RoHS
EU regulation restricting hazardous substances in EEE
HITRUST CSF
Certifiable framework harmonizing 60+ security standards
Quick Verdict
RoHS restricts hazardous substances in EEE for EU market access, while HITRUST CSF provides certifiable security controls for healthcare. Manufacturers adopt RoHS to sell legally; providers use HITRUST for trusted assurance and compliance.
RoHS
Directive 2011/65/EU (RoHS 2)
Key Features
- Homogeneous material concentration limits (0.1% default)
- Open scope for all EEE unless excluded
- Time-limited exemptions via delegated acts
- Technical file and EU Declaration of Conformity
- Tiered verification using IEC 62321 methods
HITRUST CSF
HITRUST Common Security Framework (CSF)
Key Features
- Harmonizes 60+ standards into unified controls
- Risk-based tailoring via organizational factors
- Five-level maturity scoring model
- e1/i1/r2 certifiable assessment paths
- Inheritance from cloud providers and vendors
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
RoHS Details
What It Is
RoHS (Directive 2011/65/EU, recast as RoHS 2) is an EU regulation restricting hazardous substances in electrical and electronic equipment (EEE). Its primary purpose is protecting health and environment by limiting risks in EEE waste management, alongside WEEE Directive. Scope covers all EEE unless excluded, using homogeneous material approach with maximum concentration values (MCVs): 0.1% for most, 0.01% for cadmium.
Key Components
- Ten restricted substances (Pb, Hg, Cd, Cr(VI), PBB, PBDE, four phthalates).
- Annexes III/IV for time-limited exemptions.
- Conformity via technical documentation (EN IEC 63000), EU Declaration of Conformity (DoC), CE marking.
- IEC 62321 for tiered testing (XRF screening, ICP-MS/GC-MS confirmation). No certification; self-declaration with market surveillance.
Why Organizations Use It
Mandated for EU market access; prevents fines, recalls, bans. Drives supply chain governance, substitution innovation, recyclability. Enhances ESG, level playing field, global compliance baseline.
Implementation Overview
Risk-based: scope analysis, BoM review, supplier declarations, testing high-risk materials, technical files (10-year retention). Applies to manufacturers/importers/distributors of EEE; phased (3-18 months by size). Cross-functional: design, procurement, quality.
HITRUST CSF Details
What It Is
HITRUST Common Security Framework (CSF) is a certifiable, threat-adaptive control framework that consolidates requirements from 60+ standards like HIPAA, NIST, ISO 27001, PCI DSS, and GDPR. It employs a risk-based, maturity-driven approach for security and privacy assurance.
Key Components
- 19 assessment domains and hierarchical structure (14 categories, 49 objectives, ~156 specifications).
- Five-level maturity model: Policy, Procedure, Implemented, Measured, Managed.
- Risk factors for tailoring; e1/i1/r2 certification paths via MyCSF platform.
Why Organizations Use It
- Meets multi-regulatory demands with 'assess once, report many' mappings.
- Provides credible third-party assurance, reduces audit fatigue.
- Enhances risk management, stakeholder trust, market access in healthcare/finance.
- Reported 99.4% breach-free rate among certified entities.
Implementation Overview
- Phased: scoping, gap analysis, remediation, validated assessment.
- Involves policies, evidence automation, assessor engagement.
- Suited for regulated industries; requires MyCSF, external assessors for certification.
Key Differences
| Aspect | RoHS | HITRUST CSF |
|---|---|---|
| Scope | Hazardous substances in EEE materials | Information security and privacy controls |
| Industry | Electronics manufacturing, global | Healthcare and regulated sectors, global |
| Nature | Mandatory EU product regulation | Voluntary certifiable framework |
| Testing | XRF/ICP-MS on homogeneous materials | Maturity-based assessor validation |
| Penalties | Fines, recalls by Member States | Loss of certification, no legal fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about RoHS and HITRUST CSF
RoHS FAQ
HITRUST CSF FAQ
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