On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
1/13/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Management ,
Data Protection ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Popular ,
Regulatory Requirements ,
Risk Assessment ,
Software
Your Organization’s best defense in an environment of aggressive regulators and litigious plaintiffs’ counsel is the completion of an enterprise risk assessment. Regulators and attorneys general are fining–sometimes hundreds...more
2/8/2019
/ Cybersecurity ,
Data Breach ,
Data Protection ,
Electronic Protected Health Information (ePHI) ,
Enterprise Risks ,
Hackers ,
HIPAA Breach ,
NIST ,
OCR ,
Personally Identifiable Information ,
Popular ,
Risk Assessment ,
Stakeholder Engagement