When a hospital evaluates a new cloud-based EHR module, a health plan assesses a claims processing vendor, or a digital health startup pitches to an enterprise customer — the first question is almost always: “Are you SOC 2 certified?” SOC 2 has become the default security credential in healthcare IT, validating that a service organization’s controls actually protect the data it handles. It doesn’t replace HIPAA — but increasingly, it’s the proof that HIPAA obligations are being met.
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SOC 2, which stands for System and Organization Controls 2, is an auditing framework 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 — known as the Trust Services Criteria (TSC).
A SOC 2 report is produced by an independent CPA firm that audits the organization’s control environment against the applicable TSC categories. The report documents the controls in place, tests their operating effectiveness, and provides an auditor’s opinion on whether the controls meet the criteria.
SOC 2 comes in two types:
SOC 2 Type I — Evaluates the design of controls at a specific point in time. It answers: “Are the right controls in place?” This is a snapshot assessment — useful for organizations early in their compliance journey.
SOC 2 Type II — Evaluates the design and operating effectiveness of controls over a period of time (typically 6–12 months). It answers: “Are the controls working consistently?” Type II is the standard that healthcare buyers expect — a Type I report is often considered a stepping stone, not a final destination.
SOC 2 is not healthcare-specific — it applies to any service organization across industries. However, in healthcare, SOC 2 has become the de facto security validation for SaaS vendors, cloud platforms, data analytics companies, billing services, and any third-party handling protected health information on behalf of healthcare organizations.
In simple terms: SOC 2 is the independent audit that proves your security controls actually work — the certification healthcare buyers demand before trusting a vendor with their data.
SOC 2 operates through a defined audit process that evaluates an organization’s controls against the AICPA Trust Services Criteria.
Trust Services Criteria categories:
Security (Common Criteria) — Required for every SOC 2 audit. Covers controls protecting information and systems from unauthorized access — access controls, network security, vulnerability management, incident response, change management, and risk assessment. Security is the foundation that the other four categories build on.
Availability — Controls ensuring systems are operational and accessible as committed. Covers disaster recovery, business continuity, capacity planning, monitoring, and incident management. Particularly relevant for healthcare SaaS platforms where downtime directly impacts clinical operations.
Processing Integrity — Controls ensuring system processing is complete, valid, accurate, timely, and authorized. Relevant for billing platforms, claims processing systems, and analytics tools where data processing errors have financial or clinical consequences.
Confidentiality — Controls protecting information designated as confidential — trade secrets, intellectual property, and business-sensitive data. In healthcare, this extends to PHI handling beyond what HIPAA requires.
Privacy — Controls addressing the collection, use, retention, disclosure, and disposal of personal information. Relevant for organizations handling consumer health data that may fall outside HIPAA but under state privacy laws or FTC oversight.
The audit process:
The organization engages an independent CPA firm experienced in SOC 2 audits. The auditor evaluates the organization’s control descriptions against the applicable TSC criteria, tests the operating effectiveness of controls over the audit period (for Type II), documents findings and exceptions, and issues a report with an auditor’s opinion — unqualified (clean), qualified (with exceptions), or adverse.
SOC 2 in healthcare procurement. Healthcare organizations increasingly require SOC 2 Type II reports from vendors during procurement. The report is reviewed by the buyer’s security, compliance, and legal teams to assess whether the vendor’s controls adequately protect the data being entrusted. A clean SOC 2 Type II report significantly accelerates vendor approval — while the absence of one can disqualify a vendor entirely.
The TSC framework (2017 revision, effective 2018) aligns with COSO (Committee of Sponsoring Organizations) internal control framework principles. The criteria are organized into logical security domains: control environment, communication and information, risk assessment, monitoring activities, control activities, and logical/physical access controls.
Organizations can include additional subject matter in their SOC 2 audit — most commonly HIPAA. A SOC 2 + HIPAA report evaluates the organization’s controls against both TSC criteria and HIPAA Security Rule requirements in a single audit. This is increasingly common in healthcare — it demonstrates both general security posture (SOC 2) and healthcare-specific regulatory compliance (HIPAA) in one report.
SOC 2 and HITRUST are both security frameworks used in healthcare, but they serve different purposes. SOC 2 is an audit framework — an independent CPA evaluates your controls. HITRUST is a certification framework — your organization self-assesses against the HITRUST CSF (Common Security Framework), and a HITRUST-approved assessor validates the assessment. Some organizations pursue both: HITRUST for the comprehensive healthcare-specific framework, SOC 2 for the widely recognized independent audit report.
Cloud providers (AWS, Azure, GCP) maintain their own SOC 2 reports covering their infrastructure controls. Organizations building on cloud infrastructure should understand the shared responsibility model — the cloud provider’s SOC 2 covers infrastructure-level controls, but the customer is responsible for application-level controls, access management, data encryption configuration, and monitoring. Your SOC 2 audit scope covers your controls, not your cloud provider’s.
Achieving and maintaining SOC 2 compliance requires sustained investment in security infrastructure, documentation, and organizational discipline.
Readiness assessment first. Before engaging an auditor, conduct a readiness assessment — a gap analysis comparing your current controls against TSC criteria. Identify missing controls, undocumented processes, and areas where controls exist but aren’t consistently followed. Remediate gaps before the formal audit begins. Engaging the audit firm for a readiness assessment (separate from the formal audit) is common practice.
Control documentation is as important as the controls themselves. SOC 2 auditors evaluate not just whether controls exist but whether they’re documented — policies, procedures, configuration standards, and evidence of consistent execution. If you have excellent security practices but no documentation, the audit will identify exceptions. Build documentation into your security operations from the start.
Choose TSC categories strategically. Every SOC 2 audit must include Security. The other four categories (Availability, Processing Integrity, Confidentiality, Privacy) are optional. Include the categories your healthcare customers expect — most healthcare buyers want Security + Availability + Confidentiality at minimum. Adding categories increases audit scope and cost but strengthens your market position.
Continuous compliance, not annual scrambles. SOC 2 Type II evaluates controls over a period — typically 12 months. If controls lapse during the audit period, the auditor documents exceptions. Build continuous compliance monitoring into your operations — automated evidence collection, regular access reviews, ongoing vulnerability scanning, and incident response testing throughout the year.
HIPAA BAA alignment. If you’re a business associate handling PHI for healthcare organizations, your SOC 2 controls should align with your BAA obligations. The controls protecting PHI in your SOC 2 audit scope should map directly to the safeguards you’ve committed to in your BAAs. Inconsistency between your SOC 2 report and your BAA obligations creates compliance risk.
Engineering controls into your development process. For software companies, SOC 2 requires controls around change management, code review, deployment processes, access to production systems, and vulnerability management. These controls should be built into your CI/CD pipeline — not bolted on after development. Organizations using healthcare-specific development practices should align SOC 2 controls with their SDLC.
At Taction, we build healthcare software systems with SOC 2-ready security controls from day one — and help organizations prepare for and maintain SOC 2 compliance.
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