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 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
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
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
Key Points
- FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices.
- FDA plans to pilot Real-World Performance...more
If you read one thing...
- FDA released Draft Guidance outlining steps for medical device manufacturers to ensure cybersecurity of medical devices already on the market; comments are due by April 21, 2016.
-...more