The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more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Draft Guidance ,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
More than two months after the February 2024 Change Healthcare cyber-ransom attack, the healthcare industry continues to grapple with the fallout, creating significant challenges, disruptions, and outages to the healthcare...more
5/6/2024
/ American Hospital Association ,
Compliance ,
Cyber Attacks ,
Cybersecurity Information Sharing Act (CISA) ,
Data Breach ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
NIST ,
Personal Information ,
PHI ,
Policies and Procedures ,
Popular ,
Risk Management ,
Security and Privacy Controls ,
Sensitive Personal Information ,
United Health Group
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
Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more
7/13/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Compensation Consultant ,
Compliance ,
Consultants ,
Healthcare ,
Life Sciences ,
OIG ,
Physicians ,
Safe Harbors ,
Service Advisors ,
Sunshine Act