European Parliament approves creation of the European Health Data Space: unified system for managing electronic health data across member states
Exec Summary:
On the 24th April 2024, members of the European Parliament (MEPs) approved the creation of the European Health Data Space (EHDS).
The law will make it possible to transfer health data safely to health professionals in other EU countries (based on MyHealth@EU infrastructure), for example when citizens move to another state. It will be possible to download the health record free of charge.
The European Health Data Space (EHDS) is an initiative by the European Union to create a unified system for managing electronic health data across member states. It aims to achieve several goals:
Empower individuals: The EHDS will give people more control over their health data, allowing them to access and share it electronically with healthcare providers across the EU.
Improve healthcare delivery: With easier access to a patient's medical history, doctors in different countries will be able to provide better care, especially in situations like cross-border care or emergencies.
Boost research and innovation: Researchers will have a secure platform to access and analyse large datasets for medical research, leading to advancements in disease prevention, treatment, and drug development.
The EHDS is still under development, but a political agreement between the European Parliament and the Council was reached in April 2024. This paves the way for establishing the legal framework and technical infrastructure for the data space.
Here are some key aspects of the EHDS:
Strong foundation: It builds on existing regulations like the General Data Protection Regulation (GDPR) to ensure user privacy and data security.
Interoperability: The EHDS will establish common standards for electronic health records, allowing seamless data exchange between different healthcare systems.
Governance framework: A clear set of rules will govern how data is accessed, used, and stored within the EHDS.
Additionally, the Health Data Space would unleash the research potential of health data in an anonymised or pseudonymised format. Data including health records, clinical trials, pathogens, health claims and reimbursements, genetic data, public health registry information, wellness data and information on healthcare resources, expenditure and financing, could be processed for public interest purposes, including research, statistics and policy-making (so-called secondary use).
Data could, for example, be used to find treatments for rare diseases, where small datasets and fragmentation currently prevent advances in treatments.
Secondary use will not be allowed for commercial purposes including advertising, assessing insurance requests or lending conditions or making job market decisions. Access decisions will be made by national data access bodies.
Overall, the European Health Data Space has the potential to revolutionise healthcare in Europe by fostering better patient care, enabling groundbreaking research, and creating a unified digital health market.
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What is the European Health Data Space (EHDS)?
The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at:
1. Empowering individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide.
2. Fostering a single market for electronic health record systems, relevant medical devices and high risk AI systems.
3. Providing a trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities (secondary use of data).
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 is building a strong European Health Union, in which all EU countries prepare and respond to health crises, have available, affordable, innovative and adequate medical supplies, and member countries work together to improve prevention, treatment and aftercare for diseases.
The COVID-19 pandemic shows the importance of coordination among European countries to protect health, both during a crisis and in normal times. The European Health Union improves EU-level protection, prevention, preparedness and response against human health hazards.
MyHealth@EU infrastructure
MyHealth@EU is a key initiative laying the groundwork for the European Health Data Space (EHDS) by establishing the infrastructure for secure exchange of electronic health data across European Union (EU) member states. Here's a breakdown of MyHealth@EU:
Goals:
Empowering patients: MyHealth@EU aims to give individuals control over their health data. You'll be able to access and electronically share your medical information (e.g., prescriptions, patient summaries) with healthcare providers across the EU.
Improved healthcare delivery: Doctors in different countries will have easier access to a patient's medical history, enabling them to provide better care, especially in situations like:
Cross-border care: If you receive treatment in another EU country, your doctor there can access your relevant medical data.
Emergencies: In case of an emergency, healthcare providers can quickly obtain your essential medical information.
Current functionalities:
Limited but growing: MyHealth@EU is still under development, but some functionalities are already available in some EU countries. These include:
ePrescriptions: You can get prescriptions electronically and have them filled in any participating EU country pharmacy.
Patient Summaries: A standardised summary of your key medical information can be accessed by healthcare providers across borders.
Future of MyHealth@EU:
Expansion: MyHealth@EU is expected to expand to encompass a wider range of data types beyond prescriptions and summaries. This could include lab results, hospital discharge reports, and medical imaging.
More member states: As the EHDS takes shape, MyHealth@EU services will become available in more EU countries, including Iceland and Norway. Benefits:
Continuity of care: MyHealth@EU allows for a more seamless flow of medical information when receiving care in different EU countries.
Improved medical decision-making: Doctors will have a more comprehensive view of your medical history, potentially leading to better diagnosis and treatment plans.
Patient empowerment: You'll have greater control over your health data and be able to share it more easily with healthcare providers you choose.
Challenges:
Standardization: Ensuring all EU countries adhere to the same data formats and security protocols is crucial for smooth information exchange.
Privacy concerns: Building public trust in the system's ability to protect sensitive health data is paramount.
In conclusion, MyHealth@EU is a stepping stone towards the EHDS, fostering a more connected and efficient healthcare system across Europe. It empowers patients and improves healthcare delivery by enabling secure exchange of electronic health data within the EU.
Future of the European Health Data Space
The future of the European Health Data Space (EHDS) looks promising, with the potential to significantly improve healthcare across the EU. Here's a breakdown of what we can expect:
Near future (2-3 years):
Implementation: Member states will be working on implementing the agreed-upon regulations and technical infrastructure for the EHDS. This includes setting up national digital health authorities and ensuring their systems are interoperable with the broader European system.
Early benefits: We might see initial functionalities like citizens being able to access their own health data electronically and share it with healthcare providers within their own country.
Pilot programs: There could be pilot programs testing cross-border data exchange for specific use cases, like emergency care or chronic disease management.
Mid-term future (5-7 years):
Widespread adoption: The EHDS should be more widely adopted across the EU, with most member states having their systems operational.
Improved care: Cross-border data exchange will become more common, allowing for better continuity of care for patients traveling or living in different EU countries.
Research breakthroughs: Researchers will have access to a richer pool of anonymised health data, potentially leading to breakthroughs in medical research.
Long-term future (10+ years):
Innovation: The EHDS could act as a springboard for innovation in digital health solutions, with new applications and services emerging to leverage the secure data exchange platform.
Personalised medicine: With a more comprehensive view of patient data, healthcare could become more personalised, with tailored treatment plans and preventative measures.
Ethical considerations: As the EHDS evolves, there will be ongoing discussions and potential adjustments to ensure user privacy, data security, and ethical use of health data for research and other purposes.
Challenges and uncertainties:
Standardisation: Ensuring all member states adhere to the agreed-upon standards for data formats and security protocols will be crucial.
Public trust: Building and maintaining public trust in the EHDS will be essential for its success. Transparency and robust data security measures will be key.
National interests: Balancing national healthcare systems with the unified EHDS framework could require ongoing negotiations and adjustments.
Overall, the EHDS has the potential to be a game-changer for European healthcare. While challenges remain, the future looks bright for a more connected, efficient, and data-driven healthcare system across the EU.
Mergers, Acquisitions, Growth and Strategy for Healthcare Technology companies
HealthTech M&A - Buy Side, Sell Side, Growth & Strategy services for companies in Europe, Middle East and Africa. Visit www.nelsonadvisors.co.uk
HealthTech M&A Newsletter from Nelson Advisors - HealthTech, Health IT, Digital Health Insights and Analysis. Subscribe Today! https://lnkd.in/e5hTp_xb
Healthcare Technology Buy Side, Sell Side, Growth & Strategy services for Founders, Owners and Investors. Email lloyd@nelsonadvisors.co.uk
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