News & Analysis as of

Department of Health and Human Services (HHS) Research and Development

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

Mintz - Antitrust Viewpoints

Federal Agencies Take Sweeping Action on AI in Accordance with AI EO — AI: The Washington Report (Part 2 of 2)

President Joe Biden’s October 2023 Executive Order on AI directed agencies to institute a significant number of actions on AI. On April 29, 2024, the White House announced that federal agencies had completed “all of the...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Health Care Compliance Association (HCCA)

OHRP FY 25 Budget Request Lacks Prior Plea For Funding, Staff Increases; Plans Are Modest

In December 2022, Julie Kaneshiro—then deputy director of the HHS Office for Human Research Protections (OHRP)—disclosed that the agency had 32 positions but that only 20 were filled, leaving 12 vacant or “on hold,” due to...more

Gardner Law

FDA's View on Cannabis

Gardner Law on

The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving...more

Mintz - Antitrust Viewpoints

AI Provisions in Biden’s FY 2025 Budget Proposal — AI: The Washington Report

President Joe Biden’s fiscal year (FY) 2025 budget proposal includes hundreds of millions of dollars allocated towards executive branch AI efforts. The budget proposal’s AI-related provisions can be sorted into three...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Robinson+Cole Data Privacy + Security Insider

HHS Addresses the Growing Influence of Artificial Intelligence in Health Care

Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform­ its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions,...more

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more

Mintz - ML Strategies

ML Strategies Outlook for 2024

Mintz - ML Strategies on

Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

Perkins Coie on

The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

King & Spalding

The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights

King & Spalding on

The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more

Axinn, Veltrop & Harkrider LLP

HHS to Go a March-In'

Following years of discussion and pressure being applied by certain policymakers (including Senate HELP Committee Chair Bernie Sanders), the Biden Administration announced that a framework is being put forward by HHS and the...more

Foley & Lardner LLP

ORI Proposes New Rulemaking for Research Misconduct Regulations

Foley & Lardner LLP on

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: October 2023

Report on Research Compliance Volume 20, no. 10 (October, 2023) The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its...more

Troutman Pepper

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

Troutman Pepper on

It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

Pillsbury Winthrop Shaw Pittman LLP

White House Announces Plan to Boost AI Research and Deployment

On May 23, the White House revealed three new steps advancing the research, development and deployment of AI technology nationwide. The Biden Administration has updated the National Artificial Intelligence R&D Plan for...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: June 2023

After reviewing recommendations from its Office of Inspector General (OIG), the National Science Foundation (NSF) required Yale University to repay $172,213 of the $251,973 auditors flagged in a 2020 report. According to a...more

Health Care Compliance Association (HCCA)

After GAO Report, OHRP Asks SACHRP to Tackle Elusive Goal: Define, Measure IRB Effectiveness

After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more

Fenwick & West LLP

Federal Agencies Continue Investment in Private Sector Research and Development

Fenwick & West LLP on

In December 2022, the U.S. Government Accountability Office (GAO) reported on federal research and development (R&D) spending focused on emerging technologies to further economic growth and national security. The U.S. federal...more

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