News & Analysis as of

Department of Health and Human Services (HHS) Compliance New Regulations

Ropes & Gray LLP

With Implementation Deadline Looming, ORI Releases Sample Research Misconduct Policies and Procedures

Ropes & Gray LLP on

On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more

Health Care Compliance Association (HCCA)

‘Waking Up With Panic Attacks’: NIH 15% Plan Caps Tumultuous Weeks Under New Administration

If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more

Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

Goodwin on

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

McDermott Will & Schulte

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

Holland & Knight LLP

NY Department of Health Bolsters Hospital Cybersecurity Regulations

Holland & Knight LLP on

New York hospitals have less than a year to dust off their Health Insurance Portability and Accountability Act (HIPAA) compliance programs and update them to comply with more stringent and detailed state regulations. Last...more

Lippes Mathias LLP

Hospital Administrators – Is Your Hospital Cyber-Secure?

Lippes Mathias LLP on

On October 2, 2024, New York adopted new regulations requiring general hospitals to implement heightened cybersecurity safeguards. General hospitals, as defined in Article 28 of the NY Public Health Law, generally must begin...more

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

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Regulation and Enforcement Updates

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Proskauer - Employee Benefits & Executive...

Agencies Issue Final Regulations on the Summary of Benefits and Coverage (SBC) Requirements

As promised in the FAQ issued on March 30, 2015, the U.S. Departments of the Treasury, Labor and Health and Human Services (the Departments) have issued final regulations regarding the summary of benefits and coverage (SBC)...more

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