Health Privacy

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.Continue Reading EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data holders; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 1: Five Key Take Aways on Secondary Use of Health Data

On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (“HHS OCR”) updated its “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” guidance addressing how regulated entities may use tracking technologies on their websites and mobile applications in a manner compliant with the Health Insurance Portability and Accountability Act, as amended, and its implementing regulations (collectively, “HIPAA”).  The guidance, originally published in December 2022, states that HIPAA-regulated entities are not permitted to leverage tracking technologies in ways that would result in an impermissible disclosure of protected health information (“PHI”) or other violation of HIPAA.  The guidance also emphasizes the importance of safeguarding PHI and notes that regulated entities may not share PHI with tracking technology vendors (e.g., third-party advertisers) absent a business associate agreement (“BAA”) with the vendor or pursuant to a patient authorization. Continue Reading HHS OCR Updates Tracking Technologies Guidance

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

Continue Reading HHS Publishes Final Rule to Align Part 2 and 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

Continue Reading HHS OCR Requests Comments on HIPAA Audit Review Survey