European Commission

On 8 April 2020, the European Commission adopted a recommendation on a common European Union toolbox for the use of technology and data to address the COVID-19 crisis (“Recommendation”).  The Recommendation responds to calls for a common EU approach to the use of mobile apps in combatting COVID-19—one that improves the efficacy of the technology while respecting citizens’ privacy rights.

The Recommendation has since been complemented by a separate Commission guidance paper on COVID-19 apps (“Guidance”) and release of a Common EU Toolbox for Member States (“Toolbox”) by the EU’s eHealth Network, a Commission-established body comprised of Member State authorities responsible for eHealth matters.   In addition, the European Data Protection Board (“EDPB”), which contributed to the Guidance, has published a letter to the Commission in response to the Guidance (“Letter”).

This blog will discuss the headline points contained within the Recommendation, Guidance, Toolbox, and Letter.  We will publish more detailed analyses of the Toolbox and Guidance in subsequent blogs.Continue Reading EU Commission Releases Guidance on COVID-19 Apps

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.

The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.Continue Reading European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)

On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI.  These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days.  Although the papers published this week do not set out a comprehensive EU legal framework for AI, they do give a clear indication of the Commission’s key priorities and anticipated next steps.

The Commission strategies are set out in four separate papers—two on AI, and one each on Europe’s digital future and the data economy.  Read together, it is clear that the Commission seeks to position the EU as a digital leader, both in terms of trustworthy AI and the wider data economy.Continue Reading European Commission Presents Strategies for Data and AI (Part 1 of 4)

On December 3, 2019, the EU’s new Commissioner for the Internal Market, Thierry Breton, suggested a change of approach to the proposed e-Privacy Regulation may be necessary.  At a meeting of the Telecoms Council, Breton indicated that the Commission would likely develop a new proposal, following the Council’s rejection of a compromise text on November 27.

The proposed Regulation is intended as a replacement to the existing e-Privacy Directive, which sets out specific rules for traditional telecoms companies, in particular requiring that they keep communications data confidential and free from interference (e.g., preventing wiretapping).  It also sets out rules that apply regardless of whether a company provides telecoms services, including restrictions on unsolicited direct marketing and on accessing or storing information on users’ devices (e.g., through the use of cookies and other tracking technologies).Continue Reading New E-Privacy Proposal on the Horizon?

On October 23, 2019, the European Commission (“Commission”) published its Report on the third annual review of the EU-U.S. Privacy Shield (“Privacy Shield”) (the Report is accompanied by a Staff Working Document).  The Report “confirms that the U.S. continues to ensure an adequate level of protection for personal data transferred under the Privacy Shield” (see also the Commission’s Press Release).  The Report welcomed a number of improvements following the second annual review, including efforts made by U.S. authorities to monitor compliance with the framework, as well as key appointments that have been made in the last year.  The Commission in particular noted the appointment of Keith Krach to the position of Privacy Shield Ombudsperson on a permanent basis, filling a vacancy that had been noted in previous reviews.  The Report also provided a number of recommendations for further improvement and monitoring.

Recognizing that, in its third year, Privacy Shield has “moved from the inception phase to a more operational phase,” the Report placed particular emphasis on the effectiveness of the “tools, mechanisms and procedures in practice.”  Not only has the number of Privacy Shield certifications exceeded 5,000 companies — eclipsing in three years the number of companies that had registered to the Safe Harbor Framework in its nearly 15 years of existence — the Report also noted that “an increasing number of EU data subjects are making use of their rights under the Privacy Shield and that the relevant redress mechanisms function well.”

As with prior reviews, the Commission sought feedback from trade associations, NGOs, and certified companies, and  addressed the functioning of (i) the framework’s commercial aspects, and (ii) U.S. authorities’ access to personal data.Continue Reading Privacy Shield Third Annual Review

On July 24, 2019, the European Commission (“the Commission”) published a report appraising Europe’s progress in implementing the General Data Protection Regulation (“GDPR”) as a central component of its revamped data protection framework.  In its report, the Commission highlights certain achievements resulting from implementation efforts, calls attention to issues that require further action, and describes several ongoing and planned initiatives.  The report is a follow-up to a prior report issued in January 2018, and was informed to a great extent by the ongoing work of the Multi-stakeholder Group, which is comprised of civil society and business representatives, academics and practitioners, to support the application of the GDPR.  The report will contribute to the Commission’s formal 2-year review of the GDPR to take place in May 2020.
Continue Reading European Commission Issues Report on the Implementation of the GDPR

On July 12, 2019, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) issued a joint opinion on the processing of patient data and the role of the European Commission within the eHealth Digital Service Infrastructure (“eHDSI”).

Background

The eHDSI system was established in the context…
Continue Reading The European Data Protection Board and the European Data Protection Supervisor consider the European Commission to be a processor of patient data in the eHealth Digital Service Infrastructure

On June 20, 2019, Keith Krach was confirmed by the U.S. Senate to become the Trump administration’s first permanent Privacy Shield Ombudsperson at the State Department.  The role of the Privacy Shield Ombudsperson is to act as an additional redress avenue for all EU data subjects whose data is transferred…
Continue Reading Privacy Shield Ombudsperson Confirmed by the Senate

On April 10, 2019, European Commission Directorate-General for Health and Food Safety issued a revised Q&A analyzing the interplay between the EU Clinical Trials Regulation (“CTR”) and the  EU General Data Protection Regulation (“GDPR”).  The revised Q&A takes into account the opinion of the European Data Protection Board (“EDPB”) issued…
Continue Reading European Commission Issues Updated Q&A on Interplay between the GDPR and the Clinical Trials Regulation

On April 8, 2019, the EU High-Level Expert Group on Artificial Intelligence (the “AI HLEG”) published its “Ethics Guidelines for Trustworthy AI” (the “guidance”).  This follows a stakeholder consultation on its draft guidelines published in December 2018 (the “draft guidance”) (see our previous blog post for more information on the draft guidance).  The guidance retains many of the same core elements of the draft guidance, but provides a more streamlined conceptual framework and elaborates further on some of the more nuanced aspects, such as on interaction with existing legislation and reconciling the tension between competing ethical requirements.

According to the European Commission’s Communication accompanying the guidance, the Commission will launch a piloting phase starting in June 2019 to collect more detailed feedback from stakeholders on how the guidance can be implemented, with a focus in particular on the assessment list set out in Chapter III.  The Commission plans to evaluate the workability and feasibility of the guidance by the end of 2019, and the AI HLEG will review and update the guidance in early 2020 based on the evaluation of feedback received during the piloting phase.
Continue Reading EU High-Level Working Group Publishes Ethics Guidelines for Trustworthy AI