentation to the integration and coordination of services along the continuum of care. Member States and regional authorities are already moving forward with such reforms in order to improve the effectiveness, accessibility and resilience of their health systems. To better advance health promotion, prevent disease and deliver integrated services based on people's needs, health systems have to find innovative solutions through new technologies, products and organisational changes. Central to the success of this transformation are: ·the configuration of new care models, ·the use of health technology assessment for attaining greater quality and sustainability of health services, ·the involvement of multi-disciplinary care teams with new or redesigned roles for care professionals, ·the integration of promotion and prevention into primary care, ·a health workforce of sufficient capacity and appropriate skills, ·the active cooperation between care professionals and patients, and ·the utilisation of digital solutions, all of which provide the necessary means for delivery of efficient and cost-effective care.