GLBA
U.S. law for financial privacy notices and safeguards
ISO 13485
International standard for medical device quality management systems
Quick Verdict
GLBA mandates privacy notices and security for US financial firms protecting NPI, while ISO 13485 certifies risk-based QMS for global medical device makers ensuring safety. Firms adopt GLBA for legal compliance, ISO 13485 for market access and quality.
GLBA
Gramm-Leach-Bliley Act (GLBA)
Key Features
- Mandates privacy notices and opt-out for NPI sharing
- Requires written information security program with safeguards
- Broad activity-based financial institution definition
- Designates Qualified Individual for security oversight
- 30-day FTC breach notification for 500+ consumers
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls across device lifecycle
- Design development verification and validation
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing management
- Process and software validation requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GLBA Details
What It Is
Gramm-Leach-Bliley Act (GLBA), enacted 1999, is a U.S. federal regulation for financial institutions handling nonpublic personal information (NPI). It establishes Privacy Rule, Safeguards Rule, and Pretexting Provisions using a risk-based approach to privacy transparency and data security.
Key Components
- **Privacy Rule (16 C.F.R. Part 313)Initial/annual notices, opt-out for nonaffiliated sharing.
- **Safeguards Rule (16 C.F.R. Part 314)Written security program with administrative, technical, physical safeguards; Qualified Individual; board reporting; breach notification.
- **PretextingAnti-social engineering protections. Enforced by FTC for non-banks; no certification, but compliance via audits/enforcement.
Why Organizations Use It
Mandated for broad financial entities (banks, lenders, tax firms); reduces enforcement risks ($100K+ penalties); enhances trust, vendor oversight; supports resilience amid cyber threats.
Implementation Overview
Phased: scope NPI, risk assessment, policies, controls (encryption, MFA), training, testing. Applies to activity-based financial institutions globally operating in U.S.; ongoing audits, no formal certification.
ISO 13485 Details
What It Is
ISO 13485:2016, officially Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certification standard. It outlines risk-based QMS requirements for organizations across the medical device lifecycle, from design to post-market surveillance, emphasizing regulatory compliance and patient safety.
Key Components
- Clauses 4–8 cover QMS foundation, management responsibility, resources, product realization, and measurement/improvement.
- Core elements: documented processes, design controls, validation, traceability, supplier management, CAPA, and risk integration (per ISO 14971).
- Built on process approach; certified via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Enables market access under EU MDR, FDA QMSR (2026).
- Mitigates risks, reduces recalls, cuts quality costs.
- Builds stakeholder trust, competitive edge in supply chains.
Implementation Overview
- Phased: gap analysis, documentation build, training, validation, internal audits.
- Applies to manufacturers, suppliers globally; 9–18 months typical for mid-size firms.
- Requires certification audits every 3 years.
Key Differences
| Aspect | GLBA | ISO 13485 |
|---|---|---|
| Scope | Consumer financial privacy and data security | Medical device quality management lifecycle |
| Industry | Financial institutions, non-banks (US-focused) | Medical device manufacturers, suppliers (global) |
| Nature | US federal regulation with FTC enforcement | Voluntary international certification standard |
| Testing | Risk assessments, penetration testing, annual reports | Internal audits, process validation, management reviews |
| Penalties | Civil penalties up to $100k per violation | Loss of certification, no direct legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GLBA and ISO 13485
GLBA FAQ
ISO 13485 FAQ
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