Safeguarding innovation in secondary use of health data in the European Health Data Space (EHDS)
Programme Category
Programme Name
Programme Description
IHI JU is based on the idea that interdisciplinary and cross-sector collaboration will enable perspective and breakthrough innovations in healthcare, including the pharmaceutical industry but also new fields such as biopharmaceuticals, medical technologies and biotechnologies.
Identifier Code
Call
Summary
The European Health Data Space (EHDS) is a key initiative under the European Strategy for Data and the European Health Union that enables the secondary use of health data for various purposes, including research and innovation. The outcomes of this topic will lead to the identification of pathways for enabling innovation through the EHDS while safeguarding intellectual property, Regulatory Data Protection (RDP) and trade secrets in health data.
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.
Detailed Call Description
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.
Applicants should envisage the following activities as part of their proposal: With regards to the outcome supporting the procedural and operational aspects of the EHDS:
- conduct research into data strategy, management and governance;
- conduct comparative reviews of existing data exchanges and the need for transparency, interoperability and standardisation of data;
- conduct comparative reviews with work developed in the context of national data spaces;
- through elaborate use cases, explore the procedural and operational aspects of the EHDS from various perspectives, including: assessing data sharing platforms and technologies, such as data security measures like encryption technologies, access control mechanisms, black boxes, federated learning, and their implications on the data sharing and IP system;
- investigating the sharing of different types of data covered by the EHDS, which include trade secrets and/or data protected by IP or RDP as well as complex data (for example, imaging data), for secondary use. This will help to address different scenarios regarding purpose, time of sharing, and territorial scope, potentially leveraging test environments to evaluate operational and practical aspects of data sharing and data usability under the EHDS.
- identify best practices, guidelines, standards, and tools for intellectual property, trade secret, and opt-in/out management that can be used and advanced within the EHDS frameworks;
- develop proposals for comprehensive frameworks, processes, policies and guidelines balancing the needs of HDHs to safeguard the IP system and minimise the administrative burden while facilitating data sharing and collaboration;
- develop mechanisms and technologies for IPR-aware data manipulation, including reviewing best practices in anonymisation / pseudonymisation techniques and synthetic data generation, with the goal of facilitating the reuse of electronic health data that is subject to IP protection;
- prepare recommendations for technical standards for access controls, data minimisation, secure data storage, anonymisation techniques, handling of evolving data sets, etc., which might benefit innovation related to trade secrets and IP protected data covered by the EHDS.
Call Total Budget
Thematic Categories
- Health
- Information Technology
- Research, Technological Development and Innovation
Eligibility for Participation
- Central Government
- Educational Institutions
- International Organisations
- Legal Entities
- Legal Entities under Public Law
- Local Authorities
- NGOs
- Non Profit Organisations
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- State-owned Enterprises
Eligibility For Participation Notes
The relevant stakeholders for this topic are those involved with the establishment of the EHDS for secondary use purposes and those who will provide and access data utilising the EHDS, which include, amongst others:
- HDHs and HDUs, including healthcare providers, pharmaceutical companies, and medical technology companies;
- Patient organisations and other Non-Governmental Organisations in the health research space;
- Universities and institutions or other organisations with an interest in health data;
- EU and Member State authorities responsible under the EHDS to handle and protect data of HDHs;
and - EU and Member State authorities who will establish federated data networks, HDABs and secure processing environments under the regulation for the EHDS.
The pre-identified industry consortium that will contribute to this cross-sectoral IHI JU project is composed of the following medical technology industry beneficiaries (‘constituent or affiliated entities of private members’):
- AbbVie
- Astra Zeneca
- Bayer
- bioMérieux
- Boehringer Ingelheim
- GSK
- Johnson & Johnson (Lead)
- Merck
- MSD
- Novartis
- Novo Nordisk
- Pfizer
- Sanofi (Co-lead)
- UCB
In addition, the following contributing partners will participate to the IHI project:
- Brightinsight
- Clarivate
In the spirit of partnership, and to reflect how IHI JU two-stage call topics are built upon identified scientific priorities agreed together with a number of proposing industry beneficiaries, it is envisaged that IHI JU proposals and actions may allocate a leading role within the consortium to a constituent or affiliated entity of a private member.
The pre-identified industry consortium and contributing partner(s) expect to contribute to the IHI JU project by providing the following expertise and assets:
- Legal, paralegal experts and advisors/consultants specialised in IP & trade secrets protection in the digital and medical environments;
- Governmental affairs and policy experts;
- ISRM (Information Security & Risk Management) experts;
- Data strategy and governance experts;
- Communication expertise for webinars & workshops;
- Data privacy experts;
- Public affairs experts.
Applicant consortium
The first stage applicant consortium is expected, in the short proposal, to address the scope and deliver on the expected outcomes of the topic, taking into account the expected contribution from the pre-identified industry consortium and contributing partner(s).
This may require mobilising the following expertise and/or resources:
- Academic and/or research organisations involved in innovation and competition with particular expertise in legal and IP;
- ISRM (Information Security & Risk Management) experts;
- Hospital networks/HDHs/HDUs (clinical research units);
- Implementers of large digital healthcare infrastructures for primary and secondary data use (i.e., which make use of the EU policies mentioned in the expected impact section) from across the EU;
- Project management expertise related to qualitative market research and public relations;
- Project management organisations with project management expertise of large multi-stakeholder European public-private partnerships;
- Legal expertise and, in particular, privacy and regulatory data protection expertise;
Experts from, or with connections to country ministries, involved with implementing and operating: Health Data Access Bodies / Publicly accessible datasets.
Call Opening Date
Call Closing Date
EU Contact Point
Innovative Health Initiative:
Τelephone: +32 (0)2 221 81 81
Email: infodesk@ihi.europa.eu
Address:
- IHI JU – TO56, 1049 Brussels – Belgium
- Ave de la Toison d’Or 56-60, 1060 Brussels – Belgium