RubinReflects™

Why the Future of AI in Medicine Depends on a New Accountability Contract

by Rubin Pillay

AI in healthcare is scaling faster than policy, literacy, culture, and law can keep up. Europe’s newest WHO report highlights glaring gaps in accountability—but the United States, despite being the global epicenter of AI innovation, is equally unprepared for what happens when an algorithm misdiagnoses, mis-suggests, or misleads.

We’ve built the rocket.
We’ve fueled the rocket.
We’ve strapped patients into the rocket.
But no one has agreed on who is liable if the rocket misfires.

🇪🇺 Europe Isn’t Ready… and Neither Is the U.S.

The WHO Europe findings are staggering:

Only 4 countries have any liability standards for AI in healthcare.
Meanwhile, 66% already use AI in diagnostics, and 50% use AI chatbots.

Europe’s gap is obvious.
But the U.S. gap is more subtle—and arguably more dangerous.

Because the U.S. is deploying AI at scale without a unified national framework.

What we have is:

A rapidly evolving FDA regulatory posture
A patchwork of state malpractice doctrines
Ambiguous case law
A risk-averse clinical culture
A booming healthcare-AI startup ecosystem
And no consensus on who carries liability when things fall apart

The “responsibility gap” the WHO warns about?
In the U.S., it’s not a gap—it’s a canyon.

⚖️ The U.S. Problem: Regulation by Ambiguity

In the United States, AI liability can fall into any of the following buckets, depending on the judge, the state, the software, the hospital, and the day of the week:

1. Product Liability (the AI developer)

But only if the model is considered a product, not a service.
And with adaptive, learning systems, this classification becomes murky.

2. Medical Malpractice (the clinician)

Did the physician deviate from the standard of care?
But what is the “standard of care” when AI is new, unproven, or conflicting?

3. Corporate Negligence (the hospital or health system)

Did the hospital validate, monitor, or govern the AI appropriately?

4. FDA Enforcement

If the tool is FDA-cleared, liability could shift.
But what happens when the model updates itself?
What if it drifts?
What if the hospital fine-tunes it?

There are no clear answers.

And in a country where litigation is a national sport, ambiguity becomes toxic.