On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
On July 1, 2024, the amendments to the Health Breach Notification Rule (HBNR) went into effect. First promulgated in 2009, the HBNR applies to vendors of personal health records — entities that are not covered by the Health...more
7/3/2024
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
PHI ,
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