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 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
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
On April 26, the Federal Trade Commission announced its final rule updating the health breach notification rule. According to the FTC, the update seeks to “clarify” the scope of the rule by adding new definitions and revising...more
On April 26, the Federal Trade Commission (FTC) announced its final rule (Final Rule) making changes to the Health Breach Notification Rule (HBNR)....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
On June 23, 2023, the Department of Justice (DOJ) and Federal Trade Commission (FTC) announced a stipulated resolution with Easy Healthcare Corporation to address allegations that Easy Healthcare violated Section 5 of the FTC...more
If you are involved with any health information, even if you are not covered by HIPAA, you should be aware of the government’s recent position that there may be serious privacy and serious risks with use of online tracking...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
Summary - On May 18, 2023, the Federal Trade Commission (“FTC”) announced a Notice of Proposed Rulemaking (the “Proposed Rule”), which both clarifies the scope of the Health Breach Notification Rule (“HBN Rule”) to include...more
A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal...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
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
On Thursday, May 19, 2023, the Federal Trade Commission (FTC) issued a notice of proposed rulemaking and a request for public comment on proposed changes to the Health Breach Notification Rule (HBNR or, the Rule) that would...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
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
The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on...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
On September 15, 2021, the Federal Trade Commission (“FTC”) issued a Policy Statement instructing health app and connected device companies to comply with the Health Breach Notification Rule (“the Rule”). The Rule, codified...more
In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...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
The Federal Trade Commission (FTC) recently issued a policy statement confirming that vendors of apps and other connected devices that collect personal health information, such as glucose levels, heart rate, or fertility or...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
The Federal Trade Commission (FTC) adopted a policy statement on Sept. 15, 2021, emphasizing that developers of digital health apps, connected devices and other health products have obligations under the Health Breach...more
HIPAA and Emerging Technologies - Editor’s Note: According to a HIMSS Mobile Technology Survey of healthcare provider employees, about 90% say they are using mobile devices to engage patients in their healthcare—and 36%...more