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Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more

Artificial Intelligence Briefing: Trump 2.0 Executive Orders Revoke, Overhaul Biden Administration’s Approach

The AI landscape saw developments coming in at a breakneck pace throughout January 2025. We’re diving into the latest executive orders from the new White House administration, proposed HIPAA security rule revisions addressing...more

Proposed HIPAA Security Rule Updates — Implications for Covered Entities and Their Information Security Programs

On January 6, 2025, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking (Proposed Rule) updating the Health Insurance Portability and...more

Strategies for Success With Allermi

Allermi, a San Francisco-based telehealth company, is redefining personalized allergy care by offering compounded nasal spray products that combine multiple active ingredients at varying dosages and combinations into a single...more

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