Digital Health

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 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

On May 17, the Federal Trade Commission (“FTC”) announced an enforcement action against Easy Healthcare Corporation (“Easy Healthcare”) alleging that it shared users’ sensitive personal information and health information with third parties contrary to its representations and without users’ affirmative express consent, in violation of Section 5 of the FTC Act.  It also alleges that Easy Healthcare failed to notify consumers of these unauthorized disclosures, in violation of the Health Breach Notification Rule (“HBNR”).  According to the proposed order, Easy Healthcare will pay a $100,000 civil penalty for violating the HBNR and, among other requirements, will be permanently prohibited from sharing users’ personal health data with third parties for advertising purposes.  The FTC also noted that Easy Healthcare will pay a total of $100,000 to Connecticut, the District of Columbia, and Oregon for violating their laws.Continue Reading FTC Announces Second Enforcement Action Under Health Breach Notification Rule Against Fertility App Developer Easy Healthcare

In a new post on the Covington Digital Health blog, our colleagues discuss recently issued proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).  Specifically, the proposed rule would harmonize certain provisions of the Confidentiality of Substance Use Disorder Patient Records under…

In a new post on the Covington Digital Health blog, our colleagues discuss a recent amendment to California’s Confidentiality of Medical Information Act (“CMIA”) that expands the scope of the law to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services.  Continue Reading California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information

In a new post on the Covington Digital Health blog, our colleagues discuss recently announced Federal Trade Commission (“FTC”) guidance meant to help companies determine their obligations under the Health Breach Notification Rule (the “Rule”).  The guidance follows the FTC’s September 2021 Policy Statement, which expanded the Rule’s application to the developers of health…

On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”).  The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.
Continue Reading European Commission Conducts Open Consultation on the European Health Data Space Initiative

On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”).  The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and business models.”

The Rule, which first went into effect in 2009, applies only to vendors of personal health records (“PHRs”) and other related entities that are not subject to the Health Insurance Portability and Accountability Act (“HIPAA”).  A PHR is an electronic record of individually identifiable health information “that can be drawn from multiple sources and is managed, shared, and controlled by or primarily for the individual.”  See 16 C.F.R. § 318.2(d).  Under the Rule, PHR vendors and related entities must notify individuals, the FTC, and possibly the media within 60 days after discovering a breach of unsecured personally identifiable health information, or within 10 days if more than 500 individuals are affected by the breach.
Continue Reading FTC to Consider Changes to the Health Breach Notification Rule