Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
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
Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...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
At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more
It remains unclear the extent to which the order will impact agencies like FDA. On February 11, 2025, as part of an ongoing effort to reduce the size of the federal workforce, President Trump issued an executive order titled...more
Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more
New Trump Administration tariffs on Canada, Mexico, and China. On February 1, 2025, President Donald Trump signed three Executive Orders instituting sweeping new tariffs on all goods imported from Canada, Mexico, and China,...more
As the tobacco industry anticipates a second Trump administration, it’s banking on what some public health experts describe as his unpredictable approach to regulation. Trump’s history of abrupt policy shifts makes tobacco...more
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift...more
Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more
News Briefs - HHS Drops Appeal of Court's Ruling in Hospital Web Tracking Case - The Department of Health and Human Services is dropping its appeal of a June U.S. District Court ruling that vacated the government's...more
This Week in Washington: HHS announces reorganization of health technology offices; House recesses early because of an inability to pass appropriations bills; Senate Finance Committee chairman introduces legislation to...more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more
This Week in Washington: House Energy and Commerce Committee marks up 13 healthcare bills; House Energy and Commerce Committee Subcommittee on Health holds hearing on CMMI; CMS announces it will recalculate MA Star Ratings....more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more
Earlier this week, the Department of Justice proposed reclassifying cannabis from Schedule I to Schedule III under the Controlled Substances Act. The move follows an August 2023 recommendation from the Department of Health...more
The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more
This Week in Washington: CMS releases SNF minimum staffing standards final rule; Senate HELP Committee chairman requests information on Ozempic and Wegovy pricing; HHS OCR releases final rule concerning HIPAA reproductive...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