var _paq = window._paq = window._paq || []; /* tracker methods like "setCustomDimension" should be called before "trackPageView" */ _paq.push(['trackPageView']); _paq.push(['enableLinkTracking']); (function() { var u="https://rwrregs.matomo.cloud/"; _paq.push(['setTrackerUrl', u+'matomo.php']); _paq.push(['setSiteId', '1']); var d=document, g=d.createElement('script'), s=d.getElementsByTagName('script')[0]; g.async=true; g.data-privacy-src='//cdn.matomo.cloud/rwrregs.matomo.cloud/matomo.js'; s.parentNode.insertBefore(g,s); })();

Real World Evidence (RWE) 201…THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

RWE 201 – THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

In our real world evidence (RWE) 201 series we have been exploring the regional regulatory and data access frameworks that have been implemented to support access to clinical experience data (real world data | RWD), which is crucial if we are to use this RWD to generate RWE.
 
The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease prevention. The European Health Data Space is an effort to ensure secure access and exchange of health data across EU countries, enhancing healthcare quality and research. Complementing this, the Data Governance Act seeks to foster trust and facilitate data sharing for societal benefits. The European Medicines Agency (EMA)’s 2025 Vision for Real World Evidence (RWE) and the EMA RWE Framework to Support Regulatory Decision Making are pivotal in integrating real-world data (RWD) and RWE into regulatory processes, improving drug development and monitoring. The EU’s Action Plan for RWD & RWE further emphasizes the use of real-world healthcare data in policy and decision-making. Finally, the incorporation of RWD/RWE into the new EU Medicines Regulations marks a significant shift towards evidence-based, data-driven approaches in the pharmaceutical sector, aiming to enhance patient outcomes and healthcare efficiency across the EU.
 
The following posts provide more details and visual summaries:
 
•  EU – EU4Health Program: https://lnkd.in/dFkkfp8Y
•  EU – The European Health Data Space: https://lnkd.in/dVMFrvD2
•  EU – The Data Governance Act: https://lnkd.in/dhGW5euQ
•  EU – EMA’s 2025 Vision for RWE: https://lnkd.in/d-quNktH
•  EU – EMA RWE Framework to Support Regulatory Decision Making:
•  EU – EU’s Action Plan for Real-World Data (RWD) & RWE: https://lnkd.in/d4TwfXM7
•  EU – RWD/RWE is Embedded into the New EU Medicines Regulations: https://lnkd.in/dxEZ55AT

Share this story...

Real World Evidence (RWE) 201…THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU2023-12-08T14:58:47+00:00

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.

Share this story...

EU – The Data Governance Act2023-10-14T11:38:23+00:00

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:

  1. 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.
  1. Support for Access to RWD:
    • 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.
  1. 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.
  1. Governance and Regulation:
    • The use and sharing of health data within the EHDS will be governed by EU regulations, such as the General Data Protection Regulation (GDPR) and the Data Governance Act (DGA).

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.

Share this story...

EU – The European Health Data Space2023-10-14T10:05:45+00:00

Real World Evidence (RWE) 101 – EHDS and GDPR – How does GDPR support the secondary use of existing health data for the purposes of scientific research?

RWE 101 – EHDS and GDPR – How does GDPR support the secondary use of existing health data for the purposes of scientific research?

The GDPR (General Data Protection Regulation) includes provisions that support the secondary use of existing health data for scientific research purposes, while also protecting the privacy and data protection rights of individuals.

One of the key ways that the GDPR supports the secondary use of health data for research is through the concept of “legitimate interests”. Article 6(1)(f) of the GDPR allows for the processing of personal data if it is necessary for the legitimate interests of the data controller or a third party, provided that those interests do not override the fundamental rights and freedoms of the data subject. Scientific research can be considered a legitimate interest, provided that appropriate safeguards are in place to protect individuals’ rights and freedoms.

In addition, the GDPR includes provisions that specifically address the use of health data for scientific research. For example, Article 9(2)(j) allows for the processing of special categories of personal data, such as health data, for scientific research purposes, provided that appropriate safeguards are in place.

The GDPR also requires that data controllers implement appropriate technical and organizational measures to ensure the security and confidentiality of personal data, including health data. This includes requirements for data pseudonymization and encryption, as well as procedures for data breach notification.

Overall, the GDPR strikes a balance between protecting individuals’ privacy and data protection rights, and supporting the important public interest in scientific research. By providing a framework for the responsible and transparent use of health data for research purposes, the GDPR can help to facilitate the development of new treatments and interventions that can improve public health outcomes.

Share this story...

Real World Evidence (RWE) 101 – EHDS and GDPR – How does GDPR support the secondary use of existing health data for the purposes of scientific research?2023-08-07T23:09:58+00:00

Real World Evidence (RWE) 101 – The European Health Data Space (EHDS)

RWE 101 – The European Health Data Space (EHDS)

The European Health Data Space (EHDS) is a proposed initiative by the European Union to create a secure and cross-border platform for the sharing and use of health data in the European Union. The EHDS aims to improve the quality and accessibility of health data, promote innovation in healthcare, and support research and innovation in the field of health.

The EHDS will build on existing initiatives and policies related to health data in the EU, including the General Data Protection Regulation (GDPR), the Electronic Health Record Exchange Format (EHRxf), and the European Health Insurance Card (EHIC). The initiative will also leverage emerging technologies, such as artificial intelligence and blockchain, to enhance the security, interoperability, and utility of health data.

The EHDS will focus on several key areas of health data, including electronic health records (EHRs), patient registries, medical imaging data, genomic data, and health administrative data. The initiative will establish a legal and technical framework for the sharing and use of this data, while ensuring that data privacy and security are maintained.

One of the key objectives of the EHDS is to promote the use of health data for research and innovation in healthcare. The initiative will facilitate the sharing of health data across borders and promote collaboration among researchers, clinicians, and industry partners. This is expected to lead to the development of new treatments, therapies, and medical devices, as well as improvements in healthcare delivery and outcomes.

The EHDS will also aim to improve the quality and accessibility of healthcare services by providing clinicians and patients with access to comprehensive and up-to-date health information. This will support more effective and personalized treatment decisions, as well as more efficient and coordinated healthcare delivery.

Overall, the European Health Data Space is an ambitious initiative that seeks to leverage the potential of health data to improve healthcare and drive innovation in the field. While the initiative is still in its early stages, it has the potential to transform healthcare in the European Union and to establish the EU as a leader in the use of health data for the public good.

Share this story...

Real World Evidence (RWE) 101 – The European Health Data Space (EHDS)2023-08-07T23:07:39+00:00

Real World Evidence (RWE) 101 – DARWIN-EU

RWE 101 – DARWIN-EU

DARWIN-EU is a project that aims to establish a sustainable platform for generating and using real-world evidence (RWE) to support decision-making in healthcare across Europe. The project brings together a consortium of academic institutions, patient organizations, regulatory authorities, and industry partners to build a comprehensive RWE ecosystem that supports the development, regulation, and reimbursement of innovative healthcare products and services.

The DARWIN-EU project focuses on several key areas of RWE, including data collection, data quality and management, data analytics and interpretation, and data sharing and dissemination. The project aims to address the current gaps in RWE infrastructure in Europe and to facilitate the integration of RWE into decision-making processes across the healthcare sector.

One of the key objectives of DARWIN-EU is to establish a European Health Data Space (EHDS) that enables secure and standardized sharing of health data across Europe. The EHDS will support the collection of RWE from a variety of sources, including electronic health records, claims data, patient registries, and clinical trials. The data collected through the EHDS will be analyzed using advanced analytics tools to generate insights into healthcare outcomes, patient populations, and treatment effectiveness.

Another objective of DARWIN-EU is to develop new methods and tools for analyzing and interpreting RWE. This includes the development of machine learning algorithms, natural language processing tools, and other advanced analytics techniques to help identify patterns and insights in large datasets. The project also aims to develop new methods for integrating RWE with other sources of healthcare data, such as genomic data and patient-reported outcomes.

Overall, DARWIN-EU is an important initiative in the context of RWE because it seeks to establish a sustainable infrastructure for collecting, analyzing, and using RWE to support decision-making in healthcare. The project has the potential to generate valuable insights into healthcare outcomes, patient populations, and treatment effectiveness, and to inform the development and regulation of innovative healthcare products and services.

Share this story...

Real World Evidence (RWE) 101 – DARWIN-EU2023-08-07T23:05:29+00:00
Help

About Us

Contact Us

Our Values

Follow Us

Newsletter

LinkedIn

[…]

Legal Info

Privacy Policy

Terms and Conditions

Copyright 2024 | Real-World Research Limited | All Rights Reserved |

This website uses cookies and third party services. Settings OK Reject

Cookies

We use analytical tools (Google Analytics) to help us improve the user experience. We DO NOT sell or use any of this data for any purpose beyond improving the design and usability of our own website (rwr-regs.com).
Go to Top