
On January 23, 2019, the European Data Protection Board (EDPB) issued an opinion (Opinion) on the interplay between the Clinical Trial Regulation (CTR) and the General Data Protection Regulation (GDPR), an issue which has been the subject of intense debate and that resulted in a draft, and still non-public, FAQ prepared by the EU Commission. The Opinion comments on the draft FAQ and provides some insight on data protection regulators’ view on how the GDPR applies to patient data collected as a part of a clinical trial.
In short, the EDPB takes the position that consent under the GDPR, and informed consent under the CTR, are different concepts, and that various legal grounds, including consent, are available under the GDPR to process patient personal data in the clinical trial context. Practically speaking, organizations will have to conduct a case-by-case assessment of the various options available.
Continue Reading EDPB Opinion on Consent and Legal Basis in Clinical Trials
On September 23, 2018, Governor Jerry Brown signed into law SB-1121, a bill that makes several amendments to the
Recently, Vermont became the first state to enact legislation that regulates data brokers who buy and sell personal information. Under the new law, data brokers in Vermont will now have to register with the state, adopt standard security measures, and provide information to the state regarding their data collection practices. The law was passed in response to reported risks associated with the widespread aggregation and sale of data about consumers, and is intended to provide consumers with more information about data brokers and their data collection practices.
California Signs the First IoT Security Bill into Law, and the FTC Submits Comments to the Consumer Product Safety Commission Regarding the IoT
In July 2018, the French data protection authority (the CNIL) issued two public formal notices against two marketing platform providers—
On September 1, 2018, a new Colorado law took effect that, among other things, amends the state’s data breach law to: (1) expand the scope of the categories of “personal information” that trigger notification requirements; (2) require notification to residents and the state attorney general no more than 30 days after determining that a security breach has occurred; and (3) specify what must be included in these notifications.