Inferensys

Glossary

SOC 2

An auditing procedure developed by the AICPA that ensures a service organization securely manages data to protect the interests and privacy of its clients, a common requirement for healthcare SaaS vendors.
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TRUST SERVICES CRITERIA

What is SOC 2?

SOC 2 is an auditing procedure developed by the American Institute of CPAs that evaluates a service organization's controls relevant to security, availability, processing integrity, confidentiality, and privacy.

SOC 2 is a voluntary compliance standard for service organizations, developed by the American Institute of CPAs (AICPA), that specifies how companies should manage customer data. The standard is based on five Trust Services Criteria: security, availability, processing integrity, confidentiality, and privacy. A SOC 2 report, issued by an independent auditor, attests that a SaaS vendor has implemented the necessary controls to meet these criteria.

For healthcare AI vendors, a SOC 2 Type II report is often a prerequisite for enterprise contracts, as it demonstrates operational effectiveness over a sustained period—typically 6 to 12 months. Unlike a Type I report, which assesses control design at a single point in time, a Type II audit validates that controls like encryption, access management, and continuous monitoring function reliably, complementing HIPAA compliance and HITRUST certification in a comprehensive security posture.

SOC 2 FRAMEWORK

The Five Trust Services Criteria

The SOC 2 framework, developed by the AICPA, is structured around five foundational principles known as the Trust Services Criteria. These criteria provide a comprehensive blueprint for evaluating the security, availability, processing integrity, confidentiality, and privacy of a service organization's systems and data.

01

Security

Information and systems are protected against unauthorized access, unauthorized disclosure of information, and damage to systems that could compromise the availability, integrity, confidentiality, and privacy of information or systems.

  • Core Components: Firewalls, intrusion detection, multi-factor authentication (MFA), and strict access controls.
  • Objective: This is the foundational criterion, often referred to as the 'common criteria,' and is mandatory for every SOC 2 audit. It ensures the system is fortified against logical and physical threats.
02

Availability

Information and systems are available for operation and use to meet the entity's objectives.

  • Core Components: Performance monitoring, disaster recovery protocols, and incident handling.
  • Objective: This criterion assesses whether a system is accessible for use as stipulated by a contract or service level agreement (SLA). It does not address system functionality, only its operational accessibility.
03

Processing Integrity

System processing is complete, valid, accurate, timely, and authorized to meet the entity's objectives.

  • Core Components: Quality assurance procedures, data validation checks, and process monitoring.
  • Objective: This criterion verifies that data processing is error-free and functions as intended. It focuses on whether the system achieves its purpose without delay, omission, or accidental manipulation, ensuring data inputs map correctly to outputs.
04

Confidentiality

Information designated as confidential is protected to meet the entity's objectives.

  • Core Components: Encryption at rest and in transit, access controls, and secure disposal of data.
  • Objective: This criterion applies to all types of confidential information, including business plans, intellectual property, and customer data. It ensures that sensitive data is accessible only to a defined set of persons or organizations.
05

Privacy

Personal information is collected, used, retained, disclosed, and disposed of in conformity with the commitments in the entity's privacy notice and with criteria set forth in Generally Accepted Privacy Principles (GAPP).

  • Core Components: Data minimization, consent management, and data subject access rights.
  • Objective: This criterion specifically addresses the handling of personal information (PII) in line with the organization's stated privacy policy. It is distinct from confidentiality, as it deals with the rights of the individual to whom the data relates.
AUDIT COMPARISON

SOC 2 Type I vs. Type II

Key differences between the point-in-time suitability assessment and the sustained operational effectiveness audit under the AICPA Trust Services Criteria.

FeatureSOC 2 Type ISOC 2 Type II

Audit Focus

Suitability of control design at a specific date

Operating effectiveness of controls over a period of time

Observation Window

Point-in-time (single date)

Minimum 6-month review period

Tests Control Operation

Evaluates Control Design

Typical Duration

2-4 weeks

3-6 months

Evidence Collected

System description and control walkthroughs

Operational logs, access reviews, incident records, and configuration audits

Assurance Level

Moderate

High

Regulatory Acceptance

Often insufficient for enterprise vendor due diligence

Required by most healthcare enterprise procurement teams

SOC 2 COMPLIANCE

Frequently Asked Questions

Clear, technically precise answers to the most common questions about SOC 2 audits, their role in healthcare SaaS, and how they intersect with HIPAA compliance.

A SOC 2 (System and Organization Controls 2) report is an independent attestation audit developed by the American Institute of Certified Public Accountants (AICPA) that evaluates a service organization's controls relevant to security, availability, processing integrity, confidentiality, and privacy—the five Trust Services Criteria. Unlike a prescriptive checklist, SOC 2 is a flexible framework: an organization defines its own control objectives based on the services it delivers, and a licensed CPA firm audits whether those controls are suitably designed and operating effectively over a defined period. The audit results in one of two report types: a Type I report, which assesses the design of controls at a specific point in time, or a Type II report, which evaluates the operational effectiveness of those controls over a minimum six-month observation window. For a healthcare SaaS vendor handling clinical data, the Type II report is the gold standard, providing evidence that security controls—such as access management, encryption, and change management—are not merely documented but consistently enforced in production.

Prasad Kumkar

About the author

Prasad Kumkar

CEO & MD, Inference Systems

Prasad Kumkar is the CEO & MD of Inference Systems and writes about AI systems architecture, LLM infrastructure, model serving, evaluation, and production deployment. Over 5+ years, he has worked across computer vision models, L5 autonomous vehicle systems, and LLM research, with a focus on taking complex AI ideas into real-world engineering systems.

His work and writing cover AI systems, large language models, AI agents, multimodal systems, autonomous systems, inference optimization, RAG, evaluation, and production AI engineering.