Tag archives: Clinical Trials

CCPA – Health Research Bill Passes Legislature

By David Kessler (US), Susan Ross (US) and Anna Rudawski (US) on September 9, 2020 Posted in CCPA

Norton Rose Fulbright - Data Protection Report blog

Although the bill to amend the California Consumer Privacy Act (CCPA) to extend the so-called “B-to-B” and “employee” exceptions for one more year has garnered many headlines, the California legislature passed a second CCPA amendment (AB 713) that will be of interest to anyone involved in medical research as the new bill would ease some CCPA restrictions on research. The changes pertaining to healthcare data are expected to pass and are clearly responsive to additional needs to share information and conduct research on potential treatments and vaccines for the ongoing COVID pandemic. The bill has been sent to … Continue Reading

EDPB issues new opinion on interplay between Clinical Trials Regulation and the GDPR

By David Kessler (US), Christoph Ritzer (DE), Sven Jacobs (DE), Anna Rudawski (US) and Max Kellogg (US) on February 19, 2019 Posted in Compliance and risk management, Enforcement, Regulatory response

On January 23, 2019, the European Data Protection Board (“EDPB”) issued an opinion on the interplay between the Clinical Trials Regulation (“CTR”) and the General Data Protection Regulation (“GDPR”). See our previous blog posts on the GDPR here and here. The opinion also addresses GDPR requirements regarding (1) the legal basis for processing personal data in the course of a clinical trial protocol (primary use) and (2) the further use of clinical trial data for other scientific purposes (secondary use).

Even though the CTR already entered into force on June 16, 2014, the regulation’s application depends on the … Continue Reading