HIPAA
U.S. regulation for health information privacy and security
TISAX
Automotive framework for trusted information security assessments
Quick Verdict
HIPAA mandates PHI protection for US healthcare via Privacy, Security, and Breach rules enforced by OCR fines. TISAX standardizes automotive supply chain security assessments for prototype/IP protection via shareable labels. Healthcare complies legally; automotive suppliers win contracts competitively.
HIPAA
Health Insurance Portability and Accountability Act
Key Features
- Risk-based safeguards for electronic PHI
- Minimum necessary principle limits disclosures
- Business associates direct liability via BAAs
- Presumption-of-breach with four-factor assessment
- Individual rights including PHI access
TISAX
Trusted Information Security Assessment Exchange (TISAX)
Key Features
- Risk-based assessment levels (AL1-AL3)
- ENX portal for secure result exchange
- Prototype protection modules for automotive IP
- VDA ISA catalog with 70+ controls
- Three-year labels reducing duplicate audits
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
HIPAA Details
What It Is
Health Insurance Portability and Accountability Act (HIPAA) of 1996 is a U.S. federal regulation establishing national standards for protecting individuals' health information. It comprises the Privacy Rule, Security Rule, and Breach Notification Rule, using a risk-based, flexible, scalable approach for safeguarding protected health information (PHI) and electronic PHI (ePHI) across covered entities and business associates.
Key Components
- **Privacy RuleControls PHI uses/disclosures, minimum necessary, patient rights.
- **Security RuleAdministrative, physical, technical safeguards; risk analysis required.
- **Breach Notification RuleTimely reporting of unsecured PHI breaches.
- Seven pillars including scope, TPO permissions, BAAs; no fixed control count, enforced via OCR.
Why Organizations Use It
Mandated for healthcare entities; reduces breach risks, enables secure data flows, builds patient trust, avoids penalties up to $2M annually. Strategic benefits: cyber resilience, vendor management, market differentiation.
Implementation Overview
Phased: assess risks, implement safeguards, monitor continuously. Applies to providers, plans, BAs nationwide; no certification but OCR audits, documentation retained 6 years.
TISAX Details
What It Is
TISAX (Trusted Information Security Assessment Exchange) is an industry-standardized assessment framework developed by the ENX Association and VDA for the automotive supply chain. It verifies organizations' ability to protect sensitive information like IP, prototypes, and personal data against threats. Rooted in a risk-based approach, it defines three protection levels: Normal, High, Very High.
Key Components
- VDA ISA catalog with 70+ controls across 7 groups (Policy, Access, Operations, etc.)
- Modules: Information Security, Prototype Protection, Data Protection
- Built on ISO 27001 and CIA triad
- Maturity-based assessments (AL1 self, AL2 remote, AL3 on-site); labels valid 3 years
Why Organizations Use It
- Contractual mandates from OEMs (e.g., BMW, Volkswagen)
- Reduces duplicate audits by 70-90%, cuts costs
- Enables market access, builds partner trust
- Mitigates breach risks, enhances resilience
Implementation Overview
- Phased: Gap analysis, remediation, audits (6-18 months)
- Tabletop exercises, accredited providers (e.g., DQS, TÜV)
- Applies to suppliers, OEMs, services; scalable for SMEs/multinationals
Key Differences
| Aspect | HIPAA | TISAX |
|---|---|---|
| Scope | PHI privacy, security, breach notification for healthcare | Information security, prototype protection for automotive supply chain |
| Industry | Healthcare (US covered entities, BAs) | Automotive suppliers, OEMs (primarily Europe) |
| Nature | US federal regulation with OCR enforcement | Voluntary industry assessment and exchange |
| Testing | Risk analysis, no mandatory external audits | AL1-AL3 assessments by accredited providers |
| Penalties | Civil/criminal fines up to $2M+ per violation | Contractual exclusion, no direct legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about HIPAA and TISAX
HIPAA FAQ
TISAX FAQ
You Might also be Interested in These Articles...
The Human-AI Synergy: How Modern Compliance Tools Amplify Your Team's Strategic Impact
Unlock human-AI synergy with modern compliance tools. Automate monitoring, cut non-compliance risks 3x, and boost strategic decision-making. Elevate your team's
Top 5 Reasons TISAX Tabletop Exercises Prevent €10M+ Supply Chain Breaches for ADAS Tier 1 Suppliers in 2025
Unlock top 5 reasons TISAX tabletop exercises deliver 4:1 ROI preventing €10M+ supply chain breaches for ADAS Tier 1 suppliers. ENX case studies & VDA ISA contr
Top 10 NIST CSF 2.0 Myths Busted: Separating Hype from Reality for Smarter Adoption
Bust 10 NIST CSF 2.0 myths like 'only for critical infrastructure' or 'Govern replaces Identify'. Plain-English breakdowns, evidence, and fixes for flexible ris
Run Maturity Assessments with GRADUM
Transform your compliance journey with our AI-powered assessment platform
Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.
Check out these other Gradum.io Standards Comparison Pages
ISO 27032 vs EU AI Act
ISO 27032 vs EU AI Act: Compare cybersecurity guidelines with AI risk regs. Align for compliance, resilience & innovation in digital ecosystems. Unlock strategies now!
HIPAA vs NIST 800-53
Compare HIPAA vs NIST 800-53: Key differences in privacy, security rules & compliance for healthcare. Align frameworks, master risk management & safeguard ePHI—read now!
ENERGY STAR vs PDPA
Compare ENERGY STAR vs PDPA: U.S. energy efficiency benchmarks vs Asia's data privacy laws. Gain compliance strategies, certification tips & global insights. Optimize now!