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
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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 [...]
Real World Evidence (RWE) – Event Horizon
RWE 201 - RWE Event Horizon The term "event horizon" in the context of pharmaceuticals, particularly when discussing the shift towards real-world evidence (RWE) in regulatory submissions, is metaphorically [...]
Real World Evidence (RWE) 201 – Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development
RWE 201 - Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development Australia has several real-world evidence (RWE) initiatives to support healthcare [...]
Real World Evidence (RWE) 201 – South Korea’s Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development
RWE 201 - South Korea's Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development South Korea has several initiatives to support healthcare and drug development using [...]
Real World Evidence (RWE) 201 – Taiwan: Integrating Real-World Evidence for Drug Development and Policy Making
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Real World Evidence (RWE) 201 – Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development
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RWE 201 | A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU
OCTOBER 2023 – 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.
Our RWE 201 posts can be accessed here: https://rwr-regs.com/rwe-201/
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 [Link]
- EU – The European Health Data Space [Link]
- EU – The Data Governance Act [Link]
- EU – EMA’s 2025 Vision for RWE [Link]
- EU – EMA RWE Framework to Support Regulatory Decision Making [Link]
- EU – EU’s Action Plan for Real-World Data (RWD) & RWE [Link]
- EU – RWD/RWE is Embedded into the New EU Medicines Regulations [Link]
EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation GalleryEU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation
2023, EHDS, ENCePP, EU, Members-Only, Minor Update, October 2022, RWD to Support Reg Decisions, Secondary Use of Existing Data-
- 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?
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?
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.
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Real World Evidence (RWE) 101 – ICH GCP (R3) – Real World Evidence Context
RWE 101 - ICH GCP (R3) - Real World Evidence Context Revision 2 of ICH GCP caused confusion to those of us who work with non-interventional studies. The glossary [...]
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Real World Evidence (RWE) 101 – A Career of Many Pathways
RWE 101 - A Career of Many Pathways Real-world evidence (RWE) refers to the information on health care that is derived from analysis of real-world data (RWD). RWE [...]
Real World Evidence (RWE) 101 – Evolution of Regulatory Affairs
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Real World Evidence (RWE) 101 – Project Managers
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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.
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Real World Evidence (RWE) 101 – ICH GCP (R3) – Real World Evidence Context
RWE 101 - ICH GCP (R3) - Real World Evidence Context Revision 2 of ICH GCP caused confusion to those of us who work with non-interventional studies. The glossary [...]
Real World Evidence (RWE) 101 – Non-Interventional Studies vs Market Health Research
RWE 101 - Non-Interventional Studies vs Market Health Research Key differences between a non-interventional study (NIS) and market health research include:1. Research Objective: NIS are conducted to examine real-world [...]
Real World Evidence (RWE) 101 – Real World Evidence (RWE) 101 – Audits vs Inspections
RWE 101 - Real World Evidence (RWE) 101 - Audits vs Inspections In the context of regulatory compliance for Real-World Evidence (RWE), both audits and inspections play crucial roles, [...]
Real World Evidence (RWE) 101 – A Career of Many Pathways
RWE 101 - A Career of Many Pathways Real-world evidence (RWE) refers to the information on health care that is derived from analysis of real-world data (RWD). RWE [...]
Real World Evidence (RWE) 101 – Evolution of Regulatory Affairs
RWE 101 - Evolution of Regulatory Affairs Real-world evidence (RWE) and real-world data (RWD) are increasingly influencing regulatory affairs in the biopharmaceutical and healthcare industry. This change has been [...]
Real World Evidence (RWE) 101 – Project Managers
RWE 101 - Project Managers Real-World Evidence (RWE) observational studies and clinical trials are both key elements of medical research, but they involve very different methodologies, aims, and requirements. [...]
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.
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Real World Evidence (RWE) 101 – ICH GCP (R3) – Real World Evidence Context
RWE 101 - ICH GCP (R3) - Real World Evidence Context Revision 2 of ICH GCP caused confusion to those of us who work with non-interventional studies. The glossary [...]
Real World Evidence (RWE) 101 – Non-Interventional Studies vs Market Health Research
RWE 101 - Non-Interventional Studies vs Market Health Research Key differences between a non-interventional study (NIS) and market health research include:1. Research Objective: NIS are conducted to examine real-world [...]
Real World Evidence (RWE) 101 – Real World Evidence (RWE) 101 – Audits vs Inspections
RWE 101 - Real World Evidence (RWE) 101 - Audits vs Inspections In the context of regulatory compliance for Real-World Evidence (RWE), both audits and inspections play crucial roles, [...]
Real World Evidence (RWE) 101 – A Career of Many Pathways
RWE 101 - A Career of Many Pathways Real-world evidence (RWE) refers to the information on health care that is derived from analysis of real-world data (RWD). RWE [...]
Real World Evidence (RWE) 101 – Evolution of Regulatory Affairs
RWE 101 - Evolution of Regulatory Affairs Real-world evidence (RWE) and real-world data (RWD) are increasingly influencing regulatory affairs in the biopharmaceutical and healthcare industry. This change has been [...]
Real World Evidence (RWE) 101 – Project Managers
RWE 101 - Project Managers Real-World Evidence (RWE) observational studies and clinical trials are both key elements of medical research, but they involve very different methodologies, aims, and requirements. [...]
