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 This new guidance comes at the same time as a draft guidance on privacy by design has been published by the European Data Protection Board requiring product developers to implement privacy into the design of their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.
The 25th of May, 2019 marked a year since the EU General Data Protection Regulation (“GDPR”) came into force. For most in privacy, involvement with the GDPR has been ongoing for well over this year, but on the first anniversary of the GDPR we take an opportunity to look back and reflect on where we are now in relation to some key areas of interest including enforcement action, privacy litigation, breach notification and developing guidance from the European Data Protection Board (“EDPB”).
On 23 January 2019, the European Data Protection Board (EDPB) adopted an opinion on the interplay between the EU Clinical Trials Regulation (CTR) and the EU General Data Protection Regulation (GDPR). The Opinion addresses the appropriate legal basis for the processing of personal data in the context of clinical trials (primary use), and the secondary use of clinical trial data. (more…)
In December 2018, the European Commission published its report on the second annual review of the EU-US Privacy Shield (the “Report”). The Report concluded that the Privacy Shield “continues to ensure an adequate level of protection” for personal data transferred from the EU to the US. However, the Commission did identify a number of recommendations from the first annual review which still required implementation including the appointment by the US of a permanent ombudsperson to oversee complaints. To date, the U.S. has only appointed an interim ombudsperson (Manisha Singh). In the first annual review, the Commission did not set a deadline for the appointment. However, the latest review required an appointee to be identified by 28 February 2019 failing which the Commission will “consider taking appropriate measures.”