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Real World Evidence (RWE) 201 – France – Haute Autorité de Santé (HAS) – Real World Study Guide

RWE 201 – France – Haute Autorité de Santé (HAS) – Real World Study Guide


HAS Real World Stidy Guide:

The Haute Autorité de Santé (HAS), France’s National Authority for Health, is responsible for scientifically evaluating medicinal products and medical devices in terms of their medical, economic, and public health value. While clinical trials have traditionally been the foundation for these assessments, HAS is increasingly incorporating “real-world data” (RWE) into their evaluations.

Real-world data comes from sources other than conventional clinical trials and includes observational data and data on the use, efficacy, and safety of health products. This kind of data is particularly useful because clinical trials often have limitations; their controlled conditions can differ significantly from real-life medical practice, and their results might not be applicable in all cases. For example, new therapies involving gene technologies or machine learning bring uncertainties that can only be fully understood in real-world conditions.

Real-world studies offer advantages like understanding a product’s performance in actual clinical settings, identifying the patients most likely to benefit, and foreseeing potential risks. They also allow for the inclusion of patient perspectives, which are becoming increasingly important in the evaluation process.

HAS has begun updating its methodological guide on real-world studies to provide practical guidelines for such evaluations. This is due to increased access to health data and the growing recognition of the importance of real-world data to complement clinical trials. These guidelines aim to aid all stakeholders involved in the health product evaluation process, including manufacturers, research companies, and academic teams, in the design and implementation of real-world studies.

In summary, HAS is expanding its reliance on real-world data to enhance the quality and applicability of its health product assessments. This shift is aimed at capturing a more comprehensive picture of product effectiveness and safety, which ultimately benefits patient care.

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Real World Evidence (RWE) 201 – France – Haute Autorité de Santé (HAS) – Real World Study Guide2023-09-04T08:30:12+00:00

Real World Evidence (RWE) 201 – France – CNIL Reference Methodologies: Facilitating Access to Real World Data

RWE 201 – France – CNIL Reference Methodologies: Facilitating Access to Real World Data


The CNIL (Commission Nationale de l’Informatique et des Libertés) is the French data protection authority. CNIL has issued various “Reference Methodologies” (Méthodologies de Référence or MRs) which are guidelines/frameworks for compliance with data protection regulations in specific areas e.g., MR-001 (interventional research) and MR-003 (non-interventional research) which cover research involving direct interactions with people (RIPH), or MR-004 for research involving secondary use of existing personal healthcare data i.e., research not involving direct interaction with people (RNIPH).

By declaring conformity to the applicable reference methodology to the CNIL, research sponsors do not need to seek individual authorisation for each research project that involves non-anonymous data, making this an efficient and effective form of self-regulation.

Key features of MR-004 conformity include:

  1. Data Minimisation: Only collect the data that is strictly necessary for the research or healthcare activity.
  2. Purpose Limitation: Use the data only for the specified, explicit, and legitimate purposes for which it was collected.
  3. Consent: Access to and use (re-use) of existing patient health data is subject to informing the affected patients (patient information).
  4. Security: Guidelines for data storage, encryption, and access control, in line with GDPR requirements.
  5. Data Subject Rights: Details about how to facilitate data subjects’ rights like access, rectification, deletion, and data portability.
  6. Data Retention: Sets time limits on how long the data can be stored and provides guidance on secure deletion practices.
  7. Accountability and Governance: Stresses the importance of record-keeping, conducting impact assessments, and potentially appointing a Data Protection Officer (DPO).
  8. Data Sharing: Provides guidelines for sharing data with third parties, including cross-border data transfers.
  9. Legal Compliance: Ensures that the data processing activities are compliant with other relevant laws and ethical considerations.

By adhering to MR-004 or similar CNIL Reference Methodologies (as applicable), healthcare organizations and researchers can use real-world data while fulfilling their legal obligations and ethical responsibilities for data protection (GDPR). Note that these guidelines are subject to change, so it’s crucial to consult the most current version and seek legal advice for complex scenarios.

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Real World Evidence (RWE) 201 – France – CNIL Reference Methodologies: Facilitating Access to Real World Data2023-09-03T18:11:56+00:00

Real World Evidence (RWE) 201 – France – Health Data Hub: Facilitating Access to Real World Data

RWE 201 – France – Health Data Hub: Facilitating Access to Real World Data


The purpose of France’s Health Data Hub (HDH) is to facilitate the sharing of health data to support research and innovation. Launched in December 2019, the HDH is a health data platform established by the French government to combine existing health databases and make them more accessible for research and development purposes [1].

The platform allows public interest project leaders to access large volumes of data and utilize the platform’s computing power to run complex research algorithms [2].

The reuse of health data has significant potential for enhancing healthcare quality and patient support through research. This includes [3]:

  • Evaluating the effectiveness of treatments for rare pathologies like sarcoma by combining patient and insurance data.
  • Enhancing prescription alert systems to help healthcare professionals make better decisions in complex clinical scenarios.
  • Developing early warning tools for conditions like heart failure by correlating pacemaker and hospitalization data.
  • Predicting disease progression, as in Parkinson’s disease, and improving preventive measures using patient cohort data.
  • Streamlining the reporting and analysis of adverse drug reactions to improve healthcare system transparency.
  • Utilizing AI to improve early cancer screening, thus reducing false positives and negatives, and saving medical time.
  • Gathering data on long-term effects of medications, particularly in cases of organ transplantation, to optimize therapeutic strategies.

Researchers interested in accessing real-world data (RWD) and generating real-world evidence (RWE) can benefit from the HDH in several ways:

  1. Data Accessibility: The HDH provides a single gateway for health data in France, making it easier for researchers to access various data sources [4].
  2. Data Catalogue: The platform includes a data catalogue with one of the world’s largest healthcare claims databases, offering researchers a rich source of information for their studies [4].
  3. Collaboration: The HDH brings together 56 stakeholders, including the largest French public organization for scientific research, CNRS, fostering collaboration between government, producers of health data, and users of public and private health data [1].
  4. Support for Projects: The HDH provides researchers with the necessary resources and infrastructure to carry out their studies [4].
  5. Data Security: The platform ensures the protection of health data through a data access approval process, maintaining the privacy and security of sensitive information [4].

By providing researchers with easier access to health data and the necessary resources to analyse and process this data, the HDH can help generate valuable insights and contribute to advancements in the health sector [4].



[1] Everything you need to know about Health Data Hub – Implicity


[2] The Health Data Hub publishes its roadmap for 2022 – French Healthcare (30 May 2022)


[3] Health Data Hub – FAQ in English


[4] Health Data Hub – Multi-stakeholder workshop RWD quality and RWE use (26 June 2023)


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Real World Evidence (RWE) 201 – France – Health Data Hub: Facilitating Access to Real World Data2023-09-03T17:41:34+00:00
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