News & Analysis as of

Department of Health and Human Services (HHS) Health Insurance Portability and Accountability Act (HIPAA) Medical Research

Holland & Knight LLP

Holland & Knight Health Dose: April 29, 2025

Holland & Knight LLP on

U.S. Congress returns from a two-week recess this week and has lofty goals to draft, mark up and pass a reconciliation bill by Memorial Day 2025. The U.S. House of Representatives Committee on Energy and Commerce, which was...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Health Care Compliance Association (HCCA)

As MD Anderson Keeps Up Its Legal Fight, U. Rochester Pays OCR $3M

Report on Research Compliance 17, no. 1 (January 2020) - Ah, those pesky residents. If you’re a teaching hospital, you can’t live without them, right? But sometimes living with them is mighty costly, as the University of...more

Harris Beach Murtha PLLC

OCR Issues Guidance on the Use of HIPAA Authorizations for Research

This week, the Department of Health and Human Services Office for Civil Rights (OCR) issued guidance on the use of HIPAA-compliant authorizations for research based on a mandate in the Cures Act for such guidance. The...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

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

BakerHostetler

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

BakerHostetler on

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

McDermott Will & Emery

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

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