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EU’s proposed eHealth measures focusing on broadening the availability and sharing of health data

On 25 April 2018, the European Commission (EC) issued a Communication on enabling the digital transformation of healthcare, outlining the European Union’s (EU) priorities and actions towards digital health. The EU’s plan focuses on the following core priorities:

  • Ensuring citizens’ access to their health data and introducing the possibility to share their data across borders;
  • Promoting the usage of larger data sets to enable more personalized diagnoses and medical treatment, and better anticipate epidemics;
  • Promoting appropriate digital tools, allowing public authorities to better use health data for research and for health system reforms.

In an attempt to personalize the diagnosis and treatment, the measures introduced in April encourage National authorities and other stakeholders, such as researchers, to share data and infrastructure. One of the initial targets is to provide access to at least 1 million sequenced genomes in the EU by 2022. Indeed, 13 Member States recently committed to achieve a voluntary coordination in sharing data (incl. genomic data) for disease prevention and research.

A few of the key actions foreseen in the introduced measures include:

  • Reviewing the Implementing Decision of the Directive on patients’ rights in cross-border healthcare: The revision of these rules will clarify the role of the eHealth Network in the governance of the eHealth Digital Service Infrastructure and determine the rules applicable to cross-border data transfers. The eHealth Network, composed of 28 Member States representatives is expected to start discussions on this soon.
  • Making a Recommendation on technical specifications about how citizens’ electronic health records can be exchanged across the EU (including interoperability aspects): The cross-border accessibility of electronic health records will help citizens to access and manage their health data within the EU. This would include a voluntary cooperation among Member States on cross-border exchange of e-prescriptions and patient summaries.
  • Mobilizing further investments to include the eHealth Digital Service Infrastructure: These funds will contribute to the mechanisms of electronic national health records exchange between participating Member States.
  • Implementing pilot projects based on ‘real world data’ (i.e. data after clinical trials, data gathered from real patients after the medicine or products are released in the market): With a core focus on rare diseases via the European Reference Networks, such projects will explore ways of providing treatment for these patients. The goal of these pilot projects will be to demonstrate the benefits of pooling resources and expertise while meeting patients’ needs with medicines or therapies.

The European Commission will liaise with national authorities and relevant stakeholders to facilitate the implementation of the Communication’s main objectives going forward.

© Copyright 2020 Squire Patton Boggs (US) LLPNational Law Review, Volume VIII, Number 131
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About this Author

Wolfgang A. Maschek Public Policy Attorney Squire Patton Boggs Brussels, Belgium
Partner

Wolfgang Maschek’s practice includes the representation of both private and public sector clients at EU and national level across various regulated industries and policy matters. His focus areas include environmental and chemicals policy, international trade and foreign direct investments, including investor-state disputes, financial services, anti-money laundering/counter terrorism financing, taxation, technology/ICT and data privacy cybersecurity matters, as well as the retail and aviation sector. Wolfgang chairs our strongly growing European Public Policy Practice, with members spread...

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Christina Economides Public Policy Attorney Squire Patton Boggs Brussels, Belgium
Public Policy Advisor

Christina Economides is an advisor in the firm’s Public Policy Practice in Brussels in coordination with the Public Policy International Group. She is also a member of the firm’s Healthcare Industry Group leadership team.

Christina advises clients on technology, digital economy, taxation, financial services, and health regulatory and policy matters. Prior to joining the firm, Christina worked for a Brussels-based EU public affairs consultancy, focused on financial services, ICT/data protection and competition matters, and was inter alia running the Secretariat of the...

322 627-11-05
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