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.
Share this story...
Real World Evidence (RWE) 101 – Is ICH GCP Applicable to Non-Interventional Studies?
RWE 101 - Is ICH GCP Applicable to Non-Interventional Studies? No, the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines are not applicable to non-interventional studies [...]
Real World Evidence (RWE) 101 – Ethical Principles and Safeguards for Medical AI in the Context of Real World Evidence
RWE 101 - Real World Evidence (RWE) 101 - Ethical Principles and Safeguards for Medical AI in the Context of Real World Evidence Medical AI applications hold [...]
Real World Evidence (RWE) 101 – The Declaration of Helsinki
RWE 101 - The Declaration of Helsinki The Declaration of Helsinki is a set of ethical principles that govern the conduct of medical research involving human subjects. [...]
Real World Evidence (RWE) 101 – Ethical Foundation of RWE Research
RWE 101 - Real World Evidence (RWE) 101 - Ethical Foundation of RWE Research Real-world evidence (RWE) research, which is the study of data from real-world settings, is [...]
Real World Evidence (RWE) 101 – The Impact of GDPR on RWE Research
RWE 101 - Real World Evidence (RWE) 101 - The Impact of GDPR on RWE Research The General Data Protection Regulation (GDPR) is a regulation in EU [...]
Real World Evidence (RWE) 101 – De-Identification versus Pseudo-Anonymisation
RWE 101 - Real World Evidence (RWE) 101 - De-Identification versus Pseudo-Anonymisation De-identification and pseudo-anonymization are two commonly used techniques for protecting personal information in real world [...]







