Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of clinical trials. The GDPR¹ could not fully harmonize these rules since this area is already heavily regulated by public health regulations that vary between EU Member States. One of the most disconcerting areas of divergence between EU Member States is the different national positions on whether patient consent is a valid legal ground for processing personal data in clinical trials.
On 19 March 2019, the Dutch Senate approved legislation introducing collective damages actions in the Netherlands (the “Legislation”) which will broaden the regime even further. The Legislation introduces an option to claim monetary damages in a “US style” class action, including for violations of the GDPR. This Legislation together with the mechanisms already available under […]
The European Data Protection Board has adopted the narrowest possible interpretation of ‘contractual necessity’ as a ground for processing of personal data. The Guidelines 2/2019 on the processing of personal data under Article 6(1)(b) GDPR in the context of the provision of online services to data subjects (adopted on April 9, 2019 and open for consultation until May 24, 2019) provide a detailed assessment of the regulator’s interpretation of the law.
Eduardo Ustaran was featured on the IAPP’s Privacy Advisor Podcast to discuss latest developments of Brexit—including various potential outcomes—and how companies doing business in the United Kingdom are looking ahead to prepare post-Brexit privacy and data protection compliance practices. Eduardo also outlined the state-of-legislation of the European Union’s ePrivacy update and discussed how the anticipated regulation may develop during Romania’s term in the Presidency of the Council of the European Union.
With the deadline for a no-deal Brexit looming—the UK’s exit date from the European Union is now slated for April 12—companies certified to the EU-U.S. Privacy Shield should update their Privacy Shield privacy policies if they have not done so already to ensure that they are able to lawfully receive personal data from the UK post-Brexit.
2018 was a momentous year for data protection and cyber security regulation globally – the implementation of the European Union’s General Data Protection Regulation (GDPR) was, of course, the main event. The shockwaves of GDPR hit APAC with full force, coupled with the promulgation of an important GDPR-inspired national standard in China and the tabling of a draft data protection law in India that shares the same lineage. Rising public awareness of data protection concerns, due to the ever increasing volume and scale of cyber incidents in APAC, means that these issues are front and centre for organizations in terms of brand values, effective risk management and stewardship of increasingly valuable data assets. Our Guide provides a practical toolkit for organizations seeking to create an effective data protection and cyber security compliance program.
The President of the Personal Data Protection Office in Poland imposed a fine amounting to PLN 943,470 for failing to fulfil the company’s transparency obligations towards over six million data subjects under Article 14 of Europe’s General Data Protection Regulation. This is the first fine imposed by the Polish DPA under the GDPR and Poland’s Act on Personal Data Protection of 10 May 2018 implementing the GDPR. The decision provides some limited insights into the interpretation of the term “disproportionate effort” within the meaning of Article 14(5)(b) of the GDPR.
It’s no secret that a hot topic, perhaps the hot topic, in the European data protection world at present is the interplay between the GDPR and the e-Privacy Directive, in particular how it affects online advertising involving cookies. The European Data Protection Board recently released an opinion on this topic, and on 21 March the Court of Justice of the European Union released Advocate-General Szpunar’s opinion in the case of Planet49, which discusses the requirements for valid consent, in the context of both cookies under the e-Privacy Directive and more general data processing under the GDPR.
On 12 March 2019 at its Eighth Plenary Session, the European Data Protection Board adopted its Opinion 5/2019 on the interplay between the ePrivacy Directive and the General Data Protection Regulation. The Belgian Data Protection Authority had, on 3 December 2018, requested that the EDPB examine the overlap between the two laws and in particular the competence, tasks, and powers of data protection authorities. The EDPB adopted its Opinion in response to this request and in order to promote the consistent interpretation of the boundaries of the competences, tasks, and powers of DPAs.
On 14 March 2019, the Dutch data protection authority announced its fining structure for violations of the European General Data Protection Regulation and the Dutch law implementing the GDPR.
The European Telecommunications Standards Institute has published a new standard for cybersecurity in relation to consumer IoT products. The standard builds on the UK’s Code of Practice for Consumer IoT Security, published in October last year. The Code of Practice was developed by the UK Government following publication of a draft code as part of the Secure by Design report published by the Government in March 2018 and after consultation with industry, consumer associations, and academics. The UK Code is voluntary but the UK Government was keen to work with ETSI to develop it into a global standard.
On 7 March 2019 the Dutch Data Protection Authority published guidance that it considers “cookie walls” to violate the GDPR. A cookie wall is a pop-up on a website that blocks a user from access to the website until he or she consents to the placing of tracking cookies or similar technologies. Under current Dutch cookie law, functional and analytical cookies can be used without consent. Tracking cookies like those used for advertising may only be used if a visitor has given consent. According to the Dutch DPA, the use of a cookie wall results in a “take it or leave it” approach. The Dutch DPA explains that this practice is not compliant with the GDPR as consent resulting from a cookie wall is not freely given, because withholding consent has negative consequences for the user as the user is not allowed access to the website.
Vietnam’s new Law on Cybersecurity has garnered much attention due to its sweeping attempt to regulate online content available to internet users in Vietnam. Among its more controversial provisions are the requirements that both foreign and domestic online service providers store personal data of Vietnamese end-users in Vietnam, surrender such data to Vietnamese government authorities upon request, and supervise user posts to remove “prohibited” content (defined to include content viewed as disparaging of the Vietnamese government and/or government officials or state agencies). The law also requires offshore service providers to open branches or representative offices in Vietnam, presumably to facilitate enforcement of the Cybersecurity Law against them.
Subject to the deadlock in parliament being broken, or an extension of the Article 50 Brexit process, the UK’s 46-year European Union membership will cease in a matter of days. In the privacy world, the primary focus for most companies to date has, quite rightly, been on ensuring that data flows in and out of the UK can continue lawfully after that date. But for companies operating across Europe, and indeed across the world, with establishments or customers in the UK, Brexit also has implications in terms of the applicability of the UK data protection framework to their operations. The UK government has published its catchily-titled draft Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019, which amend the territorial applicability provisions of the UK’s Data Protection Act 2018 to ensure the law applies appropriately after the exit day.
Many companies have been struggling with GDPR implementation over the past two years, putting much effort into new roles, privacy concepts, and workflows. Now that the dust of the immediate GDPR compliance rush is settling, the first details of fines imposed under the GDPR and the number of cases pending with Data Protection Authorities (DPAs) in Europe are being made public. In Germany, DPAs are investigating a broad range of non-compliance issues and showing a tendency toward increasing their enforcement activities, to the point that we expect an announcement of increasing GDPR sanctions and fines in Germany in the near future.
Article 83 of the GDPR provides for two levels of administrative fines: a lower level – maximum of €10 million or 2% of the global turnover – for violations relating to record-keeping, data security, data protection impact assessments, data protection by design and default, and data processing agreements; and a higher level – maximum of €20 million or 4% of the global turnover – for violations relating to data protection principles, the legal basis for processing, information to data subjects, the prohibition of processing sensitive data, denial of data subjects’ rights, and data transfers to non-EU countries.
A draft act on adjusting the Polish legal system to the provisions of the GDPR is under way in the lower house of the Polish Parliament (Sejm). The draft act contains, among others, provisions amending the rules for processing personal data by banks, credit institutions, loan companies and other entities regulated by Polish banking law.
With the coming into effect of the General Data Protection Regulation (“GDPR”), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions on data transfers and secondary uses. To assist with this task the European Commission is in the process of adopting a Q&A document on which it has sought the advice from the European Data Protection Board (“EDPB”).
On 23 January, the European Commission announced that it had adopted an adequacy decision in relation to Japan, to enter into force immediately. The mutual agreement, which covers Japan’s 127m citizens as well as the whole of the EU, allows personal data to be transferred between Japan and the EU without the need for additional safeguards such as Standard Contractual Clauses, and creates the largest area of safe data transfers in the world.
Right now, the whole of the U.K. appears to be on the same spot looking over a precipice. However, this is not the moment to be blind. As politicians struggle to find a magic formula for a prosperous Brexit, businesses are stepping up their efforts to mitigate the damage of a possible “no-deal Brexit.” The data protection community is no different. The proposed withdrawal agreement would have preserved the status quo in data protection terms, at least until the end of the transition period in December 2020. However, if the U.K. leaves the EU without a deal, the implications for international data flows and privacy compliance generally will be severe. Therefore, British pragmatism demands an urgent and thorough approach to preparing for the eventuality of a no-deal Brexit.
In this hoganlovells.com interview, Mark Parsons, a Hogan Lovells partner based in Hong Kong, summarizes the current status of IoT-related policies in the Asia-Pacific region and discusses changes anticipated in 2019.
Although Brazil’s new General Data Privacy Law (LGPD) significantly expands Brazil’s data protection framework and places the country among one of the few jurisdictions to provide similar data privacy protections as those offered in the European Union, the new law did not create a data protection authority. On 28 December 2018, outgoing President Michel Temer signed Medida Provisória no. 869/18, a last-minute executive order that made important changes to the LGPD and most notably created the Brazilian National Data Protection Authority (ANPD).
The Brazilian General Data Protection Law (“Lei Geral de Proteção de Dados” or “LGPD”), passed by Congress on 14 August 2018, will come into effect on 15 February 2020. The new data protection law significantly improves Brazil’s existing legal framework by regulating the use of personal data by the public and private sectors. Very similar to the General Data Protection Regulation (“GDPR”) implemented in the European Union, the LGPD imposes strict regulations on the collection, use, processing, and storage of electronic and physical personal data. In conjunction with the passing of the LGPD, the National Data Protection Authority will be created in order to adequately implement the new legislation.
Amid the constitutional and political uncertainties surrounding the Brexit process, the UK Government has provided welcome assurance on the data protection front. Guidance issued by the Department for Digital, Culture, Media & Sport (DCMS) confirms how UK data protection law will work in the event the UK leaves the EU without a deal. Whilst the Government still regards a No Deal Brexit as “unlikely”, given the extremely severe implications of that scenario for transfers of personal data into and out of the UK, the DCMS confirmation is hugely helpful in terms of the preparations needed for that eventuality.