RFAs: Safeguarding Innovation in secondary use of Health Data in the European Health Data Space

Scope

• The background to this topic arises from the EU regulation for an EHDS. This topic focuses on the secondary use aspects of the regulation establishing the EHDS and recognises that, to be successful, there is a need to consider both the societal benefits of data-driven advancements in healthcare and the legitimate interests of public and private sector innovators for a strong IP system and an efficient means of supporting the secondary use aspect of the EHDS.
• The specific challenges/problems addressed by the topic include:
  • balancing the societal benefits of data-driven innovation in healthcare against the legitimate interests of public and private sector innovators to safeguard relevant legal and regulatory rights related to their data (e.g., copyright, (sui generis) database rights, CCI (Confidential Commercial Information), trade secrets, RDP (Regulatory Data Protection), patents, etc.);
  • empowering HDHs and HDUs to engage with and use the EHDS for data-driven healthcare innovation by providing them with knowledge and tools, e.g., contractual agreements between HDHs and HDUs for data sharing or other potential legal, organisational or technical measures, to operationalise secondary data sharing and to safeguard intellectual property rights, trade secrets and regulatory data protections;
  • developing robust frameworks and guidelines to support the implementation of the EHDS to enable harmonised and efficient sharing of IP-protected data (including in the context of cross-over with data anonymisation considerations) across all member states while safeguarding IP and trade secrets in support of innovation; and
  • exploring concerns regarding commercial and competition-sensitive data and the risk of unauthorised disclosures.
• The topic objectives are to:
  • build trust and confidence in the EHDS: respecting and keeping proprietary information confidential, creating trust and confidence among stakeholders and promoting their active participation in the EHDS to enable responsible and timely data sharing;
  • propose implementation practices that will support the efficient inclusion of health data in the EHDS for secondary research purposes and support the procedural and operational aspects of the EHDS;
  • support innovators’ competitiveness by safeguarding valuable IP and trade secrets data whilst fostering further research and innovation;
  • advance data governance and confidentiality practices within the EHDS to ensure appropriate protection of IP and trade secrets;
  • ensure data governance throughout the whole product life cycle, from development to post market monitoring and update;
  • minimise the administrative burden for HDABs, HDHs and HDUs impacted by the EHDS;
  • ensure that relevant legal and regulatory rights of innovators are respected and timely preserved to minimise uncertainty and maximise opportunities for innovation under the EHDS;
  • support an EHDS implementation that facilitates data sharing, innovation, and research to advance healthcare for EU citizens, and uses processes that take advantage of existing practices in industry and health authorities and are resource efficient.

Expected Impact

• The action contributes to all the general objectives of IHI JU, particularly to specific objective 4 ‘exploit the full potential of digitalisation and data exchange in health care’.
• The action under this topic is expected to achieve all of the following impacts:
  • Fostering data-driven research and innovation advancing healthcare in the EU;
  • A world-leading approach to IP protection of data;
  • Improved balance between data utilisation and access control rights;
  • Best practices for data sharing, data security and prevention of unauthorised disclosure;
  • Recommendations for legal and ethical standards; and
  • Increased industry confidence in the EHDS.
• The action will also contribute to several European policies/initiatives, which include:
  • The European Health Data Space;
  • The European Commission’s Pharmaceutical Strategy for Europe, specifically the pillar on competitiveness, innovation, and sustainability;
  • Related measures under the ongoing revision of the pharmaceutical legislation;
  • The Trade Secret Directive;
  • The European Strategy for Data, incl. GDPR, Data Act, Data Governance Act, AI Act;
  • The Digital Strategy; and
  • The Digital Single Market Strategy.
• Overall, these expected impacts aim to create a secure, collaborative, and innovative ecosystem within the EHDS, which will increase trust and confidence among stakeholders, optimise data utilisation, enhance protection of intellectual property, and facilitate advancements in healthcare research and innovation.

Expected Outcome

• This topic must contribute to all of the following outcomes:
  • comprehensive frameworks, processes, policies and guidelines are available to support the procedural and operational aspects of the EHDS from an innovation perspective;
  • recommendations to inform EHDS governance are available to address the needs of a broad set of stakeholders, including citizens, hospitals, public institutions and the healthcare industry. The right balance must be struck between the need for an EHDS that enables efficient data sharing for the secondary use of health data to promote research and innovation in healthcare, and the need for maintaining a strong Intellectual Property (IP) system2 while preserving confidential information within health research data;
  • recommendations are available for enabling dialogues between health data holders (HDHs), health data users (HDUs) and health data access bodies (HDABs) to address issues around innovation, as well as dealing with IP, RDP, and Trade Secrets, utilising the EHDS and the operationalisation of the EHDS; and
  • materials, guidance, recommendations, training and other support tools are available to educate interested parties about innovation and data sharing under the EHDS.

For more information, visit European Commission.