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AccueilCNIL FRANCEHealth data processing and Health Research Authorization: Key Criteria and Information.

Health data processing and Health Research Authorization: Key Criteria and Information.

Health authorization requests (outside of research) must be submitted to the CNIL if the planned processing does not fall within the exceptions provided for in article 65 of the Data Protection Act. Before submitting an authorization request, it is important to verify if the processing is in accordance with a sectorial reference established by the CNIL. If not, an authorization request must be submitted to the CNIL by providing all the required information to allow the CNIL to process the request.

Health data processing : Health research authorization requests are a crucial step for researchers and healthcare professionals who wish to collect and use personal data for research purposes. For doctors who wish to conduct health research, it is essential to understand the information to be provided in an authorization request and the grant criteria. In this article, we will examine these elements in detail.

Information to be provided in a health research authorization request

When you submit a health research authorization request to the CNIL, you must provide precise and detailed information about the nature of the research, the personal data that will be collected and the protection measures in place to ensure the security and confidentiality of the data.

The first step for doctors is to determine if their research requires CNIL authorization. If the research involves collecting, processing or storing personal data for research purposes, CNIL authorization may be required. Personal data may include information such as name, address, social security number, medical history, etc.

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Doctors must then provide detailed information about the research, including the research objective, data collection methods, the types of data that will be collected, inclusion and exclusion criteria for participants, security and confidentiality measures, and expected research results.

Grant criteria for health research authorization – Health data processing

The CNIL gives special attention to health research authorization requests because these data are often considered sensitive and can be used to identify individuals. The CNIL authorization grant criteria include:

Justification of research: Doctors must clearly explain why the research is necessary, how it will contribute to improving health and how it fits into the regulatory framework for data protection.

Proportionality: Doctors must ensure that data collection is proportional to the research objective and that the data collected is relevant and not excessive.

Security and confidentiality measures: Doctors must implement appropriate security and confidentiality measures to ensure the security and confidentiality of the collected data.

Participant rights: Doctors must inform participants of their right to withdraw their consent at any time, their right to access their personal data and their right to have their data erased.

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