Compliance infrastructure built into the product — not checked at the end.
HIPAA compliance is not a badge applied after the product is built. It is an architecture decision made at the start — PHI boundaries, encryption model, IAM controls, audit logging, and BAA scope designed before the first feature sprint. SanoWorks has delivered this across five years of production HealthTech without a single HIPAA breach.
Most HealthTech products are not HIPAA-compliant — they are HIPAA-adjacent, and the difference surfaces at enterprise sales.
The pattern is consistent: a HealthTech product is built, the first health system buyer asks for a security review, and the engineering team discovers that compliance was never actually designed into the product. PHI is not encrypted at rest. Audit logging is incomplete. IAM roles are too permissive. There is no documented incident response process. The product has a HIPAA policy document but not HIPAA-compliant architecture.
HIPAA compliance is not a documentation exercise. It is a set of technical controls — PHI boundary design, encryption at rest and in transit, role-based access controls, audit logging of all PHI access events, BAA-aware infrastructure — that must be designed into the product architecture from the start. Retrofitting these controls after the product is built is significantly more expensive than building them in from the beginning, and the gaps are usually discovered at the worst possible moment: during an enterprise procurement review.
The proof is Kencor Health. SanoWorks designed HIPAA-compliant architecture into the Kencor platform from day one — and maintained it across five years of production use without a single HIPAA breach. That outcome is not a compliance policy. It is the result of getting the technical controls right at the architecture level and maintaining them through every feature addition and infrastructure change.
You are in the right place if:
- Your product handles PHI and needs HIPAA-compliant architecture from day one
- A health system buyer has asked for a security review and you are not confident it will pass
- You need GDPR compliance for a HealthTech product operating in the EU
- Your current compliance posture is documentation-based rather than architecture-based
- You need ISO 27001-aligned security management processes, not just a checklist
- Compliance infrastructure needs to be demonstrable to payers, health systems, or investors
The security and compliance infrastructure SanoWorks delivers
Security and compliance infrastructure covers a range of technical controls depending on the regulatory framework, deployment context, and buyer requirements. SanoWorks has production experience across all of them.
PHI Boundary & Encryption Design
PHI boundary mapping, AES-256 encryption at rest, TLS encryption in transit, encrypted database fields, and secure key management — the foundational controls that determine whether a HealthTech product can handle patient data safely.
IAM & Role-Based Access Controls
Identity and access management design, role-based access controls scoped to the minimum necessary PHI access, multi-factor authentication, and session management — the access control layer that enterprise security reviews examine first.
Audit Logging & Compliance Trails
Comprehensive audit logging of all PHI access events, user actions, and system changes — with tamper-evident log storage and reporting tools that satisfy HIPAA audit requirements and enterprise security reviews.
Secure VPC & Network Architecture
Private subnet design, security group configuration, network access controls, and WAF implementation that isolate PHI workloads and satisfy the network security requirements of health system procurement teams.
BAA & Compliance Documentation
Business Associate Agreement scope design, vendor BAA management, HIPAA risk assessment documentation, and the compliance evidence package that enterprise health system buyers require before signing a contract.
GDPR & Multi-Framework Compliance
GDPR-compliant data processing architecture for EU-market HealthTech products — lawful basis design, data subject rights implementation, data processing agreements, and data residency controls alongside HIPAA requirements.
The five compliance architecture decisions that determine whether a HealthTech product passes enterprise scrutiny
SanoWorks uses the HealthSprint Framework to front-load compliance architecture decisions. Compliance infrastructure designed at the start of a build costs a fraction of what it costs to retrofit after an enterprise buyer asks for a security review.
PHI boundaries defined before any feature work begins
Every piece of PHI the product will handle, where it will be stored, who will have access to it, and how it will be encrypted must be defined before the first feature sprint. PHI boundary decisions made mid-build are significantly more expensive to implement correctly than PHI boundary decisions made at the architecture stage.
Encryption model designed for the full data lifecycle
Encryption at rest and in transit is the baseline. The encryption model must also cover database field-level encryption for sensitive PHI, secure key management and rotation, and encrypted backups. SanoWorks designs the full encryption model — not just the API layer — before feature development begins.
IAM and access controls scoped to minimum necessary access
HIPAA's minimum necessary standard requires that access to PHI is limited to what is required for each role's function. SanoWorks designs IAM roles and access controls around this principle from the start — not as a post-build tightening exercise that inevitably misses edge cases.
Audit logging designed to satisfy a compliance review, not just an engineering requirement
Audit logs that satisfy a HIPAA compliance review must capture who accessed what PHI, when, from where, and what action was taken — with tamper-evident storage and retention policies that meet regulatory requirements. SanoWorks designs audit logging for compliance reviewers, not just for debugging.
Compliance documentation produced as a build output, not a post-launch project
Enterprise health system buyers require compliance documentation — risk assessments, BAA scope, security architecture diagrams, incident response procedures — before signing a contract. SanoWorks produces this documentation as part of the build process so it is ready when the first enterprise procurement review begins.
Kencor Health: zero HIPAA breaches across a five-year production partnership
The clearest proof of SanoWorks's security and compliance capability is Kencor Health — a US-based RPM and chronic care management platform that has operated for five years without a single HIPAA breach.
Zero HIPAA breaches. Five years. ISO 27001 certified delivery.
SanoWorks designed HIPAA-compliant architecture into the Kencor platform from day one: PHI boundary design, AES-256 encryption throughout the data pipeline, role-based access controls scoped to minimum necessary access, comprehensive audit logging, BAA-aware infrastructure, and documented incident response procedures. The platform has operated for five years across a growing patient population without a single HIPAA breach. That outcome is not a compliance policy document. It is the result of getting the technical controls right at the architecture level and maintaining them through every feature addition and infrastructure change.
Read the full Kencor Health case studyWant to know if your product's compliance architecture will pass an enterprise security review?
A free architecture audit can identify HIPAA compliance gaps, security risks, and documentation gaps before a health system procurement review surfaces them. Most compliance audits are completed within one week.
Get a free architecture auditCommon questions about HIPAA compliance and security infrastructure
Where to go from here
Whether you are ready to build, want to see the Kencor proof in detail, or need to understand the cloud infrastructure layer, these are the most useful next pages.
Kencor Health
Five years, zero HIPAA breaches — the full story behind the compliance architecture that kept a production RPM platform secure at scale.
Healthcare Cloud & DevOps
The cloud infrastructure layer — HIPAA-compliant AWS architecture, automated CI/CD, and zero-downtime deployment that the security controls sit on top of.
Compliance & Secure Infrastructure
The full compliance infrastructure service — HIPAA, GDPR, and security architecture for HealthTech products that need to survive enterprise sales diligence.