What is the primary objective of **HITRUST CSF**?

**The primary objective of HITRUST CSF is to provide a certifiable, threat-adaptive control framework that harmonizes requirements from over 60 authoritative sources into a single assurance program enabling "assess once, report many."** It consolidates controls across 19 assessment domains and a hierarchical taxonomy of 14 categories, 49 objectives, and approximately 156 specifications, using risk-based tailoring via organizational, system, and regulatory factors. The maturity model (Policy 15%, Process 20%, Implemented 40%, Measured 10%, Managed 15%) ensures operational effectiveness, supported by MyCSF for scoping, evidence management, and validated certification (e1: 44 controls/1-year; i1: 182 requirements/1-year; r2: tailored/2-years with interim).

Who is legally or professionally required to comply with **HITRUST CSF**?

**No organization is legally required to comply with HITRUST CSF, as it is a voluntary, industry-agnostic framework; however, professional requirements arise contractually from healthcare payers, providers, and vendors mandating certification for business associates handling PHI/ePHI.** Primary users include covered entities, business associates, Health IT vendors, life sciences firms, financial services, and cloud providers in regulated ecosystems. Adoption is driven by stakeholder demands for standardized third-party assurance via validated reports shared through RDS.

Does **HITRUST CSF** require an external audit or third-party certification?

**Yes, HITRUST CSF requires external audits by Authorized External Assessors for validated assessments leading to certification.** Self-assessments or readiness via MyCSF provide internal gap analysis but lack third-party validation. Validated assessments involve evidence-based testing (documentation, interviews, technical scans), HITRUST centralized QA review, and issuance of certification letters for e1, i1, or r2 levels.

How often should an assessment for **HITRUST CSF** be performed?

**HITRUST CSF assessments should be performed annually for e1 and i1 certifications (1-year validity) and every two years for r2 with a mandatory interim assessment at the one-year mark.** Controls must operate for ~90 days pre-fieldwork, with continuous monitoring via MyCSF to address updates, threat adaptations, and CAPs for sustained compliance.

What are the consequences of non-compliance with **HITRUST CSF**?

**Non-compliance with HITRUST CSF results in no direct legal penalties since it is voluntary, but it leads to lost contracts, exclusion from healthcare ecosystems, higher cyber insurance premiums, and increased third-party risk management costs.** Organizations forfeit "assess once, report many" efficiencies, facing duplicative audits and reduced market access where certification is contractually required.

Can **HITRUST CSF** be mapped to other international frameworks?

**Yes, HITRUST CSF includes built-in mappings to over 60 frameworks, enabling requirement-level results to roll up into reports for HIPAA, NIST SP 800-53, ISO 27001/27002, SOC 2, PCI DSS, GDPR, and others via MyCSF cross-references.** This supports "assess once, report many" without separate efforts.

What is the first step to begin implementing **HITRUST CSF**?

**The first step to implement HITRUST CSF is to access MyCSF, complete the scoping questionnaire to define organizational, system, and regulatory risk factors, and generate a tailored control requirement set.** This identifies inheritance opportunities (up to 60-85% from cloud providers) and prioritizes remediation via readiness assessment.

What is the primary objective of **AS9120B**?

**AS9120B's primary objective is to establish a quality management system (QMS) for aerospace distributors that procure, store, split, and resell parts without altering product characteristics.** Built on ISO 9001:2015's 10-clause structure, it adds over 100 aerospace-specific requirements addressing distribution risks like loss of traceability, counterfeit/suspected unapproved parts, documentation errors, and external provider controls. This ensures chain-of-custody integrity, product safety, and conformity from receipt to delivery, functioning as a gatekeeper for aviation, space, and defense supply chains.

Who is legally or professionally required to comply with **AS9120B**?

**AS9120B applies to organizations in aviation, space, and defense that procure, store, split, or resell aerospace parts without altering product characteristics.** It targets stockist distributors, pass-through distributors, and batch splitters, excluding those performing value-added modifications, manufacturing, or maintenance/repair. While not legally mandatory, it is a commercial requirement imposed by OEMs and primes for supply chain approval, with ~2,442 global certifications (836 in the U.S. as of May 2023) enabling OASIS listing and market access.

Does **AS9120B** require an external audit or third-party certification?

**Yes, AS9120B requires third-party certification through a two-stage external audit process by an accredited certification body.** Stage 1 reviews documentation and scope; Stage 2 verifies implementation and effectiveness via on-site audits using AS9101F criteria like PEAR sheets. Certification, valid for 3 years with annual surveillance, lists organizations in the IAQG OASIS database, confirming QMS conformity to all applicable clauses.

How often should an assessment for **AS9120B** be performed?

**AS9120B requires internal audits at planned intervals to cover the entire QMS annually, plus management reviews at defined intervals aligned with strategic direction.** Internal audits (Clause 9.2) ensure conformity and effectiveness, with competent auditors using process-based methods like Turtle Diagrams. Management reviews (Clause 9.3) occur periodically (e.g., quarterly or semi-annually), incorporating performance data, risks, and audits. External surveillance audits follow certification, typically annually.

What are the consequences of non-compliance with **AS9120B**?

**Non-compliance with AS9120B results in audit nonconformities, certification denial/suspension, and commercial exclusion from OEM supply chains.** Major findings (e.g., weak traceability, counterfeit controls) trigger corrective actions; unresolved issues lead to recertification failure and OASIS delisting. Operationally, it risks product safety incidents, recalls, contractual penalties, and legal liability for nonconforming parts entering aviation/space/defense applications.

Can **AS9120B** be mapped to other international frameworks?

**AS9120B aligns directly with ISO 9001:2015's high-level structure, enabling seamless mapping and integration.** Its 10-clause PDCA framework shares Clauses 4-10 verbatim as a baseline, with aerospace additions (e.g., counterfeit prevention, traceability) layered on. Organizations with ISO 9001 certification can transition by addressing ~100 distributor-specific amplifications, retaining dual certification where scopes overlap.

What is the first step to begin implementing **AS9120B**?

**The first step for AS9120B implementation is conducting a formal gap analysis against all clauses using an AS9120B-specific checklist.** Form a cross-functional team to assess current processes versus requirements, prioritizing distributor risks like supplier controls and traceability. Document scope (Clause 4.3), justify "not applicable" determinations (e.g., 8.3 Design), and produce a prioritized backlog, risk register, and project charter with executive sponsorship.

HITRUST CSF vs AS9120B

Standards Comparison

HITRUST CSF

Voluntary

2022

Certifiable framework harmonizing 60+ security and privacy standards

AS9120B

Mandatory

2016

Aerospace QMS standard for distributors of parts.

Quick Verdict

HITRUST CSF delivers certifiable security assurance for healthcare via maturity-scored controls, while AS9120B ensures quality management for aerospace distributors through traceability and counterfeit prevention. Organizations adopt them for regulatory compliance, market access, and supply chain trust.

Information Security

HITRUST CSF

HITRUST Common Security Framework

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Harmonizes 60+ frameworks into single certifiable assessment
Risk-based tailoring via organizational/system/regulatory factors
Five-level maturity model from policy to managed
MyCSF platform for scoping, evidence, remediation workflows
Tiered assurance: e1 essentials, i1 implemented, r2 risk-based

Quality Management

AS9120B

AS9120B: Quality Management Systems - Distributors

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Counterfeit and suspect unapproved parts prevention
Traceability and chain-of-custody controls
External provider evaluation and monitoring
Risk-based operational planning
Product preservation and configuration management

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 authoritative sources like ISO 27001, NIST 800-53, HIPAA, PCI DSS, and GDPR. It employs a risk-based, maturity-driven approach for security and privacy assurance across industries, especially healthcare.

Key Components

19 assessment domains and hierarchical taxonomy (14 categories, 49 objectives, ~156 specifications).
Five-level maturity model: policy, procedure, implemented, measured, managed.
Tiered products: e1 (44 controls), i1 (182 requirements), r2 (tailored, 2-year).
MyCSF platform and centralized certification via authorized assessors.

Why Organizations Use It

Enables "assess once, report many" for multi-regulatory compliance.
Provides credible third-party assurance, reducing questionnaires and audits.
Drives operational maturity, risk reduction (99.4% breach-free claim), and market differentiation.
Supports cloud inheritance, TPRM, and insurance benefits.

Implementation Overview

Phased: scoping, readiness, remediation, validated assessment, continuous monitoring.
Applies to regulated sectors (healthcare, finance); scales by size/risk.
Requires MyCSF, evidence management, assessor validation for certification.

AS9120B Details

What It Is

AS9120B is the IAQG quality management system standard for aerospace distributors, based on ISO 9001:2015's high-level structure. It applies to organizations procuring, storing, splitting, and reselling parts without alteration, emphasizing risk-based thinking to address distribution risks like traceability loss and counterfeits.

Key Components

Over 100 aerospace-specific requirements beyond ISO 9001.
Core areas: context analysis, leadership, planning, support, operations (traceability, counterfeit prevention, supplier controls), performance evaluation, improvement.
Built on PDCA cycle; requires documented information, not a full manual.
Certification via accredited bodies, listed in OASIS database.

Why Organizations Use It

Commercial necessity for OEM/Tier-1 supply chains.
Mitigates risks of nonconformities, counterfeits, legal liabilities.
Enhances market access, customer trust, operational efficiency.
Builds resilience through KPIs, audits, continual improvement.

Implementation Overview

Phased: gap analysis, process design, training, audits (6-12 months).
Cross-functional teams; prioritizes supplier controls, traceability.
For distributors globally; voluntary but often contractually required.

Key Differences

Aspect	HITRUST CSF	AS9120B
Scope	Security/privacy controls, maturity scoring, 19 domains	Quality management for aerospace distribution, traceability
Industry	Healthcare, regulated sectors, industry-agnostic	Aerospace distributors, aviation/space/defense
Nature	Voluntary certifiable framework with assurance program	Voluntary QMS certification standard
Testing	External assessors, MyCSF platform, maturity model scoring	Internal audits, certification body Stage 1/2 audits
Penalties	Loss of certification, market exclusion	Loss of certification, supply chain exclusion

Scope

HITRUST CSF

Security/privacy controls, maturity scoring, 19 domains

AS9120B

Quality management for aerospace distribution, traceability

Industry

HITRUST CSF

Healthcare, regulated sectors, industry-agnostic

AS9120B

Aerospace distributors, aviation/space/defense

Nature

HITRUST CSF

Voluntary certifiable framework with assurance program

AS9120B

Voluntary QMS certification standard

Testing

HITRUST CSF

External assessors, MyCSF platform, maturity model scoring

AS9120B

Internal audits, certification body Stage 1/2 audits

Penalties

HITRUST CSF

Loss of certification, market exclusion

AS9120B

Loss of certification, supply chain exclusion

Frequently Asked Questions

Common questions about HITRUST CSF and AS9120B

HITRUST CSF FAQ

AS9120B FAQ

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HITRUST CSF

AS9120B

Quick Verdict

HITRUST CSF

Key Features

AS9120B

Key Features

Detailed Analysis

HITRUST CSF Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

AS9120B Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

HITRUST CSF FAQ

What is the primary objective of HITRUST CSF?

Who is legally or professionally required to comply with HITRUST CSF?

Does HITRUST CSF require an external audit or third-party certification?

How often should an assessment for HITRUST CSF be performed?

What are the consequences of non-compliance with HITRUST CSF?

Can HITRUST CSF be mapped to other international frameworks?

What is the first step to begin implementing HITRUST CSF?

AS9120B FAQ

What is the primary objective of AS9120B?

Who is legally or professionally required to comply with AS9120B?

Does AS9120B require an external audit or third-party certification?

How often should an assessment for AS9120B be performed?

What are the consequences of non-compliance with AS9120B?

Can AS9120B be mapped to other international frameworks?

What is the first step to begin implementing AS9120B?

You Might also be Interested in These Articles...

Beyond the Boardroom: 5 Ways Modern Compliance Software Elevates Every Department

CMMC Level 3 Implementation Guide: Integrating NIST SP 800-172 Enhanced Controls for APT Defense

CIS Controls v8.1, Operationalized: Top 10 Reasons Compliance Monitoring Software Accelerates Real-World Implementation

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

CE Marking vs ISO 45001

PDPA vs ISO 17025

PCI DSS vs RoHS