White House Releases America’s AI Action Plan On July 23, 2025, the White House released America’s AI Action Plan. The plan, initiated by President Donald J. Trump's Executive Order 14179, "Removing Barriers to American...more
Welcome to the June edition of Akin Intelligence. To ensure continued receipt, please subscribe to future issues here if you have not already done so. For past issues and other AI content, check out Akin’s AI & ML Insights...more
Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
On May 13, 2025, the Commerce Department’s Bureau of Industry and Security (BIS) announced that the Commerce Department initiated a rescission of the Biden Administration’s Framework for Artificial Intelligence Diffusion (“AI...more
6/30/2025
/ Artificial Intelligence ,
Biden Administration ,
Bots ,
Bureau of Industry and Security (BIS) ,
Collective Actions ,
Deep Fake ,
Department of Defense (DOD) ,
Enforcement Actions ,
Export Administration Regulations (EAR) ,
Export Controls ,
Free Speech ,
Government Agencies ,
New Guidance ,
New Regulations ,
Regulatory Reform ,
Secretary of Commerce ,
Semiconductors ,
Technology Sector ,
Training ,
U.S. Commerce Department
On May 19, 2025, President Trump signed the bipartisan TAKE IT DOWN Act into law. The Act criminalizes the publication of nonconsensual intimate visual depictions of individuals, including AI-generated deepfakes. Threats to...more
Welcome to the November-December edition of Akin Intelligence. As the end of 2024 approached, the European Union (EU) sustained progress on guidance and supporting materials for its AI Act and international AI Safety...more
2/3/2025
/ Artificial Intelligence ,
Bureau of Industry and Security (BIS) ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
Clinical Trials ,
Compliance ,
Department of Homeland Security (DHS) ,
Enforcement Actions ,
EU ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
GAO ,
New Rules ,
NIST ,
Regulatory Agenda ,
Semiconductors ,
Technology Sector
Welcome to the Akin Intelligence September-October recap. Around the one-year anniversary of the AI Executive Order, the White House announced that agencies had carried out their directives. Members of Congress introduced a...more
12/16/2024
/ Artificial Intelligence ,
Bureau of Industry and Security (BIS) ,
China ,
COPPA ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
EU ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Interim Final Rules (IFR) ,
National Security ,
NIST ,
Notice of Proposed Rulemaking (NOPR) ,
Semiconductors ,
UK
Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of...more
Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...more
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more
FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety...more
On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here. FDA intends the glossary to be...more
Welcome to the July edition of Akin Intelligence. This month, United States agencies released several key pieces of artificial intelligence (AI) guidance, including patent eligibility guidance from the United States Patent...more
9/3/2024
/ Artificial Intelligence ,
Bias ,
Deceptive Intent ,
Department of Energy (DOE) ,
Department of Homeland Security (DHS) ,
Department of Justice (DOJ) ,
Equal Employment Opportunity Commission (EEOC) ,
EU ,
FCC ,
Federal Trade Commission (FTC) ,
General Services Administration (GSA) ,
HUD ,
Machine Learning ,
NTIA ,
Patent-Eligible Subject Matter ,
Proposed Rules ,
Regulatory Agenda ,
USPTO
Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more
7/15/2024
/ Artificial Intelligence ,
Clinical Trials ,
Consumer Financial Protection Bureau (CFPB) ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Department of Defense (DOD) ,
EU ,
FCC ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
General Services Administration (GSA) ,
Healthcare ,
Innovation ,
Machine Learning ,
Medicare ,
NIST ,
OSTP ,
Political Advertising ,
Transparency
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
1/5/2024
/ AHRQ ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Transparency
Key Points -
President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
11/13/2023
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
Joe Biden ,
Life Sciences ,
Machine Learning ,
ONC ,
Popular
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
Issued by the White House Office of Science and Technology Policy (OSTP) on October 4, 2022, the “Blueprint for an AI Bill of Rights” is the Biden-Harris administration’s seminal work on its vision for the future of...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation -
Key Points -
The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML).
• The white paper distinguishes three...more