On the Commission’s Digital Health Plans

Digitalisation is a fast-developing trend that will have a profound impact on all aspects of our societies. Harnessing the digital transformation is one of the six high-level priorities of the new European Commission for 2019-2024. This priority, entitled “A Europe fit for the digital age”, aims to make sure the transformation works for people and the economy while also closely linking it to the “green transition” towards the target of a climate-neutral Europe by 2050.   

Digitalisation is often cited as a solution towards sustainability of healthcare, in a context of growing healthcare demand due to demographic change, and shortages of healthcare professionals. Digital health refers to healthcare practices supported by electronic processes and communication. It includes a wide range of services and information technology such as electronic medical records, eHealth, mHealth, telemedicine, consumer health informatics, etc.

While digitalisation holds many promises for EU patients and healthcare systems, EPF calls on the EU institutions and Member States to foster patient-centred development of digital health, with equity of access, patient safety, and quality of care as key pillars.


The European Comission is developing several actions flowing from the overall priority of the Commission. On 19 February the Commission published three major documents: a communication entitled “Shaping Europe’s digital future” which sets out policy actions under three broad headings related to technology that works for people, the economy, and democratic society; a European data strategy whose ambition is to enable the EU to become the most attractive, most secure and most dynamic data-agile economy in the world; and a white paper on Artificial Intelligence.

The mission letter of Stella Kyriakides, Commissioner for Health, includes a mandate to create a so-called European Health Data Space “to promote health-data exchange and support research on new preventive strategies, as well as on treatments, medicines, medical devices and outcomes” in compliance with the EU data protection rules.

As part of this it should be ensured that citizens have control over their own personal data. Building upon its 2019 recommendations, the European Commission wants to promote health records based on a common European exchange format to give European citizens secure access to and exchange of health data across the EU. It specifically wants to support the development of national electronic health records (EHRs) and interoperability of health data through the application of the Electronic Health Record Exchange Format. They aim to scale up cross-border exchange of health data and enable the exchange of electronic patient summaries and ePrescriptions between participating Member States participating in the eHealth Digital Service Infrastructure (eHDSI) by 2022.


EPF supports efforts to promote electronic health records based on a common exchange format. However, we stress that the involvement of patient organisations and further research are required to better understand and implement user requirements at EU and national level. Better access to health data can significantly support the work of regulatory bodies in the healthcare system, the assessment of medical products and demonstration of their safety and efficacy. Patients have the right to access and control their personal health data and to request their portability, but implementation of this right is fragmented.

While the General Data Protection Regulation (GDPR) has created a harmonised European legislative framework for the use of personal health data,EPF calls on the EU to closely monitor the application of the data protection regulation and encourage digital service developers to consult with patients to ensure their privacy concerns and needs comply with the Data Protection Regulation requirements for consent.

Patient-centred digital health is one of EPF’s priorities for the new Commission. Our message is clear: digital tools should start from the needs of healthcare users and be developed with the users, to ensure technology actually facilitates participatory, person-centred healthcare and leads to better outcomes for patients, and better value for society. Digitalisation need to be integrated as part of national and European strategies to tackle health inequalities and avoid creating a new digital divide.  As a member of the Commission’s eHealth Stakeholder Group 2019-2022 EPF will aim to ensure that the potential of digitalisation is harnessed for the benefits of patients.


Health is an area where the EU can benefit from the data revolution, increasing the quality of patient-centred healthcare, while potentially decreasing costs. Europe can own this digital transformation and set the global standards when it comes to technological development. Most importantly, it must do so while ensuring the inclusion, empowerment and respect of every single human being within the healthcare system.

  • EPF calls for an evaluation framework to be developed to ensure the safety and quality of digital health tools, with the involvement of patients.
  • We further call on the EU policy-makers to mandate user involvement, including patients and family carers, as a criterion for all EU projects related to digital health, and to undertake researh to develop a model for meaningful patient involvement throughout the entire patient journey using digital services.
  • We strongly advise the Commission to enact a patient empowerment strategy encompassing health literacy, and further investigate and address the surrounding issues around user acceptance and awareness of digital health services.


In the coming weeks, EPF will publish a policy briefing paper on digital health that will delve further into the EU plans and focus on big data, AI and real-world data, in order to better inform the patient community and support our dialogue with our members to shape our advocacy in this fast-developing field. We will also consult our membership on our input into the European Commission’s public consultations on the white paper on Artificial Intelligence and the data strategy, both of which are open until 31 May 2020.

For more information please contact Kaisa Immonen, EPF Director of Policy, at policy@eu-patient.eu