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Department of Health and Human Services (HHS) National Institute of Standards and Technology

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to the IRA and Other Drug Pricing Initiatives: Impact on Life Sciences Investments

The Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022, and includes key sections addressing climate and clean energy, corporate taxes and health care. The health care provisions...more

Latham & Watkins LLP

US AI Standards Take Shape: Key 180-Day Developments Following White House AI Executive Order

Latham & Watkins LLP on

Companies should consider how new AI risk standards may align to their operations and whether to comment on the draft standards to shape their development. On April 29, 2024, the White House announced that several federal...more

Mintz - Antitrust Viewpoints

Federal Agencies Take Sweeping Action on AI in Accordance with AI EO — AI: The Washington Report (Part 2 of 2)

President Joe Biden’s October 2023 Executive Order on AI directed agencies to institute a significant number of actions on AI. On April 29, 2024, the White House announced that federal agencies had completed “all of the...more

Faegre Drinker Biddle & Reath LLP

Race Against the Clock: Federal Agencies Issue Their Six-Month Updates on AI Activities in Accordance With President Biden’s...

Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Clark Hill PLC

Right To Know - April 2024, Vol. 16

Clark Hill PLC on

Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more

Robinson+Cole Health Law Diagnosis

Forecasting the Integration of AI into Health Care Compliance Programs

Health care entities maintain compliance programs in order to comply with the myriad changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial...more

Mintz - Health Care Viewpoints

HHS Health Care Cybersecurity Performance Goals: Proposed Incentives, Penalties and Compliance Standards

As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and...more

Mintz - Antitrust Viewpoints

AI Provisions in Biden’s FY 2025 Budget Proposal — AI: The Washington Report

President Joe Biden’s fiscal year (FY) 2025 budget proposal includes hundreds of millions of dollars allocated towards executive branch AI efforts. The budget proposal’s AI-related provisions can be sorted into three...more

Clark Hill PLC

Right To Know - March 2024, Vol. 15

Clark Hill PLC on

Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more

Epstein Becker & Green

2024 Update: Regulators Use “Carrots and Sticks” to Incentivize Healthcare Sector Cybersecurity Compliance

Epstein Becker & Green on

Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Regulators Unveil Revised Final Guidance for Healthcare Cybersecurity and HIPAA Compliance

On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

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

Saul Ewing LLP

New Cybersecurity Guide Released

Saul Ewing LLP on

On February 16, 2024, the HHS Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a final version of the cybersecurity resource guide (the “Guide”) with respect to the HIPAA...more

Baker Donelson

HIPAA Updates: The Obligations Continue to Unfold

Baker Donelson on

There has been a notable emphasis on proactive enforcement of the privacy and security of protected health information in recent weeks as evidenced by multiple developments regarding compliance with the Health Insurance...more

BakerHostetler

HHS Publishes ‘Voluntary’ Healthcare Cybersecurity Performance Goals in Record Time but Leaves Questions Unanswered

BakerHostetler on

As previously reported in this blog, on Dec. 6, 2023, the Department of Health and Human Services (HHS or the Department) released a “concept paper,” which laid out its vision of future action regarding healthcare...more

Moore & Van Allen PLLC

The AI Executive Order: What’s Happened and What’s Coming Up… 

Last week, the White House issued an update on President Biden’s October 30, 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (the “AI EO” or “EO”). The update detailed...more

Alston & Bird

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

Alston & Bird on

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

McDermott Will & Emery

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

McDermott Will & Emery on

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

WilmerHale

PTAB/USPTO Update - January 2024

WilmerHale on

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

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

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

King & Spalding

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

King & Spalding on

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

McDermott+

McDermottPlus Check-Up: December 8, 2023

McDermott+ on

Senate Finance Committee Examines Drug Shortages. The hearing addressed concerns and explored potential solutions related to drug shortages in the United States, particularly focusing on essential medications. The hearing...more

Akin Gump Strauss Hauer & Feld LLP

Timeline: Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence

On October 30, 2023, the Biden administration issued its long-awaited artificial intelligence (AI) executive order (EO), which issues directives to over 20 federal agencies, with the deadline for implementation spanning...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on

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

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