active
HIPAA · HITECH
Audited Q1 · next Q1 2027
BAA template within 24h of NDA. PHI handling end-to-end with immutable audit trails.
01 / 04Next
An Onix Systems company · est. 2000
Healthcare software, finished.
We build and rescue HIPAA-ready, FHIR-native products for US digital health teams. From stalled EHR rebuilds to FDA-class telemedicine launches — the work that has to be right the first time.
- 25+
- years shipping
- 370+
- engineers · US-aligned
- 95%
- audits uncover prior-vendor issues
Compliance, by design — not by checklist
HIPAA·HITECH·SOC 2 Type II·ISO 13485·ISO 27001·GDPR·HL7 FHIR R4·AWS HIPAA-eligible·BAA-ready·PCI DSS·HIPAA·HITECH·SOC 2 Type II·ISO 13485·ISO 27001·GDPR·HL7 FHIR R4·AWS HIPAA-eligible·BAA-ready·PCI DSS·
Who we serve
Built for the people who own the outcome.
Three buyers, three pain points, one team. Pick the one that sounds like yours.
Series A founders don't need another agency — they need engineers who've taken 40+ products from prototype to scale. We build HIPAA-ready MVPs in 12 weeks, augment your team when you need to ship faster, and don't disappear after launch.
- HIPAA-compliant MVP in 12 weeks, not 6 months
- Investor-grade architecture review under NDA
- Fractional CTO, clinical-product PM, and FHIR engineers on call
40+ products shipped to Series B and beyond
Full breakdown for startupsClinical
Rx
HIPAA
Audit
Your Epic isn't going anywhere — and it shouldn't. We integrate with what you already run, build the modules your vendors won't, and stand up patient portals, telehealth, and RPM that actually get used by clinicians.
- FHIR + HL7v2 integration with Epic, Cerner, Athenahealth
- Patient portals, telehealth, and RPM your staff will adopt
- RFI response template + 24-48h security questionnaire SLA
$1.4M+ saved on third-party license costs
Full breakdown for hospitalsFHIR
EHR
Portals
SOC 2
SaMD development under IEC 62304 and ISO 13485, FDA submission documentation, firmware-to-cloud pipelines, and the companion mobile apps that ship alongside your device. Built by a team that's been through the audit.
- IEC 62304 process, ISO 13485 quality system from day one
- 510(k) and De Novo submission documentation produced inline
- Firmware ↔ cloud pipelines with device data interoperability
510(k) cleared on first review
Full breakdown for MedTech510(k)
IEC 62304
ISO 13485
Cloud
What you actually ship
Engineering operations, healthcare-grade.
Audit trails, integration health, sprint velocity — operating posture you'd expect from a healthcare engineering partner.
Active engagements
14
+2 wkUptime · last 90d
98.40%
Across BAA-eligible AWS, Azure, and on-prem deployments. Annual third-party penetration tests included.
monitoring active
Integrations · live
- Epiclive
- Cernerlive
- Athenahealthlive
- Redoxlive
- Health Gorillalive
- 1upHealthlive
Audit log · live stream
streaming- 09:42BAA signed for [Healthcare Network]
- 09:31Pen test cleared · all clear
- 09:17SOC 2 evidence packet exported
- 08:55FHIR R4 conformance run · passed
Services
The full stack, ready on day one.
Strategy, design, engineering, QA, and compliance under one contract — with the same names on the call from kickoff to launch.
Custom EHRs and integrations with Epic, Cerner, Athenahealth, eClinicalWorks. FHIR-native from day one — no migration drama later.
- Bidirectional FHIR R4 read/write
- HL7v2 ADT, ORM, ORU, MDM message handlers
- SMART on FHIR launch + EHR-embedded apps
FHIR
HL7v2
SMART
HIPAA
HIPAA-compliant video, scheduling, e-prescribing, and post-visit workflows. Mobile and web, designed for clinicians who don't have time to relearn software.
- BAA-eligible video (Twilio, Daily, Vonage)
- Async + sync visit workflows
- State-level e-prescribing integrations
Clinical
Rx
Vitals
BAA
Connected-device data pipelines, AI alerting, caregiver dashboards. From wearables to in-home hubs — built for the realities of intermittent connectivity and edge data.
Full RPM breakdownMedical coding, clinical decision support, risk stratification, voice-to-note documentation. Audit-ready models with explainability baked in — not chatbots bolted onto a database.
- Explainable clinical decision support
- Ambient voice documentation pipelines
- Model evaluation + clinical validation harness
Coding
CDS
Risk
Audit
FHIR, HL7v2, DICOM, X12. Redox, Health Gorilla, 1upHealth, and direct EHR integrations — the connective tissue most teams underestimate.
Full interoperability breakdownPortals patients actually use — booking, secure messaging, results, billing, education. Designed against real adoption metrics, not vendor checklists.
Full patient engagement breakdownRule-based and ML-driven CDS, integrated into clinician workflow at the point of care. Evidence-graded, audit-ready, and built to stay out of the clinician's way until it matters.
Full CDS breakdownIEC 62304-aligned, ISO 13485-process, FDA submission-ready firmware and companion apps. We produce the documentation alongside the code, not after it.
- IEC 62304 + ISO 14971 risk management
- 510(k) and De Novo submission packets
- Firmware ↔ cloud connected-device pipelines
If you're stuck
Already mid-build and watching the timeline slip?
About half of our healthcare engagements start as rescues — a stalled vendor build, a non-compliant MVP days before a demo, an EHR migration gone sideways. We don't lecture and we don't restart from scratch.
Book your 5-day auditWhat the audit covers
Code & architecture audit
What's salvageable, what's not, and why — line by line if needed.
Compliance gap analysis
What's missing for HIPAA, SOC 2, and FDA readiness.
Fixed-price remediation plan
Scoped roadmap with weekly milestones — not vague estimates.
95%
of teams we audit say we surface issues their previous vendor missed.
What's new
Medical-grade AI — not chatbots bolted to a database.
Clinical models trained, validated, and deployed under audit-grade governance. Designed to assist clinicians, not replace them.
AI medical coding & billing
ICD/CPT autosuggestion with explainability. Up to 40% coder throughput improvement.
Voice-to-note documentation
Ambient capture during patient visits. HIPAA-compliant pipeline.
Clinical decision support
Evidence-graded recommendations embedded in clinician workflow.
Risk stratification
Population health and readmission risk scoring on your data.
Healthcare fraud detection
Claims anomaly detection for payers and self-insured providers.
Imaging & surgical assist
Computer vision for radiology, pathology, intraoperative guidance.
How we deliver
From your data — to compliant systems.
EHR feeds, device telemetry, claims, raw PHI — through the engineering layer, out the other side as audit-ready, integrated, compliant systems.
Inputs
EHR
Epic · Cerner · Athena
Devices
BLE · IoT · wearables
Claims
X12 · 837 / 835
PHI
HIPAA-scope data
Onix Health
Engineering layer
live
Outputs
Audit-ready
DHF · V&V evidence
Compliance
HIPAA · SOC 2 · ISO 13485
Integrations
FHIR · HL7 live
Decisions
CDS · risk scores
Case studies
What “done right” looks like.
95%
Hospitalsreduction in inbound calls and emails
United States · TPA · Provider Network
Healthcare Provider Portal
Self-service portal for healthcare providers serving 120+ outpatient surgery centers. MVP in 10 weeks. Claims and referrals 3× faster; 95% fewer inbound calls.
CakePHPAngularPostgreSQLAWS
Read the case study
6 apps
Startupslive on the white-label platform
Australia · Aged Care · 2017–present
Digital Healthcare at Home
White-label mobile + dashboard platform enabling aged-care organizations to launch branded apps for patient-network coordination. Six apps live, 5+ year partnership.
React.jsReact NativeSassNode.js
Read the case study
6 mo
Payersfrom kickoff to rollout · zero recurring SaaS fees
California, USA · Health Insurance
Custom CRM for Health Insurance
Custom HIPAA-compliant CRM replacing off-the-shelf SaaS. Mapped directly to the agent workflow; deployed on the client's private server to eliminate recurring per-seat costs.
CakePHPPostgreSQLAngularFigma
Read the case studyOur process
Predictable delivery — even when the scope isn't.
015 days
Audit & plan
We review your code, infrastructure, and compliance posture. You get a written report, architecture diagram, gap analysis, and a fixed-price roadmap.
022-week sprints
Rescue or build
Weekly demo. Live dashboard with sprint velocity, open issues, and burndown. Read access to our repo from day one.
03Continuous
QA & compliance
Automated and manual testing, security review, HIPAA-readiness check, optional third-party penetration test.
04Ongoing
Deploy & optimize
Production launch with monitoring, on-call rotation if you want it, continuing development at a steady cadence.
Tools we work in
We bring senior expertise from day one.
EHRs
EpicCernerAthenahealtheClinicalWorksNextGen
Standards
HL7 FHIRHL7v2DICOMX12CDA
Integration
RedoxHealth GorillaMirth1upHealth
Cloud
AWSAzureGCP
Platforms
Salesforce Health CloudTwilio HealthMicrosoft Cloud for Healthcare
AI / ML
PyTorchTensorFlowHugging FaceOpenAIAnthropic Claude
Recognition
Independent recognition for the work.
Selected awards earned by Onix Systems — the engineering practice Onix Health is built on. Verifiable on each issuing platform.
Clutch Global 2025
2025Machine Learning · Winner
Top global engineering firm for machine-learning delivery in Clutch's 2025 awards.
Clutch 1000
2024Top-rated B2B service providers
Featured on the Clutch 1000 list of top-rated B2B service providers globally.
Clutch Champion
2023Top B2B company globally
Recognized for sustained client-satisfaction performance year over year.
TechBehemoths
2024ReactJS services · Ukraine
Award-winning company in Ukraine for ReactJS engineering.
TechBehemoths
2024UX/UI Design · Ukraine
Award-winning team in Ukraine for UX/UI design.
TrueFirms
2024Annual Award · Software Development
Annual recognition for software-development excellence by TrueFirms.
Insights
What we're learning, writing, and shipping.
Free 5-day technical audit
Tell us what's not working. We'll show you how to fix it.
A free 5-day technical and compliance audit. You get a written report, architecture diagram, and a fixed-price plan. No sales pressure, no commitment.
- Written audit report with risk-ranked findings
- Architecture diagram of your current system
- HIPAA / SOC 2 / FDA compliance gap analysis
- Fixed-price remediation roadmap
Prefer email? Reach us at healthtech@onix-systems.com.
FAQ
The questions we get on every first call.
If yours isn't here, ask us directly — replies in under 4 business hours.
Will you sign a BAA?
Yes — every healthcare engagement is covered by a Business Associate Agreement before any PHI is touched. We can provide a template within 24 hours of NDA.
Are you SOC 2 Type II?
We operate under SOC 2-aligned controls and can share our current attestation status under NDA. Final status to be confirmed for your specific engagement scope.
How quickly can you start?
A typical audit starts within 5 business days of signed NDA. A full build engagement starts within 2–3 weeks of audit completion.
Do you do FDA-class software (SaMD)?
Yes. We run development under IEC 62304 process, ISO 13485 quality system, and produce 510(k) and De Novo submission documentation.
Will you rescue our project even if it's not currently with you?
That's a substantial portion of our work. The audit is designed exactly for this: we tell you what's salvageable, what's not, and what it takes to ship.
Who owns the code and IP?
You do. Always. Every contract includes full IP assignment on payment of invoices. No retained-rights clauses, no platform lock-in.
What's the typical engagement size?
Range from $40K rescue audits + remediation to $500K+ multi-quarter platform builds. Most fall between $120K–$400K. We'll quote a fixed-price scope after the audit.
Do you work onshore, offshore, or hybrid?
Hybrid by default. US-based product leads and architects, with engineering distributed across Ukraine, Poland, and the US. All work in US business-hour overlap.