Scientific Research

The German Conference of Independent Supervisory Authorities (“DSK”) published on March 23, 2022 a statement on scientific research and data protection (see here, in German).  The DSK published the statement in response to the German Government’s initiative on a general law on research data as part of its Open Data Strategy, announced on July 6, 2021.  The DSK also refers to the Government’s intention to introduce a law on the use of health data, including the storage of data in electronic health records.
Continue Reading German Supervisory Authorities Publish Paper on Scientific Research and Data Protection

On May 19, 2021, the Italian Supervisory Authority (“Garante”) fined a physician €5,000 for publishing a patient’s medical records without obtaining that patient’s specific consent to do so.  As background, the physician downloaded medical records about a patient she treated at a local hospital from the hospital’s online archive system, including images taken during surgery.  The physician used these records for a presentation at a medical conference, and also included them as documentation supporting a scientific research paper she submitted for a competition hosted by a surgeons’ association.  The physician’s paper was ultimately selected as the winner of that competition, resulting in the publication of her work on the association’s website.
Continue Reading Italian Supervisory Authority Fines Physician for Secondary Use of Patient Data Without Specific Consent

On February 2, 2021, the European Data Protection Board (“Board”) responded to questions submitted by the European Commission (“Commission”) on the application of the General Data Protection Regulation (“GDPR”) to health research.  The Board also announced that it is currently working on guidelines on the processing of personal data for scientific research purposes, which it aims to publish in the course of 2021.
Continue Reading European Data Protection Board Answers Commission’s Questions on Health Research

On April 21, 2020, the European Data Protection Board (“Board”) issued guidelines on the processing of personal data for scientific research related to COVID-19.  The Board indicates that the GDPR takes into account the needs of scientific research and should not be a barrier to conduct such research, while at the same time, it helps ensure respect for the fundamental rights of patients.
Continue Reading European Data Protection Board Issues Guidelines on Processing Personal Data for Scientific Research Related to COVID-19

On March 28, 2020, the “Federal Act for the Protection of the Population against an Epidemic of National Significance” (Bevölkerungsschutzgesetz) went into effect.  The law forms part of an emergency legislative package introduced by the German government in response to COVID-19.

The law amends the Social Code V (SGB V)

As scientists work around the clock to gain insights into the Corona virus and how to fight it, public and private-sector stakeholders are in discussions to promote the rapid exchange of scientific data. During these discussions, the GDPR acronym inevitably rears its head and casts doubt over what is lawful. The GDPR and national data

On April 3, 2019, the Association of German Supervisory Authorities (“Datenschutzkonferenz” or “DSK”) issued a paper (available here in German) on the interpretation of “broad consent” for scientific research in Recital 33 of the GDPR and the interplay with the definition of consent  and the principle of purpose limitation.

According to the DSK, broad consent

On March 28, 2019, the Council of Europe* issued a new Recommendation on the protection of health-related data.  The Recommendation calls on all Council of Europe member states to take steps to ensure that the principles for processing health-related data (in both the public and private sector) set out in the Appendix of the Recommendation

The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”).  The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health.  The Directorate General decided to create this Q&A