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
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
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
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
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!
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 December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more
Key Points -
U.S. hospitals, health systems, suppliers, pharmaceutical companies and other industry stakeholders are invited to submit voluntary pledges to reduce greenhouse gas emissions and increase their climate...more
Background on Cures 2.0 -
The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more