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 HHS Centers for Medicare & Medicaid Services (CMS) and Wisconsin Physicians Service Insurance Corporation (WPS) are notifying 946,801 people whose protected health information or other personally identifiable information...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 July 29, 2024, the FTC’s revised Health Breach Notification Rule (HBNR) takes effect. The Rule requires vendors of personal health records (PHRs) and related entities not covered by HIPAA to notify individuals, the FTC,...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
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
The FTC issued a final rule to lock in changes to the Health Breach Notification Rule (HBNR) that it proposed in May 2023. While the HBNR began as a breach notification rule seemingly focused on a narrow set of applications...more
On February 14, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued its annual reports to Congress detailing its actions to enforce the privacy, security, and breach notification...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
2023 marked a pivotal moment in US data privacy and cybersecurity, characterized by substantial regulatory and legislative advances at the international, federal, and state levels. The Federal Trade Commission (FTC) took a...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
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
On June 30, 2023, ARx Patient Solutions filed a notice of data breach with the Attorney General of Maine after discovering that an employee’s M365 email account was accessed by an unauthorized party. In this notice, ARx...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 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
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
On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for...more
On January 24, New York Attorney General Letitia James announced a settlement with EyeMed Vision Care LLC based on shortcomings in the company’s data security procedures. The problems were discovered during the state’s...more
Last week’s news that the Federal Trade Commission is taking steps to begin rulemaking on consumer privacy and artificial intelligence drew plenty of attention from privacy professionals, and suggests 2022 could be an...more
With COVID-19, employers are receiving and processing an ever-increasing amount of their employees' confidential health information. From COVID-19 test results to vaccination status, many employers are routinely collecting...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, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach...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