Insights
Blog
Thoughts on AI, quality, and the humans caught between the two — from the stage, the whiteboard, and occasionally over espresso.
Guardians of the Record: What Happens When AI Enters the Archive
Fabrizio Maniglio · April 10, 2026
Between 60 and 73 percent of enterprise data goes entirely unused. In pharma, it's worse. The archive was supposed to be the institutional memory. AI is both the most promising fix and the most dangerous accelerant of that brokenness.
Read article →
AI Helped Me Face My Own Chaos
March 31, 2026
My Gmail inbox had thousands of unread emails. Not hundreds. Thousands. AI didn't replace me. It helped me face something I'd been avoiding for years.
Your AI Vendor's Data Problem Is Your Compliance Problem
February 27, 2026
The AI industry's IP mess will get sorted out by lawyers and settlements. But the data that matters isn't what went into building Claude or GPT. It's yours. And once it's out, no settlement will make you whole.
The Moral Imperative of AI Adoption
November 15, 2025
The industry frames AI adoption as a risk question: 'Is AI safe enough?' But the real question is the uncomfortable inverse: 'Is NOT using AI safe enough, given what we now know it can do?'
Regulators Are Moving Faster Than Industry
October 1, 2025
For the first time, regulations are being written for things that don't exist yet. With Annex 22, the historical pattern has reversed: regulators are out ahead of industry, and the consequences are more complex than anyone expected.
Shadow AI Is Already Here
May 8, 2025
Shadow AI, the unsanctioned use of generative tools like ChatGPT, Claude, or Copilot, is already reshaping how regulated industries work. This article explores why ungoverned AI adoption poses deep risks to compliance, data integrity, and patient safety, and how organizations can replace fear with transparency.
Newsletter
HealthTech Synapse
Insights on AI, quality, and digital transformation in life sciences. Delivered to 1,000+ subscribers who care about making healthcare better.