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
On November 20, 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the “Nursing Facility ICPG,” an industry-specific compliance program guidance for nursing facilities....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 May 31, 2024, more than four months after the February 2024 Change Healthcare ransomware attack, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) updated its Change Healthcare FAQs. ...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
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
Welcome to our inaugural issue of The Health Record - our healthcare law insights e-newsletter! As such, we wanted to pull together our insights and pass them along to you. Our goal is to create a publication that is...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
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
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
The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more
On February 16, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights and its Substance Abuse and Mental Health Services Administration (“SAMHSA”), published the long-awaited Final Rule...more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more
On February 16, 2024, the HHS Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a final version of the cybersecurity resource guide (the “Guide”) with respect to the HIPAA...more
A new HHS Final Rule overhauls the federal Part 2 regulations on the confidentiality of substance use disorder (SUD) records. Our Heath Care Health Care and Privacy, Cyber & Data Strategy Groups unpack how the changes will...more
February 29, 2024, is the date by which HIPAA-covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR) of all "small" breaches of unsecured protected health information that...more
Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...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
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