Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
The FTC's Health Privacy Enforcement Actions
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Medical Device Legal News with Sam Bernstein: Episode 17
Podcast - Data Privacy and Tracking Technology Compliance
Podcast - A Conversation on Cannabis: Are Challenges or Changes Coming?
Heed Caution: Takeaways From the OIG's Advance Care Planning Report
2023 Human Resources Outlook Podcast Series: EMEA
Telehealth Risk Report: What the Government Found
UPIC Report Card: The OIG’s Evaluation of the UPICs Provides Insight Into the Future of Hospice Audits
HIPAA Tips With Williams Mullen - Telehealth After the Pandemic
Beyond Hospice: The OIG Renews Its Scrutiny of Home Health Agencies
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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