Health Privacy

Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, published on February 21, 2024, a white paper with various proposals to update privacy protections for health data. In Part 1 of this blog series (see here), we discussed the first section of Senator Cassidy’s February 21, 2024, white paper. Specifically, we summarized Senator Cassidy’s proposals on how to update the existing framework of the Health Insurance Portability and Accountability Act, as amended, and its implementing regulations (collectively, “HIPAA”) without disrupting decades of case law and precedent. In this blog post, we discuss the other sections of the white paper, namely proposals to protect other sources of health data not currently covered by HIPAA.Continue Reading Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 2: Safeguarding Health Data Not Covered by HIPAA 

On February 21, 2024, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, issued a white paper, “Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era”, which proposes several updates to the privacy protections for health data. This follows Senator Cassidy’s September 2023 request for information from stakeholders about how to enhance health data privacy protections covered by the Health Insurance Portability and Accountability Act (“HIPAA”) framework and to consider privacy protections for other sources of health data not currently covered by HIPAA. The white paper notes that several entities, including trade associations, hospitals, health technology companies, and think tanks, responded to the RFI.Continue Reading Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 1: Updates to the HIPAA Framework

On February 14, 2024, Nebraska enacted a genetic privacy law (LB 308) regulating direct-to-consumer (“DTC”) genetic testing companies. The law is one of a flurry of bills regarding DTC genetic testing that have been introduced in several states since the beginning of 2024, following the enactment of several DTC genetic testing laws in 2023, such as in Virginia.Continue Reading Nebraska Enacts Direct-to-Consumer Genetic Privacy Law as Several Other States Propose Similar Bills at the Start of 2024

On February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule to amend the Confidentiality of Substance Use Disorder (“SUD”) Patient Records regulations (“Part 2”) to more closely align Part 2 with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”)

On February 12, the U.S. Department of Health and Human Services (“HHS”), Office of Civil Rights (“OCR”), published a notice requesting comment on an upcoming information request.  Specifically, OCR invites comments regarding its burden estimate for a “HIPAA Audit Review Survey.”  The Survey consists of “39 online survey questions” and will be sent to “207

On February 6, the U.S. Department of Health and Human Services (“HHS”), Office of Civil Rights (“OCR”), announced that it had settled a cybersecurity investigation with Montefiore Medical Center (“Montefiore”), a non-profit hospital system based in New York City, for $4.75 million.  As brief background, OCR is responsible for administering and enforcing the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”).  Among other things, HIPAA requires that regulated entities take steps to protect the privacy and security of patients’ protected health information (“PHI”).Continue Reading HHS Settles Malicious Insider Cybersecurity Investigation for $4.75 Million

While the EU GDPR regulates the international transfer of personal data, several recently enacted EU laws regulate the international transfer of non-personal data, which is any data that is not “personal data” under the GDPR.  In other words, these new laws apply to data that does not relate to an identified or identifiable natural person, including anonymized data and data about industrial equipment, significantly expanding the types of data subject to international transfer restrictions.  Some of this legislation has been enacted recently, and other legislation on this topic is making its way through the legislative process but has yet to be adopted.  In this blog post, we outline the current and forthcoming EU legislation on the international transfer of non-personal data.Continue Reading EU Rules Restricting the International Transfers of Non-Personal Data

Digital health apps are increasingly used in practice. They raise various questions under regulatory and data protection and data security laws. On November 6, 2023, the German Conference of the Independent Data Protection Supervisory Authorities (Datenschutzkonferenz, DSK), a national body which brings together Germany’s federal and regional data protection authorities, issued a paper about the GDPR’s application to cloud-based digital health applications (“health apps”) that are not subject to the German Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, the “DiGA Regulation”).Continue Reading German Data Protection Authorities Publish Paper on Cloud-Based Digital Health Applications

On October 12, 2023 the Italian Data Protection Authority (“Garante”) published guidance on the use of AI in healthcare services (“Guidance”).  The document builds on principles enshrined in the GPDR, national and EU case-law.  Although the Guidance focuses on Italian national healthcare services, it offers considerations relevant to the use of AI in the healthcare space more broadly.

We provide below an overview of key takeaways.Continue Reading Italian Garante Issues Guidance on the Use of AI in the Context of National Healthcare Services

In a new post on the Covington Digital Health blog, our colleagues discuss recent amendments to California’s Confidentiality of Medical Information Act (“CMIA”) that (i) expand the scope of the law to cover reproductive or sexual reproductive or sexual health services that are delivered through digital health solutions and the associated health information generated from