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
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
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
• The Centers for Medicare and Medicaid Services (CMS) have issued a long-awaited proposal to reform the Physician Self-Referral Law’s (Stark Law’s) regulatory exceptions and to provide updated guidance for physicians and...more
10/18/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
EHR ,
Fair Market Value ,
Health Care Providers ,
OIG ,
Physicians ,
Popular ,
Proposed Rules ,
Public Comment ,
Safe Harbors ,
Stark Law ,
Value-Based Care
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- FDA released Draft Guidance outlining steps for medical device manufacturers to ensure cybersecurity of medical devices already on the market; comments are due by April 21, 2016.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