Lab №01 · Healthcare

Healthcare
Lab.

Products shipped
84since 2014
Active engineers
96FT
Compliance audits
12passed
Patient records
38Mprocessed/mo

Healthcare software fails for the same reason every time — the engineering team didn't read the regulation. We did. HIPAA-native from line one, HL7 v2 and FHIR R4/R5 in the bones, IEC 62304 where the device demands it. We've built telemedicine platforms, remote monitoring systems, clinical AI, and the messy interop glue that makes American healthcare almost work.

What we build inside
the Healthcare Lab.

Nine practices · One team
P.01

Clinical AI & ML

Risk stratification, diagnostic assistance, and signal analysis. Trained on de-identified clinical data, evaluated against held-out cohorts, deployed with drift monitoring.

PyTorch FDA pre-sub SHAP
P.02

Interoperability Gateways

HL7 v2 → FHIR R4/R5 translation. Direct integrations with Epic, Cerner, Athena, eClinicalWorks. Mirth and Redox-trained engineers on staff.

HL7 v2 FHIR Mirth
P.03

Telemedicine Platforms

Async messaging, video visits, e-prescription, and scheduling. WebRTC stacks tuned for low-bandwidth clinics, with offline-first patient apps.

WebRTC SUREScripts Offline-first
P.04

Remote Patient Monitoring

Wearable telemetry, alert routing, and clinician dashboards. We've built the firmware-to-EMR pipeline for cardiac, neuro, and chronic-care programs.

BLE / LoRa Wearable SDK CMS RPM
P.05

Medical Device Software

IEC 62304 lifecycle. Class B and Class C device firmware. We've shipped on FDA-cleared and CE-marked devices in cardiac, motion, and respiratory categories.

IEC 62304 ISO 13485 510(k)
P.06

Imaging & DICOM

PACS integration, viewer construction, and AI overlays on radiology. Cornerstone and OHIF-tier viewers, multi-modal annotation pipelines.

DICOM OHIF PACS

This quarter's
featured work.

CS-2026-014
↳ EEG signal · 6h pre-onset window · subject 384
δ θ α β risk threshold ↑
Subject
384 · Cohort B
α-band amp.
9.81 Hz / 27μV
Risk score
0.74 / 1.0
Featured · Healthcare · Mar 2026

Predicting migraine risk from EEG, six hours before onset.

A US neurology clinic asked: could you give patients a six-hour warning window? Twelve months later we'd built the model, the wearable firmware integration, and the clinician dashboard. The 89.3% AUC is independently evaluated on a held-out cohort of 1,200 subjects. FDA pre-submission was filed in Q1 2026.

89.3% AUC
Held-out test set
6.0hr window
Pre-onset prediction
1,200subjects
Eval cohort, multi-site

Regulatory posture.
Listed, dated, audited.

↗ Compliance dossier on request

Standards we engineer to.

All current as of Q1 2026
HIPAA
Since 2014
Administrative, physical, and technical safeguards baked into our SDLC. Annual external attestation.
HL7 v2.x
Since 2014
ADT, ORM, ORU, MDM, SIU. Mirth-trained engineers on staff. 1,840 msg/sec sustained.
FHIR R4 / R5
Since 2018
SMART on FHIR, Bulk Data, CDS Hooks. US Core, IPS, and custom profiles.
DICOM
Since 2016
PACS integration, OHIF/Cornerstone viewers, AI overlays on radiology pipelines.
IEC 62304
Since 2019
Class A, B, and C medical device software. ISO 13485 quality management.
SOC 2 Type II
Since 2021
Annual audit, public Trust Services Criteria report. Security, availability, confidentiality.
GDPR
Since 2018
Data subject rights workflows, DPIA templates, EU data residency builds.
FDA Pre‑Sub
Since 2022
3 active pre-submissions. 510(k) traceability matrices, SaMD classification.

Twelve years of
healthcare engineering.

Selected milestones
2014
Lab founded.
First three healthcare engineers hired. Initial HIPAA SDLC drafted. First HL7-integrated EMR pilot ships in Q4.
Indore
2016
DICOM & imaging practice.
PACS integrations for two US imaging networks. First Cornerstone-based viewer in production.
US Clinics
2018
FHIR R4 from launch.
Adopted FHIR R4 the month it was released. First SMART on FHIR app shipped to a multi-state payer by year-end.
US Payer · 38M records
2019
IEC 62304 device practice.
First medical device firmware engagement, Class B respiratory monitor. Lab grows to 40 engineers.
CE Mark · EU
2021
SOC 2 Type II.
Audited and certified. Telemedicine platform shipped to a US chronic-care provider during the post-pandemic wave.
SOC 2
2023
Clinical AI portfolio launched.
Six production AI models across imaging, time-series, and risk stratification. First model card published.
6 models live
2026
EEG migraine model · FDA pre-sub.
89.3% AUC on held-out cohort. Interop Accelerator v2.4 released. Lab now 96 engineers, 84 products shipped to date.
Q1 · Pre-Sub

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Sales · +1‑408‑409‑7548 · sales@emorphis.com
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The healthcare
stack we run.

As of 2026.03
H.01

De-identify before training.

Every dataset we touch passes through a HIPAA Safe Harbor + Expert Determination workflow before a model ever sees it.

H.02

Audit logs are first-class.

Every PHI access — query, view, edit — is logged immutably. We've used the same audit schema since 2014.

H.03

Read the regulation, then write the test.

For each clause of HIPAA, IEC 62304, or FDA guidance we touch, there's a corresponding unit or integration test.