Life science

This blog was prepared in collaboration with, and was originally published by, the UK BioIndustry Association, here. We are grateful to the UK BioIndustry Association for collaborating on this blog, and for the opportunity to post it here.

What are the UK’s plans to reform data protection law?

After an extended period of legislative back and forth, the Data (Use and Access) Bill has now received Royal Assent, becoming the Data (Use and Access) Act (we will therefore refer to it as the “Act” in this blog). The Act addresses various matters related to the use of data, and will to an extent distinguish the UK’s approach to data protection from that set out in the EU’s General Data Protection Regulation (“GDPR”). The European Commission will, therefore, assess whether these changes warrant stripping the UK of its adequacy status for data transfers, with a decision due by 27 December 2025. While the Commission is unlikely to withdraw its finding of adequacy, it is possible that a challenge to this finding could be brought before the Court of Justice of the EU, which could reach a different conclusion.

In summary, the Act is not a complete overhaul of data protection law in the UK; instead, it is more a package of targeted amendments. Of the changes most relevant to biotechs, the most significant is the more permissive regime for the use of personal data for scientific research – although, companies must still meet a number of requirements to fall within scope. More significant changes may take place in the future, as key parts of the Act enable the UK Government to pass secondary legislation in areas that may be relevant to biotechs.Continue Reading The UK’s new Data Legislation – What does it mean for the Life Science sector?

This quarterly update summarizes key legislative and regulatory developments in the first quarter of 2023 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity.Continue Reading U.S. AI, IoT, CAV, and Privacy & Cybersecurity Legislative & Regulatory Update – First Quarter 2023

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act, which entered into force on 26 June 2022. The new rules will become fully operational once the Ministry of Health sets up the public database where companies will have to disclose their data.  In

Continue Reading The New Italian Sunshine Act Introduces Mandatory Individual Disclosure With Implied Consent Mechanism For Transfers Of Value

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 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.

One of
Continue Reading Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes

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
Continue Reading Association of German Supervisory Authorities issues paper on broad consent for research

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
Continue Reading European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation