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
It’s not immediately obvious why someone would want to disclose a health care test result as part of a job application. But one such request spurred a Pennsylvania entity to provide a lot more than that: it sent her whole...more
Although 2024 saw several states enact comprehensive privacy legislation, another year is nearly gone, and we still do not have a comprehensive federal privacy law to resolve the rapidly evolving patchworks of state laws....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 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 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
Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. 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
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
As our loyal Practical Privacy readers may remember, back in December of 2021, the Federal Trade Commission (the “FTC” or “Commission”) began a rulemaking process to update the Commission’s Health Breach Notification Rule...more
On April 26, 2024, the Federal Trade Commission (“FTC”) announced it had finalized changes to modernize the Health Breach Notification Rule (the “HBNR”) by clarifying its applicability to health and wellness apps and other...more
On April 26, the FTC released a final rule that will amend its Health Breach Notification Rule to require vendors of health apps and related entities not covered by the Health Insurance Portability and Accountability Act...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
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
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
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
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
GoodRx Faces Million Dollar Proposed Penalty from FTC in First Enforcement Action Under the Health Breach Notification Rule - Settlement reveals views on application of unfairness authority to sharing of sensitive...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
As the collection and use of health data drastically expands, the agency issued a recent guidance to officially put health apps and connected medical devices “on notice.” On September 15, the Federal Trade Commission...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