News & Analysis as of

Final Rules Compliance Safe Harbors

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

King & Spalding

SEC Adopts Final Climate Disclosure Rules

King & Spalding on

Proposed rules are moderately scaled-back in final version; Scope 1 and 2 are required if material; Scope 3 is out; compliance will still be burdensome - On March 6, 2024, by a split vote of 3-2, the U.S. Securities and...more

Holland & Knight LLP

Substance Use Disorder Confidentiality Regulations Modified to Align with HIPAA

Holland & Knight LLP on

After more than a year since the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued the proposed changes to the...more

A&O Shearman

SEC Rule 192: Prohibition against conflicts of interest in certain securitizations

A&O Shearman on

Seven months after our initial note on the subject, the United States Securities and Exchange Commission (the SEC) on November 27, 2023 adopted Rule 192 (Rule 192 or the Final Rule)1 pursuant to Section 27B of the Securities...more

Health Care Compliance Association (HCCA)

Defensibility of a fair market value analysis

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Health Care Compliance Association (HCCA)

[Event] 2020 Virtual Columbus Regional Conference - May 1st, Columbus, OH

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

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