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
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
This year, the federal government has made significant changes to longstanding health care privacy rules, while state lawmakers continue to enact privacy restrictions on consumer health data. These reforms modify legal...more
The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) updated its guidance in mid-March on the “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” to highlight...more
On February 16, 2024, the HHS Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a final version of the cybersecurity resource guide (the “Guide”) with respect to the HIPAA...more
Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...more
As we have detailed previously, 2023 was a landmark year for privacy law, featuring numerous developments at the federal, state and international levels, ranging from newly enacted statutes to massive regulatory enforcement...more
With recent events underscoring the Federal Trade Commission’s (FTC) heightened scrutiny of and enforcement efforts against health app companies collecting or using consumer health information, it's imperative for these same...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
Our Privacy, Cyber & Data Strategy, Consumer Protection/FTC, and Health Care Teams examine the Federal Trade Commission’s continued focus on consumer privacy in the digital health care space....more
A legal case that involves any type of injury, illness, or healthcare means accessing medical records, either for your client or the opposition. Regardless of whether you use them for direct evidence or background...more
Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...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
It has been a while since we last gathered for one of the monthly public meetings of the Federal Trade Commission (FTC or Commission). Clearly, the monthly nature of the meetings is questionable, but then again, there are...more
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...more
The Office of Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently submitted two annual reports to Congress setting forth a summary of complaints and breaches reported to the OCR during...more
For the first time ever, the Federal Trade Commission (FTC) is seeking enforcement under the Health Breach Notification Rule. This regulation requires certain businesses not covered by the Health Insurance Portability and...more
Report on Patient Privacy 22, no. 8 (August, 2022) - Oklahoma State University Center for Health Sciences’ (OSUCHS) breach might not have seemed all that serious at the time: No data is believed to have been misused,...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
Back in September, the Federal Trade Commission (FTC) issued (by a 3-2 vote) a policy statement (the Statement) regarding the oft-forgotten Health Breach Notification Rule (the Rule). I was at the FTC when the Statement was...more
The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more
In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors...more
On September 15, the Federal Trade Commission (“FTC”) issued a policy statement (“Statement”) addressing the scope of its Health Breach Notification Rule (“Rule”) on health apps and connected devices. The Rule, first issued...more
The Federal Trade Commission (FTC) just released a Policy Statement emphasizing how telemedicine and digital health apps can be held accountable under the Health Breach Notification Rule, even if the company is not subject to...more
On September 15, 2021, in response to the “proliferation of apps and connected devices that capture sensitive health data” the Federal Trade Commission (FTC) issued a Policy Statement (the Statement) offering guidance on the...more
Yesterday, the FTC issued a policy statement announcing a new interpretation of the FTC’s 10-year-old “Personal Health Record Breach Notification Rule.” As the FTC acknowledges, this rule has never been enforced by the FTC....more