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
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 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
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
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
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
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 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
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
As the COVID-19 pandemic in the United States is easing, telemedicine is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers...more
The worldwide COVID-19 pandemic visited on America in the past several months has quickly reinvigorated the foundational and important debate concerning where, in a free society, individual autonomy ends (or should end) and...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
The HHS Office for Civil Rights (OCR) released a new guidance document regarding which HIPAA violations business associates (BAs) can and cannot be held directly liable for. In the guidance, OCR states that BAs can be held...more
The health care industry is racing to adopt cutting-edge technology to provide patients with the best treatment possible at the lowest possible cost. ...more
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health,...more