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Department of Health and Human Services (HHS) Regulatory Standards

Holland & Knight LLP

Regulation of AI in Healthcare Utilization Management and Prior Authorization Increases

Holland & Knight LLP on

Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...more

McDermott+

Regs Coming Through the End of the Year: Expect the Expected and the Unexpected

McDermott+ on

There could be an all-you-can-eat buffet of regs (and eggs) from now until the end of the year! As you may recall, a July 2024 Regs & Eggs blog post highlighted the spring 2024 “unified agenda” that listed all the regs...more

Bass, Berry & Sims PLC

HHS Proposed Rule Seeks to Align Health IT Procurement Standards to Leverage Interoperable Data

Bass, Berry & Sims PLC on

On August 9, the Department of Health and Human Services (HHS) published a proposed rule that seeks to amend and update the Health and Human Services Acquisition Regulation (HHSAR) to align health IT procurement requirements....more

Proskauer - Health Care Law Brief

No Surprises Here!  Fifth Circuit Upholds Health Care Provider Challenge to No Surprises Act Regulations

In a recent win for health care providers, the United States Court of Appeals for the Fifth Circuit has affirmed a lower court’s decision to vacate key portions of regulations issued by the U.S. Departments of Treasury,...more

Husch Blackwell LLP

Healthcare Founders Face New Exit Considerations

Husch Blackwell LLP on

Exiting a business, whether you are a serial entrepreneur looking to move on to the next project or a healthcare provider like a physician or therapist who has nurtured your practice for decades, can be difficult. After all,...more

Chambliss, Bahner & Stophel, P.C.

OCR Finalizes Post-Dobbs HIPAA Regulatory Changes Impacting Health Care Organizations

On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...more

McCarter & English, LLP

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

Health Care Compliance Association (HCCA)

An international standard for healthcare quality management

In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

Rothwell, Figg, Ernst & Manbeck, P.C.

White House AI Order Balances Innovation And Regulation

On Oct. 30, President Joe Biden issued an executive order on safe, secure and trustworthy artificial intelligence. The executive order provides a sprawling list of directives aimed at establishing standards for AI safety...more

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more

Nelson Mullins Riley & Scarborough LLP

The OIG Provides Stakeholders a Newly Expanded FAQ Process

The Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published a revamped frequently asked questions (“FAQs”) page and process on March 23, 2023, creating a new platform to...more

Health Care Compliance Association (HCCA)

Compliance Today - December 2022. Intersection of ESG, health equity, and 501(r) compliance

Compliance Today - December 2022 - We are at a critical moment of change when it comes to truly addressing health inequities in this country. With the intersection of environmental, social, and governance (ESG) reporting and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. Groups Seek Substantive Revisions to HHS Misconduct Regs, Investigations:...

Two organizations representing research institutions and integrity officials have called for a virtual rewrite of the regulations that govern misconduct in Public Health Service-funded studies. The Association of Research...more

Lowndes

Senior Communities Opening Up to Legalized Marijuana

Lowndes on

Senior Housing News recently offered some insights into how senior living communities are addressing the desire of some residents to use marijuana in states where such use has been legalized, while also trying to avoid...more

Polsinelli

HHS OCR Issues New, Post-Dobbs Guidance

Polsinelli on

In the wake of the Dobbs decision, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued new guidance regarding the privacy of patients seeking reproductive health care. The guidance...more

Manatt, Phelps & Phillips, LLP

When California Minors Need Mental Health Treatment, Who Can Consent, and to What?

Increasing mental health care needs for minors present a range of legal issues for children, parents, health care providers and health care payors. While state laws typically govern who has the power to consent to or refuse...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #4

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Hogan Lovells

In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

Hogan Lovells on

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI). ...more

Hogan Lovells

HHS Publishes Final SUNSET Rule With New Exemptions and Timelines

Hogan Lovells on

On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...more

Lowenstein Sandler LLP

Contradictory Responses by Privacy Regulators Post-COVID-19: Balancing the Economy With Cybersecurity in a Changed World (Privacy)

The COVID-19 pandemic has had a disparate effect on privacy regulators, with varying levels of enforcement advocated by different government entities; the California Attorney General, the U.S. Department of Health & Human...more

Foley & Lardner LLP

COVID-19: Privacy and Cybersecurity Regulatory and Enforcement Guidance

Foley & Lardner LLP on

As industry continues to adapt to the evolving realities of shelter-in-place orders, companies face challenges in supporting an unprecedented remote workforce while balancing compliance with a variety of regulatory agencies....more

Dorsey & Whitney LLP

CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates

Dorsey & Whitney LLP on

In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the...more

Burr & Forman

Top Three Challenges Health Care Payers and Providers Will Face in 2020

Burr & Forman on

Health care providers operate in one of the most highly regulated industries in terms of compliance and governmental oversight. As a result, providers face a number of regulatory and compliance challenges each year....more

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