Which Compliance Framework
Do You Need?
Compare SOC 2 Type II, ISO 27001/42001, GDPR, HIPAA, EU AI Act, and NIST AI RMF
Compare AI compliance frameworks side-by-side by timeline, cost, geography, certification requirements, and AI-specific controls. Use our decision tree to find the best fit for your SaaS, healthcare, or AI company.
Framework Overview
Click to expand details for each framework
SOC 2 Type II
Trust Service Criteria for service organizations
SaaS companies, cloud service providers
ISO 27001 / 42001
Information security & AI management systems
Enterprise, international operations
GDPR
EU data privacy regulation
Companies processing EU citizen data
HIPAA
US healthcare data protection
Healthcare providers, health tech
EU AI Act
EU regulation for high-risk AI systems
High-risk AI systems in EU
NIST AI RMF
AI risk management framework
US federal contractors, AI developers
Side-by-Side Comparison
Key differences at a glance
| Aspect | SOC 2 | ISO 27001 | GDPR | HIPAA | EU AI Act | NIST |
|---|---|---|---|---|---|---|
| Primary Focus | Security controls | ISMS & AI governance | Data privacy | Healthcare data | High-risk AI | AI risk management |
| Certification Required | Yes (auditor) | Yes (certification body) | No (compliance) | No (compliance) | Yes (conformity) | No (voluntary) |
| Annual Audit | Yes | Yes (surveillance) | No | No | Yes | No |
| AI-Specific | No | Yes (42001) | Partial (DPIA) | No | Yes | Yes |
| Penalties | Contract breach | Certification loss | Up to €20M or 4% revenue | Up to $1.5M per violation | Up to €30M or 6% revenue | None (voluntary) |
Decision Tree
Answer these questions to find the right framework
Do you process EU citizen data?
GDPR is mandatory
Continue
Do you handle US healthcare data (PHI)?
HIPAA is mandatory
Continue
Are you selling to enterprise customers?
SOC 2 Type II recommended
Continue
Do you operate internationally?
ISO 27001 recommended
Continue
Is your AI system high-risk in the EU?
EU AI Act mandatory
NIST AI RMF recommended
Frequently Asked Questions
Common questions about AI compliance frameworks
Which compliance framework is best for a SaaS company?
SOC 2 Type II is the most common starting point for SaaS companies because enterprise buyers frequently require it. If you process EU data, add GDPR. If you build AI features, consider NIST AI RMF or ISO 42001 alongside SOC 2.
Do I need both SOC 2 and ISO 27001?
Not always. SOC 2 is preferred by North American enterprises, while ISO 27001 is more common internationally. If you sell globally, pursuing both gives you broader market access. ISO 27001 also includes a certifiable ISMS that SOC 2 lacks.
Is the EU AI Act mandatory for US companies?
Yes, if your AI system is placed on the EU market or its outputs are used in the EU, the EU AI Act applies extraterritorially. High-risk AI systems require conformity assessment, technical documentation, and human oversight measures.
How much does SOC 2 compliance cost?
SOC 2 Type II typically costs $15,000–$50,000 including auditor fees, with timelines of 3–6 months. Ongoing surveillance audits add recurring annual costs. Automation tools like HAIEC reduce evidence-collection effort by up to 70%.
What is the difference between ISO 27001 and ISO 42001?
ISO 27001 covers information security management systems (ISMS). ISO 42001 extends this to AI management systems, adding AI-specific controls for risk, transparency, and governance. Organizations often pursue them together.
Is NIST AI RMF legally required?
No, NIST AI RMF is voluntary. However, US federal contractors and agencies are expected to align with it, and it is increasingly referenced in procurement requirements. It is a practical starting point for AI risk management before pursuing stricter frameworks.