The novel COVID-19 global pandemic continues to raise numerous issues for employers and consequences for employees across all industries. This situation is without precedent in modern times and is extremely dynamic with rapidly occurring new developments, guidance and issues that will impact employers. In this webinar, we consider the privacy and employment law issues for employees returning to work, and discuss strategies to deal with this situation in a holistic and coordinated manner.
On April 30, 2020, four Republican Senators announced plans to introduce the COVID-19 Consumer Data Protection Act. The four Senators, John Thune (R-S.D), Roger Wicker (R-Miss.), Jerry Moran (R-Kan.), and Marsha Blackburn (R-Tenn.), are all Members of the Commerce Committee, with Wicker the Committee’s chair.
According to the April 30 Senate press release regarding the COVID-19 Consumer Data Protection Act, the legislation would “provide all Americans with more transparency, choice, and control over the collection and use of their personal health, geolocation, and proximity data” for data processing related to fighting the COVID-19 pandemic. The press release also states that the bill would “hold businesses accountable to consumers if they use personal data to fight the COVID-19 pandemic.” Under the bill, covered purposes include “(1) collecting, processing, or transferring the covered data of an individual to track the spread, signs, or symptoms of COVID-19; (2) collecting, processing, or transferring the covered data of an individual to measure compliance with social distancing guidelines or other requirements related to COVID-19 that are required by federal, state, or local government order; (3) collecting, processing, or transferring the covered data of an individual to conduct contact tracing for COVID-19 cases.” (more…)
Since COVID-19 was declared a pandemic, the U.S. Department of Health and Human Services (“HHS”) and its Office for Civil Rights (“OCR”) have taken a variety of steps to relax HIPAA restrictions particularly pertinent to the COVID-19 response.
First, as covered in an earlier posting, HHS took action to waive penalties and assure companies that it would exercise enforcement discretion with respect to the Privacy Rule’s application to telehealth services and certain limited communication activities related to COVID-19 treatment efforts. (more…)
Ongoing confusion about lawful basis for data processing in a clinical study environment: European Data Protection Board and European Commission on the one hand and certain Member States on the other differ on the correct approach. Swiss sponsors operating clinical studies in the EU face ongoing uncertainty around the appropriate lawful basis for processing study subject personal data in spite of guidance being published by the European Commission and the European Data Protection Board.
This week the U.S. Department of Health and Human Services (HHS) took action to waive penalties and refrain from enforcing certain federal health information privacy restrictions under the Health Insurance Portability and Accountability Act (HIPAA) in response to COVID-19.
In light of the ongoing Coronavirus (COVID-19) pandemic, the ICO has today issued guidance on “Data protection and coronavirus: what you need to know” for data controllers. The ICO has also published advice for healthcare practitioners. Guidance has also been issued by many other Data Protection Authorities in other European countries. (more…)
This post seeks to help parties navigate issues arising from COVID-19 risks from an employment and privacy law perspective in both the United States and Europe.
Novel coronavirus (COVID-19) presents significant issues for employers to navigate and significant consequences for employees across industries as COVID-19 reduces consumer spending, disrupts supply chains and presents challenges for managing workforces globally. Employers should be aware of their responsibilities and proactively put in place action plans to address this growing problem. Designing these plans, and addressing requested or mandated leaves and other restrictions on employee work, presents myriad employment law issues that may vary by jurisdiction. Employers are also likely to confront privacy questions as they seek information on employees’ and others’ health and travel across jurisdictions. In developing a plan, employers will want to consider these issues in a holistic and coordinated manner.
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.”