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The Most Overlooked Risk in AI for Pathology? It’s Not What You Think…

Welcome, my trailblazing digital pathologists! In this episode, I dive headfirst into the regulatory maze of Artificial Intelligence (AI) in pathology, covering global frameworks, safety risks, ethics, and the future of software as a medical device. While regulation might not be the flashiest part of AI, ignoring it could cost us innovation—or worse, patient safety.

We’re on Part 5 of our 7-part AI in Pathology series, and this one’s vital for anyone developing, using, or simply curious about AI and machine learning tools in healthcare.

If you thought regulation was boring, think again—it’s what separates a helpful algorithm from a dangerous black box.

🎧 Listen to the full episode and reference the latest study discussed here: Modern Pathology Journal Article

🔍 Highlights & Timestamps

[00:00:00] Welcome & Why Regulation Matters
Pixelation aside, I introduce today's critical topic—regulatory frameworks that define how AI tools are used, approved, and reimbursed in pathology.

[00:03:00] The Risks AI Brings to Healthcare
We’re not just talking about patient data—think security, ethical biases, economic consequences, and even environmental impact from heavy computation.

[00:05:00] HIPAA, GDPR, and the Common Rule Explained
What protects patient privacy globally? Dive into U.S. and European legislation like HIPAA and GDPR, and how IRBs and the Common Rule ensure ethical compliance in clinical research.

[00:08:00] FDA & Global Agencies Breakdown
Get to know the role of Health Canada, UK’s MHRA, Japan’s PMDA, and others in approving AI tools. Discover how the U.S. FDA sets the gold standard—and why CE Mark devices often hit Europe first.

[00:17:00] What Makes Software a Medical Device (SaMD)?
Four critical questions to ask to determine if your AI tool is considered a regulated device. If the software diagnoses, directs, or lacks transparency—chances are, it’s a device.

[00:22:00] FDA Pathways: Clearance vs. Approval
I break down Class I, II, and III device categories, and what 510(k) clearance means versus pre-market approval (PMA). Yes, we even cover why some tools like Paige AI needed full PMA.

[00:40:00] Why Reimbursement Is the Elephant in the Room
No billing codes, no incentives. I share a personal story about my husband’s five-year reimbursement battle and the challenges of proving economic and clinical value.

[00:45:00] The LDT (Lab Developed Test) Controversy
In 2024, the FDA formally categorized LDTs as medical devices, igniting debate about oversight, innovation, and compliance.

[00:47:00] Generative AI: A New Beast to Regulate
ChatGPT and similar tools pose fresh challenges: reproducibility, explainability, and dynamic outputs. Current frameworks simply can’t keep up—but regulation must.

[00:51:00] USCAP Event Invite & Digital Pathology Collaboration
I’m thrilled to invite you to Muse Microscopy’s USCAP presentation—join live or virtually! Plus, learn how we’re reshaping the digital pathology workflow with direct-to-digital imaging.

🧠 Resource From This Episode

Referenced Study:
📄 Artificial Intelligence in Pathology: Regulatory Challenges & Opportunities
👉 Read the

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