The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The Health Resources and Services Administration (HRSA) has issued two Teaching Health Center Graduate Medical Education (THCGME) notices of funding opportunities for the academic year (AY) 2024-2025 and AY 2025-2026. These...more
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
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
On October 5, 2023, the U.S. Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) issued a Notice of Proposed...more
The purpose of Public Health Service (PHS) regulations regarding scientific research misconduct—and, by extension, related institutional policies and procedures—is to protect the public’s health and safety, promote research...more
This week, the Court addresses the standard of causation for a “stigma-plus” due process claim under Section 1983 and the scope of the immunity granted to entities deemed Public Health Service employees....more
Establish firm footing in the world of government contracting with this advanced course of study in Big Four pharmaceutical purchasing. ACI’s Big Four Pharmaceutical Pricing Boot Camp will introduce and reinforce core...more
The American Conference Institute is hosting the 21st Annual Rx Drug Pricing Boot Camp in New York. With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when...more
On March 15, 2023, the Chicago City Council overwhelmingly voted to approve an ordinance requiring labor peace agreements between workers and Chicago-funded nonprofit organizations providing critical public health and social...more
On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas) for marketing...more
Let’s say your organization decides to pursue a new charitable venture in New York and takes the initial step of creating a not-for-profit corporation in the state. Your organization contributes assets and the new corporation...more
The explosion of telemedicine and telehealth, or virtual patient care and monitoring, presents many opportunities for enhanced, more streamlined care. But it also threatens to outpace laws regarding the delivery of care, as...more
Report on Research Compliance 18, no. 5 (May 2021) - For the first time since 2012, the HHS Office of Research Integrity (ORI) issued an annual report, but for those used to previous updates or looking for useful details,...more
On October 28, 2020, CMS released an interim final rule with comment period (IFC) that implements several CARES Act requirements to prepare for the availability of a COVID-19 vaccine. Among other changes, the IFC establishes...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
On September 17, 2020, California Governor Gavin Newsom signed into law AB 685, effective January 1, 2021 through January 1, 2023. The law authorizes the Division of Occupational Safety and Health of California (Cal/OSHA) to...more
The Centers for Disease Control and Prevention has issued an order titled “Temporary Halt in Residential Evictions To Prevent the Further Spread of COVID-19” (“Order”) forbidding evictions of residential tenants who do not...more
On August 11, the Center for Medicare & Medicaid Services ("CMS") announced the creation of its new Community Health Access and Rural Transformation (“CHART”) Model. The CHART Model seeks to provide new seed funding and...more
The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more
Organ procurement organizations (OPOs) and transplant centers should take note: as expected, and as outlined in our recent organ procurement and transplant alert, the U.S. Department of Health and Human Services (HHS)...more