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Real World Evidence (RWE) 201 – France – CNIL Regulatory Sandbox: Digital Health

RWE 201 – France – CNIL Regulatory Sandbox: Digital Health

The French Data Protection Agency (CNIL) has been actively supporting digital health technology innovators through its regulatory “sandbox.” These projects range from federated learning across health data warehouses to building diagnostic tools in oncology, statistical indicators for medical research, and a therapeutic game for minors with eating disorders. The CNIL provides crucial guidance on overcoming regulatory challenges, including the nature of data, legal frameworks, and data security measures.

Benefits for RWD, RWE, and Digital Health Innovators:

  1. Navigating Regulatory Challenges: The CNIL’s sandbox provides a safe environment to test solutions and understand regulations. For RWD and RWE developers, this means an easier path to compliance with GDPR and other privacy laws.
  2. Interconnected Data Sources: For projects like Resilience in oncology, CNIL’s guidance enabled the interconnection of various data sources. This has implications for RWD, as it becomes easier to integrate data from disparate sources for more comprehensive Real-World Evidence.
  3. Data Security: With its focus on secure data processing, the sandbox offers a blueprint for ensuring the safety of health data, which is invaluable for digital health innovators dealing with sensitive patient information.
  4. AI and Machine Learning: Projects like the one carried out at Lille University Hospital utilized federated learning protocols, offering a roadmap for implementing machine learning algorithms in healthcare. This aids RWD and RWE applications where machine learning could provide new insights.
  5. Specialized Use-Cases: The Vertexica project focusing on minors with eating disorders shows how data protection can be maintained even in specialized healthcare solutions, thereby ensuring the ethical use of Real-World Data.
  6. Knowledge Sharing: The joint work and multiple exchanges with CNIL have generated lessons that could be useful for the broader health sector, facilitating faster and more secure innovation.
  7. ‘Privacy by Design’: The emphasis on integrating GDPR compliance from the design phase benefits all stakeholders by baking in data protection from the outset, which is a fundamental need in RWD and RWE applications.
  8. Stakeholder Collaboration: The sandbox projects involve multi-disciplinary teams, demonstrating a collaborative approach that could benefit digital health innovators, RWD and RWE developers in addressing complex regulatory and ethical issues.

In essence, the CNIL’s regulatory sandbox serves as an invaluable resource, not just as a testing ground but as a knowledge base for RWD, RWE, and digital health innovators. It provides practical insights into overcoming regulatory challenges and implementing secure, effective healthcare solutions.

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Real World Evidence (RWE) 201 – France – CNIL Regulatory Sandbox: Digital Health2023-09-03T18:17:48+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].

 

References:

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

Link: https://www.implicity.com/everything-you-need-to-know-about-health-data-hub/

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

Link: https://frenchhealthcare.fr/the-health-data-hub-publishes-its-roadmap-for-2022/

[3] Health Data Hub – FAQ in English

Link: https://www.health-data-hub.fr/page/faq-english

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

Link: https://www.ema.europa.eu/en/documents/presentation/presentation-rwd-data-quality-experience-france-e-bacry-health-data-hub_en.pdf

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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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