The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
1/15/2025
/ Artificial Intelligence ,
Comment Period ,
Compliance ,
Data Management ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
On September 28, California Gov. Gavin Newsom signed Senate Bill 1120 Health Care Coverage: Utilization Review into law, amending § 1367.01 of the Health and Safety Code and § 10123.135 of the state’s Insurance Code....more
11/8/2024
/ Amended Legislation ,
Artificial Intelligence ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Duty of Oversight ,
Employer Group Health Plans ,
Governor Newsom ,
Health and Safety ,
Health Insurance ,
Insurance Code ,
Medicare Advantage Organizations (MAOs) ,
New Legislation ,
Penalties ,
Qualified Health Plans
What is the new Washington My Health My Data Act (MHMDA)?
MHMDA aims to provide stronger privacy protections for “consumer health data” by:
- Requiring additional disclosures for the collection, use, and sharing of...more