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
The Final Rules keep rolling in, but with a twist. Each of the two Final Rules released in March were accompanied by Supplemental Notices of Proposed Rulemaking. In both cases, the Supplemental Rulemakings, if adopted, would...more
The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...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
Background: In March 2022, President Joe Biden signed the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA) into law, ushering in a new era of enhanced cybersecurity measures. This legislation...more
On May 18, 2023 the Federal Trade Commission (FTC) released a Notice for Proposed Rule Making (NPRM) for updates to the Health Breach Notification Rule, 16 C.F.R. Part 318 (the Rule). The Rule serves to ensure entities that...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
A recent survey found that the average wait time for a new patient to see a physician in 15 of the largest cities in the U.S. was 26 days, up from 24.1 days in 2017. Timely access to health care providers has long been an...more
On April 27, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice of Proposed Rulemaking entitled Ensuring Access to Medicaid Services (Proposed Rule) which would, among other things, establish...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
Over the years, one of the biggest challenges many businesses face when assessing TCPA risks posed by a new calling or texting campaign has been determining whether the proposed use case can defensibly rely on one of the...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
Colorado’s uninsured rate is down 9 percentage points in four years; Michigan requests increased cost-sharing for its Medicaid expansion population above the federal poverty line; and, HHS’s proposed guidance strengthens...more