COPPA
U.S. regulation protecting children under 13 online privacy
ISO 13485
International standard for medical device quality management systems
Quick Verdict
COPPA mandates parental consent for child data online, protecting kids under 13 via FTC enforcement. ISO 13485 certifies QMS for medical devices, ensuring safety through audits. Companies adopt COPPA for legal compliance, ISO 13485 for market access and quality.
COPPA
Children's Online Privacy Protection Act (COPPA)
Key Features
- Mandates verifiable parental consent for child data collection
- Targets operators of child-directed websites and apps
- Defines broad personal information including geolocation and IDs
- Imposes up to $43,792 civil penalties per violation
- Grants parents data review, access, and deletion rights
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for device lifecycle processes
- Design/development verification and validation requirements
- Supplier evaluation and outsourcing management
- Post-market surveillance and complaint handling
- Process validation and traceability mandates
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
COPPA Details
What It Is
Children's Online Privacy Protection Act (COPPA) is a U.S. federal regulation enacted in 1998, effective 2000, enforced by the FTC. It protects children under 13 from unauthorized online data collection by commercial websites, apps, and IoT devices directed at kids or with actual knowledge of their users. Core approach mandates verifiable parental consent (VPC) before collecting, using, or disclosing personal information.
Key Components
- **Operator obligationsPrivacy policies, VPC, parental access/review/deletion, data minimization, security.
- Covers expansive **PIInames, addresses, device IDs, geolocation, audio/video files.
- 11+ VPC methods (e.g., credit card, video call).
- Safe harbor programs for compliance.
Why Organizations Use It
Legal requirement avoids $43,792 per violation fines (e.g., YouTube's $170M). Enhances parental trust, reduces breach risks, supports global operations targeting U.S. kids. Builds reputation amid rising enforcement.
Implementation Overview
Assess audience for child appeal, implement age screens/VPC, post policies, audit trackers. Applies to commercial operators worldwide; high burden for small firms but tools ease startup. No formal certification; FTC audits/enforces.
ISO 13485 Details
What It Is
ISO 13485:2016, titled Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certification standard. It specifies a risk-based QMS for organizations providing medical devices and services across the lifecycle, from design to decommissioning, emphasizing regulatory compliance and patient safety.
Key Components
- Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Core elements: documented procedures, risk management (per ISO 14971), validation, traceability, CAPA, audits.
- Requires quality manual, medical device files; built on process approach.
- Third-party certification by accredited bodies with stage 1/2 audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR 2026).
- Mitigates risks, ensures consistent conformity.
- Drives efficiency, scalability, supplier control.
- Builds stakeholder trust, reduces recalls/liabilities.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, internal audits.
- Applies to manufacturers/suppliers globally; scales by size/complexity.
- Involves eQMS, management reviews; surveillance audits post-certification.
Key Differences
| Aspect | COPPA | ISO 13485 |
|---|---|---|
| Scope | Child online privacy and data collection | Medical device quality management lifecycle |
| Industry | Online services, apps targeting children under 13, US/global | Medical device manufacturers, suppliers worldwide |
| Nature | US federal law, mandatory, FTC enforced | Voluntary certification standard, regulatory aligned |
| Testing | FTC audits, compliance reviews, no certification | Stage 1/2 audits, surveillance, certification bodies |
| Penalties | $43,792 per violation, e.g. YouTube $170M | No direct fines, loss of certification/market access |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about COPPA and ISO 13485
COPPA FAQ
ISO 13485 FAQ
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