HIPAA
US federal regulation for protecting health information privacy security
AS9120B
Aerospace QMS standard for distributors of parts.
Quick Verdict
HIPAA mandates privacy/security for healthcare PHI, enforced by OCR penalties. AS9120B certifies aerospace distributors' QMS for traceability/counterfeit prevention. Organizations adopt HIPAA for legal compliance, AS9120B for supply chain access.
HIPAA
Health Insurance Portability and Accountability Act of 1996
Key Features
- Risk-based safeguards for ePHI confidentiality, integrity, availability
- Minimum necessary principle limiting PHI uses and disclosures
- Presumption-of-breach model with four-factor risk assessment
- Direct liability for business associates via BAAs
- Individual rights to access, amend, and account for PHI
AS9120B
AS9120B Quality Management Systems - Requirements
Key Features
- Counterfeit and unapproved parts prevention
- Traceability and chain-of-custody controls
- Risk-based external provider evaluation
- Configuration management for split lots
- Product safety and ethical awareness
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
HIPAA Details
What It Is
HIPAA (Health Insurance Portability and Accountability Act of 1996) is a US federal regulation establishing national standards to protect individuals' protected health information (PHI). It includes Privacy, Security, and Breach Notification Rules, adopting a flexible, risk-based, technology-neutral approach for covered entities and business associates.
Key Components
- Privacy Rule (45 CFR Part 164 Subparts A/E): Controls PHI uses/disclosures, minimum necessary, TPO permissions, patient rights.
- Security Rule (Subpart C): Administrative, physical, technical safeguards for ePHI; requires risk analysis/management.
- Breach Notification Rule (Subpart D): Presumption-of-breach notifications within 60 days. Seven pillars like scope, BA governance; enforced by OCR, no certification.
Why Organizations Use It
- Mandatory compliance for healthcare providers, plans, clearinghouses, BAs.
- Mitigates breach risks, multimillion penalties.
- Enables secure data flows, builds patient trust.
- Supports operations, partnerships, cyber resilience.
Implementation Overview
Phased: Assess (risk analysis, scoping), Build (safeguards, BAAs, training), Operate (monitoring), Assure (audits). Applies US-wide to healthcare; ongoing program with 6-year documentation.
AS9120B Details
What It Is
AS9120B is the IAQG quality management system standard for aviation, space, and defense distributors. It augments ISO 9001:2015's high-level structure with over 100 aerospace-specific requirements. Primary purpose: ensure safe procurement, storage, splitting, and resale of parts without altering characteristics. Adopts risk-based thinking and PDCA approach focused on distribution risks like traceability loss and counterfeits.
Key Components
- **Core clausesContext (4), Leadership (5), Planning (6), Support (7), Operation (8), Evaluation (9), Improvement (10).
- Distributor emphases: counterfeit prevention, traceability, supplier controls, configuration management.
- Built on ISO 9001:2015; certification via accredited bodies with IAQG OASIS listing.
Why Organizations Use It
- Commercial necessity for OEM supply chains.
- Mitigates risks of nonconformities, counterfeits.
- Enhances market access, customer trust, efficiency.
Implementation Overview
- Phased: gap analysis, process design, training, audits (6-12 months).
- For distributors globally; requires internal audits, management reviews.
Key Differences
| Aspect | HIPAA | AS9120B |
|---|---|---|
| Scope | PHI privacy, security, breach notification | Aerospace distribution QMS, traceability, counterfeit prevention |
| Industry | Healthcare, covered entities, business associates | Aerospace parts distributors, stockists |
| Nature | Mandatory US federal regulation | Voluntary certification standard |
| Testing | Risk analysis, internal audits, OCR investigations | Internal audits, certification body surveillance audits |
| Penalties | Civil monetary penalties, criminal prosecution | Loss of certification, market exclusion |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about HIPAA and AS9120B
HIPAA FAQ
AS9120B FAQ
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