Linda Malek

Key Developments In AI And Digital Health Signal Growing Federal Activity (Q1 2025)

Ready To Know Your Data? DOJ Issues Implementation And Enforcement Guidance For Data Security Program Protecting Bulk Sensitive Data

HHS Announces "Dramatic Restructuring"

HHS Suggests It Will Provide Less Notice And Opportunity For Comment On Grant And Contract Rules

FDA Clarifies Enforcement Policy Around Communications Of Scientific Information On Unapproved Uses Of Drugs And Medical Devices

FDA Proposes Framework To Assess AI Model Output Credibility To Support Regulatory Decision-Making

After Trump Executive Orders, FDA Removes Diversity Guidance From Website

New Draft Guidance From FDA Explains When An Accelerated Approval Trial Is "Underway"

Proposed Rule On Protecting Bulk Sensitive Data And Its Impact On Health Care

AI's Cybersecurity Risks: New York Provides Guidance On Developing Cybersecurity Programs To Address Emerging AI Concerns