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Final Rules Data-Sharing Compliance

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

Brownstein Hyatt Farber Schreck

CFPB Finalizes Data Sharing Rule

On Oct. 22, 2024, the Consumer Financial Protection Bureau (CFPB) issued a final rule on Personal Financial Data Rights, which changes the way financial institutions hold and distribute customer-generated data. The rule, once...more

Goodwin

FinCEN Adopts Final AML Program Rule for Investment Advisers

Goodwin on

The U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN) adopted a final rule (the Final Rule) on August 28 that will treat certain investment advisers and exempt reporting advisers as financial...more

BakerHostetler

The Long-Awaited Part 2 Modifications Are Finalized with New Obligations for Part 2 Providers and Less Friction for Sharing...

BakerHostetler on

On February 8, 2024, the U.S. Department of Health & Human Services (HHS) released a final rule modifying 42 CFR Part 2 (Part 2) provisions regarding the confidentiality of Substance Use Disorder (SUD) Patient Records. The...more

McDermott Will & Emery

California DxF Policies and Procedures Released for Public Comment

McDermott Will & Emery on

On January 17, 2023, the California Health and Human Services Agency (CalHHS) released updated drafts of four policies and procedures (P&Ps) under the California Data Exchange Framework (DxF) to support the implementation of...more

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