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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