On the April 25, 2018 the European Commission (the “Commission”) adopted a plan of action to enable the digital transformation of health and care in the Digital Single Market (the “Communication”), intended to put EU citizens at the centre of the healthcare system.  This is to be achieved in three ways:

1. Citizens’ secure access to and sharing of health data

The Commission wishes to ensure that EU citizens should have secure access, anywhere in the EU, to a comprehensive electronic record of their health data. Citizens should remain in control of their health data (wherever it is located) and be able to share it securely with others for purposes chosen by those citizens, for example, medical treatment or research.

The Commission recommends the:

• development and adoption of a “European electronic health record exchange format”, which would expand the existing eHealth digital services infrastructure; and
• establishment of interoperable standards that would minimise barriers to cross-border transfer of health information and data within the EU and identify incentives for adopting the common format, and tackle practices that impede interoperability.

2. Better data to promote research, disease prevention and personalised health and care

The Commission recognises that there needs to be better coordination between existing national and regional initiatives with respect to the pooling of genomic and other health data in the fields of research and personalised medicine. To achieve that goal, the Commission intends to:

• set up a mechanism for the voluntary coordination of authorities and other stakeholders to share genomics and other health data;
• support the development of common technical standards for the exchange of information for research and public health purposes; and
• demonstrate the benefits of data-pooling by launching pilot schemes that will coordinate relevant programmes, initiatives and actors at both a national and EU level.

The pilot schemes will, initially , focus on:

• faster diagnosis and better treatment of rare diseases;
• better anticipation of epidemics and EU-wide identification of cross-border infection threats; and
• use of real world data to ensure that healthcare products, innovative technologies and therapies meet patients’ needs and lead to favourable health outcomes.

3. Digital tools for citizen empowerment and for person-centred care

In its Communication, the Commission observes that there is a steadily increasing demand for health and care as a consequence of an ageing population, together with the “growing burden of chronic conditions and multi-morbidity”.

The Commission notes that 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 wellbeing and individuals, and from service fragmentation to the integration and coordination of services along the continuum of care.”

Accordingly, the Commission intends to:

• support cooperation to stimulate the supply and uptake of digital health, by promoting common principles;
• support the exchange of innovative and best practices, capacity building and technical assistance for health and care authorities;
• support investment by EU Member States and regions in large-scale deployment of digitally-enabled, integrated, person-centred care; and
• raise awareness of innovative procurement and investment possibilities.

Funding to support these initiatives will come from (variously) the Horizon 2020, Connecting Europe Facility and third “Health” programmes, with further funding to be considered under the next EU multi-annual financial framework.

The Commission explicitly notes that data protection  principles are core elements of the proposals in the Communication and that compliance with EU data protection rules and adequate security measures are “essential” to achieve the goals stated in the Communication.

All parties involved in healthcare solutions are intended to contribute to the main objectives of the Communication. The Commission will monitor progress in the context of the EU’s Digital Style Market Strategy.