ISO 37301
International standard for compliance management systems
HITRUST CSF
Certifiable framework harmonizing 60+ security standards.
Quick Verdict
ISO 37301 provides a certifiable compliance management system for all organizations worldwide, emphasizing leadership, risk planning, and culture. HITRUST CSF delivers prescriptive security controls for healthcare and regulated sectors, harmonizing 60+ frameworks for threat-adaptive assurance. Companies adopt them for integrated governance and trusted third-party validation.
ISO 37301
ISO 37301:2021 Compliance management systems – Requirements with guidance
Key Features
- Certifiable requirements standard replacing guidance-only ISO 19600
- High-Level Structure enables integration with ISO 9001/14001/27001
- Risk-based compliance obligations assessment and planning
- Leadership commitment and compliance culture emphasis
- Mandatory whistleblowing channels with anti-retaliation protections
HITRUST CSF
HITRUST Common Security Framework (CSF)
Key Features
- Harmonizes 60+ frameworks into single assessment
- Risk-based tailoring via scoping factors
- Maturity scoring across five levels
- Centralized certification with assessor ecosystem
- MyCSF platform for evidence management
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 37301 Details
What It Is
ISO 37301:2021 Compliance management systems – Requirements with guidance for use is a certifiable international standard for establishing, implementing, maintaining, and improving effective compliance management systems (CMS). It applies to all organization sizes and sectors, using a risk-based approach via the Plan-Do-Check-Act (PDCA) cycle and High-Level Structure (HLS) for integration.
Key Components
- Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
- Emphasizes leadership commitment, risk assessment, whistleblowing, competence, monitoring, audits, continual improvement.
- Built on HLS; companion standards like ISO 37302 (effectiveness), ISO 37303 (competence).
- Third-party certification via accredited bodies (e.g., ANAB).
Why Organizations Use It
- Manages compliance obligations (legal, regulatory, contractual) to prevent breaches, fines, reputational damage.
- Enhances investor trust, ESG reporting, market access.
- Drives culture of integrity, risk resilience; supports UN SDGs.
Implementation Overview
- Phased: initiation, design, implementation, measure/audit, sustain.
- Centralized registers, training, KPIs; scalable for SMEs/enterprises.
- Global applicability; certification involves audits, 3-year cycles.
HITRUST CSF Details
What It Is
The HITRUST Common Security Framework (CSF) is a certifiable, threat-adaptive control framework consolidating requirements from 60+ sources like HIPAA, NIST SP 800-53, ISO 27001, PCI DSS, and GDPR. It provides risk-tailored assurance via structured scoping of organizational, system, and regulatory factors.
Key Components
- 19 assessment domains spanning governance, technical controls, and resilience.
- 14 categories, 49 objectives, ~156 specifications with tiered implementation levels.
- Maturity model evaluating policy, procedure, implemented, measured, managed.
- e1/i1/r2 certification paths supported by MyCSF platform and assessors.
Why Organizations Use It
- Enables assess once, report many for unified compliance.
- Delivers third-party assurance, reducing audits and questionnaires.
- Correlates with 99.4% breach-free rate; aids insurance, market access.
- Builds stakeholder trust in healthcare, finance, regulated sectors.
Implementation Overview
- Phased: scoping, gap analysis, remediation, validation, monitoring.
- Applies to sensitive data handlers; scalable by size/risk.
- Demands policies, evidence, training; 1-2 year certification validity.
Key Differences
| Aspect | ISO 37301 | HITRUST CSF |
|---|---|---|
| Scope | Compliance obligations, risks, culture across all operations | Security/privacy controls for sensitive data handling |
| Industry | All sectors, sizes, global applicability | Healthcare primary, regulated industries, industry-agnostic |
| Nature | Voluntary certifiable management system standard | Certifiable control framework with maturity scoring |
| Testing | Accredited body audits, 3-year certification cycle | Authorized assessors, MyCSF platform, 1-2 year validity |
| Penalties | Loss of certification, no legal penalties | Loss of certification, no direct legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 37301 and HITRUST CSF
ISO 37301 FAQ
HITRUST CSF FAQ
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