Clinical Trials & Patient's Rights to Delete Data

Three questions about the new privacy law: General Data Protection Regulation (GDPR), that went into effective on May 25, 2018...

BACKGROUND: GDPR introduces a right for individuals to have personal data erased. Under Article 17, individuals have the right to have personal data erased. This is also known as the ‘right to be forgotten’.

DATA ERASURE: Specifically, individuals have the right to have their personal data erased when "relying on consent as the lawful basis for holding the data, and the individual withdraws their consent."

QUESTION: How is your Privacy Officer or Legal Department interpreting a patient's request to erase their clinical trial data under GDPR, if a patient withdraws consent?

EXEMPTION?: The GDPR specifies circumstances where the right to erasure will not apply to special category data. The following clause sounds as though clinical trials may be exempted:

"If the processing is necessary for public health purposes in the public interest (eg protecting against serious cross-border threats to health, or ensuring high standards of quality and safety of health care and of medicinal products or medical devices)"

QUESTION: Does this GDPR clause exempt clinical trials?

CHILDREN: GDPR addresses the protection of children’s data throughout by indicating which provisions warrant a higher standard. Children requesting data erasure must be respected

QUESTION: Are pharmaceutical and medical device companies handling requests for the deletion of personal data in pediatric clinical trials differently?

Please share your response or send me a message: lizmoench@PatientDTC.com