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.”
When the GDPR came into effect on May 25, 2018, several European Member States had yet to put in place further implementing legislation. And while the data protection world watches and eagerly digests each new interpretive guidance from data protection authorities, Member State legislation provides additional interpretive tones of harmony or discord in data protection across Europe. After much delay and almost seven months after the EU’s General Data Protection Regulation (“GDPR”) came into force, the Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights (“LOPDGDD”) – which implements the GDPR in Spain – entered into force on 7 December 2018. (more…)
Brexit will have fundamental implications for data protection and in particular, the ongoing flow of personal data from the EU to the UK. However, as with many other issues, the precise implications will depend on the type of deal reached between the EU and the UK.
On 28 November 2017, the Article 29 Working Party (the “WP29”) published detailed draft guidelines on consent under the EU General Data Protection Regulation (the “GDPR”), which is to come into effect on 25 May 2018. The draft guidance has been submitted for public consultation for a six week period before being adopted.
The WP29 guidance on consent (“Consent Guidelines”) provides an analysis of the notion of consent under the GDPR as well as practical guidance for organisations on the requirements to obtain and demonstrate valid consent under the GDPR. (more…)
The EU-U.S. Privacy Shield has survived its infancy, although the October 18, 2017 European Commission report on its first annual review of the functioning of the EU-U.S. Privacy Shield (the “Report”) leaves uncertainty as to the long-term future of EU-U.S. Privacy Shield if the U.S. is unwilling or unable to adopt further Commission “recommendations”. The Report details the Commission’s findings on the implementation and enforcement of the Privacy Shield during its first year of operation. (more…)
On 4 October 2017 the Article 29 Working Party (“WP29”) published its final Guidelines on Data Protection Impact Assessment (“DPIA”) which were initially released in draft form in April 2017. Article 35 of the General Data Protection Regulation (“GDPR”) requires the use of DPIAs, or risk assessments of the proposed processing of personal data by an organisation, as part of regular business processes. The key revisions to note are in relation to the following concepts: (more…)
The EU Commission, through a joint statement on 4 July 2017 by Vera Jourova, EU Commissioner for Justice, and Haruchi Kumazawa, a Commissioner of Japan’s Personal Information Protection Commission, announced that the process is underway to provide Japan an EU adequacy decision on international data transfers by early 2018. Once approved, Japan will become the 13th country (crediting the US with an adequacy finding for organizations certifying under the Privacy Shield) globally and the first Asian country to be given adequate status by the EU Commission. (more…)
Big Data has been a hot topic of discussion in recent years. This was especially the case in Brussels, where the fiercely debated EU General Data Protection Regulation (GDPR) was adopted in 2016. A major concern for all of us is personal privacy. Less discussed is the use of Big Data for social good.
A traditional sectoral approach to harnessing the potential of Big Data for social good is insufficient. This is the case in terms of organisations from different sectors partnering to develop new technologies. It also means that legislation and policies on Big Data must be forward thinking and facilitate cross-sectoral co-operation. (more…)
In a statement of intent published on 7 August 2017, the UK Government has committed to updating and strengthening data protection laws through a new Data Protection Bill (the “Bill”). The Bill will incorporate the new EU General Data Protection Regulation (the “GDPR”) into UK law.
According to the UK’s Minister of State for Digital, Matt Hancock, the Bill will “give [the UK] one of the most robust, yet dynamic, set of data laws in the world. The Bill will give people more control over their data, require more consent for its use, and prepare Britain for Brexit.” (more…)