With the surge of artificial intelligence (AI) development in recent years, state legislatures, including California's, have contemplated how to balance patient safety and quality of care with the need for and expectation of...more
10/11/2024
/ Artificial Intelligence ,
Consumer Protection Laws ,
Electronic Communications ,
Governor Newsom ,
Governor Vetoes ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Machine Learning ,
New Legislation ,
Patient Privacy Rights ,
Physicians ,
Regulatory Oversight ,
Standard of Review
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
9/17/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Enforcement Priorities ,
Final Rules ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Genetic Testing ,
Inspections ,
Laboratory Developed Tests ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Social Security Act ,
Warning Letters ,
Work Plans