On 15 March 2024, a consensus was achieved between the European Parliament and the Council of the EU concerning the European Health Data Space (EHDS), a pivotal element in the establishment of a robust European Health Union. The subsequent step involves the formal adoption of the new Regulation by both the European Parliament and the Council.
What is the European Health Data Space (EHDS)?
The EHDS represents a specialised health ecosystem characterised by regulations, standardised practices, infrastructures, and governance mechanisms, aiming to achieve the following:
- Empowerment of individuals through enhanced digital access to and control over their electronic personal health data, both at the national and EU levels;
- Facilitation of a unified market for electronic health record systems, relevant medical equipment, and high-risk AI systems; and
- Establishment of a reliable and efficient framework for utilising health data in research, innovation, policy-making, and regulatory endeavours (secondary data usage).
The European Health Data Space is a key pillar of the European Health Union. It builds further on the General Data Protection Regulation (GDPR), and the NIS 2 Directive.
The European Union endeavours to construct a resilient European Health Union, wherein member states collaborate to prepare for and address health crises, ensure the availability and affordability of innovative medical resources, and collectively strive to enhance disease prevention, treatment, and post-care.
Purpose?
The EHDS creates a strong legal structure to enable the use of health data for research, innovation, public health initiatives, policy-making, and regulation. It provides access to high-quality health data for researchers, innovators, public institutions and industry, under strict conditions. This access is vital for developing life-saving treatments, vaccines and medical devices, as well as for improving healthcare accessibility and strengthening health systems. Key components include strengthening individuals' rights over their electronic health data, creating a health-specific data exchange framework, enhancing access to health data, and supporting research and innovation.
Concerns?
However, the initial draft text of the EHDS undergoing trilogues has raised profound concerns within the European healthcare ecosystem. Stakeholders express apprehensions regarding the extensive sharing of sensitive medical data. The concept of the EHDS, aimed at enabling the sharing of medical data across borders, has long been on the horizon. The agreement between the European Parliament and the Council of the EU on legislation signifies a significant step forward.
The primary objectives of this initiative include facilitating the availability of patient data to hospitals, doctors and medical personnel. Additionally, it seeks to promote secondary uses of electronic health records for societal purposes such as scientific research, policy-making, and innovation. While the aspiration to make data easily shareable is commendable and promises considerable benefits, it also raises significant privacy concerns.
The forthcoming legislation aims to streamline the exchange of data while ensuring vigilance towards secondary uses. However, there are concerns about potential loopholes that could lead to more liberal sharing of data than originally intended. Furthermore, default data sharing mechanisms have raised concerns, as stakeholders argue to only incorporate an opt-out mechanism as long as it does not lead to inconsistent implementation, increased health data disparities and excessive administrative burdens. Even with opt-out provisions, there are numerous exceptions that allow for data sharing, which undermines the intended safeguards. As the legislation transitions from theory to practice, these issues are likely to become even more pronounced in the coming months.
Conclusion
In conclusion, while the EHDS holds the promise of advancing healthcare and fostering innovation, it also presents significant challenges regarding data privacy, professional ethics, and the balance between facilitating data sharing and safeguarding individual rights. These challenges must be addressed effectively to realise the full potential of the European Health Data Space.
On 15 March 2024, a consensus was achieved between the European Parliament and the Council of the EU concerning the European Health Data Space (EHDS), a pivotal element in the establishment of a robust European Health Union. The subsequent step involves the formal adoption of the new Regulation by both the European Parliament and the Council.
What is the European Health Data Space (EHDS)?
The EHDS represents a specialised health ecosystem characterised by regulations, standardised practices, infrastructures, and governance mechanisms, aiming to achieve the following:
- Empowerment of individuals through enhanced digital access to and control over their electronic personal health data, both at the national and EU levels;
- Facilitation of a unified market for electronic health record systems, relevant medical equipment, and high-risk AI systems; and
- Establishment of a reliable and efficient framework for utilising health data in research, innovation, policy-making, and regulatory endeavours (secondary data usage).
The European Health Data Space is a key pillar of the European Health Union. It builds further on the General Data Protection Regulation (GDPR), and the NIS 2 Directive.
The European Union endeavours to construct a resilient European Health Union, wherein member states collaborate to prepare for and address health crises, ensure the availability and affordability of innovative medical resources, and collectively strive to enhance disease prevention, treatment, and post-care.
Purpose?
The EHDS creates a strong legal structure to enable the use of health data for research, innovation, public health initiatives, policy-making, and regulation. It provides access to high-quality health data for researchers, innovators, public institutions and industry, under strict conditions. This access is vital for developing life-saving treatments, vaccines and medical devices, as well as for improving healthcare accessibility and strengthening health systems. Key components include strengthening individuals' rights over their electronic health data, creating a health-specific data exchange framework, enhancing access to health data, and supporting research and innovation.
Concerns?
However, the initial draft text of the EHDS undergoing trilogues has raised profound concerns within the European healthcare ecosystem. Stakeholders express apprehensions regarding the extensive sharing of sensitive medical data. The concept of the EHDS, aimed at enabling the sharing of medical data across borders, has long been on the horizon. The agreement between the European Parliament and the Council of the EU on legislation signifies a significant step forward.
The primary objectives of this initiative include facilitating the availability of patient data to hospitals, doctors and medical personnel. Additionally, it seeks to promote secondary uses of electronic health records for societal purposes such as scientific research, policy-making, and innovation. While the aspiration to make data easily shareable is commendable and promises considerable benefits, it also raises significant privacy concerns.
The forthcoming legislation aims to streamline the exchange of data while ensuring vigilance towards secondary uses. However, there are concerns about potential loopholes that could lead to more liberal sharing of data than originally intended. Furthermore, default data sharing mechanisms have raised concerns, as stakeholders argue to only incorporate an opt-out mechanism as long as it does not lead to inconsistent implementation, increased health data disparities and excessive administrative burdens. Even with opt-out provisions, there are numerous exceptions that allow for data sharing, which undermines the intended safeguards. As the legislation transitions from theory to practice, these issues are likely to become even more pronounced in the coming months.
Conclusion
In conclusion, while the EHDS holds the promise of advancing healthcare and fostering innovation, it also presents significant challenges regarding data privacy, professional ethics, and the balance between facilitating data sharing and safeguarding individual rights. These challenges must be addressed effectively to realise the full potential of the European Health Data Space.