Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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Articles and Reports
In (Digital) Defense of HIPAA
How clinical laboratories and pathology groups can ensure that their digital pathology and AI workflows are HIPAA-compliant
Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
Special Report: The Lab Kickback Risks of “Freebies”
How to avoid six common compliance risks involving free supplies, equipment, software, and other non-monetary compensation
Special Report: Will the COVID-19 Recovery Be Bumpier than Expected?
Though IVD and commercial lab Q3 2023 earnings reports held promising signs, Q4 2024 and FY2023 results tell a different story.
Special Report: 5 Lab Kickback Risks Involving Incentives
Strategies to avoid compliance issues related to registries, space rentals, and other common incentives.
Special Report: How to Avoid Problematic Lab Business Arrangements
When structuring business arrangements, addressing six key risk areas can help laboratories avoid major compliance issues.
Inside the Lab Industry: Q3 Earnings Signal Beginning of the End of ‘COVID-19 Hangover’
What 2023 Q3 earnings from 30 key US lab companies indicate about the current state of the industry and outlook for 2024.
Special Report: The OSHA Inspection Process and How to Survive It
The basics of how the OSHA inspection process works and how laboratories can successfully navigate it.
