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Department of Health and Human Services (HHS) NPRM

Health Care Compliance Association (HCCA)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

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

Health Care Compliance Association (HCCA)

ORI’s Garrity: Final Rule ‘Walks Delicate Line’

Sheila Garrity, director of the HHS Office of Research Integrity (ORI), recently spoke to RRC about the agency‘s new rule revising research misconduct regulations, which has a compliance date of Jan. 1, 2026 (see related...more

Hinckley Allen

ORI Issues Final Revisions to 2005 PHS Research Misconduct Regulations

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On September 12, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Office of Research Integrity (“ORI”) issued its Final Rule, the long-anticipated update to the 2005 Public Health Service Policies...more

McDermott Will & Emery

DOJ Proposes to Reschedule Marijuana (Cannabis) to Schedule III

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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

Jackson Lewis P.C.

Department of Justice Publishes Notice of Proposed Rulemaking to Reschedule Marijuana to Schedule III

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The Department of Justice (DOJ) published a Notice of Proposed Rulemaking to reschedule marijuana from Schedule I to Schedule III of the federal Controlled Substances Act (CSA) in the Federal Register on May 21, 2024. If the...more

Husch Blackwell LLP

Schedule 3 Marijuana Alert: DEA Publishes NPRM

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On May 16, the Drug Enforcement Administration (“DEA“) published its 92-page notice of proposed rulemaking (“NPRM“) to move marijuana from schedule 1 on the Controlled Substances Act (“CSA”) to schedule 3 (ironically, the...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Health Care Compliance Association (HCCA)

Penn Calls for Withdrawal of ORI’s Misconduct Proposed Reg; Many Commenters Also Critical

The HHS Office of Research Integrity (ORI) gets an “A” for effort on its new proposed regulation revising research misconduct rules, but maybe a “D” overall. Most of the nearly 200 comments on the proposed rule posted online...more

Williams Mullen

42 CFR Part 2 Final Rule Harmonizes Substance Use Disorder Confidentiality Protections with HIPAA

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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

Verrill

HIPAA Privacy Rule Changes: Just in time for the New Year?

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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

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

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

Arnall Golden Gregory LLP

Information Blocking Penalties for Healthcare Providers: HHS Proposed Rule

The U.S. Department of Health and Human Services (“HHS”) on October 30, 2023, issued a Notice of Proposed Rulemaking (“NPRM”) to establish penalties for healthcare providers found to have committed information blocking. This...more

Goodwin

HHS OCR Proposes Changes to HIPAA to Support Reproductive Health Care Privacy

Goodwin on

On April 17, 2023, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking to modify the Standards for Privacy for Individually Identifiable...more

Wiley Rein LLP

FTC and HHS Caution Hospitals and Telehealth Providers on Tracking Tech

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This month, the Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights sent letters warning about privacy and security risks related to online tracking technologies...more

Wiley Rein LLP

Wiley Consumer Protection Download (July 10, 2023)

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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

Burr & Forman

Potential HIPAA Changes Related to Reproductive Health on the Horizon

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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

Goodwin

DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances

Goodwin on

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

Holland & Knight LLP

ONC Proposes Updates to Information Blocking Regulations

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The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) on April 11, 2023, released a Notice of Proposed Rule Making called the Health Data,...more

K&L Gates LLP

HHS Proposes Heightened Protections for "Highly Sensitive" PHI Related Reproductive Health Care in the Wake of Dobbs

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SUMMARY - The US Department of Health and Human Services’ Office for Civil Rights (HHS) is proposing changes to the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA). HHS's proposed changes...more

Clark Hill PLC

HHS Issues Notice of Proposed Rulemaking on Reproductive Health Care Privacy

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The U.S. Department of Health & Human Services (HHS), Office for Civil Rights (OCR), recently issued a Notice of Proposed Rulemaking (NPRM) that would prohibit the use or disclosure of protected health information (PHI) to...more

Bass, Berry & Sims PLC

Proposed Changes to HIPAA Privacy Rule Strengthening PHI Protections for Reproductive Health Care Information Have Broad...

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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

Polsinelli

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

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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

Hogan Lovells

HHS ONC proposes new AI / ML requirements for certified Health IT

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On April 11, the U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, and Interoperability: Certification Program Updates,...more

Robinson+Cole Health Law Diagnosis

HHS Seeks to Strengthen Protections of Confidential Reproductive Health Information with Proposed Changes to HIPAA

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

Saul Ewing LLP

Notice of Proposed Rulemaking to Support and Strengthen Reproductive Health Care Privacy

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On April 12, 2023, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (the “Notice”) to solicit comments on its proposal to modify the HIPAA...more

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