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
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
U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences. Universities often out-license patents protecting inventions created using federal...more
One of 2023’s more significant — and potentially disruptive — developments in business and culture was the arrival of a slew of generative artificial intelligence (AI) systems. At the beginning of 2023, ChatGPT quickly...more
Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more
On January 4, the USPTO announced the appointment of new leaders for the agency’s policy and communications teams. Sharon Israel will serve as the Chief Policy Officer and Director for International Affairs, and Jack...more
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...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
I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more
The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to “information and statements material to patentability … received from or submitted to the...more
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more
On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of declaration” conferring broad-based immunity from tort (including product liability) litigation for...more
Last month, the United States government, acting on behalf of its Department of Health and Human Services (HHS), filed suit in Delaware against Gilead Sciences, Inc. and Gilead Sciences Ireland UC for infringing four patents...more
In a landmark decision on June 3, 2019, the Supreme Court held that the Department of Health and Human Services (HHS) was required to engage in notice and comment rulemaking before publishing methodology (Medicare Fractions)...more
A bill introduced in the House last July by Rep. Lloyd Doggett (D-TX) (at right), which could adversely impact pharmaceutical manufacturers holding drug patents, is starting to draw the attention of those outside the patent...more
Highlights this week include a lame duck update on year-end health bills and tax provisions; lawmakers reacting to a federal judge ruling the Affordable Care Act is unconstitutional; Sen. Hatch seeks to update Hatch-Waxman;...more
Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
On December 12, 2016, the Office of the U.S. Intellectual Property Enforcement Coordinator (IPEC) in the Executive Office of the President issued a much-awaited interagency plan on intellectual property (IP) enforcement. The...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. UCB Inc. et al. v. Watson Laboratories Inc. (NV) et al. 1:14-cv-01083; filed August 21, 2014 in the District Court of...more
In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care News ...more
In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the “Mega-Reg” ...more