In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more
On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) delivered a late-December surprise: a draft overhaul of the Health Insurance Portability and Accountability Act of 1996’s (HIPAA) Security Rule....more
‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more
Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more
In 2021, the Department of Health and Human Services (HHS) proposed changes to the Privacy Rule under the Health Insurance Portability and Accessibility Act of 1996 (HIPAA) that would significantly alter the current...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
On April 12, 2023, the Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced proposed changes to HIPAA’s Privacy Rule with regard to reproductive health information. The proposed changes are set out in a...more
On April 12, 2023, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“Notice” or “NPRM”) to solicit comments on proposed modifications to the HIPAA...more
On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...more
On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of...more
On June 28, 2016, the U.S. Department of Health and Human Services (HHS) released a series of regulatory changes in the Notice of Proposed Rule Making (NPRM) designed to curtail the massive backlog of Medicare claim appeals....more
The comment period for the Notice of Proposed Rule Making (NPRM) regarding proposed changes to the Human Subjects Protection “Common Rule” issued by 16 federal departments and agencies in September has been extended an...more
A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule. ...more
The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more