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
On May 30, 2024, the Federal Trade Commission (FTC or the Commission) published finalized amendments to the Health Breach Notification Rule (HBNR) that augment the prior rule’s scope and application. The updated final rule...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 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,...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
To protect patients seeking addiction treatment, the federal government passed strict regulations limiting the disclosure of substance abuse patient records. Substance abuse treatment programs must not only comply with the...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 February 16, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights and its Substance Abuse and Mental Health Services Administration (“SAMHSA”), published the long-awaited Final Rule...more
The Federal Trade Commission (FTC) has been aggressively pursuing enforcement actions that involve companies using applications that share consumer personal health information with third parties in violation of the Health...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
The Federal Trade Commission (FTC), at its May 18, 2023, open Commission meeting, voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment...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
A proposed HHS regulation on the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 C.F.R. Part 2 would bring it further in line with HIPAA, which is somewhat of a double-edged sword, attorneys say....more
The FTC recently published two new resources for complying with the Health Breach Notification Rule. The Rule requires vendors of personal health records (PHR), PHR-related entities and service providers to these entities, to...more
This year has started with the Federal Trade Commission's (FTC) renewed attention to its Health Breach Notification Rule (Breach Rule) and the publication of the Health Privacy resource page to help companies with their...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
Vendors of health applications (“health apps”) and connected devices that collect or use individuals’ health information, along with their service providers, are now on notice that they must provide timely notice to consumers...more
On September 15, 2021, recognizing the ever-increasing growth and use of mobile health apps as well as connected devices that capture individuals' health data, the Federal Trade Commission (FTC) issued a Policy Statement...more
On May 22, 2020, the Federal Trade Commission (the “FTC”) published its decennial request for public comment (the “RFC”) on the FTC’s Health Breach Notification Rule (the “HBN Rule”)....more
Report on Patient Privacy 20, no. 6 (June 2020): A divided Indiana Court of Appeals has reinstated a patient’s claim that a hospital is vicariously liable for the actions of a medical assistant who accessed the patient’s...more
In April 2016, the sensitive personal medical information of NFL players was stolen from the car of a trainer who had left the files in a backpack in his locked car. In 2014, Safeway, Inc. settled charges brought by the...more
There are several reasons an employer might have employee health information, ranging from the results of a pre-employment physical to the contents of a request for FMLA leave to what’s written in a health provider’s note...more
The 2015 HIPAA Security conference held by the National Institute of Standards and Technology (“NIST”) and the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) kicked off last week with OCR’s...more
Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities have reported that the U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently sent pre-audit screening surveys...more
A recent Health Insurance Portability and Accountability Act ("HIPAA") settlement, which is notable as the first HIPAA settlement with a covered entity for failure to have policies and procedures in place to comply with...more