ISO 42001 Compliance for HealthTech DevOpss
Navigating ISO 42001 as a DevOps in the HealthTech sector requires a balance between technical rigour and operational velocity. This guide breaks down the critical priorities for your specific role and industry context.
Tailored for HealthTech and DevOps.
Head of Compliance Strategy • CPA, CISA, ISO 27001 Lead Auditor
Strategic Priorities for HealthTech DevOps
HealthTech-Specific Controls
Implement controls that address the unique risks of HealthTech, such as data privacy for sensitive AI training sets.
DevOps Accountability
As a DevOps, you are responsible for overseeing the compliance roadmap and auditor communication.
Evidence Automation
Leverage automation tools to minimize the manual burden on your HealthTech startup team while maintaining a continuous compliance posture.
Raphael N
Head of Compliance Strategy
Raphael leads go-to-market compliance strategy for high-growth SaaS and AI teams. With over a decade of experience across Big Four firms and fintech startups, he specializes in translating complex SOC 2 requirements into automated, engineering-friendly workflows.
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Audit readiness checklist
- •Define scope and evidence owners for ISO 42001 readiness
- •Map controls to your HealthTech workflows
- •Confirm evidence cadence and review approvals
- •Document exceptions and compensating controls
- •Validate auditor expectations before kickoff
Evidence to prepare
- •Policy ownership records
- •Control testing results
- •Risk assessments
- •Monitoring evidence
Frequently Asked Questions
How does ISO 42001 differ for HealthTech startups?
HealthTech companies often face higher scrutiny due to the nature of their data. ISO 42001 provides the foundational trust layer needed to close enterprise deals.
What is the role of a DevOps during the audit?
The DevOps typically manages the technical responses and ensures that the evidence provided matches the control descriptions in the ISO 42001 framework.
About RiscLens
Our mission is to provide transparency and clarity to early-stage technology companies navigating the complexities of SOC 2 (System and Organization Controls 2) compliance.
Who we serve
Built specifically for early-stage and growing technology companies—SaaS, fintech, and healthcare tech—preparing for their first SOC 2 audit or responding to enterprise customer requirements.
What we provide
Clarity before commitment. We help teams understand realistic cost ranges, timeline expectations, and common gaps before they engage auditors or expensive compliance vendors.
Our Boundaries
We do not provide legal advice, audit services, or certifications. Our assessments support internal planning—they are not a substitute for professional compliance guidance.
SOC 2 (System and Organization Controls 2) is a voluntary compliance standard for service organizations, developed by the AICPA, which specifies how organizations should manage customer data based on the Trust Services Criteria: security, availability, processing integrity, confidentiality, and privacy.
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