By

Francesca Blythe

07 April 2021

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.

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17 March 2021

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.

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09 March 2021

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.

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19 February 2021

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).

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18 February 2021

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.

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21 January 2021

A Digital Europe – Digital Health and other Recent EU Data Initiatives

Taking a step into the digital age, the European Commission announced that the 2020s shall become the EU’s Digital Decade.  The EU’s digitalization, including in the area of health, is one of the Commission’s key priorities and covers a wide range of actions and related initiatives.

Building on prior initiatives, in 2019 the Commission announced six key priorities (since supplemented by the COVID-19 recovery plan) that would shape the coming five years of policy making.  One of these six key priorities is to create a Europe fit for the digital age and work on a digital strategy that will empower people with a new generation of technologies.

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13 November 2020

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

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25 September 2020

The Swiss Parliament Agrees on the Draft Bill of a New Data Protection Act

After three years of discussions and in a final debate, the Swiss parliament has agreed on the final draft bill of a new and modernized data protection law.

In particular, the National Council and the Council of States found a compromise on the these outstanding issues: (more…)

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22 September 2020

Swiss Parliament Fails to Reach Agreement on New Swiss Data Protection Act

In 2017, the Swiss government issued a draft bill for a new Swiss Data Protection Act (“nDPA”) with two main goals:  (1) to enhance the level of protection of personal data provided in the current Swiss Data Protection Act which dates back to 1992 (largely, to align with the EU GDPR); and (2) to ensure that there is an “adequate” level of data protection to allow for the continued flow of personal data from the EEA to Switzerland.

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18 September 2020

EDPB Publishes Draft Guidelines on the Concepts of Controller and Processor under the GDPR

On 2 September 2020, the European Data Protection Board (EDPB) published draft guidelines on the concepts of controller and processor under the GDPR (Draft Guidelines). The Draft Guidelines are intended to expand on and ultimately replace the guidance issued by the former Article 29 Working Party in 2010 (WP29 Guidance). The Draft Guidelines should be reviewed carefully to assess whether: (i) the understanding of an organisation’s role as a controller, joint controller or processor should be revised; and (ii) changes to existing vendor processes and contracts are needed in light of the assessment of guarantees provided by vendors and the more detailed processing provisions and ongoing diligence now required.

The Draft Guidelines consist of two parts. The first part seeks to further clarify the meaning of these concepts—which are crucial in determining compliance responsibilities under the GDPR—by reference to various examples. The second part provides detailed guidance on their respective roles and responsibilities, and the relationships between them.

The Draft Guidelines, accessible here, are subject to public consultation until 19 October 2020.

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