News & Analysis as of

Department of Health and Human Services (HHS) Innovation

Manatt, Phelps & Phillips, LLP

[Webinar] Family Caregivers as a Healthcare Workforce: Innovations and Investment Across Policy and Business - June 5th, 1:00 pm -...

One-fifth of the U.S. workforce is comprised of family caregivers, whose unpaid contributions include nearly 24 hours of care per week, on average, and amount to nearly $600 billion. As populations age across the globe and in...more

King & Spalding

The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights

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The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more

Benesch

President Biden’s Executive Order on Artificial Intelligence Provides Important Initial Guidelines in Governmental Regulation for...

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With growing concerns related to how artificial intelligence is developed, regulated, and implemented in the United States, this Executive Order represents possibly the first of several governmental actions to address this...more

Baker Donelson

President Biden's AI Executive Order: What Private Sector Organizations Need to Consider

Baker Donelson on

On October 30, 2023, President Biden signed an Executive Order as a part of the administration's continued efforts to regulate the development and use of artificial intelligence (AI)-based technologies. Although many...more

Foley & Lardner LLP

New Biden EO on AI Oversight, Development, and Use: Implications for the Health Care Industry

Foley & Lardner LLP on

On Monday, October 30, President Biden signed an executive order (EO) aimed at overhauling the governance and oversight of artificial intelligence (AI) and technological infrastructure, including setting standards for AI used...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Rothwell, Figg, Ernst & Manbeck, P.C.

White House AI Order Balances Innovation And Regulation

On Oct. 30, President Joe Biden issued an executive order on safe, secure and trustworthy artificial intelligence. The executive order provides a sprawling list of directives aimed at establishing standards for AI safety...more

Balch & Bingham LLP

Eight Categories Summarizing the Directives of Biden’s Executive Order on Artificial Intelligence

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On October 30, 2023, President Biden issued an “Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence” (“EO”) that issues a multitude of directives across a wide swath of federal agencies and departments,...more

Health Care Compliance Association (HCCA)

Compliance Today - December 2022. Intersection of ESG, health equity, and 501(r) compliance

Compliance Today - December 2022 - We are at a critical moment of change when it comes to truly addressing health inequities in this country. With the intersection of environmental, social, and governance (ESG) reporting and...more

Holland & Knight LLP

Holland & Knight Health Dose: November 15, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more

Goodwin

Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

Goodwin on

​​​​​​​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

MoFo Life Sciences

CURES 2.0: WILL IT BE BETTER THAN THE ORIGINAL?

MoFo Life Sciences on

It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2021

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The pace of impact through digital health in 2021 is off to a rapid start—be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated...more

Proskauer - Health Care Law Brief

Propelled by COVID-19, State Governments Attempt to Keep Up With Telemedicine Innovation and Digital Health Platforms

As is the case with most new technologies or significant industry innovations, companies embracing and driving the disruptions often move very fast in a legal and political landscape that is always playing catch-up. This is...more

Manatt, Phelps & Phillips, LLP

Transforming Primary Healthcare for Women: The Path Forward

Editor’s Note: An array of care gaps and structural barriers inhibits the U.S. primary healthcare system from fully meeting the needs of women across the life course. Recently, new models of technology-enabled primary...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

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

Hogan Lovells

HHS announces public meeting on ways to accelerate clinical innovation

Hogan Lovells on

Government seeks industry comment on expediting medical product development - The U.S. Department of Health and Human Services' (HHS) Immediate Office of the Secretary (IOS) has announced it will hold a public meeting...more

Cooley LLP

Blog: HHS Announces Innovation and Investment Summit

Cooley LLP on

Yesterday, Department of Health and Human Services Deputy Secretary Eric Hargan announced the launch of the Deputy Secretary’s Innovation and Investment Summit (DSIIS). DSIIS follows a June 2018 request for information to...more

Knobbe Martens

The FDA's Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

Knobbe Martens on

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including...more

BakerHostetler

21st Century Cures: Not Just a Biomed Bill

BakerHostetler on

The 21st Century Cures Act signed into law on December 13, 2016 is gaining significant attention as landmark legislation promoting medical innovation. But the massive Cures Act goes much further and includes some relief...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

King & Spalding

Also In The News - Health Headlines - October 2015 #2

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HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

Foley & Lardner LLP

Precision Medicine - Even Medicare Will Pay for It!

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President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

King & Spalding

Also In The News - Health Headlines - February 2015

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House Committee Releases 21st Century Cures Discussion Document – On January 27, 2015, the U.S. House of Representatives Energy and Commerce Committee released a discussion document as part of its 21st Century Cures...more

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