On January 13, 2020, the U.S. Department of the Treasury (Treasury) issued final and interim regulations implementing the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA), which expands the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS) to review foreign investments and mitigate any potential national security concerns. While the final regulations largely track the proposed regulations issued on September 17, 2019, Treasury has made refinements and added several clarifying examples. See Sidley’s previous Update on the proposed regulations.
Following the structure of the proposed regulations, the final regulations were issued in two parts: one part covers investments in real estate, available here, while the other covers certain other investments in U.S. businesses, available here. Treasury simultaneously released a number of frequently asked questions on the proposed regulations, available here, and a fact sheet, available here.
The final CFIUS regulations will go into effect on February 13, 2020.
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.”
The National Association of Insurance Commissioners (the NAIC) held its Fall 2019 National Meeting (Fall Meeting) in Austin, Texas, from December 7 to 10, 2019. The Fall Meeting was highlighted by the following activities.
On December 4, 2019, the Senate Commerce Committee addressed data privacy in a hearing titled, “Examining Legislative Proposals to Protect Consumer Data Privacy.” The hearing focused on the two leading privacy proposals that were put forward in the week leading up to the hearing, the Consumer Online Privacy Rights Act (COPRA), introduced by Sen. Maria Cantwell, D-Wash., ranking member on the Committee, and a Staff Discussion Draft of the United States Consumer Data Privacy Act of 2019 (CDPA), introduced by Sen. Roger Wicker, R-Miss., Chairman of the Committee. The competing proposals share many similarities, including their scope of covered data and entities, as well as their approaches to consumer transparency and access. However, as witness testimony during the hearing revealed, the proposals diverge on a few critical issues.
In the evening of December 17, 2019, Californians for Consumer Privacy, the consumer privacy rights organization led by Alastair Mactaggart that propelled California towards the U.S.’s first comprehensive privacy legislation, tweeted the Attorney General’s release of the title and summary for Initiative 19-0021. This Initiative would substantively amend and essentially replace the California Consumer Privacy Act (“CCPA”) with the proposed Consumer Privacy Rights Act of 2020—also known colloquially as CCPA 2.0. (more…)
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.
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: