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
As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more
A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more
The biotech mergers and acquisitions market faces significant headwinds in the first half of 2025. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug Administration (FDA) and...more
On March 14, 2025, President Trump rescinded a number of Biden-era executive orders (EOs), two of which are health related. Executive Order 13994 (2021): The Ensuring a Data Driven Response to COVID-19 and Future...more
The outcome of the 2024 U.S. election had far-reaching implications for the global investment landscape, especially in the dynamic field of venture capital and early-stage investing. Speaking at the J.P. Morgan Healthcare...more
News Briefs - HHS Offers 75,000 Pages in Defense of Nursing Home Staffing Mandate - The Department of Health and Human Services filed more than 75,000 pages of rule-making records with a federal court, beginning its formal...more
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects...more
In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in...more
On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more
President Biden has revealed the next areas of focus in his effort to protect the United States’ technological leadership and economic competitiveness: biotechnology, biomanufacturing, and the bioeconomy....more
Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are both in session this week. Senate Majority Leader Chuck Schumer (D-NY) filed cloture last week on the Kigali amendment to the Montreal...more
In the latest of a series of Presidential actions intended to promote biotechnology and confirm the continued support of advances in biotechnology as official policy of the United States, on September 12, 2022, President Joe...more
Ensuring a responsive CFIUS in an evolving national security landscape - On September 15, 2022, President Biden signed an Executive Order on Ensuring Robust Consideration of Evolving National Security Risks by the...more
On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more
The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.The treatment costs for patients...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
The Situation: The Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") released an advisory opinion providing new insight into the evaluation of fraud and abuse risks of per-click fee...more
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more
On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more
Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more