Medical Device Legal News with Sam Bernstein: Episode 10
Drafting Consumer Breach Notices — From a Litigation Perspective - Unauthorized Access Podcast
IP|Trend: Dust up After the Breach
Hot Topics Roundtable for Fund Managers - Cybersecurity, Valuation, and More
Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more
The Federal Trade Commission (“FTC”) recently published its Final Rule amending the Health Breach Notification Rule (“HBNR”). The updated HBNR, which regulates entities that handle certain personal health information, other...more
Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more
The Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule requires certain entities that handle unsecured personally identifiable health data to notify...more
On April 26, the Federal Trade Commission (FTC) approved its Final Rule revising the Health Breach Notification Rule (HBNR) (“Final Rule”) by a 3-2 vote. The HBNR requires vendors of personal health records (PHR) and related...more
On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a complement and counterpart to the breach notification requirements...more
Welcome to our inaugural issue of The Health Record - our healthcare law insights e-newsletter! As such, we wanted to pull together our insights and pass them along to you. Our goal is to create a publication that is...more
As our loyal Practical Privacy readers may remember, back in December of 2021, the Federal Trade Commission (the “FTC” or “Commission”) began a rulemaking process to update the Commission’s Health Breach Notification Rule...more
Organizations typically deal with ransomware attacks out of the public eye, but the massive scale of United Healthcare Group’s (UHG) February breach made that an impossibility. UHG CEO Andrew Witty was recently on the hot...more
On April 26, 2024, the Federal Trade Commission (“FTC”) announced it had finalized changes to modernize the Health Breach Notification Rule (the “HBNR”) by clarifying its applicability to health and wellness apps and other...more
On April 26, 2024, the Federal Trade Commission (FTC) released a pre-publication version of its final changes to the Health Breach Notification Rule (HBNR) designed to clarify the scope of the HBNR, including its coverage of...more
The FTC has updated its HBNR to clarify that the rule also restricts marketing practices involving personal health information. This update to the HBNR was announced on April 26, 2024, and follows several recent enforcement...more
It’s widely known but seldom said that many of the biggest challenges in our healthcare system stem from how its laws and regulations were written by many hands working decades apart. Inevitably, as revisions and overlapping...more
On May 18, 2023 the Federal Trade Commission (FTC) released a Notice for Proposed Rule Making (NPRM) for updates to the Health Breach Notification Rule, 16 C.F.R. Part 318 (the Rule). The Rule serves to ensure entities that...more
The 21st Century digital age has provided women with numerous sexual and reproductive health tools that track periods, ovulation, and pregnancy. By simply plugging certain health data inputs into these apps, women can now...more
The Federal Trade Commission (FTC) recently proposed changes to the Health Breach Notification Rule (Rule), enacted in 2009, to clarify that the Rule applies directly to an estimated 170,000 health and wellness mobile...more
The FTC recently proposed amendments to the Health Breach Notification Rule (HBNR). This is on trend with its aggressive interest over the last couple of years in health data not covered by HIPAA....more
For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more
On February 1, the DOJ filed a complaint on behalf of the FTC against a telehealth and prescription drug discount provider for allegedly violating the FTC Act and the Health Breach Notification Rule by failing to notify...more
Mobile health apps are growing in popularity and their number is increasing every year. Many of us find it convenient to use an app to schedule medical appointments, check medical records, track and store health data, and...more
The use of apps, wearables, and other devices used to track health and wellness data have continued to rise. The FTC again signaled its focus on this growing industry in a statement on the scope of the Health Breach...more
Certain California-licensed healthcare facilities are now subject to additional breach reporting obligations pursuant to regulations (Regulations)[1] issued by the California Department of Public Health (Department) on July...more
Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more
Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more
In light of numerous recent data breaches, cybersecurity has emerged as an issue impacting organizations ranging from the local hardware store to the largest multi-national firms in the world. In short, no industry is immune...more