For digital health platforms, MedTech, and clinical SaaS running production AWS workloads under HIPAA, GDPR, MDR, NHS Digital, or equivalent patient-data regulations. We build environments that hold PHI safely without slowing clinical iteration.
GDPR · MDR · NHS DigitalDrawn from discovery calls with HealthTech founders and CTOs over the last 18 months. If two or three of these sound familiar, we should talk.
Logging service routing PHI through a region not covered by your AWS Business Associate Agreement. Or backups replicating to a region without proper data residency controls. HIPAA scope leak that nobody noticed until the audit. Common, and remediation is structural, not cosmetic.
UK NHS Data Security and Protection Toolkit, or French HDS (Hébergeur de Données de Santé) hosting certification. Both require specific control attestations. The audit checklist exists; the AWS configuration to evidence each control doesn't. Adding it retroactively is painful.
EU Medical Device Regulation took effect May 2024. Software that influences clinical decisions can be classified as a medical device. Quality management systems, audit trails, and change control now have regulatory weight. The dev team's pace doesn't match the new regulatory reality.
Some RDS instances encrypted, some not. KMS key rotation policies missing. Backups encrypted with default keys instead of customer-managed. CloudTrail logs unencrypted at rest. The encryption story doesn't survive a competent auditor's questions.
Multi-tenant SaaS for clinics, hospitals, or healthcare networks. Per-tenant data isolation depends on application-level checks. One bug or misconfiguration risks cross-tenant PHI exposure. Defense-in-depth at infrastructure level isn't there.
RTO and RPO commitments in the contract; no tested DR procedure. Last year's "DR test" was a failover spreadsheet review. Clinical platforms cannot afford a real disaster being the first test. But nobody has time to actually exercise recovery.
HealthTech compliance varies sharply by geography. US-only platforms care most about HIPAA. EU operations layer GDPR, MDR, and country-specific frameworks. UK adds NHS Digital. Below: the frameworks we work within most often.
US Health Insurance Portability and Accountability Act. AWS BAA defines covered services, encryption requirements, audit logging, access controls. Many HealthTech CTOs misunderstand HIPAA scope — we map it precisely.
Discuss HIPAA architecture →Health data is special category data under Article 9. Higher consent thresholds, mandatory DPIA, restricted lawful bases. Region selection (Frankfurt, Paris, Ireland) matters more than for general SaaS.
GDPR architecture →Medical Device Regulation in full effect since May 2024. Software classified as medical devices needs quality management system, technical documentation, post-market surveillance. Affects AWS architecture for clinical decision software.
Discuss MDR scope →NHS Data Security and Protection Toolkit. Mandatory annual self-assessment for organizations accessing NHS data. Specific controls around access management, encryption, incident reporting. Maps closely to ISO 27001.
UK delivery context →Hébergeur de Données de Santé certification. Required for hosting French health data. AWS Paris (eu-west-3) holds HDS, but customer responsibilities still apply: encryption, access management, incident response.
France delivery →Information security management. Baseline that most HealthTech audit cycles assume. We hold ISO 27001:2022 ourselves — meaning we operate the standard, not just recommend it.
ISO 27001 implementation →Most HealthTech engagements combine two or three of these. A typical growth-stage HealthTech: HIPAA architecture + DevSecOps + cost optimization. A typical early-stage company: ISO 27001 prep + DevOps capacity + tenant isolation.
Map AWS workloads to HIPAA Security Rule. BAA-covered service selection, encryption-at-rest with customer-managed KMS keys, audit logging through CloudTrail, access controls via IAM and SCPs. Audit evidence baked in.
Discuss HIPAA →SAST/DAST gates, IaC scanning, container security, SBOM generation, secrets management. Integrated with your CI/CD pipeline. Audit evidence collected automatically. Continuous instead of annual pen-test.
DevSecOps service →EU data residency architectures, GDPR-aligned data processing flows, ISO 27001:2022 implementation. Region selection (Frankfurt, Paris, Ireland) tied to your data flows. Audit-ready from day one.
GDPR architecture →Augment your DevOps function. ECS, EKS, CodePipeline, Terraform with healthcare-specific patterns (multi-tenant isolation, encryption-everywhere). Same engineers retained across months, not body-shop rotations.
DevOps service →24/7 managed operations with documented runbooks, incident response, audit evidence collection. Pro tier suits most HealthTech scale-ups; Enterprise tier for clinical platforms where downtime affects care delivery.
CloudOps service →HealthTech cost patterns: large RDS instances for clinical data, log retention required by regulation, encrypted backup costs, multi-region for resilience. Typical engagement: 15-25% cost reduction within Q1.
Cost optimization →Different growth stages have different AWS architecture patterns. Honest advice: HealthTech needs more compliance maturity earlier than general SaaS, but you can still over-engineer for stages you haven't hit yet.
One AWS region in correct geography. AWS BAA signed. ECS Fargate or EC2 deployment, all BAA-covered services. Single-AZ RDS encrypted at rest. CodePipeline for CI/CD. HIPAA baseline controls operational. ISO 27001 prep started. AWS bill: typically $4-12k/month.
Multi-AZ deployment for production. RDS Multi-AZ encrypted, customer-managed KMS keys. EKS for stateful services. AWS WAF, GuardDuty, Security Hub. SOC 2 Type II in progress, HITRUST or HDS started where applicable. AWS bill: typically $25-75k/month.
Active-active or active-passive multi-region. Aurora Global Database with cross-region replication. Comprehensive observability. HIPAA + GDPR + ISO 27001 + sector-specific (HITRUST / HDS / NHS DSPT) all current. Mature FinOps. AWS bill: typically $125-500k/month with active cost discipline.
Most AWS partners say "we work with healthcare" because every consultancy does. The structural differences below are why HealthTech buyers actually choose us.
HAZERCLOUD INFOTECH LLP holds ISO 27001:2022. We're not just helping you implement the standard — we live inside the audit cycle ourselves. The same procedures we recommend, we operate. Structural credibility for healthcare buyers, not marketing claim.
Jobin holds AWS Security Specialty. The discovery call you have is with the AWS-certified specialist who leads the implementation team on your engagement. No bait-and-switch. No "our security team handles that." Founder accessible for HIPAA-critical decisions.
HealthTech AWS architecture decisions hinge on region selection. Frankfurt vs. Paris vs. Ireland for EU data. AWS BAA-covered services. HDS-certified Paris region. NHS Digital connectivity from London. We've made these decisions for HealthTech clients and know the trade-offs.
We don't run the body-shop economics. Our engagement model requires founder-attended weekly reviews, which structurally caps how many concurrent engagements we can run. The result: AWS-certified engineers actually doing the work, not just selling the discovery call.
No sales pitch. We'll walk through your current AWS environment, identify the highest-leverage gaps for your data classification, regulatory exposure (HIPAA, GDPR, MDR), and tell you honestly whether we're a fit. If we're not, we'll suggest who is.
★ AWS Advanced Tier Services Partner · ISO 27001:2022 · ISO 9001:2015 · 5× AWS-Certified Founder
