Health Privacy

On September 28, California’s governor signed a number of bills into law, including to regulate health care facilities’ use of artificial intelligence (“AI”).  This included AB 3030, which regulates certain California-licensed health care facilities’ use of AI and SB 1223, which amends the California Consumer Privacy Act (CCPA) to cover “neural data.”  We discuss each bill in turn below.

AB 3030Continue Reading California Enacts Health AI Bill and Protections for Neural Data

On September 26, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS OCR”) announced that it had settled its cybersecurity investigation with Cascade Eye and Skin Centers, P.C. (“Cascade”), a privately-owned health care provider in Washington.  For background, HHS OCR is responsible for administering and enforcing the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations, which include the HIPAA Privacy, Security, and Breach Notification Rules (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 OCR Settles Ransomware Cybersecurity Investigation for $250,000

The French Public Health Code requires that certain service providers hosting health data hold a specific “HDS” certification.  In order to obtain this certification, providers must comply with the requirements set out in the “HDS” certification standard.  On May 16, 2024, France officially published an updated version of this “HDS”…

Continue Reading France Publishes Updated Certification Standard for the Hosting of Health Data

Last month, the Federal Trade Commission (“FTC”) announced its enforcement action against telehealth firm, Cerebral, Inc. (“Cerebral”), for its alleged unauthorized disclosures of consumers’ sensitive personal health information and other sensitive data to third parties for advertising purposes in violation of the FTC Act.  The complaint also alleges that Cerebral violated the Opioid Addiction Recovery Fraud Prevention Act (“OARFPA”), and the Restore Online Shoppers’ Confidence Act (“ROSCA”), which permits the court to order permanent injunctive relief, civil penalties, and other monetary relief for actions in violations of specific sections of the FTC Act, the OARFPA, and the ROSCA.  According to the proposed order, Cerebral must pay more than $7 million in civil penalties and consumer refunds.  In addition, Cerebral will be banned from using or disclosing consumers’ personal and health information (including online identifiers, such as IP addresses or other persistent identifiers) for advertising and must obtain consumers’ affirmative express consent before disclosing such information to outside parties.

Below is a discussion of the complaint and proposed order.Continue Reading FTC Announces Health Privacy Enforcement Action Against Telehealth Company, Cerebral

On April 26, 2024, the Office for Civil Rights (“OCR”) at the U.S. Department of Health & Human Services (“HHS”) published a final rule that modifies the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act (“HIPAA”) regarding protected health information (“PHI”) concerning reproductive health. We previously covered the proposed rule (hereinafter, “the NPRM”), which was published on April 17, 2023. The final rule aligns closely with the NPRM.Continue Reading HHS Modifies Privacy Rule to Support Reproductive Health Care Privacy

On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates.  We previously covered the proposed rule, which was issued on May 18, 2023.

In the FTC’s announcement of the final rule, the FTC emphasized that “protecting consumers’ sensitive health data is a high priority for the FTC” and that the “updated HBNR will ensure [the HBNR] keeps pace with changes in the health marketplace.”  Key provisions of the final rule include:Continue Reading FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule

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