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Digital Health - Regulation and Policy



 

The ESC aims to play a leading role in all aspects of the Digital Health agenda, helping to develop, assess and implement effective Digital Health innovation to support cardiovascular (CV) health.

This includes being part of the conversation at a policy and regulatory level, as well as, supporting healthcare professionals directly through education forums and providing Digital Health solutions to support clinical practice and CV research.

EU Policy and Regulation

Advisory Bodies 

The ESC has representatives working with the European Commission's expert group on Digital Health, the eHealth Stakeholder Group, to ensure the interests of cardiovascular healthcare professionals and their patients.

As a member of the eHealth Stakeholder group, the ESC contributed to the drafting of three policy reports recently, covering the following topics:
 

EU Communications and Positions

The European Commission's communication on Digital Health from 25 April 2018 sets our priorities to enable:
  • secure sharing of electronic health records
  • consolidation of large data sets through a shared European data infrastructure
  • digital tools for health data management
The text below offers further explanation on some key areas covered in the communication.
Secure Information Exchange

The eHealth Network, composed of EU member state representatives, will engage in discussions to ensure the secure exchange of electronic health records. The network will also with with the commission to revise rules on cross-border data transfers. Striking the right balance between securing the protection of personal data, aligning with the General Data Protection Regulation (GDPR), and ensuring continued research and efficient and effective care and treatment are principal concerns.

Pooling Expertise and Resources
In promoting the open sharing of data, the European Commission will also implement pilot projects based on 'real world data' that is patient data gathered outside of clinical trials or after the market-release of medicines/products to assist in developing new medicines and therapies. The Commission hopes to increase the quality of data and standardise data protection to promote the interoperability of European disease registries.
Digital Health Tools

The European Commission commits to creating more research, innovation and exchange opportunities to support the large-scale deployment of integrated care models. Much of this work will be made possible thorough digital health tools and investment their creation, testing and deployment is key.

Commitment to Mobilise Funding
The European Commission intends to mobilise funding through the Connecting Europe Facility (CEF) and Horizon 2020 programmes to further develop electronic health record exchange and developing the digital service infrastructure.
 

ESC Cardiovascular Round Table

The ESC Cardiovascular Round Table (CRT) is a high level strategic group brings together key stakeholders from across the health sector. On 12 October 2017 the CRT brought together academic, health, industry and Digital Health experts to discuss emerging trends and how the ESC could and should support its members.

Read the ESC Cardiovascular Round Table paper published on Electronic Health Records.