SOC 2 vs HIPAA: How They Compare for Healthcare Data

At Agency, we work with dozens of healthcare technology companies navigating the intersection of SOC 2 and HIPAA — and the most common question we hear is whether one framework can substitute for the other. The short answer is no. HIPAA is a federal law that imposes mandatory requirements on covered entities and their business associates for protecting protected health information (PHI). SOC 2 is a voluntary attestation framework developed by the AICPA that evaluates a service organization's controls against the Trust Service Criteria. Healthcare technology companies frequently encounter both frameworks because their customers — hospitals, health systems, health plans — require HIPAA compliance as a legal obligation and SOC 2 reports as an independent verification of security controls during vendor procurement.

This guide compares SOC 2 and HIPAA across their scope, requirements, enforcement mechanisms, and practical implications for healthcare technology companies. We cover where the frameworks overlap, where they diverge, why most health tech companies pursue both, and how to build a compliance program that satisfies both frameworks efficiently.

Fundamental Differences

Framework Origins and Authority

Dimension	SOC 2	HIPAA
Type	Voluntary attestation framework	Federal law (enacted 1996)
Governing body	AICPA (American Institute of Certified Public Accountants)	US Department of Health and Human Services (HHS), Office for Civil Rights (OCR)
Who it applies to	Any service organization that chooses to undergo the attestation	Covered entities and business associates that handle PHI
Enforcement	Market-driven — customers require SOC 2 reports during procurement	Regulatory — HHS/OCR enforces through audits, investigations, and penalties
Penalty for non-compliance	Loss of customer deals; no regulatory penalty	Civil penalties up to $2.1 million per violation category per year; criminal penalties for willful violations
Assessment method	Independent CPA firm attestation engagement	Self-assessment, business associate agreements, OCR audits and investigations
Output	SOC 2 report (Type I or Type II) with auditor opinion	No standard report — compliance demonstrated through policies, BAAs, risk analysis, and breach history

Scope Comparison

SOC 2 evaluates controls across five Trust Service Criteria — Security, Availability, Processing Integrity, Confidentiality, and Privacy. The scope is defined by the organization and its auditor based on the services provided and customer requirements. SOC 2 applies to any type of data, not exclusively healthcare data.

HIPAA focuses specifically on protected health information. The HIPAA Security Rule establishes safeguards for electronic PHI (ePHI), the Privacy Rule governs the use and disclosure of PHI in any form, and the Breach Notification Rule defines requirements for reporting PHI breaches.

Scope Dimension	SOC 2	HIPAA
Data in scope	Any data the organization processes (defined by system boundaries)	Protected health information (PHI) specifically
Control framework	Trust Service Criteria (CC1-CC9, plus optional criteria)	Security Rule (administrative, physical, technical safeguards), Privacy Rule, Breach Notification Rule
Geographic applicability	Global (used primarily in US but recognized internationally)	US federal law (applies to US-based entities and those handling US PHI)
Industry applicability	Any industry	Healthcare and healthcare-adjacent industries
Flexibility	Organization selects which Trust Service Criteria to include	Required safeguards are prescribed by regulation (some addressable, some required)

Where SOC 2 and HIPAA Overlap

Despite their different structures and purposes, SOC 2 and HIPAA share significant control overlap. In our experience working with health tech clients, organizations implementing controls for one framework will find that many of those controls also satisfy requirements in the other.

Control Overlap Areas

Control Domain	SOC 2 Requirement	HIPAA Requirement	Overlap Level
Access management	CC6 — logical access controls, authentication, provisioning, deprovisioning	Security Rule §164.312(a) — access controls, unique user identification, emergency access	High
Risk assessment	CC3 — formal risk assessment, risk register, change-driven reassessment	Security Rule §164.308(a)(1)(ii)(A) — risk analysis	High
Incident response	CC7 — incident detection, response, communication, post-incident review	Breach Notification Rule §164.400-414 — breach detection, notification to individuals and HHS	High
Encryption	CC6 — data protection at rest and in transit	Security Rule §164.312(a)(2)(iv) and §164.312(e)(1) — encryption (addressable)	High
Audit logging	CC7 — security event logging and monitoring	Security Rule §164.312(b) — audit controls	High
Employee training	CC1 — security awareness and training	Security Rule §164.308(a)(5) — security awareness and training	Medium
Change management	CC8 — change authorization, testing, deployment	Security Rule §164.308(a)(8) — evaluation after changes	Medium
Business continuity	CC9, A1 — business continuity and disaster recovery	Security Rule §164.308(a)(7) — contingency plan	Medium
Vendor management	CC9 — vendor risk assessment and monitoring	Security Rule §164.308(b)(1) — business associate contracts	Medium
Physical security	CC6 — physical access controls (if applicable)	Security Rule §164.310 — physical safeguards	Medium

What we consistently see is that an organization implementing SOC 2 Common Criteria (Security) controls thoroughly addresses approximately sixty to seventy percent of HIPAA Security Rule requirements. The remaining HIPAA requirements are specific to PHI handling, breach notification, and the Privacy Rule — areas that SOC 2's optional Privacy and Confidentiality criteria partially address.

What SOC 2 Covers That HIPAA Does Not

SOC 2 Area	Description
Availability criteria	Specific uptime commitments, capacity planning, recovery testing — HIPAA addresses contingency planning but not availability SLAs
Processing Integrity criteria	Data processing accuracy, completeness, and timeliness — not addressed by HIPAA
Independent attestation	Third-party CPA firm opinion on control effectiveness — HIPAA has no equivalent independent assessment requirement
Continuous monitoring evidence	GRC platform evidence of ongoing control effectiveness — HIPAA requires periodic evaluation but not continuous monitoring

What HIPAA Covers That SOC 2 Does Not

HIPAA Area	Description
PHI-specific privacy rules	Detailed rules governing use and disclosure of PHI, minimum necessary standard, patient authorization requirements
Breach notification requirements	Specific notification timelines — sixty days to individuals, annual HHS reporting for breaches under 500 records, immediate reporting for larger breaches
Patient rights	Right to access, amend, and receive an accounting of disclosures of PHI
Business Associate Agreements	Required contractual provisions between covered entities and business associates
Regulatory enforcement	OCR investigations, corrective action plans, civil and criminal penalties
Designated privacy and security officers	Required designation of individuals responsible for HIPAA compliance

Why Healthcare Technology Companies Need Both

The Customer Expectation

Healthcare organizations — hospitals, health systems, health plans, pharmacy benefit managers — evaluate technology vendors through two parallel lenses:

1. Legal compliance: Is the vendor HIPAA-compliant? Will they sign a Business Associate Agreement? Do they have appropriate safeguards for PHI?
2. Security assurance: Can the vendor demonstrate, through independent assessment, that their security controls are effective? This is where SOC 2 fills a critical gap that HIPAA alone cannot address.

HIPAA compliance is self-attested. There is no standard HIPAA certification or report — a vendor can claim HIPAA compliance without any independent verification. Healthcare buyers increasingly recognize this limitation and require SOC 2 reports as third-party evidence that security controls actually work as described.

The Procurement Reality

Procurement Requirement	What Satisfies It
"Are you HIPAA compliant?"	Signed BAA, HIPAA policies, security risk analysis, workforce training evidence
"Provide your SOC 2 report"	SOC 2 Type II report from a licensed CPA firm
"Complete our security questionnaire"	Combination of SOC 2 report, HIPAA documentation, and supplementary evidence
"Do you have a HITRUST certification?"	HITRUST CSF certification (some healthcare buyers require this additionally)

Most enterprise healthcare procurement processes require all of the above. SOC 2 alone does not satisfy HIPAA obligations, and HIPAA compliance alone does not provide the independent assurance that enterprise buyers demand.

Building a Combined SOC 2 and HIPAA Program

Trust Service Criteria Selection for Healthcare

Criterion	Recommendation for Health Tech	Rationale
Security (Common Criteria)	Required	Mandatory for SOC 2; addresses core HIPAA Security Rule requirements
Availability	Strongly recommended	Healthcare systems support clinical workflows; downtime has patient safety implications
Processing Integrity	Recommended for clinical data	Required when processing clinical data where accuracy affects patient outcomes
Confidentiality	Strongly recommended	Aligns with HIPAA PHI confidentiality requirements; demonstrates data protection commitment
Privacy	Recommended	Addresses PHI privacy requirements and aligns with HIPAA Privacy Rule obligations

We recommend including Security, Availability, Confidentiality, and Privacy in your SOC 2 scope to create the broadest overlap with HIPAA requirements and demonstrate to healthcare buyers that your SOC 2 program was designed with PHI protection in mind.

Implementation Priority

Priority	Control Area	SOC 2 Mapping	HIPAA Mapping
1	Access management (MFA, RBAC, deprovisioning)	CC6	§164.312(a)
2	Encryption at rest and in transit	CC6	§164.312(a)(2)(iv), §164.312(e)(1)
3	Risk assessment	CC3	§164.308(a)(1)(ii)(A)
4	Audit logging and monitoring	CC7	§164.312(b)
5	Incident response and breach notification	CC7	§164.400-414
6	Employee security training	CC1	§164.308(a)(5)
7	Vendor management and BAAs	CC9	§164.308(b)(1)
8	Business continuity and disaster recovery	CC9, A1	§164.308(a)(7)

We advise our clients to implement these controls in priority order because it addresses the highest-impact requirements of both frameworks simultaneously. Access management and encryption produce the most findings in SOC 2 audits and the most enforcement actions under HIPAA — addressing them first reduces risk across both frameworks.

HIPAA-Specific Requirements Beyond SOC 2

Even with a comprehensive SOC 2 program, healthcare technology companies must implement HIPAA-specific requirements that SOC 2 does not cover:

HIPAA Requirement	What to Implement
Business Associate Agreement	Standard BAA template reviewed by legal counsel; executed with every covered entity customer
Designated Security Officer	Named individual responsible for HIPAA Security Rule compliance
Designated Privacy Officer	Named individual responsible for HIPAA Privacy Rule compliance (can be the same person as Security Officer)
PHI-specific risk analysis	Risk analysis focused specifically on ePHI — covering all systems that create, receive, maintain, or transmit ePHI
Minimum necessary standard	Policies limiting PHI access and disclosure to the minimum necessary for each use
Patient rights procedures	Procedures for responding to patient requests for access, amendment, and accounting of disclosures
Breach notification procedures	Specific procedures meeting HIPAA timelines — sixty days to affected individuals, annual report to HHS for small breaches, immediate report for breaches affecting 500+ individuals
Workforce sanctions policy	Policy establishing sanctions for employees who violate HIPAA policies

Using GRC Platforms for Both Frameworks

GRC platforms like Vanta, Drata, Secureframe, and Sprinto support both SOC 2 and HIPAA compliance within a single platform. The platform maps controls across both frameworks, so implementing a control once satisfies the corresponding requirements in both SOC 2 and HIPAA.

Platform Feature	SOC 2 Benefit	HIPAA Benefit
Cross-framework control mapping	Single control satisfies both SOC 2 and HIPAA requirements	Reduces duplicate effort
Automated evidence collection	Continuous SOC 2 evidence gathering	Ongoing HIPAA compliance monitoring
Policy management	SOC 2 policy templates and tracking	HIPAA policy templates and tracking
Employee training tracking	Security awareness training evidence	HIPAA workforce training evidence
Risk assessment tools	SOC 2 risk assessment documentation	HIPAA security risk analysis

Common Misconceptions

Misconception	Reality
"SOC 2 compliance means we are HIPAA compliant"	SOC 2 addresses many HIPAA Security Rule requirements but does not cover HIPAA-specific obligations like BAAs, PHI-specific breach notification, patient rights, or Privacy Rule requirements
"HIPAA compliance means we do not need SOC 2"	HIPAA is self-attested with no standard report; enterprise healthcare buyers require SOC 2 as independent third-party verification of security controls
"HITRUST replaces both SOC 2 and HIPAA"	HITRUST CSF certification covers both SOC 2 and HIPAA control domains but is a separate framework with its own assessment process and cost (typically two to three times more expensive than SOC 2)
"We only need HIPAA if we are a hospital"	Any organization that handles PHI on behalf of a covered entity is a business associate subject to HIPAA — this includes most health tech companies
"SOC 2 with Privacy criterion fully covers HIPAA Privacy Rule"	The SOC 2 Privacy criterion addresses personal information broadly, not PHI specifically; HIPAA Privacy Rule has requirements (minimum necessary, patient rights, authorizations) not covered by SOC 2 Privacy

HITRUST as a Combined Alternative

Some healthcare technology companies pursue HITRUST CSF certification as a comprehensive alternative that maps to both SOC 2 and HIPAA requirements. HITRUST incorporates control requirements from multiple frameworks — including HIPAA, SOC 2, ISO 27001, NIST, and PCI DSS — into a single assessment.

Factor	SOC 2 + HIPAA	HITRUST
Cost	$50,000-$150,000 combined (SOC 2 audit + HIPAA program)	$100,000-$250,000 for initial certification
Timeline	Three to six months for SOC 2; HIPAA program is ongoing	Six to twelve months for initial certification
Market acceptance	Universally accepted across healthcare and non-healthcare buyers	Strong acceptance in healthcare; less recognized outside healthcare
Maintenance	Annual SOC 2 audit + ongoing HIPAA compliance	Biennial recertification with annual interim assessment
Independent verification	SOC 2 provides CPA attestation; HIPAA is self-attested	HITRUST provides third-party certification for both

For most healthcare technology companies, we recommend pursuing SOC 2 first and HIPAA compliance in parallel. SOC 2 provides broader market value (accepted by non-healthcare buyers too), while HIPAA compliance is a legal obligation. HITRUST is most valuable for companies whose customer base is predominantly large healthcare organizations that specifically require HITRUST certification.

Key Takeaways

• HIPAA is a federal law with mandatory requirements for organizations handling PHI; SOC 2 is a voluntary attestation framework — they serve different purposes but overlap significantly on security controls
• We consistently see that SOC 2 Common Criteria controls address approximately sixty to seventy percent of HIPAA Security Rule requirements — organizations implementing one framework get substantial progress toward the other
• Healthcare technology companies typically need both: HIPAA compliance is a legal obligation; SOC 2 provides the independent third-party verification that enterprise healthcare buyers require
• HIPAA is self-attested with no standard report — SOC 2 fills the assurance gap by providing an auditor-attested evaluation of security controls
• We recommend including Security, Availability, Confidentiality, and Privacy in your SOC 2 scope to maximize alignment with HIPAA requirements
• HIPAA-specific requirements beyond SOC 2 include Business Associate Agreements, designated privacy and security officers, PHI-specific breach notification timelines, and patient rights procedures
• GRC platforms support both frameworks with cross-framework control mapping, reducing duplicate implementation effort
• HITRUST CSF certification is a comprehensive alternative that maps to both SOC 2 and HIPAA but costs two to three times more than SOC 2 alone

Frequently Asked Questions

Does a SOC 2 report satisfy HIPAA requirements?

What we tell clients is: no, but it gets you a significant head start. A SOC 2 report demonstrates effective security controls but does not fulfill all HIPAA obligations. HIPAA requires specific elements — Business Associate Agreements, designated privacy and security officers, PHI-specific breach notification procedures, patient rights processes, and compliance with the Privacy Rule — that SOC 2 does not address. However, a SOC 2 report provides strong evidence of security control effectiveness that supports HIPAA compliance. Healthcare buyers view SOC 2 as complementary to HIPAA, not a substitute.

Should we pursue SOC 2 or HIPAA compliance first?

The advice we give most often here is to start both simultaneously. For healthcare technology companies, HIPAA compliance should begin immediately — it is a legal requirement from the moment you handle PHI. SOC 2 should be pursued in parallel because enterprise healthcare buyers require it during procurement. In practice, many of the controls you implement for HIPAA (access management, encryption, audit logging, risk assessment) directly support your SOC 2 program. Starting both simultaneously leverages the control overlap and avoids duplicate effort.

Do we need HITRUST if we already have SOC 2 and HIPAA compliance?

Based on what we see across our client base, not necessarily. HITRUST CSF certification is valuable when your customer base consists primarily of large healthcare organizations (major hospital systems, national health plans) that specifically require HITRUST as a procurement condition. If your customers accept SOC 2 reports and HIPAA compliance documentation, HITRUST adds cost without proportional benefit. We recommend surveying your top customers and prospects to determine whether HITRUST is a stated requirement before investing in the certification.

Which Trust Service Criteria should healthcare companies include?

In our experience, the strongest combination is Security (mandatory), Confidentiality, Availability, and Privacy. Confidentiality aligns with HIPAA PHI requirements. Availability matters because clinical systems must be reliable. Privacy aligns with HIPAA Privacy Rule obligations. Processing Integrity should be included if your platform processes clinical data where accuracy affects patient outcomes — EHR systems, clinical decision support tools, and lab information systems fall into this category. Including all five criteria provides the most comprehensive SOC 2 report for healthcare buyer evaluation.