HITRUST CSF
Certifiable framework harmonizing 60+ security standards
ISO 13485
International standard for medical device quality management systems
Quick Verdict
HITRUST CSF delivers certifiable security assurance harmonizing 60+ frameworks for healthcare and regulated sectors, while ISO 13485 mandates QMS rigor for medical device safety and regulatory compliance. Organizations adopt them for trusted assurance and market access.
HITRUST CSF
HITRUST Common Security Framework
Key Features
- Harmonizes 60+ standards into certifiable assessment
- Risk-based tailoring via structured factors
- Five-level maturity model evaluates effectiveness
- MyCSF platform automates scoping and evidence
- Inheritance reduces cloud control duplication
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls across device lifecycle stages
- Mandatory design and development controls
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing management
- Process validation and traceability requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
HITRUST CSF Details
What It Is
HITRUST Common Security Framework (CSF) is a certifiable, threat-adaptive control framework harmonizing over 60 standards like ISO 27001, NIST 800-53, HIPAA, and PCI DSS. Its primary purpose is providing risk-tailored security and privacy assurance via a prescriptive control library, maturity scoring, and centralized validation.
Key Components
- 19 assessment domains covering governance, technical controls, and resilience.
- 14 categories, 49 objectives, ~156 specifications with tiered implementation levels.
- Built on ISO-derived taxonomy and NIST PRISMA maturity model (policy, procedure, implemented, measured, managed).
- Certification via e1/i1/r2 assessments using MyCSF platform.
Why Organizations Use It
- Rationalizes multi-regulatory compliance (assess once, report many).
- Delivers credible third-party assurance reducing audit fatigue.
- Enhances risk management, breach reduction (99.4% breach-free), and market differentiation in healthcare/finance.
- Builds stakeholder trust via standardized reports.
Implementation Overview
Multi-phase: scoping, readiness, remediation, validated assessment by authorized assessors, continuous monitoring. Suited for regulated industries handling sensitive data; requires policies, evidence, and MyCSF. (178 words)
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework for organizations to demonstrate consistent provision of safe medical devices across their lifecycle, from design to post-market surveillance.
Key Components
- Organized into **Clauses 4-8QMS foundation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, validation, traceability, risk management (linked to ISO 14971).
- Requires quality manual, medical device files, CAPA, internal audits.
- Certification via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks of recalls, non-conformities via robust controls.
- Builds stakeholder trust, supplier assurance, operational efficiency.
Implementation Overview
- Phased approach: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- Involves eQMS tools, cross-functional teams; 9-18 months typical.
Key Differences
| Aspect | HITRUST CSF | ISO 13485 |
|---|---|---|
| Scope | Security/privacy controls across 19 domains | QMS for medical device lifecycle processes |
| Industry | Healthcare, regulated sectors, industry-agnostic | Medical devices, suppliers, healthcare-specific |
| Nature | Certifiable security framework, voluntary | QMS standard for regulatory compliance, certifiable |
| Testing | Maturity-scored validated assessments by assessors | Internal audits, management reviews, certification audits |
| Penalties | Loss of certification, no legal penalties | Regulatory actions, market access denial |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about HITRUST CSF and ISO 13485
HITRUST CSF FAQ
ISO 13485 FAQ
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