Healthcare AIFDA / HIPAA / SaMD

Lossless 5-bit transformer compression for healthcare AI inference

FDA Software-as-Medical-Device requires bit-identical model behavior across deploys. AWQ / GPTQ / EXL3 leave reproducibility ambiguous — you cannot bit-compare two runs. Sipsa proves SHA-256 verifiable bit-identical reconstruction across 22 architectures, every deploy, every customer-bound model.

The healthcare-AI inference problem

Every healthcare-AI customer that ships a clinical-decision-support model under FDA Software-as-Medical-Device (SaMD) regulation hits the same compliance wall: regulators require provable reproducibility of model behavior.

Current quantization frameworks (AWQ, GPTQ, EXL3, QTIP) deliver "approximately equal to the original" model output. That language fails FDA Computational Model Validation. It also fails HIPAA model-risk audit when a healthcare provider needs to demonstrate why the same patient input produced a different inference output across two deploys.

Sipsa's substrate is the only 5-bit-class compression that proves bit-identical reconstruction via SHA-256, every run, every deploy. That moves a clinical AI deploy from "approximately reproducible" to "cryptographically verifiable" — the regulatory-equivalence floor your FDA submission needs.

What Sipsa delivers for healthcare AI customers

NeedSipsa deliveryCompliance hook
Same model, same answer, every deploySHA-256 verifiable bit-identical reconstructionFDA SaMD; FDA Computational Model Validation
Auditable model versioningPer-Linear SHA-256 manifest + customer-side uc verifyHIPAA model risk; OCR audit
Smaller GPU footprint per clinical deploy3-4× lower memory at sub-1.5% PPL driftPer-clinician TCO reduction at hospital scale
On-prem deploy (HIPAA / no-cloud customers)BUSL-1.1 + Additional Use Grant (no cloud dependency)Air-gapped hospital + clinic deploys
Defense / pharma / biotech adjacencySame substrate also used for AFWERX / NIH SBIR / proteomicsCross-vertical platform credibility

Verified at scale

22 architectures verified end-to-end, including 405B-class dense (Hermes-3-Llama-3.1-405B at 1.0066× PPL on a single 32 GB GPU), MoE (Mixtral-8x7B at 1.00368×), and state-space (Mamba-2.8B). 40 model artifacts at huggingface.co/SipsaLabs, customer-side reproducible:

pip install ultracompress
hf download SipsaLabs/qwen3-8b-uc-v3-bpw5 --local-dir ./qwen3-8b
uc verify ./qwen3-8b   # confirms bit-identical reconstruction
uc bench ./qwen3-8b    # measures TTFT / tokens/sec / VRAM

Phase 0 POC for healthcare-AI teams ($5K–$25K, 1 week)

We compress one of your production models, deliver the lossless artifact + SHA-256 manifest + customer-side uc verify dashboard. You confirm bit-identical reconstruction against your bf16 reference. If we miss the spec, you don't pay. Phase 1 commercial license follows if Phase 0 lands.

Email founder@sipsalabs.com

FAQ

How is this different from AWQ / GPTQ / EXL3?

Those frameworks leave reproducibility ambiguous — you cannot bit-compare two runs. Sipsa's substrate produces a per-Linear SHA-256 fingerprint that the customer can verify locally. For FDA / HIPAA / SR-11-7 audit purposes, "bit-identical" is qualitatively different from "approximately equal".

Does this require special hardware?

No. Standard PyTorch path on the reconstructed model — runs on any CUDA GPU. We have customer-side reproducibility on consumer GPUs (RTX 5090) and datacenter GPUs (A100 / H100) alike.

What about NIH SBIR alignment?

Sipsa Labs has a NIH SBIR Phase I draft submission-ready with FDA bit-identical reproducibility as the science-merit hook. Healthcare-AI customers who partner with us at Phase 0 may be cited as Letters of Support in the NIH submission, accelerating both timelines.

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