News & Analysis as of

The Common Rule Pharmaceutical Industry

BCLP

Implications of CCPA and CPRA on Clinical Trial Data

BCLP on

Given the recent updates to CCPA, and the possible approval of California Privacy Rights Act (CPRA) which is on the November 3 ballot, it is increasingly likely that personal information collected in the course of clinical...more

Epstein Becker & Green

Six Key Changes to the Common Rule

Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

BakerHostetler

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

BakerHostetler on

On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) to update the federal policy for the Protection of Human Subjects, more...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

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