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McGuireWoods LLP

HHS Proposes Updates to 20-Year-Old Public Health Service Policies on Research Misconduct

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The U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) released a notice of proposed rulemaking to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. HHS seeks...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

K&L Gates LLP

K&L Gates Triage: ONC Signals Federal Health IT Priorities with 2020-2025 Strategic Plan

K&L Gates LLP on

In this week’s episode, Ryan Severson discusses the Federal Health IT Strategic Plan, which was recently released by the Office of the National Coordinator for Health Information Technology (“ONC”). Mr. Severson discusses...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Foley & Lardner LLP

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

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Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....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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