HIPAA
US regulation safeguarding PHI privacy, security, breach notification
ISO 19600
International guidelines for compliance management systems
Quick Verdict
HIPAA mandates privacy/security for US healthcare PHI with OCR enforcement, while ISO 19600 provides voluntary CMS guidelines for all organizations. Healthcare entities adopt HIPAA for legal compliance; others use ISO 19600 for risk-based governance frameworks.
HIPAA
Health Insurance Portability and Accountability Act of 1996
Key Features
- Mandates risk-based safeguards for ePHI confidentiality, integrity, availability
- Requires Business Associate Agreements extending liability to vendors
- Presumption-of-breach model with four-factor risk assessment
- Minimum necessary principle limits PHI uses and disclosures
- Individual rights to access, amend, and account for PHI
ISO 19600
ISO 19600:2014 Compliance management systems — Guidelines
Key Features
- Risk-based compliance management framework
- Good governance principles with independence
- Scalable for all organization sizes
- PDCA cycle for continual improvement
- Integrates with existing management systems
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
HIPAA Details
What It Is
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 is a US federal regulation via Administrative Simplification rules (45 CFR Parts 160, 162, 164). It establishes national standards protecting protected health information (PHI) through Privacy Rule (uses/disclosures), Security Rule (ePHI safeguards), and Breach Notification Rule. Employs a risk-based, flexible, scalable approach tailored to entity size, risks, and costs.
Key Components
- **Privacy RuleMinimum necessary, TPO permissions, authorizations, patient rights.
- **Security RuleAdministrative (risk analysis, training), physical (access controls), technical (encryption, audit) safeguards.
- **Breach Notification60-day notifications, presumption-of-breach.
- Seven pillars: scope, individual rights, BA governance, enforcement; anchored in documented risk management; OCR-driven compliance.
Why Organizations Use It
- Mandatory for covered entities (providers, plans, clearinghouses) and business associates.
- Mitigates penalties (up to $2M+ annually), builds trust, enables secure care/operations.
- Reduces breach risks, supports innovation via de-identification.
Implementation Overview
Phased: assess (risk analysis), implement safeguards/BAAs/training, monitor/audit. Applies US-wide to healthcare; no certification but OCR investigations/settlements require documentation retention (6 years).
ISO 19600 Details
What It Is
ISO 19600:2014, titled Compliance management systems — Guidelines, is a Type B guidance standard from the International Organization for Standardization. It provides recommendations for establishing, developing, implementing, evaluating, maintaining, and improving a Compliance Management System (CMS) using a risk-based approach applicable to all organization sizes, sectors, and geographies.
Key Components
- Follows Annex SL high-level structure with 10 clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
- Core principles: good governance, proportionality, transparency, sustainability.
- Emphasizes PDCA cycle; no mandatory requirements or certification.
Why Organizations Use It
- Reduces legal penalties, operational disruptions, reputational damage.
- Drives efficiency (10-20% cost savings), better decision-making, market access.
- Fosters integrity culture, prepares for ISO 37301 certification.
- Builds stakeholder trust via demonstrated compliance benchmarking.
Implementation Overview
- Phased roadmap: leadership commitment, gap analysis, design/documentation, rollout, continuous improvement.
- Scalable for SMEs (lightweight) to multinationals; integrates with ISO 9001/14001.
- No formal audits; self-benchmarking and internal reviews.
Key Differences
| Aspect | HIPAA | ISO 19600 |
|---|---|---|
| Scope | PHI privacy, security, breach notification | General compliance management systems |
| Industry | US healthcare covered entities, BAs | All industries, all organization sizes |
| Nature | Mandatory US federal regulation | Voluntary international guidelines |
| Testing | Risk analysis, OCR audits, settlements | Internal audits, management reviews |
| Penalties | Civil fines up to $2M+, criminal charges | No direct penalties, certification optional |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about HIPAA and ISO 19600
HIPAA FAQ
ISO 19600 FAQ
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