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
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
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
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 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 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 in the consumer health space, you have (or at least we hope you have...) figured out by now that there are health-related privacy and security laws and regulations that apply to your business. The Federal Trade...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
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
Report on Patient Privacy 22, no. 8 (August, 2022) - Oklahoma State University Center for Health Sciences’ (OSUCHS) breach might not have seemed all that serious at the time: No data is believed to have been misused,...more
The U.S. Department of Health & Human Services (HHS) just announced increased penalty amounts for entities who violate the privacy, security, and breach notification rules under the Health Insurance Portability and...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
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
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