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information blocking
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
Final Rule on AI Transparency Can Benefit Clinical Labs
ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING are becoming ubiquitous in today’s modern hospital systems and clinical laboratories. In response to these developments, federal officials issued a new rule that has major implications on how healthcare providers use artificial intelligence. T…
HHS Publishes Final Rule for Health IT Interoperability
THERE IS A NEW FEDERAL RULE intended to improve interoperability and portability of patient information. This rule could be a significant benefit for clinical laboratories and anatomic pathology groups. In December, the US Department of Health and Human Services (HHS) Offi…
CURRENT ISSUE
Volume XXXII, Number 16 – November 17, 2025
The Dark Report offers insights into innovative ways to engage employees, streamline workflows, and build talent pipelines. Standard Health Care’s Jennifer Fralick outlines strategies to retain talent and improve efficiency. Also, The Dark Report provides a review of NYU Langone Health’s Digital Pathology Implementation, and the Pathology director explains why smaller labs should consider DP.
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