News & Analysis as of

Health Care Providers Department of Health and Human Services (HHS) Penalties

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

Holland & Hart LLP

Avoiding HIPAA Penalties: A Checklist for Covered Entities

Holland & Hart LLP on

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

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Burr & Forman

Proposed Penalties for Information Blocking Violations

Burr & Forman on

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

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

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

K&L Gates LLP

Blocking and Tackling: What Every Health Care Provider's Legal, IT, and Compliance Teams Need to Know About Information Blocking...

K&L Gates LLP on

INTRODUCTION - The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) is responsible for the implementation of key provisions of Title IV of the 21st Century...more

Health Care Compliance Association (HCCA)

DAB Affirms OIG's $1.32M Penalty on Provider for Breaching CIA

Report on Medicare Compliance 29, no. 23 (June 22, 2020): The HHS Departmental Appeals Board (DAB) has upheld the largest stipulated penalty imposed by the HHS Office of Inspector General (OIG) in years. OIG fined...more

Baker Donelson

Physicians, Think Before You Yelp??

Baker Donelson on

Health care providers should take heed of the $10,000 settlement announced on October 2, 2019 between the U.S. Department of Health and Human Service (HHS) Office for Civil Rights (OCR) and a small dental practice based on...more

Hogan Lovells

HIPAA Penalty Caps to Be Reduced and Tied to Culpability Level

Hogan Lovells on

In a dramatic turn, the US Department of Health and Human Services (HHS) has announced that effective immediately, penalties for many HIPAA violations will be subject to substantially reduced limits. ...more

Akerman LLP - Health Law Rx

Lack of Timely Action and Knowledge of Risk Results in $3.2 Million Civil Monetary Penalty for HIPAA Violations

Children’s Medical Center of Dallas (Children’s) was hit with a $3.2 million civil penalty from the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) for failing to take steps to properly protect...more

McCarter & English, LLP

Health Law Insights Newsletter - Issue 13

McCarter & English, LLP on

McCarter & English, LLP’s Health Care Group presents Issue 13 of the Health Law Insights, which discusses the latest legal issues in the health care industry. - Failure to Update Business Associate Agreement Results in...more

Winstead PC

New ADA and GINA Wellness Regulation Changes Complicate Wellness Program Compliance Analysis and Risks

Winstead PC on

Wellness programs should all be reviewed considering the Americans with Disabilities Act (“ADA”) and the Genetic Information Nondiscrimination Act (“GINA”) regulatory changes because noncompliance with the new requirements do...more

Womble Bond Dickinson

A Detailed Analysis of Changes to HIPAA and the Implications for Healthcare Providers and Others in the Healthcare Industry: HIPAA...

Womble Bond Dickinson on

Changes to the HIPAA Enforcement Rule - Background: On October 30, 2009, HHS issued an interim final rule revising the Enforcement Rule to incorporate provisions of the HITECH Act. The NPRM then proposed a number of...more

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