News & Analysis as of

Department of Health and Human Services (HHS) New Guidance

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

King & Spalding

HHS Abandons Appeal of AHA’s Lawsuit Challenging HHS Website-Tracking Guidance

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Last week, HHS filed a motion asking the Fifth Circuit’s permission to voluntarily dismiss its appeal of a District Court order directing HHS to rescind its guidance restricting hospitals’ ability to track online traffic to...more

Jones Day

U.S. District Court Invalidates HHS Guidance Overreading HIPAA's Application to Online Technologies

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On June 20, 2024, a U.S. federal district court held, in a suit brought by Jones Day, that the Department of Health and Human Services ("HHS") had misapplied the Health Insurance Portability and Accountability Act ("HIPAA")...more

Napoli Shkolnik

Controls on Social Media Use are Taking Hold—at School

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As the inherent risks of social media use become more broadly understood, pressure is building on government bodies at every level to enact effective regulations. There has been some action at the federal level: both the...more

Moore & Van Allen PLLC

New OCR Guidance on Tracking Technologies

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On March 18, 2024, the Office for Civil Rights ("OCR") at the U.S. Department of Health and Human Services ("HHS") published updated guidance on the use of online tracking technologies by HIPAA covered entities and business...more

Verrill

Don’t Wait – CMS Expects Hospitals to Take Action on Informed Consent for Certain Exams and Procedures

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Hospitals should not delay in reviewing and revising their surgical informed consent forms and policies. On April 1, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued new guidance regarding informed consent...more

Holland & Knight LLP

While You Were Sleeping: HHS Releases New Guidance on Sensitive Examinations

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"Informed consent" has been described as "a bedrock principle of healthcare in a free society," and if a "patient is denied the ability to exercise or even consider informed consent, the patient's personal liberty suffers."1...more

Epstein Becker & Green

Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform...more

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

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

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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

Health Care Compliance Association (HCCA)

HHS OIG General Compliance Program Guidance: An empowered and independent compliance function

Corporate Compliance & Ethics Week 2023 kicked off with a gift for healthcare and life sciences compliance practitioners by way of the U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG)...more

Mintz

EnforceMintz — DOJ and OIG Guidance Emphasizes the Importance of a Robust and Dynamic Compliance Program

Mintz on

2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice (DOJ) issued significant compliance...more

Foley & Lardner LLP

“Let’s Talk Compliance”: OIG’s General Compliance Program Guidance: How to Refresh Compliance Programs

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Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

King & Spalding

OCR Provides Guidance Regarding Patient Visitation Rights

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On January 25, 2024, HHS Office for Civil Rights (OCR) issued guidance and responses to frequently asked questions regarding nondiscrimination regulations related to patient visitation. Hospitals, long term care facilities,...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

McNees Wallace & Nurick LLC

The OIG Releases Updated General Compliance Program Guidance

As 2023 came to a close, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated General Compliance Program Guidance (GCPG) manual, which serves as a reference guide for...more

Bass, Berry & Sims PLC

HHS Releases Cybersecurity Performance Goals for Healthcare Organizations

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In response to the number of successful, large-scale ransomware attacks affecting healthcare organizations nearly tripling since 2018, the Department of Health and Human Services (HHS) has released guidance outlining its...more

Proskauer - Health Care Law Brief

HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector

The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more

Bass, Berry & Sims PLC

HHS Releases Groundbreaking General Compliance Program Guidance, Setting New Standards for Healthcare Entities

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On November 6, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released the most up-to-date, comprehensive, and practical general compliance guidance in decades. The new...more

Fox Rothschild LLP

In Case You Missed It: New OIG General Compliance Program Guidance

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On November 6, 2023, the HHS Office of Inspector General published a new compilation of compliance guidance under the title General Compliance Program Guidance (GCPG) for the healthcare compliance community and other health...more

Ankura

OCR Issues Guidance to Patients and Providers on Telehealth Privacy and Security

Ankura on

On October 18, 2023, the Department of Health and Human Services (DHHS) through the Office for Civil Rights (OCR) issued an update1 containing two resource documents to help educate patients regarding privacy and security...more

Goodwin

A Practical Look at OIG’s New Compliance Guidance

Goodwin on

On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more

Lathrop GPM

OIG Publishes New Compliance Guidance for Health Care Entities, Along with Plan for Targeted “Industry Specific” Guidance Starting...

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On October 6, 2023, the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) released brand new “General Compliance Program Guidance” to assist health care providers, entities, and other...more

Mintz - Health Care Viewpoints

Key Takeaways from the OIG’s New Comprehensive General Compliance Program Guidance

The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance...more

Epstein Becker & Green

Dr. Jack of All Trades? OCR’s New Telehealth Guidance Suggests High Expectations on Providers

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On October 18, 2023, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), which is tasked with enforcing the Health Insurance Portability and Accountability Act (“HIPAA”), issued two new...more

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