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The U.S. Department of Health and Human Services (HHS) has issued an unpublished Notice of Proposed Rulemaking (NPRM) that strengthens the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and, if...more
The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more
On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the...more
On February 8, 2024, the federal Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 (Part 2) were revised in part to increase patient protection and streamline patient consent...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more
On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts 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
The U.S. Department of Health and Human Services (HHS) has proposed to significantly revise rules governing patient records in substance use disorder (SUD) programs, commonly known as the Part 2 rules, with important...more
Senate Scrambles Ahead of Summer Escape. While members of the U.S. House of Representatives returned home for the August congressional recess, the U.S. Senate remained in Washington, D.C., this week to wrap up some...more
On December 10, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) announcing its plan to modify the Health Insurance Portability and...more
Today, the Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) which proposes significant changes to the Health Insurance Portability and...more
Privacy revisions under the Health Insurance Portability and Accountability Act (HIPAA) may be on the horizon, with some potential changes that could benefit both patients and the healthcare industry. Other changes, if...more
Through two separate notices of proposed rule-making (NPRMs), the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG), seek to remove...more
On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more
The Department of Health and Human Services (HHS) and 16 other federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) proposing to delay the compliance date for updates to the Common Rule for an...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
On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more