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On February 19, 2020, the European Commission released a Communication entitled "A European strategy for data".

In the document, the Commission sets out the goal for the European Union to develop the infrastructure, knowledge, and technologies it needs to be a leading player in the global digital economy. The approach takes into account that Europe needs to match the level of data innovation in other large economies, such as the United States of America and China, and even some much smaller economies.

The Communication calls for an increase in European Union research funding, including the creation of a network of research hubs focused on artificial intelligence (AI). Major initiatives are to be launched, including the creation of data pools in key sectors such as health and care.

Establishing a Common European health data space is therefore considered to be essential.

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Why a Common European health data space?

The 2018 General Data Protection Regulation (GDPR) has created a level playing field for the use of personal data, including health data. Yet the landscape of digital health services, within and between European Member States, remains fragmented – especially when those services are provided cross-border.

Progress on de-fragmentation will depend on the willingness of Member States and healthcare providers to join forces. They will need to find ways to use and combine data, in a manner compliant with the GDPR (under which health data merit specific protection).

In more detail, a common European health data space can:

  • Help healthcare authorities to take evidence-based decisions to improve the accessibility, effectiveness, and sustainability of the healthcare systems.
  • Contribute to the competitiveness of the European Union’s health industry.
  • Support the work of regulatory bodies in the healthcare system, the assessment of medical products, and demonstration of their safety and efficacy.
  • Support citizens’ right to secure access, control, and portability of personal health data by implementing an Electronic Health Record (EHR) while safeguarding privacy.


What will the European Commission do?

The Commission plans to take at least three very specific actions in the area of health:
  • Take measures to strengthen citizens’ access to health data and portability.
  • Facilitate the establishment, in accordance with Article 40 of the GDPR, of a Code of Conduct for the processing of personal data in the health sector.
  • Support the development of national electronic health records (EHRs) and interoperability of health data through the application of the Electronic Health Record Exchange Format.
These actions will support prevention, diagnosis and treatment of diseases (in particular for cancer, rare diseases, and both common and complex diseases), research and innovation, policy-making, and regulatory activities of Member States in the area of public health.


What does EHTEL plan to do?

EHTEL is seeking to keep its members as up-to-date as possible on developments in this field.

  • We have already begun to concentrate on the implications of AI for health and care: this was a major theme of its 2019 Symposium and promises to be a key topic for exploration in its Innovation Initiative.
  • Furthermore, with the competence center member of the ELO Network Working Group, we will explore enablers for real world health data to be used for research and public health.
Future uses of health data are important aspects of projects in which the association is involved, such as DigitalHealthEurope.
In addition, EHTEL is extremely interested in the ways in which a European health data space can assist public health and population health, as well as help combat the spread of infectious diseases.

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