EDPB Gives the Green Light to the Commission’s Draft UK Adequacy Decisions
On 13 April 2021, the European Data Protection Board (EDPB) adopted two Opinions on the draft UK adequacy decisions: (i) Opinion 14/2021 for transfers of personal data under the EU General Data Protection Regulation (EU GDPR); and (ii) Opinion 15/2021 for transfers of personal data under the Law Enforcement Directive (LED).
Digital Health Passports in Europe: Facilitating a Return to the “New Normal” or an Intrusion of Privacy?
With the roll-out of the COVID-19 vaccine and the start of easing of social distancing measures, the latest initiative being considered at a national as well as an international level is the introduction of so-called “digital health passports” or “immunity passports,” i.e., a tool to record and share the immune status of an individual whether by virtue of a COVID-19 test result or vaccination record – indeed, it is estimated there are currently more than 70 digital health passports and 14 vaccine passport apps in operation globally. However, the privacy concerns (and indeed the broader ethical implications) of introducing such measures, without the implementation of appropriate safeguards are significant and a current topic of intense debate.
New Guidance on the Revised Swiss Data Protection Act Published by the Swiss Regulator
On 5 March 2021, the Federal Data Protection and Information Commissioner (FDPIC) published a short position paper on the revised Swiss Data Protection Act (revDPA). The position paper provides guidance for companies that are subject to the revDPA as to how to meet its requirements once it enters into force, which is expected to be in the second half of 2022 after the Federal Administration has completed drafting the associated implementing ordinances.
EU Council Agrees on Proposed ePrivacy Regulation
On February 10, 2021, the Council of the European Union (which includes representatives of the European Union (EU) member states, hereinafter Council) reached an agreement on the ePrivacy Regulation proposal that governs the protection of privacy and confidentiality of electronic communications services (ePrivacy Regulation).
The first draft of the ePrivacy Regulation was approved by the European Commission in 2017 and has since been under discussion in the Council. The current agreement in the Council comes shortly after Portugal took over the Council presidency (on January 1, 2021) and released a revised draft of the ePrivacy Regulation (on January 5), which was the 14th draft including the original EU Commission proposal. The present agreement is therefore a breakthrough in the negotiation process and allows the Portuguese Council presidency to start negotiations with the European Parliament on the final text.
European Commission Releases Assessment of the EU Member States’ Rules on Health Data in Light of GDPR
On February 12, 2021, the European Commission (Commission) published an “Assessment of the EU Member States’ rules on health data in the light of GDPR” (the Assessment). The Assessment concludes, amongst other things, that there are variations in the implementation of the EU General Data Protection Regulation (GDPR) at a national level with regards to the processing of health data. In turn, this has led to a fragmented approach to the processing of health data for health and research purposes across the EU. To avoid further fragmentation, the Assessment proposes various future EU-level actions, including stakeholder-driven Codes of Conduct as well as new targeted and sector-specific legislation.
European Commission Publishes Draft UK Adequacy Decisions
On February 19, 2021, the European Commission (EC) published two draft implementing decisions to enable the continuing free-flow of personal data from the EU to the UK (the Draft Adequacy Decisions) i.e., post-Brexit: (i) for transfers of personal data under the EU General Data Protection Regulation (EU GDPR); and (ii) for transfers of personal data under the Law Enforcement Directive (LED). This will come as a huge relief to companies across all industries who are in parallel already grappling with the repercussions of Schrems II. In fact, the Draft Adequacy Decisions (which collectively run to almost 140 pages) are the first of their kind in a post-Schrems II world and will likely be closely reviewed—including by privacy advocate Max Schrems who has promised his Twitter followers to “take a look at” the Draft Adequacy Decisions in particular with regard to the LED (i.e., which addresses UK government surveillance activities).
European Medicines Agency Issues Updated Good Clinical Practice Q&A
On February 17, 2021 the European Medicines Agency (EMA) published an updated version of its good clinical practice questions and answers (GCP Q&A). The updated section relates to access to patient medical records by GCP inspectors from European Economic Area (EEA) Member States. It stresses the importance of sponsors conducting studies in countries outside the EEA obtaining the prior explicit consent of a clinical trial participant for the review of their medical records by EEA GCP inspectors.
European Commission Proposes Revised Standard Contractual Clauses
The European Commission (EC), on 12 November 2020, published a draft decision implementing revised Standard Contractual Clauses (draft SCCs) – (the EC’s Draft). The EC’s Draft was published following the Court of Justice of the European Union’s (CJEU) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems on 16 July 2020 (Schrems II), which found (amongst other things) that supplementary protections may need to be implemented when SCCs are used to ensure an ‘essentially equivalent’ level of data protection. The publication of the EC’s Draft comes just one day after the European Data Protection Board (EDPB) published its draft recommendations describing how controllers and processors transferring personal data outside the European Economic Area (EEA) may comply with the Schrems II ruling. The EC’s Draft is open for public consultation until 10 December 2020, after which it will undergo a process of review by representatives of every EU Member State (the Committee) who will each need to provide a positive opinion in relation to the EC’s Draft as part of the EU examination procedure. The European Data Protection Supervisor must also be consulted and it is recommended that the EDPB is consulted. The EC’s College of Commissioners may then adopt the EC’s final decision
European Data Protection Board Issues Schrems II Recommendations
Following the Court of Justice of the European Union’s (“CJEU”) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems on 16 July 2020 (“Schrems II”), the European Data Protection Board, tasked with overseeing compliance with the GDPR (“EDPB”), on 11 November 2020 issued its anticipated recommendations describing how controllers and processors transferring personal data outside the European Economic Area (“EEA”) may comply with the Schrems II ruling. These recommendations are applicable immediately but are open for public consultation until November 30. Information on submitting public comments is accessible here.
In Schrems II, the CJEU invalidated the EU-U.S. Privacy Shield program (“Privacy Shield”) and potentially required supplementary protections to be implemented when Standard Contractual Clauses (“SCCs”) are used to ensure an ‘essentially equivalent’ level of data protection. Under the GDPR, personal data transfers outside the EEA to jurisdictions which are not found to provide an ‘adequate level of protection’ to the data, are restricted unless appropriate safeguards are implemented. The Privacy Shield and SCCs were two key appropriate safeguard mechanisms used to legitimize transfers of personal data outside the EEA to ‘non-adequate’ recipient countries, referred to as “Third Countries.”
European Data Protection Supervisor Issues Schrems II Guidelines
Following the Court of Justice of the European Union’s (“CJEU”) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems on 16 July 2020 (“Schrems II”), the European Data Protection Supervisor, tasked with overseeing compliance with EU data protection laws by the EU institutions (“EUIs” and “EDPS”), issued guidance on 29 October 2020 on how EU institutions should comply with the Schrems II ruling (“EDPS Guidance”). In Schrems II, the CJEU invalidated the EU-U.S. Privacy Shield program and potentially required additional protections to be implemented when Standard Contractual Clauses are used. Both are key legal mechanisms used to enable transfers of personal data outside the EU.