Part II – Digital Health Passports in Europe: Amended Proposal for a Digital Green Certificate and Eligible Testing Methods
In March 2021, the European Commission released a proposal for the creation of a “Digital Green Certificate,” which will allow EU citizens to travel easier throughout the EU during the COVID-19 pandemic. Last week, the EU Member States agreed on some proposed changes to the proposal, including strengthening of the data privacy provisions. According to the proposal, in order to obtain a Digital Green Certificate, individuals must prove that they have been vaccinated, present a negative test result, or have recently recovered from COVID-19. The proposal allows the issuance of a certificate for all COVID-19 vaccines, which have received an EU-wide marketing authorisation, however only the results of certain in vitro diagnostic tests will be considered valid.
Part I – Digital Health Passports in Europe: Facilitating a Return to the “New Normal” or an Intrusion of Privacy?
With the roll-out of the COVID-19 vaccine and the start of easing of social distancing measures, the latest initiative being considered at a national as well as an international level is the introduction of so-called “digital health passports” or “immunity passports,” i.e., a tool to record and share the immune status of an individual whether by virtue of a COVID-19 test result or vaccination record – indeed, it is estimated there are currently more than 70 digital health passports and 14 vaccine passport apps in operation globally. However, the privacy concerns (and indeed the broader ethical implications) of introducing such measures, without the implementation of appropriate safeguards are significant and a current topic of intense debate.
European Commission Releases Assessment of the EU Member States’ Rules on Health Data in Light of GDPR
On February 12, 2021, the European Commission (Commission) published an “Assessment of the EU Member States’ rules on health data in the light of GDPR” (the Assessment). The Assessment concludes, amongst other things, that there are variations in the implementation of the EU General Data Protection Regulation (GDPR) at a national level with regards to the processing of health data. In turn, this has led to a fragmented approach to the processing of health data for health and research purposes across the EU. To avoid further fragmentation, the Assessment proposes various future EU-level actions, including stakeholder-driven Codes of Conduct as well as new targeted and sector-specific legislation.
East Coast Meets West Coast: Enter the Virginia Consumer Data Protection Act
For over two and a half years, California has enjoyed the spotlight of having the most comprehensive data privacy law in the United States. On March 2, 2021, Virginia forced California to share the honors, when Democratic Gov. Ralph Northam signed into law the Virginia Consumer Data Protection Act (VCDPA).
The VCDPA, which will not enter into effect until January 1, 2023, borrows heavily from the California Consumer Privacy Act (CCPA) and the European Union (EU) General Data Protection Regulation (GDPR). Perhaps because Virginia was able to benefit from the experience of businesses that have spent the better part of the last five years implementing the GDPR or the CCPA, the Virginia law is less prescriptive and more straightforward than its predecessors, with (one would hope) a correspondingly lighter implementation burden on companies. Nonetheless, there is just enough different in the VCDPA that businesses with a connection to Virginia will need to evaluate whether the law applies to them and how they will comply.
While an exegesis of the VCDPA is beyond the scope of today’s Data Matters post, this alert is designed to assist such efforts in three ways. First, we lay out the VCDPA’s scope, providing preliminary insight into which businesses the law will cover. Second, we highlight the key ways the VCDPA differs from — and, more important, extends beyond — the CCPA and GDPR so that businesses will have an initial sense of what, if any, unique obligations the VCDPA will place on them. Finally, for completeness’s sake, the post briefly summarizes the law’s key elements.
European Medicines Agency Issues Updated Good Clinical Practice Q&A
On February 17, 2021 the European Medicines Agency (EMA) published an updated version of its good clinical practice questions and answers (GCP Q&A). The updated section relates to access to patient medical records by GCP inspectors from European Economic Area (EEA) Member States. It stresses the importance of sponsors conducting studies in countries outside the EEA obtaining the prior explicit consent of a clinical trial participant for the review of their medical records by EEA GCP inspectors.
A Digital Europe – Digital Health and other Recent EU Data Initiatives
Taking a step into the digital age, the European Commission announced that the 2020s shall become the EU’s Digital Decade. The EU’s digitalization, including in the area of health, is one of the Commission’s key priorities and covers a wide range of actions and related initiatives.
Building on prior initiatives, in 2019 the Commission announced six key priorities (since supplemented by the COVID-19 recovery plan) that would shape the coming five years of policy making. One of these six key priorities is to create a Europe fit for the digital age and work on a digital strategy that will empower people with a new generation of technologies.
HHS Issues Proposed Rule Modernizing HIPAA Privacy Rule
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed Rule) that would make a number of key changes to the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, HIPAA). HHS stated that the Proposed Rule is intended to reduce burdens that may limit or discourage care coordination and case management communications among individuals and HIPAA-covered entities while continuing to protect the privacy of individuals. The proposed changes are designed to lead to increased data access, sharing, and portability and to further HHS’s emphasis on patients’ right of information access, which has been highlighted through a series of enforcement actions in 2020. If enacted as proposed, the amendments would require healthcare providers and electronic health records (EHR) vendors to update policies and disclosures related to information access and perhaps even to redesign certain EHR processes. Comments are due 60 days after publication in the Federal Register.
