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
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
On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment. As previously discussed here, FDA...more
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 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
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
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 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
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
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
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
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more
Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...more
In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...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
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions.
• The revised draft guidance on CDS further elaborates on how to make CDS...more
10/8/2019
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Devices ,
Medical Software ,
Patients ,
Popular ,
Public Comment ,
Regulatory Requirements ,
Software Developers