News & Analysis as of

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

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

Foley & Lardner LLP on

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

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

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...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

Proskauer Rose LLP

The ERISA Litigation Newsletter - August 2015

Proskauer Rose LLP on

Editor's Overview - As the summer draws to a close, this month's Newsletter previews three cases that the U.S. Supreme Court already has agreed to hear that ought to be of particular interest to ERISA plan sponsors and...more

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