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:

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)1, and trade secrets in health data.

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.

The target groups for all the outcomes are:

• those establishing the EHDS and the EHDS infrastructure, through which health data will be made available for secondary purposes;
• member state agencies involved with the establishment and functioning of HDABs;
• HDHs making IP, RDP and trade secret protected data, which may include sensitive and confidential data, available through the EHDS for secondary use; and
• HDUs intending to access IP, RDP and trade secret protected data for secondary use.

1 ‘RDP’: regulatory data protection rights, i.e. Article 10(1) of Directive 2001/83/EC, and Article 14(11) of Regulation (EC) 726/2004

2 ‘IP System‘: the set of legal and regulatory measures established within the EU for the protection of IP rights, including RDP and Trade Secrets

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.

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.

With regards to the outcome striking the appropriate balance:

• evaluate and comparatively study laws, including trade secret laws and other laws of the EU Strategy for Data and of the EU Member States, to identify common and differentiating features and legal bases in order to propose recommendations for Member State implementation of HDABs and to develop guidance for IP and regulatory data protection covering areas such as dataset descriptions, data sharing policies and agreements, access controls, and governance practices and data use;
• conduct comprehensive research into the interplay between IP, transparency, regulatory data protection, state aid, competition laws, international treaties, the need for openness, and the potential risk for misuse of data under the EHDS;
• conduct research exploring compatibility and gaps of the EHDS versus existing laws around data and data sharing, IP, including protection of confidential information and trade secrets, and related laws, such as privacy, the EU data governance act, the EU data act, the EU AI act and regulatory data protection;
• propose guidelines and frameworks regarding data sharing and data use to support the balance of the societal benefits of data-driven healthcare research and innovation under the EHDS against the legitimate interests of public and private sector innovators for a strong IP system, including, for example, a classification of data into categories depending on IP sensitivity;
• develop guidance on responsible use and mechanisms to hold irresponsible / misusing HDUs accountable and prevent misuse;
• develop clear rules for data ownership and IP ownership determination for all kinds of newly generated data using EHDS;
• propose a harmonisation framework including standard agreements for IP ownership to enable secondary use of data provided via the EHDS for research purposes;
• analyse and provide recommendations on exploitation and publication of results by HDU and impact on HDHs with IP and trade secret protected data.

With regards to the outcome establishing frameworks for dialogues:

• engage public and private innovators in the European Health Data Space 2 (EHDS2) Stakeholder Engagement initiative to shape the definition of responsible secondary use of data for research and innovative purposes under the EHDS, including territorial considerations;
• prepare recommendations to develop a framework for dialogues between innovators and HDABs to address issues around innovation and operationalisation under the EHDS, balancing all the relevant stakeholders’ legitimate interests. This engagement should, where possible, leverage and complement the action providing support to stakeholders on secondary use of data within the European Health Data Space1.

With regards to the outcome educational aspects:

• develop training packages, including educational materials, guidance, recommendations, and other support tools to educate stakeholders about innovation, data sharing and the IP system under the EHDS. Training packages developed as part of this action should, where possible, leverage and complement outputs from the action developing capacity building for secondary uses of health data for the European Health Data Space2;
• educate stakeholders about using the EHDS for innovative purposes.
• Applicants are expected to consider the potential regulatory impact of the results and, as relevant, develop a regulatory strategy and interaction plan for generating appropriate evidence as well as engaging with relevant regulators in a timely manner.
• Applicants should consider as relevant existing infrastructures/networks/collaborations to ensure synergies and complementarities.