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Faegre Drinker Biddle & Reath LLP

NIH Funding Guidance; FDA Reinstates Key Staff Amid Industry Pressure; Make America Healthy Again Commission; and the Latest on...

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

Ice Miller

FDA Final Rule for “Healthy” Nutrient Content Claims Effective Date Looms but Rule’s Future Is Uncertain

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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

Latham & Watkins LLP

President Trump Issues Executive Order to Advance “Large-Scale” Reductions in Federal Workforce

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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

Cozen O'Connor

COVID Vaccine No Longer Required for Adjustment of Status Applicants

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On January 22, 2025, USCIS posted an alert pertaining to the I-693 immigration medical exam required for most individuals applying to become lawful permanent residents. USCIS indicates that they now “waive[s] any and all...more

BakerHostetler

What a Second Trump Administration Could Mean for Tobacco Industry Regulations

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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

Chambliss, Bahner & Stophel, P.C.

OCR Finalizes Post-Dobbs HIPAA Regulatory Changes Impacting Health Care Organizations

On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...more

Seyfarth Shaw LLP

FTC and DOJ Seek Public Help Identifying “Serial Acquisition Strategy” Targets

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The Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) announced on Thursday, May 23, that they are expanding their search for businesses using “roll up” strategies to consolidate...more

King & Spalding

FDA Publishes White Paper on Artificial Intelligence & Medical Products

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On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more

Jones Day

HHS Releases Cybersecurity Performance Goals to Enhance Cybersecurity for Health Care and Public Health Sectors

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The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more

Alston & Bird

HHS Issues Cybersecurity Performance Goals Specific to the Health Care and Public Health Sector

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Our Health Care and Privacy, Cyber & Data Strategy Groups delve into the Department of Health and Human Services’ extensive efforts to encourage health care organizations to better protect patients’ privacy through better...more

Jones Day

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

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The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

Goodwin

Cybersecurity Toolkit for Healthcare and Public Health Sector

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On November 1, 2023, the Cybersecurity and Infrastructure Security Agency (“CISA”) and the Department of Health and Human Services (“HHS”) co-hosted a roundtable discussion on the cybersecurity challenges that the US...more

Vinson & Elkins LLP

White House Issues First-of-its-Kind Executive Order on AI

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On October 30, 2023, President Biden issued an Executive Order (“Order”) that drastically increased the U.S. government’s engagement with artificial intelligence (“AI”). The sweeping Order touches on everything from bias in...more

Alston & Bird

Health Care Week in Review: President’s Budget and ASPR Cybersecurity Guide

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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

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 22, Number 9. Privacy Briefs: September 2022

Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 21

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Outlook for This Week in the Nation’s Capital Congress. The House and Senate are in recess this week. Sen. Chris Murphy (D-CT) is trying to find a bipartisan deal on gun control ahead of the planned vote on the issue after...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

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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

Troutman Pepper Locke

HHS Provides Liability Immunity for Coronavirus Countermeasures

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Makers, distributors, program planners and administering entities of coronavirus (COVID-19) countermeasures are protected from liability under a declaration issued by the Department of Health and Human Services (HHS)...more

Farrell Fritz, P.C.

Healthcare Bills Passed in the 2018 Legislative Session

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The scheduled 2018 New York State Legislative Session concluded last week amid many of the same speculations and controversies that have characterized all of the Legislature’s activities in recent years. ...more

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