The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently proposed a sweeping rewrite of the HIPAA Security Rule that, if finalized, will require that many Covered Entities and their Business Associates (Regulated Entities) invest significant resources to comply with new, less flexible requirements designed to strengthen the cybersecurity posture … Continue Reading
The increased use of artificial intelligence (AI) in the banking, insurance, and financial services industries has led the New York State Department of Financial Services (NYDFS or Department) to publish an Industry Letter on October 16, 2024, that highlights cybersecurity risks resulting from the use of AI, the dangers posed by threat actors utilizing AI, … Continue Reading
The healthcare sector has seen an alarming uptick in cybersecurity incidents, including ransomware attacks, in recent years. In response to these cybersecurity threats, New York State is ramping-up efforts to protect patient data by issuing new cybersecurity regulations governing “general hospitals” and by requiring that a healthcare provider spend $2.25 million to improve its internal … Continue Reading
The Federal Trade Commission’s (FTC) years-long effort to modernize its Health Breach Notification Rule (HBNR) in the midst of a swiftly changing technological landscape appears to be coming to an end. On Thursday, May 30, 2024, the FTC published its final rule implementing the HBNR. And so begins a new robust enforcement landscape for health and wellness … Continue Reading
On July 20, 2023, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) announced they were sending a joint letter to approximately 130 unidentified hospital systems and telehealth providers highlighting the agencies’ concerns about the use of tracking technologies on websites and mobile apps in … Continue Reading
On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to information blocking (CMP Final Rule or Rule). The CMP Final Rule was published in the Federal Register on July 3, 2023. … Continue Reading
Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement the HBNR’s applicability to a broad swath of direct-to-consumer health and wellness applications (apps) and confirm that a breach of security includes not only … Continue Reading
The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen privacy protections for individuals’ protected health information (PHI) related to reproductive healthcare (the Proposed Rule). The Proposed Rule would … Continue Reading
On April 11, 2023, the Department of Health and Human Services’ Office for Civil Rights (OCR) confirmed that four notifications of enforcement discretion regarding enforcement of the HIPAA Privacy, Security, and Breach Notification Rules (the HIPAA rules) during the COVID-19 public health emergency (PHE) will expire at the end of the PHE.1 The notifications, which … Continue Reading
The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for sharing consumer health information for advertising purposes (see our blog posts on each respective action here and here), and in a post published by the FTC … Continue Reading
Following its February settlement with GoodRx, the Federal Trade Commission (FTC) has fired another shot across the bow in its ongoing campaign to protect consumers’ digital health information. Earlier this month the FTC announced a consent order with BetterHelp, Inc., an online mental health counseling service, to resolve alleged violations of the Federal Trade Commission … Continue Reading
The Federal Trade Commission (FTC) didn’t mince words. On September 2021, it called out the health app industry for failing to understand the agency’s Health Breach Notification Rule (HBNR) and for not disclosing its breaches. Apparently dissatisfied with the industry’s response, the agency enforced the HBNR against GoodRx for the first time since the rule … Continue Reading
What does it mean to “knowingly” or “recklessly” violate the law when that law consists of highly complex and ever-changing regulations, which may be open to interpretation? The U.S. Supreme Court recently agreed to review that question in two consolidated cases from the Seventh Circuit: U.S. ex rel. Tracy Schutte, et al. v. SuperValu Inc., … Continue Reading
