SOC 2

History and overview

SOC 2 is an auditing standard developed by the American Institute of CPAs (AICPA). It evaluates how service organizations handle data based on five Trust Service Criteria: security, availability, processing integrity, confidentiality, and privacy.

Why is it relevant?

– Demonstrates internal control reliability

– Essential for vendor due diligence

– Helps secure sensitive healthcare data and comply with HIPAA

Scope of Application

Applies to AI vendors offering SaaS platforms for healthcare:

– AI model hosting providers

– Analytics platforms for medical data

– Patient engagement apps

Key Obligations and Requirements

– Annual SOC 2 Type 1 or Type 2 audits

– Controls over access, security, availability

– Continuous monitoring and incident response

Documentation and Governance Requirements:

– System descriptions

– Risk management policies

– Control testing evidence and audit trails

Risks and Challenges

– High cost of implementation and auditing

– Resource burden for small vendors

Best Practices

– Implement SOC 2-aligned controls early

– Automate compliance monitoring

Future Developments

– Expansion to AI-specific control frameworks