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Penalties Department of Health and Human Services (HHS)

Davis Wright Tremaine LLP

21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more

Clark Hill PLC

Right To Know - June 2024, Vol. 18

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Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more

Holland & Hart LLP

Avoiding HIPAA Penalties: A Checklist for Covered Entities

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The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more

Dechert LLP

Dechert Cyber Bits - Issue 54

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European Data Protection Board Publishes Strategy for 2024-27 - The European Data Protection Board (“EDPB” - the EU body tasked with promoting consistency and cooperation in enforcement of the GDPR) has outlined its...more

Mintz - Health Care Viewpoints

HHS Health Care Cybersecurity Performance Goals: Proposed Incentives, Penalties and Compliance Standards

As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Sheppard Mullin Richter & Hampton LLP

HHS Announces 42 Part 2 Final Rule to Align with HIPAA

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more

Davis Wright Tremaine LLP

Old Rule, New Tricks: HHS Finalizes Most Substantial Changes to Substance Use Disorder Confidentiality Rule in Decades

The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more

Foley & Lardner LLP

HIPAA and Part 2 Harmonized: What Health Care Organizations Need to Know

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Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...more

Seyfarth Shaw LLP

Child Labor Law Penalties on the Rise – Employers Face Various Avenues to Increased Exposure

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Seyfarth Synopsis: Child labor laws remain fertile ground for government enforcement as evaluate key issues for 2024. Late last year, the Wage Hour Division released guidance for new processes to assess greater penalties...more

Burr & Forman

Proposed Penalties for Information Blocking Violations

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On October 30, 2023, the Department of Health and Human Services (HHS) released a proposed rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century...more

Harris Beach PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Snell & Wilmer

2023 End-of-Year Plan Sponsor “To Do” Lists (Part 1) Health and Welfare

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We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Foley & Lardner LLP

Ensuring Child Labor Law Compliance Amid Growing Scrutiny

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In February, the New York Times published an investigative report regarding alleged employment of underage migrants, many from Central America, at U.S. companies. While employment of certain minors is permitted under federal...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Health Care Compliance Association (HCCA)

Revised Privacy Rule May Not Emerge for Two Years; Info Blocking Penalty Regulation Published

Report on Patient Privacy Volume 23, no 7 (July 2023) In two public talks this spring, Melanie Fontes Rainer, director of the HHS Office for Civil Rights (OCR), said completing the 2021 proposed regulation extensively...more

Foley & Lardner LLP

Child Labor: 9 Key Strategies to Mitigate Risk of Child Labor in the Supply Chain

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Since 2018, the U.S. Department of Labor has seen a 69 percent increase of children being employed illegally by companies. Last month, the U.S. Department of Labor (“DOL”) and Department of Health and Human Services (“DHHS”)...more

ArentFox Schiff

Investigations Blog: Government Wins $43 Million Verdict in False Claims Act Case

ArentFox Schiff on

Headlines that Matter for Companies and Executives in Regulated Industries- Government Wins $43 Million Verdict in False Claims Act Case - On February 28, 2023, a federal jury in Minnesota handed down a $43 million...more

DarrowEverett LLP

A HIPAA Privacy Notice A Day Keeps The Doctor Away (And Out Of Trouble)

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The start of 2023 has brought with it significant changes to data privacy – new state laws concerning data privacy came into effect January 1 (the California Privacy Rights Act and the Virginia Consumer Data Protection Act),...more

Snell & Wilmer

HHS Proposed Changes To Part 2 Rules To Align With HIPAA Privacy Rules

Snell & Wilmer on

On November 28, 2022, the U.S. Department of Health and Human Services (“HHS”) proposed sweeping changes to the rules that govern use and disclosure of protected health information (“PHI”) about patients receiving substance...more

Woods Rogers

HIPAA Security Rule: What are “Recognized Security Practices” and why are they important?

Woods Rogers on

A strong cybersecurity program can help defend against cyber attacks and protect sensitive patient data. Thanks to a 2021 amendment of the HITECH Act, when a breach occurs, it can also reduce enforcement penalties. The...more

Foley & Lardner LLP

Compliance Officers Lookout! DOJ and OIG Tag Team Corporate Integrity Agreements

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The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - July 2022

The July Monthly Minute addresses a steep settlement and corrective action plan resulting from a widespread HIPAA breach, along with recent employer-friendly cases that highlight judicial support for inclusion of actively...more

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