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.
Following the Court of Justice of the European Union’s (“CJEU”) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems (“Schrems II”), the Swiss Federal Data Protection and Information Commissioner (“FDPIC”) concluded in a position paper published on 8 September that the Swiss-US Privacy Shield no longer provides a valid mechanism for the transfer of personal data from Switzerland to the US.
In a decision with significant implications for international trade and cross-border data flows, the EU’s highest court – the Court of Justice of the European Union (“CJEU”) ruled on 16 July 2020 that a key legal mechanism (called the EU-US Privacy Shield program) used to enable transfers of personal data from the European Union (“EU”) was invalid, while also potentially requiring additional protections to be implemented when another key transfer mechanism (called Standard Contractual Clauses) is used. The case – Data Protection Commissioner v. Facebook Ireland, Max Schrems (“Schrems II”) – considered the validity of the EU-US Privacy Shield (“Privacy Shield”) program (a privacy certification made available for US organizations through an agreement between the European Commission and the US government) and Standard Contractual Clauses (“SCC”) (a form of international data transfer agreement made available for use by the European Commission).
Ongoing confusion about lawful basis for data processing in a clinical study environment: European Data Protection Board and European Commission on the one hand and certain Member States on the other differ on the correct approach. Swiss sponsors operating clinical studies in the EU face ongoing uncertainty around the appropriate lawful basis for processing study subject personal data in spite of guidance being published by the European Commission and the European Data Protection Board.
On 8 January 2020, the UK’s Information Commissioner’s Office (ICO) published a draft Direct Marketing Code of Practice (Draft Code) for public consultation. The Draft Code is intended to update existing guidance published pre-GDPR and provide clarity on certain important issues.
Summarised below are the key takeaways from the Draft Code: (more…)
A recent opinion from the European Data Protection Supervisor (EDPS) on data protection and scientific research builds on an opinion from January 2019 from the European Data Protection Board on the GDPR and clinical trials. The Opinion from the EDPS should be taken into account by life sciences companies in their ongoing assessment of how to apply the GDPR to scientific research both in clinical trials and more broadly.
The EDPS – an independent supervisory authority whose primary objective is to ensure that European institutions and bodies respect the right to privacy and data protection – recently published a preliminary opinion on data protection and scientific research (the Opinion). The EDPS acknowledges the critical importance of scientific research but states that “data protection obligations should not be misappropriated as a means […] to escape transparency and accountability.” In particular, according to the EDPS, compliance with data protection laws is “wholly compatible” with responsible scientific research. However, the EDPS recommends intensifying dialogue between data protection authorities (DPAs) and ethical review boards for a common understanding of which activities amount to genuine research and expects further guidance to be published by the European Data Protection Board – an independent European body, composed of representatives of the national DPAs and the EDPS.
New European medical device guidance will require manufacturers to carefully review cybersecurity and IT security requirements in relation to their devices and in their product literature. This new guidance comes at the same time as a draft guidance on privacy by design has been published by the European Data Protection Board requiring product developers to implement privacy into the design of their products.
In December 2019, the Medical Device Coordination Group (MDCG) published its guidance on cybersecurity for medical devices (the Guidance). The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The Guidance is intended to assist medical device manufacturers meet the new cybersecurity requirements in the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) (collectively, the Regulations). In particular, the Guidance aims to assist with regard to both the pre-market and post-market requirements of the Regulations to ensure companies achieve “an adequate balance between benefit and risk during all possible operation modes of a medical device.”
Following an extensive public consultation, the European Data Protection Board (“EDPB”) has published a final version of its guidelines on the territorial scope of the GDPR (“Guidelines”). This comes almost one year since the draft guidelines were originally published. Please read this blog together with our previous blog on the draft guidelines, as this blog addresses only the key differences between the draft guidelines and the Guidelines. (more…)
On 4 November 2019, the European Data Protection Board (EDPB), the EU-wide data supervisory authority, held a stakeholders’ event on data subject rights under the GDPR. At the event, various stakeholders including e.g., corporates and NGOs, raised a number of issues including, for example:
Today we saw the ICO issue a notice of its intention to fine British Airways £183.39m for infringements of the GDPR – a record fine and the largest seen in the UK and the EU. The proposed fine relates to a cyber incident which BA notified to the ICO (as BA’s lead data protection authority, DPA) in September 2018. The incident involved the theft from the BA website and mobile app of personal data relating to customers over a two-week period. In terms of next steps, BA now has an opportunity to make representations to the ICO as to the proposed findings and sanction.