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 (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
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
Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more
On May 30, 2024, the FTC published amendments to its Health Breach Notification Rule (“HBNR” or “Rule”) in the Federal Register, memorializing the Rule’s expanded scope that now explicitly includes direct-to-consumer 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
On April 26, the Federal Trade Commission (FTC) approved its Final Rule revising the Health Breach Notification Rule (HBNR) (“Final Rule”) by a 3-2 vote. The HBNR requires vendors of personal health records (PHR) and related...more
After months of uncertainty and multiple letters from industry associations advocating on behalf of the healthcare industry with the U.S. Department of Health and Human Service (HHS) Office for Civil Rights (OCR), covered...more
The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...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
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 U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently published an executive summary (Report) outlining key enforcement activities of the Health Insurance Portability and...more
On Feb. 16, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published its 2022 Annual Report to Congress. ...more
For healthcare providers and health systems covered by the privacy and security regulations under the Health Insurance Portability and Accountability Act (HIPAA), a breach of unsecured protected health information (PHI)...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
On June 30, 2023, Mount Desert Island Hospital (“MDIH”) filed a notice of data breach with the U.S. Department of Health and Human Services Office for Civil Rights after discovering that an unauthorized party had gained...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
The Federal Trade Commission earlier this month undertook an enforcement action against online pharmacy and telehealth provider GoodRx, in the latest example of the agency seriously pursuing its role as the nation’s de facto...more
In a groundbreaking decision, the Federal Trade Commission (FTC) announced it was diagnosing GoodRx’s use of tracking pixel codes and analytics, its digital strategy, as not only an unfair or deceptive act or abusive practice...more
On November 28, 2022, the U.S. Department of Health and Human Services (“HHS”) proposed sweeping changes to the rules that govern use and disclosure of protected health information (“PHI”) about patients receiving substance...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
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
Halloween or HIPAA: Which is Scarier? HIPAA and the Pandemic - Telehealth: - On Friday, March 20, 2020, OCR announced it will “exercise its enforcement discretion and will not impose penalties for noncompliance with...more