EU – The Data Governance Act
RWE 201 – EU – The Data Governance Act
Data Governance Act: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0868
The EU Data Governance Act (DGA) aims to establish a legal framework for data sharing across sectors. It promotes the sharing of data, including personal data, in a secure and standardized manner. This is relevant for health data, as it facilitates the sharing of RWD among healthcare providers, researchers, and institutions.
[1] Data Intermediaries: The DGA introduces the concept of “data intermediaries” and “data intermediary service providers” (DISPs), which are entities that facilitate data sharing between data providers (e.g., healthcare organizations) and data users (e.g., researchers). These intermediaries may play a role in managing access to health data within the EHDS, ensuring compliance with data protection regulations.
Examples of DISPs: Salus Coop, Midata, Data Trusts Initiative, UK Biobank, INSIGHT, The Pistoia Alliance
[2] Data Governance Mechanisms: The Act promotes the development of data governance mechanisms (e.g., mandatory registration of DISPs by Sept 2025), including codes of conduct, interoperability standards and certification mechanisms, to ensure that data sharing activities adhere to data protection and privacy regulations. This is crucial in the context of health data, where sensitive information is involved.
[3] Cross-Border Data Sharing: The Act encourages cross-border data sharing within the European Union, which is particularly relevant for research purposes within the EHDS, as it enables access to a more diverse and comprehensive set of health data from different member states.
[4] Data Portability and Data Altruism: The Act recognizes the importance of data portability and data altruism, allowing individuals to have more control over their data and choose to share it for research or public interest purposes, which supports the availability of RWD for research in the health sector.
[5] Security and Privacy: The DGA places a strong emphasis on data security and privacy (e.g., secure processing environments), requiring data sharing activities to comply with EU data protection regulations, such as the General Data Protection Regulation (GDPR). This is crucial when dealing with health data to ensure the protection of patients’ sensitive information.
In summary, the EU Data Governance Act, provides a legal framework for secure and standardized data sharing that is essential for supporting access to Real-World Data and research activities within the European Health Data Space. It helps to ensure that data sharing is conducted in compliance with data protection regulations while promoting transparency, security, and cross-border collaboration in health research.
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EU – EMA RWE Framework to Support Regulatory Decision Making
RWE 201 - EU – EMA RWE Framework to Support Regulatory Decision Making EMA RWE Framework 2023: https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-report-experience-gained_en.pdfThe European Medicine Agency (EMA) is actively working on creating a framework [...]
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EU – The Data Governance Act
RWE 201 - EU – The Data Governance Act Data Governance Act: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0868The EU Data Governance Act (DGA) aims to establish a legal framework for data sharing across sectors. [...]
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EU 2021 – Setting the Scene for the European Health Data Space
RWE 201 - EU 2021 – Setting the Scene for the European Health Data Space Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.CI.2021.269.01.0003.01.ENGIn the evolving healthcare framework of the European Union (EU), the prominence of [...]
EU – The European Health Data Space
RWE 201 – EU – The European Health Data Space
[Image Source: https://tehdas.eu/results/tehdas-identifies-user-journey-for-cross-border-health-data-sharing/]
EHDS: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
The European Health Data Space (EHDS) is an initiative by the European Commission to foster the exchange and usage of health data in the European Union (EU) for the purposes of healthcare provision, health research, and health policymaking. Its core concepts and the relation to Real-World Data (RWD) are as follows:
- Key Concepts:
-
- Interoperability: The EHDS aims to ensure that health data can be easily and effectively shared across borders and systems within the EU. This is to be achieved by adopting common data formats, standards, and protocols.
- Trust and Security: A central pillar of the EHDS is to ensure that health data is shared and used in a secure manner, with stringent measures in place to protect patient confidentiality and data privacy.
- Data Quality: Ensuring the reliability and quality of health data is crucial. The EHDS focuses on ensuring that the data used is of high quality and is reliable for the purposes of health research and policymaking.
- Infrastructure: The initiative emphasises the need for robust data infrastructures to store, manage, and analyse the vast amounts of health data.
- Support for Access to RWD:
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- RWD is data derived from sources other than traditional clinical trials, such as electronic health records (EHRs), claims and billing data, and patient registries. The EHDS’s emphasis on interoperability and data sharing naturally supports the access and utilisation of RWD.
- By facilitating the sharing of data across the EU, the EHDS allows for the aggregation of vast amounts of RWD from diverse sources, making it a rich resource for health research.
- Data Access for Researchers:
-
- Researchers will have access to the data through secure platforms, ensuring that only authorised personnel can access the necessary datasets.
- With the EHDS, researchers across the EU can tap into a broader and more diverse dataset, which can potentially lead to more accurate and generalisable research findings.
- Governance and Regulation:
In summary, the European Health Data Space aims to revolutionise the way health data is used and shared in the EU, providing a reliable and secure platform for accessing real-world data for the purposes of health research, healthcare provision, and policymaking. The governance and regulatory frameworks in place ensure that data privacy and security are upheld, while still allowing for the effective use of this invaluable resource.
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EU – EMA RWE Framework to Support Regulatory Decision Making
RWE 201 - EU – EMA RWE Framework to Support Regulatory Decision Making EMA RWE Framework 2023: https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-report-experience-gained_en.pdfThe European Medicine Agency (EMA) is actively working on creating a framework [...]
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EU – EU4Health Program
RWE 201 – EU – EU4Health Program
EU4Health: https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en
EU4Health is an ambitious EU health program for the years 2021-2027. Its primary goal is to bolster the resilience of Europe’s health systems and to spur innovation in the health sector. The program has a budget of €5.3 billion, making it one of the largest health budgets in the history of the European Union.
Key objectives include:
– Strengthening health systems so that they can face epidemics and other long-term challenges.
– Supporting global commitments and protecting citizens from serious cross-border health threats.
– Making medicines and medical devices available and affordable, and fostering innovation.
[1] Real-World Data (RWD) and Real-World Evidence (RWE):
– RWD refers to data that are collected outside of conventional clinical trials. This includes electronic health records (EHRs), claims and billing activities, product and disease registries, and patient-related activities in smartphones and wearables.
– RWE is the evidence derived from RWD through the analysis of these real-world outcomes. RWE can provide insights into medication safety and effectiveness, treatment guidelines, and health technology assessment (HTA).
[2] Context of RWD and RWE in EU4Health: The EU recognizes the potential of RWD and RWE to bring about significant changes in healthcare decisions. By tapping into the vast amount of data generated daily in healthcare settings, decision-makers can:
– Understand the real-world effectiveness of treatments.
– Inform regulatory and reimbursement decisions.
– Understand disease patterns and trends.
[3] EU RWD Collection and RWE Generation Action Plan: This action plan represents a strategic effort to harness the power of RWD and RWE. Some of its goals and activities may include:
– Standardizing the collection and use of RWD across EU member states.
– Collaborating with stakeholders to ensure the quality and reliability of RWE.
– Building infrastructures that support data sharing and analytics.
– Training professionals in the methodologies of RWE.
It’s worth noting that as the landscape of RWD and RWE evolves, so too will the EU’s strategies and policies. The collaboration between healthcare professionals, policymakers, patients, and other stakeholders will be crucial in harnessing the full potential of RWD and RWE in the EU4Health framework.
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EU – EMA RWE Framework to Support Regulatory Decision Making
RWE 201 - EU – EMA RWE Framework to Support Regulatory Decision Making EMA RWE Framework 2023: https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-report-experience-gained_en.pdfThe European Medicine Agency (EMA) is actively working on creating a framework [...]
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EU 2021 – Setting the Scene for the European Health Data Space
RWE 201 - EU 2021 – Setting the Scene for the European Health Data Space Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.CI.2021.269.01.0003.01.ENGIn the evolving healthcare framework of the European Union (EU), the prominence of [...]
EU 2021 – Setting the Scene for the European Health Data Space
RWE 201 – EU 2021 – Setting the Scene for the European Health Data Space
Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.CI.2021.269.01.0003.01.ENG
In the evolving healthcare framework of the European Union (EU), the prominence of Real-World Data (RWD) and Real-World Evidence (RWE) is unmistakable. These tools play a critical role in shaping decisions about treatment affordability and efficacy. The early EU initiatives focused on fostering collaborations, enhancing data precision, and championing a healthcare environment that is transparent and sustainable for all its member states.
[1] Stakeholder Engagement: Collaboration with regulators, HTA bodies, healthcare experts, and patients boosts the validity and utility of data, promoting both affordability and better decision-making processes.
[2] Value of Randomised Evidence: While controlled randomised trials are a cornerstone, the insights from electronic health records and registry-based trials capture a more genuine reflection of patient experiences and outcomes.
[3] RWE Bridging Knowledge Gaps: With initiatives like EHDS and DARWIN EU, RWE promises to supplement existing regulatory knowledge, enhancing aspects like digital health integration, ensuring data privacy, and promoting system interoperability.
[4] Tackling Affordability Issues: In light of spiralling healthcare costs, strategies like the International Horizon Scanning Initiative and the Pharmaceutical Strategy underline the essence of collaborative drug pricing and cost transparency.
[5] Advantages of Cross-border HTA Collaborations: Initiatives like EUnetHTA facilitated joint evaluations of medicines and devices, fostering synergy amongst EU nations.
[6] Enhanced RWE Collection: The EU’s ambition to streamline RWE collection via digital strides within the EHDS platform aims to augment clinical trial findings and thus positively influence regulatory decisions.
[7] Focus on Pricing & Reimbursement: The NCAPR accentuates the need for pricing that champions affordability and promotes a competitive market, particularly emphasizing the role of generics and biosimilars.
[8] Catalysing Innovation: The drive to incentivize innovation ensures a steady influx of effective, accessible medical solutions, maintaining an equilibrium between ground-breaking advancements and affordability.
In summary, the EU’s dedication to leveraging RWD and RWE showcases its resolve to merge innovation with cost-effectiveness in healthcare. Through fostering robust collaborations, championing data-centric initiatives, and prioritizing transparency in medical pricing, the EU is poised to navigate the delicate balance between advancing medical technologies and ensuring accessible, patient-focused care informed by real-world patient experiences.
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EU – EMA RWE Framework to Support Regulatory Decision Making
RWE 201 - EU – EMA RWE Framework to Support Regulatory Decision Making EMA RWE Framework 2023: https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-report-experience-gained_en.pdfThe European Medicine Agency (EMA) is actively working on creating a framework [...]
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