On January 14, 2020, the French data protection authority, the CNIL, proposed a consultation on its draft recommendations on practical ways to collect website user consent for cookies and similar technologies (the “Recommendations”). The Recommendations follow the publication in July 2019 of updated guidance on cookies, including requirements for obtaining GDPR-standard consent, by various European data protection authorities, including the CNIL and the ICO (the latter guidance was reported by Data Matters here). The CNIL has since undertaken a consultation to develop practical methods to obtain user consent.
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…)
On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. However, the CJEU indicated that certain information may be protected if the interested party can specifically show that the disclosure will cause it harm. This is the first time the CJEU has ruled on this matter, upholding the EMA’s approach to handling access to documents requests.
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.”
Further to the publication of the ICO’s notices of intention to fine British Airways and Marriott in July 2019, the ICO has recently issued a statement delaying the issuance of both GDPR fines which had originally been expected by the end of 2019. (The ICO’s initial notices of intention to fine had stated that British Airways would face a fine of £183m ($228m) and Marriott, a fine of £99m ($123m). We reported on these here: British Airways and Marriott.)
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…)
Recently, the Association of German Data Protection Authorities (“Datenschutzkonferenz” or “DSK”) issued guidelines setting a GDPR fining methodology (“Fining Methodology”). GDPR enforcement across the EU has picked up over the past year. This Fining Methodology has been issued at the time of a significant increase in GDPR enforcement action across the EU. The European Data Protection Board (“EDPB”) reported a total of 281,088 national enforcement actions being initiated as of May 22, 2019 (approximately one year after the GDPR’s entry into application). Since then, data protection authorities across the EU have been initiating enforcement and fines on a daily basis. In particular, in the UK, the Information Commissioner’s Office (“ICO”) has issued two notices of intention to fine of €114m and €215m for failure to implement appropriate data security measures.
On 13 November 2019, the European Data Protection Board (“EDPB”) adopted guidelines on the GDPR’s data protection by design and by default principle (“Guidelines”). The Guidelines provide further guidance into the technical and organizational measures and safeguards that data controllers must take into account when designing their processing activities. The EDPB encourages early consideration of data protection by design and by default principles (“DPbDD”) and considers DPbDD to be at the forefront of GDPR compliance. Data controllers, processors and technology providers should consider re-assessing their processing operations and products against the standards put forward in the Guidelines.