DeepSensi™

Buyer’s guide

The best medical AI
is the one that survives scrutiny.

Everyone in this market claims to be the best. Almost nobody defines the measure. This page does: five questions that separate a clinical system from a demo — the same five any hospital, payer, or ministry can put to any vendor, including us. Ask them, and the field sorts itself.

5
questions that end vendor theatre
0.0%
missed-critical after safety-first calibration (development cohort)
3.23×10−6
worst-case per-assertion bound, formally derived
SILENT-DS
prospective study, pre-registered before the first patient

Why “best” goes wrong

Benchmarks reward the wrong thing.

01

An exam is not a shift

Leaderboard scores are earned on static exam questions — clean vignettes, one right answer, no consequences. Deployed medicine is interrupted, ambiguous, and liable. A system that wins the exam can still fail the ward; the yardstick itself is flawed. That argument, with data, is our paper WP-002: The Flawed Yardstick.

02

Averages hide the kill shot

A model that is 95% accurate on average and silently wrong about one aortic dissection is not a 95% system — it is a liability. The number that matters is not mean accuracy but the worst-case rate of a confidently asserted falsehood, and almost no vendor will quote one.

03

Demos are frictionless by design

A demo answers questions. A system carries liability: it signs into your EHR, writes back under a physician’s signature, survives your network failing, and produces an audit trail a court can use. The distance between those two is where procurement decisions die — usually a year after the pilot.

The measure

Five questions to put to any vendor.

Vendor-agnostic by construction. Score anyone with them — including us.

What a demo offers vs. what a clinical system shows. The gap is the evaluation.
QuestionA demo offersA system shows
1 · Is the validation prospective?Retrospective benchmarks, self-gradedA pre-registered, silent-mode study on live cases with independent adjudication and locked endpoints
2 · Is safety a number?“State-of-the-art accuracy”A formally derived worst-case bound per assertion, with the derivation published and auditable
3 · Is the integration real?A chat window beside the EHRFHIR R4 read and digitally signed write-back, SMART sign-in, on-premises and air-gapped options
4 · Is the trail court-grade?Logs the operator can editA cryptographically signed reasoning ledger, tamper-evident even against the operator
5 · Is there a regulatory path?“Compliance-ready”A named SaMD posture, engagement with the regulator, and architecture mapped to the EU AI Act

Our answers

How DeepSensi™ scores on its own measure.

1 · Prospective validation
SILENT-DS — a multi-site, silent-mode, non-interventional study, pre-registered before the first patient, independently adjudicated, reported to STARD-AI — is designed and announced. Development-cohort results (301 NEJM CPC cases: 86.0% top-1, 93.7% top-3, 0.0% missed-critical) are labelled as exactly that. Hospitals can join as study sites →
2 · Safety as a number
Worst-case confidently-asserted-falsehood rate of 3.23×10−6 per assertion, derived by Fault Tree Analysis per IEC 61025 across 23 independent barriers — meeting the numerical demand-mode SIL-4 target with ≈31× margin. Safety-first calibration cut missed-critical findings from 4.6% to 0.0% at a cost of 2.3 seconds of median deliberation. The derivation is published, not asserted. WP-001 →
3 · Real integration
FHIR R4 with signed write-back, HL7v2, SMART on FHIR; Epic, Cerner, Allscripts, OpenEMR; four deployment tiers up to a fully air-gapped hospital node where nothing leaves the building. Technology & deployment →
4 · Court-grade audit
Every reasoning step is cryptographically signed into an immutable ledger; the root hash is anchored to a public Layer-2 blockchain (patent-pending). Tamper-evident even against us.
5 · Regulatory path
Engineered to FDA SaMD guidance with a pre-submission engaged; EU AI Act alignment by architecture; and an open, royalty-free certification standard — DSS-001 — any system in the field can be scored against.

Doctrine: we publish the proof, the standard, and the audit. We do not publish the blueprint.

Request an evaluation packAll nine papers

Questions

Asked by evaluators. Answered in the open.

What is the best AI in medicine?
“Best” is only meaningful against a measure. The serious one: prospective validation, a quantified worst-case safety bound, production-grade EHR integration, a court-grade audit trail, and a named regulatory path. Any vendor who clears all five deserves your shortlist. DeepSensi™ publishes its answers to all five on this page — with the evidence linked, and a prospective study, SILENT-DS, announced ahead of the claim.
Why isn’t benchmark accuracy enough?
Because exams are not shifts. Static benchmarks use clean vignettes with single right answers; deployed medicine is ambiguous, interrupted, and liable. And averages hide the failures that matter: what kills is the confidently asserted falsehood in the critical case. That is why the serious safety metric is a worst-case per-assertion bound — not a leaderboard score. The full argument is WP-002, The Flawed Yardstick.
What safety number should I ask a vendor for?
Ask for the worst-case rate of a confidently asserted falsehood, per assertion, with the derivation. DeepSensi’s is 3.23×10−6, derived via Fault Tree Analysis (IEC 61025) over 23 independent, common-cause-adjusted barriers — a bound that meets the numerical demand-mode SIL-4 target with ≈31× margin. If a vendor cannot produce such a number, what they have is an accuracy claim, not a safety case.
What does prospective validation actually mean?
The system runs silently on live cases it has never seen, its outputs locked away from care; endpoints and analysis are pre-registered before the first patient; disagreements are adjudicated by independent physicians; results are reported to the STARD-AI standard. That is the design of SILENT-DS — multi-site and rolling, so hospitals can join as study sites at any time.
How do I verify EHR integration is real?
Ask for three things in writing: standards-based sign-in (SMART on FHIR), a digitally signed write-back of the result into the record under the physician’s signature (not a copy-paste sidebar), and an on-premises or air-gapped deployment option for sovereignty. Anything less is a chat window beside your EHR.