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
With 2025 barely three weeks old, the US Department of Health and Human Services Office for Civil Rights (OCR) has already announced six enforcement actions for the new year. Particularly significant is the advancement of...more
Recent federal enforcement actions have brought home the lesson that there’s really no acceptable reason for denying a patient timely access to medical records. Last year, for example, the HHS Office for Civil Rights (OCR)...more
Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more
The revamped Health Breach Notification Rule by the Federal Trade Commission (FTC) took effect on July 29, 2024, expanding consumer privacy protections to the users of online health platforms and health and wellness apps. Our...more
The Federal Trade Commission (FTC) continues to enforce and update its Health Breach Notification Rule (HBNR) amidst a fast-changing regulatory environment. A new rule, which took effect this week, expands the scope of the...more
The Federal Trade Commission (FTC) has updated its Health Breach Notification Rule that applies to non-HIPAA, consumer health data. Among the revisions, the FTC expanded or introduced key definitions and modified the...more
On July 1, 2024, the amendments to the Health Breach Notification Rule (HBNR) went into effect. First promulgated in 2009, the HBNR applies to vendors of personal health records — entities that are not covered by the Health...more
On July 29, 2024, the FTC’s revised Health Breach Notification Rule (HBNR) takes effect. The Rule requires vendors of personal health records (PHRs) and related entities not covered by HIPAA to notify individuals, the FTC,...more
On May 30, 2024, the FTC published amendments to its Health Breach Notification Rule (“HBNR” or “Rule”) in the Federal Register, memorializing the Rule’s expanded scope that now explicitly includes direct-to-consumer health...more
On April 26, 2024, the Federal Trade Commission (FTC) announced that it had finalized changes to the Health Breach Notification Rule (HBNR). These changes, which go into effect on June 25, 2024, are intended to modernize...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
The FTC issued a final rule to lock in changes to the Health Breach Notification Rule (HBNR) that it proposed in May 2023. While the HBNR began as a breach notification rule seemingly focused on a narrow set of applications...more
On February 14, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued its annual reports to Congress detailing its actions to enforce the privacy, security, and breach notification...more
2023 marked a pivotal moment in US data privacy and cybersecurity, characterized by substantial regulatory and legislative advances at the international, federal, and state levels. The Federal Trade Commission (FTC) took a...more
On July 20, 2023, the Department of Health and Human Services (DHHS) through the Office of Civil Rights (OCR) and the Federal Trade Commission (FTC) issued a joint letter to hospitals and telehealth providers alerting them to...more
The Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) recently published a warning letter that they jointly sent to more than 130 hospital systems and...more
In an effort to formalize its Sept. 15, 2021, Statement of the Commission on Breaches by Health Apps and Other Connected Devices, as previously discussed in a McGuireWoods Oct. 5, 2021, alert, the Federal Trade Commission...more
The Federal Trade Commission and the U.S. Department of Health and Human Services' Office for Civil Rights are cautioning hospitals and telehealth providers about the privacy and security risks related to the use of online...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
In the post-Roe era, the federal government and state governments continue to focus on consumer digital health privacy. On May 17, 2023, the Federal Trade Commission (FTC) announced a settlement with Easy Healthcare...more
On May 18, 2023, the Federal Trade Commission (FTC) filed a Notice of Proposed Rulemaking and Request for Public Comment (“NPRM”) seeking to amend the Health Breach Notification Rule (“HBNR”). We previously wrote about the...more
The FTC released a Notice of Proposed Rulemaking (NPRM) to introduce changes to the Health Breach Notification Rule (HBNR). While the HBNR began as a breach notification rule seemingly focused on a narrow set of applications...more
For the first time since it became law on Aug. 25, 2009, the Federal Trade Commission (“FTC”) has taken enforcement action under 16 C.F.R. § 318, also known as the Health Breach Notification Rule, with a $1.5 million civil...more