On May 5, the Trump Administration issued a pair of executive orders that could signal big changes for the drug industry and health research efforts in the United States. The orders, in part, direct federal agencies to take actions by
Latest from Health Industry Washington Watch
Elimination of the Richardson Waiver Means Changes . . . But To What End?
In February 1971, at the tail end of Richard Nixon’s first term, his Secretary of Health, Education and Welfare, Elliot Richardson, approved a directive that was printed in the Federal Register as a Statement of Policy on “Public Participation
Information blocking victory in favor of access to health data
In a significant ruling among the first to analyze the application of information blocking regulations, the U.S. Court of Appeals for the Fourth Circuit affirmed a preliminary injunction against an EHR company in favor of a diagnostic analytics services company.
Reed Smith’s 11th Annual (Virtual) Health Care Conference Coming March 17-21
Reed Smith has announced the dates and topics for it’s 11th annual health care conference from March 17-21, 2024. The conference will be conducted entirely virtually this year with CLE webinars offered throughout the week on important and timely topics
California to Reconsider Restrictions on Private Equity Influence in Medicine and Dentistry
California lawmakers are once again considering legislation targeting private equity’s influence in health care. Senate Bill 351 (SB 351), introduced on February 12, 2025, seeks to limit the influence of management service organizations (MSOs) and dental service organizations (DSOs)
FBA’s Qui Tam Conference reinforces that FCA Enforcement is here to stay
At the Federal Bar Association’s (FBA) Annual Qui Tam Conference on February 20, 2025, Department of Justice (DOJ) representatives Michael Granston (Deputy Assistant Attorney General for Commercial Litigation) and Jamie Yavelberg (Director of the Fraud Section in the Civil Division)
California AG Explains How Laws May Apply to AI in Healthcare
The California Attorney General’s Office (AG) unsurprisingly takes an expansive view of how the development, sale, and use of artificial intelligence technology (AI) in healthcare could lead to potential violations of existing California laws. In a recent legal advisory the
What Does DEA’s Proposed Special Registration Framework for Tele-prescribing Controlled Substances Mean?
On January 17, 2025, the Drug Enforcement Administration (DEA) announced a proposed rule to establish a special registration framework for prescribing controlled substance medications via telemedicine in the post-COVID era (the 2025 Proposed Rule). The DEA had, in
HHS Recent Guidance on AI Use in Health Care
The U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights (“OCR”), recently issued a “Dear Colleague” letter, Ensuring Nondiscrimination Through the Use of Artificial Intelligence (“AI”) and Other Emerging Technologies, which emphasizes the importance
DOJ exceeds $2.9 billion in FCA recoveries in 2024 and reports a record number of qui tams
On January 15, the Department of Justice (DOJ) reported that False Claims Act (FCA) recoveries for civil cases in fiscal year 2024 totaled approximately $2.9 billion, representing about a $200 million increase from 2023. And these numbers do not account