Compliance built in.
Not bolted on.
HIPAA, FHIR R4, GDPR, SOC 2. SanoWorks engineers every control into your HealthTech product from sprint one — so you never face a failed audit, a frantic retrofit, or a breach disclosure.
Every regulatory framework
your product faces
Compliance requirements vary by product type, geography, and data category. SanoWorks engineers know exactly which controls apply — and how to implement them without slowing your delivery.
HIPAA Technical Safeguards — built from sprint one
HIPAA isn't a checkbox. It requires specific technical controls — and most vendors don't implement them until a compliance consultant flags the gaps. SanoWorks builds them into the architecture before the first line of application code is written.
Our HIPAA foundation covers the full Technical Safeguard rule: access controls, audit controls, integrity controls, transmission security, and automatic logoff. BAA structuring and breach notification workflows are documented as part of delivery.
- Role-based access controls (RBAC) with least-privilege enforcement
- AES-256 encryption at rest, TLS 1.3 in transit
- PHI audit logging — who accessed what, when, from where
- Automatic session timeout and re-authentication
- Integrity controls preventing unauthorised PHI alteration
- BAA template and third-party sub-processor documentation
- Breach notification workflow and incident response runbook
FHIR R4 and HL7 — interoperability that actually ships
FHIR R4 is the current US interoperability mandate (21st Century Cures Act). Most HealthTech startups underestimate the complexity: resource mapping, terminology bindings, SMART on FHIR auth, and EHR-specific quirks all require deep implementation knowledge.
SanoWorks has a prebuilt FHIR layer that accelerates greenfield implementations significantly. For EHR integrations, we handle the full Epic, Cerner, or Athena sandbox-to-production cycle including app certification where required.
- FHIR R4 resource modelling and profile validation
- SMART on FHIR OAuth 2.0 authentication flows
- CDS Hooks implementation for clinical decision support
- HL7 v2 and v3 message parsing and transformation
- Epic, Cerner, Athena API integration and certification support
- Bulk FHIR export for analytics and population health
- FHIR Subscription and webhook infrastructure
GDPR — engineered for UK and European HealthTech
Health data is a special category under GDPR Article 9, requiring explicit consent, processing restrictions, and data subject rights automation. UK GDPR applies post-Brexit with additional ICO guidance for health data processors.
SanoWorks implements GDPR-compliant data architectures for HealthTech — privacy by design from Article 25, data minimisation, automated data subject request handling, and cross-border transfer controls for EU-UK-US data flows common in clinical research products.
- Privacy by design architecture (Article 25)
- Special category health data processing controls (Article 9)
- Consent management and withdrawal workflows
- Automated Data Subject Access Request (DSAR) handling
- Right to erasure — clinical data retention exceptions documented
- Data Processing Agreement (DPA) template and third-party register
- Cross-border transfer mechanisms (SCCs, UK adequacy)
SOC 2 Type II — the enterprise sales prerequisite
Enterprise health system customers will ask for a SOC 2 Type II report before signing. Most Seed-stage products can't produce one — and spend 9–12 months scrambling to implement controls retroactively. SanoWorks builds SOC 2 readiness into the product from the start.
We implement the Security and Availability trust service criteria — the two most commonly required — as engineering defaults. This means your SOC 2 audit observation period starts the day you launch, not the day you realise you need the report.
- Logical access controls and user provisioning/deprovisioning
- Continuous infrastructure monitoring and alerting
- Change management controls with audit trail
- Incident response and escalation procedures
- Vendor risk management documentation
- Availability and performance monitoring targets defined
- Penetration test cadence and remediation tracking
GCC and regional frameworks — UAE, KSA, and beyond
Healthcare data regulation across the GCC is evolving rapidly. UAE has NABIDH (Abu Dhabi) and DOH (Dubai) requirements for clinical data exchange. Saudi Arabia's PDPL and NDMO cloud guidelines apply to health data processors operating in-Kingdom.
SanoWorks has delivered compliant HealthTech products across the GCC for five years. We understand data residency requirements, Arabic-language clinical data handling, regional HL7 profiles, and the practical realities of regulator engagement in each market.
- NABIDH data exchange and integration standards (Abu Dhabi)
- DOH compliance framework requirements (Dubai)
- Saudi PDPL and NDMO cloud governance controls
- Data residency — in-country hosting and sovereignty controls
- Arabic clinical data handling and RTL interface compliance
- Regional HL7 and FHIR profile adaptations
- Regulator engagement and submission documentation support
Compliance as engineering,
not paperwork
Most teams treat compliance as documentation produced after the code is written. SanoWorks treats it as an architectural constraint from the first sprint — the same way you'd treat performance or scalability.
Compliance Discovery
Before writing a line of code, we map every data flow — what PHI touches which system, crosses which border, and requires which control. Surprises eliminated up front.
Prebuilt Compliance Layer
SanoWorks maintains a prebuilt infrastructure layer: HIPAA-ready AWS/Azure environments, FHIR server scaffolding, audit logging pipelines, and IAM templates. Your product inherits weeks of work on day one.
Controls Woven into Sprints
Each sprint's definition of done includes the relevant compliance controls. Encryption isn't a final sprint item. Audit logging isn't a post-launch add-on. They ship with the feature.
Continuous Compliance Validation
Automated security scanning, dependency auditing, and infrastructure drift detection run in every CI/CD pipeline. Compliance isn't a point-in-time state — it's a continuous property of the codebase.
Documentation as a Deliverable
Every engagement produces a compliance documentation package: data flow diagrams, BAA templates, control evidence library, risk register, and audit-ready documentation — produced throughout delivery.
Audit Readiness Hand-Off
At launch, you receive everything your HIPAA, SOC 2, or ISO 27001 auditor will ask for — organised, evidenced, and ready. The audit is a formality, not a fire drill.
The SanoWorks compliance
infrastructure stack
Every SanoWorks engagement starts from a prebuilt, validated infrastructure foundation. These components aren't built from scratch on your dime — they're refined across years of HealthTech delivery and drop into your architecture from day one.
Know what compliance gaps
your product has right now.
The free audit takes 72 hours. You'll get a written breakdown of every control gap, data exposure risk, and remediation step — before your investors or customers find it.
Get a free compliance auditFive years. Zero breaches.
Kencor Health's remote patient monitoring platform handles continuous biometric data from patients across US hospital networks. HIPAA compliance isn't optional — it's existential. SanoWorks has maintained zero HIPAA breaches across five years of continuous product delivery.
HIPAA-compliant RPM at scale — 5 years, zero breaches, 156% billing growth
Kencor's platform processes continuous biometric streams from patients across US hospital networks. SanoWorks built the HIPAA-compliant architecture from the ground up — PHI vault, audit logging, access controls — and has maintained that compliance posture through five years of feature development and scale.
Read the full case studyWhat founders ask about
compliance engineering
Compliance is the foundation.
Here's what sits on top.
A compliant product is the baseline. SanoWorks helps HealthTech startups build, rescue, integrate, and scale — all on top of that foundation.
Build Your HealthTech MVP
Compliance-ready architecture, FHIR infrastructure, and a shippable product in 6–9 weeks.
EHR & Health System Integration
Epic, Cerner, Athena. FHIR R4, SMART on FHIR, HL7 pipelines — engineered and production-certified.
Rescue a Failing Product
Already failed an audit? Stalled build? SanoWorks takes over and ships in 6–9 weeks.
Free Compliance Audit
72 hours. Written findings. Know exactly where your compliance gaps are before your investors do.
SanoWorks is an AI-augmented HealthTech software engineering partner founded in 2011, helping Seed to Series A digital health startups ship compliant products faster across the US, UK, and Middle East. Powered by Peerbits — 100+ engineers, ISO 9001, ISO 27001, CMMI certified.
The audit is free. The findings are yours. If there are compliance gaps in your product, you need to know before your next investor meeting — or your next customer's security review.