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 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, FluMist, is administered by nasal spray and prevents the flu by using a weakened...more
On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more
Roughly one out of every ten people in the United States are affected by rare diseases. Many of these conditions are life‑threatening, and most lack FDA-approved treatments. Developing therapies for rare diseases, however, is...more
FDA’s Center for Devices and Radiological Health (CDRH) recently announced a pilot program to provide consumers and health care professionals with key information about clinical trials that supported the FDA’s approval of new...more
Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent...more
On October 9, the FDA announced that the agency is providing exemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading...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
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
6/14/2024
/ Artificial Intelligence ,
Bureau of Industry and Security (BIS) ,
CFTC ,
Department of Homeland Security (DHS) ,
Draft Guidance ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Know Your Customers ,
Machine Learning ,
Memorandum of Understanding ,
National Science Foundation ,
NIST ,
OMB ,
Risk Management ,
UK ,
USPTO
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
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
4/25/2024
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
NIST ,
Nursing Homes ,
OIG ,
OIRA ,
OMB ,
Payment Systems ,
PHI ,
Policies and Procedures ,
Prescription Drugs ,
Presidential Elections ,
Proposed Guidance ,
Regulatory Agenda ,
Regulatory Standards ,
Rulemaking Process
Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more
4/10/2024
/ Artificial Intelligence ,
Biden Administration ,
Commercial Litigation ,
Copyright ,
Corporate Governance ,
Cybersecurity ,
Data Privacy ,
Data Security ,
EU ,
Executive Orders ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
National Security ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government ,
Technology Sector ,
UK
2024 is shaping up to be a busy year in Washington for telecom, media and technology (TMT) companies. A number of notable topics will require public comment this year, including net neutrality, digital discrimination, data...more
2/9/2024
/ Artificial Intelligence ,
Broadband ,
Consumer Protection Laws ,
FCC ,
Federal Aviation Administration (FAA) ,
NDAA ,
Outer Space ,
Public Comment ,
Regulatory Requirements ,
Spectrum ,
Technology Sector ,
Telecommunications
Welcome to the January edition of Akin Intelligence. Artificial Intelligence (AI) remains a key area for state and federal legislators in the new year. State executives and legislators continue to propose AI-related...more
1/29/2024
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Biden Administration ,
Cyber Attacks ,
Employment Discrimination ,
Executive Orders ,
FCC ,
Federal Trade Commission (FTC) ,
Machine Learning ,
OMB ,
Request For Information ,
Software Developers ,
Trump Administration
On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more
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
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
Welcome to the November edition of Akin Intelligence. Looking back, October 2023 may be remembered as the month when the U.S. government tried to assume the mantle of global leadership on responsible artificial intelligence...more
11/22/2023
/ Artificial Intelligence ,
Biden Administration ,
Bitcoin ,
China ,
Copyright ,
Deep Fake ,
Department of Defense (DOD) ,
Digital Health ,
Disclosure Requirements ,
Energy Sector ,
Executive Orders ,
Export Controls ,
Federal Trade Commission (FTC) ,
Infrastructure ,
Innovation ,
Know Your Customers ,
Medicare ,
Medicare Fraud ,
NIST ,
Notice of Inquiry ,
Proposed Legislation ,
Reporting Requirements ,
Semiconductors ,
U.S. Commerce Department
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
Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more
Welcome to the October edition of Akin Intelligence. We continue to see bipartisan and international interest in artificial intelligence (AI) regulation. In the executive branch, agencies are working towards developing...more
10/19/2023
/ Artificial Intelligence ,
Biden Administration ,
Copyright ,
Copyright Office ,
Cybersecurity ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare ,
Intellectual Property Protection ,
ISOs ,
Machine Learning ,
National Security ,
National Security Agency (NSA) ,
New Regulations ,
NIST ,
OMB ,
SAG ,
Screenwriters ,
Shareholders ,
USPTO ,
Writers
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more