News & Analysis as of

Final Rules Compliance Department of Health and Human Services (HHS)

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

Saul Ewing LLP

Trump on Transparency: Making America Healthy Again Through Executive Order 14221; How Plan Sponsors Can Respond

Saul Ewing LLP on

One mandate under the PPACA required health care providers, non-grandfathered health insurance issuers and self-insured group health plans to provide consumers with access to information about the cost of services before they...more

Epstein Becker & Green

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Epstein Becker & Green on

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Foley & Lardner LLP

Make Food “Healthy” Again: FDA’s Resolution for a Healthier 2025

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more

McDermott Will & Emery

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

Sheppard Mullin Richter & Hampton LLP

May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace

The Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) recently issued the final “HHS Notice of Benefit and Payment Parameters for 2026” (hereinafter referred to as the “Rule”)...more

Buchalter

Significant New HIPAA Obligations on Their Way for 2025

Buchalter on

The Department of Health & Human Services (HHS) issued proposed changes to the HIPAA Security Rule (“Proposed Rule”) on January 6, 2025, and is accepting comments from the public until March 7, 2025. The Proposed Rule...more

Husch Blackwell LLP

Compliance with the HIPAA Privacy Rule to Support Reproductive Healthcare Privacy

Husch Blackwell LLP on

On April 22, 2024, the Health and Human Services’ Office for Civil Rights (OCR) issued the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule. The final rule limits the sharing of protected health...more

Foley & Lardner LLP

DEA Tightens Buprenorphine Telemedicine Prescribing Rules

Foley & Lardner LLP on

The Drug Enforcement Administration (DEA) and the U.S. Department of Health & Human Services (HHS) just finalized their March 2023 proposed rule regarding telemedicine prescribing of buprenorphine. The final rule, effective...more

McDermott Will & Emery

ASTP Adopts New Protecting Care Access Exception

McDermott Will & Emery on

On December 17, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

McDermott Will & Emery

ASTP Final Rule Codifies Requirements for TEFCA-Qualified Health Information Networks

McDermott Will & Emery on

On December 16, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

Goodwin on

On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

McCarter & English, LLP

Nursing Home Update

The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more

McDermott Will & Emery

CMS Updates Scope of Providers Subject to Provisional Period of Enhanced Oversight

The Centers for Medicare & Medicaid Services’ (CMS) 2025 Home Health Prospective Payment System final rule (Final Rule) expanded the scope of providers subject to a provisional period of enhanced oversight (PPEO) to include...more

Ropes & Gray LLP

Biden Administration Finalizes Its Last Changes To Health Data Interoperability and Information Blocking Regulations

Ropes & Gray LLP on

In December 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”) published two...more

Harris Beach Murtha PLLC

"No Surprises Act" Ruling Favors Regulators, Insurers

Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act (the...more

Holland & Knight LLP

HHS Finalizes Key Information Blocking Exceptions

Holland & Knight LLP on

The finalization of information blocking exceptions were announced just in the "St. Nick" of time by the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP), formerly known as...more

Stevens & Lee

Compliance Deadline Imminent: HIPAA Final Rule to Support Reproductive Health Care Privacy

Stevens & Lee on

Around the corner is the Dec. 23 deadline to have your organization bring its HIPAA Notice of Privacy Practices into compliance with the U.S. Department of Health & Human Services’ Office for Civil Rights Final Rule modifying...more

King & Spalding

HIPAA Reproductive Healthcare Privacy – Recent Settlement Related to Privacy Rule Violation and Reminder of December 2024 Privacy...

King & Spalding on

Last week, HHS Office of Civil Rights (OCR) announced a settlement with a Pennsylvania provider (the Provider) concerning an alleged violation of the HIPAA Privacy Rule. Specifically, the Provider impermissibly disclosed a...more

King & Spalding

End of Year Compliance Updates

King & Spalding on

On June 25, 2024, the Office for Civil Rights and the U.S. Department of Health and Human Services issued the HIPAA Privacy Rule To Support Reproductive Health Care (the “HIPAA Final Rule”) aimed at strengthening privacy...more

Holland & Knight LLP

HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations

Holland & Knight LLP on

The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Justice Department Rule on Accessible Medical Diagnostic Equipment Carries Broad Implications for Healthcare Industry

The U.S. Department of Justice (DOJ) recently published a final rule on the accessibility of medical diagnostic equipment (MDE) and other accessibility-related practices that promises to have broad impact on the health care...more

Holland & Hart LLP

Are You Ready for It? Section 1557's Upcoming Deadlines

Holland & Hart LLP on

The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) published its final rules implementing the anti-discrimination provisions under Section 1557 of the Affordable Care Act (“Final Rule”) on May...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

40 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide