Clinical software
under sign-off
Healthcare systems are regulated artefacts. We build clinical workflows, patient portals, imaging pipelines and interop layers that stay auditable, de-identified on the right sides, and clinician-approved on every decision that touches a patient.
CAPABILITIES
Six surfaces we ship under clinical review
Clinical workflow, patient portals, imaging, interop, RCM and research — run under one team with BAAs in place and decisions signed off by named clinicians.
Clinical workflow tools
EHR-aware front-ends, order entry, note templates, decision support pills under explicit clinician review.
Patient-facing portals
Appointment, telemedicine, secure messaging, pre-visit intake with SMART-on-FHIR and SSO.
Clinical imaging
DICOM pipelines, PACS integration, AI-assisted triage under radiologist sign-off, audit-ready.
Interop & HL7 / FHIR
Epic / Cerner / Allscripts connectors, HL7 v2 ingestion, FHIR R4 resource mapping, terminology binding (SNOMED, LOINC, ICD-10).
RCM & claims
Claims generation, 835/837 handling, denial routing, coding suggestions reviewed before submission.
Research platforms
Registry systems, eCOA / ePRO, de-identification pipelines, secure data enclaves for sponsored studies.
RISK LEDGER
Four failure modes we plan for from day one
Clinical software fails in specific, known ways. The four rows below are on every risk file we open — severity at the left, mechanism on the right. Mitigations ship before the product does.
De-identification drift
Re-identification risk when synthetic datasets leak quasi-identifiers; formal k-anonymity + DP audit.
Model bias on demographic slice
Accuracy gap across age, ethnicity, insurance. Fairness metrics stay on the release dashboard.
Terminology drift
Codes (SNOMED, LOINC, ICD) update quarterly; mappings versioned and diffed per release.
Alert fatigue
Decision-support pills tuned to precision, not recall; dismissal rate becomes a first-class signal.
AI-assisted triage does not dismiss the clinician. The MLOps layer carries the eval, bias audit and explainability needed for regulated model-in-the-loop decisions.
COMPLIANCE MAP
Four regulatory tracks we design against
Controls traced to evidence on each track. Ready for audit without a sprint of screenshot archaeology.
HIPAA · HITECH
- PHI handling in-region
- BAA and subprocessor registry
- Audit-log coverage
- Breach playbook + drill
GDPR · healthcare
- Article 9 special-category handling
- Data-residency (EU, UK)
- DPIA per engagement
- Delete-on-request + right to rectify
Clinical safety
- ISO 13485 hooks where applicable
- IEC 62304 software lifecycle
- DTAC / NHS Digital
- Risk file + hazard log
FDA / EU MDR
- SaMD classification
- 510(k) doc path
- Clinical evaluation ready
- Post-market surveillance hooks
Adjacent disciplines
Where clinical software connects
MLOps & Governance
Eval suites, bias audit, explainability and the retraining pipeline behind clinical-decision models.
SecurityCyber Security & Risk Ops
PHI handling, IAM, BAA management, incident workflow and HIPAA / GDPR audit readiness.
ImagingComputer Vision
Medical imaging pipelines: MRI, CT, X-ray, histopathology with radiologist-in-the-loop review.
ProductSaaS Product Development
Six-surface subscription products: patient portals, admin consoles, billing and identity.
Build clinical software clinicians actually trust
Share the workflow, the EHR landscape, the patient cohort and the regulatory jurisdictions. We come back with an architecture sketch, BAA map and risk file inside ten working days.