(Governing the Algorithm — Article #9)
The Validation Study Was Never Meant to Be the Whole Story
Pre-market validation answers a specific, bounded question: did this model perform safely and effectively against this dataset, under these conditions, at this point in time? That's a real and necessary answer — but it's a snapshot, not an ongoing guarantee.
For years, that snapshot was treated as sufficient on its own. A strong validation study got a product through clearance, through a sales cycle, and often through the entire lifetime of the deployment, with no further performance reporting expected by either party. That expectation is changing.
What Hospitals Are Starting to Ask For
"What does ongoing performance reporting look like once this is live in our environment?"
This question is increasingly showing up in procurement and renewal conversations — not as a hypothetical concern, but as a specific, expected deliverable. Hospitals are starting to treat post-deployment reporting the way they treat any other clinical quality metric: something they expect on a cadence, not something they'd have to specifically request during an incident.
What's typically being asked for:
✔ Ongoing performance metrics in the actual deployment environment, not just the original validation cohort
✔ A defined reporting cadence — quarterly, monthly, or triggered by specific events — rather than reporting only on request
✔ Visibility into both directions of the relationship — the hospital sees how the model is performing on their population, and the vendor sees deployment-specific context that pre-market data never captured
✔ A clear escalation path if reported performance falls outside expected bounds, connecting directly back to the drift monitoring and change-control commitments discussed earlier in this series
Why This Is a Two-Way System, Not Just a Vendor Obligation
Post-market surveillance often gets framed as something the vendor owes the hospital — a one-directional reporting duty. In practice, the most effective programs run as a genuine feedback loop: the vendor needs deployment-specific data from the hospital (case volumes, local population characteristics, workflow context) to interpret performance correctly, and the hospital needs the vendor's aggregated cross-site view to understand whether an issue is local or systemic.
Neither party has the full picture alone. A surveillance program that only flows in one direction is missing half of what makes it useful.
What This Looks Like When It's Done Well
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A named point of contact on both sides responsible for the surveillance relationship, not a shared inbox
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A standard reporting template established before go-live, so early data is comparable to later data
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Defined thresholds that convert a passive report into an active review, tying directly to the drift-monitoring and change-control infrastructure already discussed in this series
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Documentation that survives personnel turnover on either side — because surveillance obligations are commonly measured in years, and the people managing them at launch often aren't the same people managing them two years later
Final Thought
A validation study proves a model was ready to launch.
Post-market surveillance proves it's still worth trusting, month after month, in the specific environment where it's actually being used.
Validation is a starting line.
Post-market surveillance is the race that follows.
The vendors who treat this as a genuine, resourced commitment — not a compliance afterthought — are the ones building the kind of long-term institutional trust that survives past a single successful pilot.
Next in the Governing the Algorithm Series:
ISO 42001 and the Rise of AI Management Systems in Healthcare
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