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
Can you remember healthcare security 20+ years ago? It seems like a different world from now. Believe it or not, the HIPAA Security Rule has barely changed since it was first enacted in 2003 and has been long overdue for a...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 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
The FTC has updated its HBNR to clarify that the rule also restricts marketing practices involving personal health information. This update to the HBNR was announced on April 26, 2024, and follows several recent enforcement...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
The Federal Trade Commission (FTC) recently has signaled its intent to inject new life into a longstanding but rarely triggered rule governing health breach notifications for non-HIPAA-covered health records. Specifically,...more
As we start 2022, as part of our Spotlight series, we connect with Reece Hirsch, the co-head of Morgan Lewis’s privacy and cybersecurity practice, to discuss the recent policy statement issued by the US Federal Trade...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
A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be covered by a Health Breach Notification...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
Dive into a broad spectrum of topics affecting healthcare organizations. Explore the latest laws, regulations, and developments to help you effectively manage your organization’s privacy compliance program. Our Academies are...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
Proposed Modifications to HIPAA Regulations under Consideration - On December 14, 2018, HHS issued its Request for Information on Modifying HIPAA Rules to Improve Coordinated Care as part of its Regulatory Sprint to...more
The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more
The Department of Health and Human Services (HHS) has released a fact sheet on the privacy, security, and breach notification rules of the Health Insurance Portability and Accountability Act (HIPAA). Designed to apply to...more