Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
2/13/2025
/ Artificial Intelligence ,
Chevron Deference ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Investment ,
Investors ,
Legislative Agendas ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Machine Learning ,
Medical Devices ,
Medicare Advantage ,
Popular ,
Prescription Drugs ,
Private Equity ,
Regulatory Agenda ,
Regulatory Reform ,
SCOTUS ,
Technology Sector ,
Trump Administration
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 January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...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
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
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
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
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
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
Welcome to the September edition of Akin Intelligence. As the U.S. Congress reconvenes after the August recess, we continue to see bipartisan interest in artificial intelligence (AI) regulation. In the executive branch,...more
9/18/2023
/ Age Discrimination ,
Artificial Intelligence ,
Biden Administration ,
China ,
Class Action ,
Consumer Financial Protection Bureau (CFPB) ,
Copyright ,
Copyright Office ,
Cybersecurity ,
Deep Fake ,
Department of Defense (DOD) ,
EU ,
Executive Orders ,
Fair Credit Reporting Act (FCRA) ,
Federal Election Commission (FEC) ,
Foreign Investment ,
Healthcare ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Jurisdiction ,
NDAA ,
Outbound Transactions ,
Preliminary Injunctions ,
Rulemaking Process ,
Securities and Exchange Commission (SEC) ,
Thought Leadership ,
UK ,
USPTO
Welcome back to Akin Intelligence: Hot AI Summer Edition! This month’s newsletter reflects the ongoing and increasing global activity around artificial intelligence (AI), including more proposed AI legislation and court...more
8/15/2023
/ Artificial Intelligence ,
Consumer Protection Laws ,
Cybersecurity ,
Federal Trade Commission (FTC) ,
Innovative Technology ,
Legislative Agendas ,
Machine Learning ,
NIST ,
Proposed Legislation ,
Regulatory Agenda ,
Working Groups
Welcome to the July edition of Akin Intelligence. In this month’s AI news, the U.S. Senate receives member-only briefings on AI, U.S. states continue to debate and legislate on AI issues, the U.S. prepares new AI-related...more
Welcome back to Akin Intelligence!
May featured major congressional hearings and state action in the United States, calls from industry and lawmakers for artificial intelligence (AI) regulation, and significant...more
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...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