SOC 2 for Healthcare SaaS: What Healthtech Companies Need to Know

We work with healthtech companies at every stage of growth, and one question comes up in nearly every initial conversation: "We're already HIPAA compliant — do we really need SOC 2 too?" The short answer is yes, and here's why it matters more than most healthtech founders expect.

Healthtech companies need SOC 2 in addition to HIPAA because the two frameworks serve different but complementary purposes. HIPAA establishes minimum safeguards for protected health information (PHI), while SOC 2 provides independent, third-party attestation that your security controls are designed and operating effectively over time. Hospital systems, health plans, and large provider organizations increasingly require both — HIPAA compliance alone is no longer sufficient to pass enterprise vendor security reviews in the healthcare sector.

This guide explains how SOC 2 applies specifically to healthcare SaaS companies, covering which Trust Service Criteria matter most for healthtech, how SOC 2 and HIPAA overlap and diverge, the healthtech-specific controls auditors expect to see, and what healthcare enterprise buyers look for when evaluating your SOC 2 report. Whether you are building EHR integrations, patient-facing platforms, telehealth tools, or clinical data analytics, this playbook addresses the compliance challenges unique to your vertical.

Why Healthtech Companies Need Both SOC 2 and HIPAA

HIPAA is a legal requirement for entities that handle PHI. SOC 2 is a market requirement driven by enterprise buyer expectations. The distinction matters because each framework addresses different questions:

• HIPAA answers: Are you meeting the minimum legal requirements for protecting health information?
• SOC 2 answers: Has an independent auditor verified that your security controls are well-designed and consistently effective over time?

Healthcare enterprise buyers — hospital systems, health plans, pharmacy benefit managers, and integrated delivery networks — have vendor risk management programs that evaluate both. They need to confirm HIPAA compliance as a legal baseline, and they need SOC 2 as independent verification that your broader security program meets professional standards.

Three factors drive this dual requirement:

1. Regulatory audit exposure. When a healthcare organization onboards a technology vendor, they accept risk. If a breach occurs through that vendor, the healthcare organization faces OCR (Office for Civil Rights) investigation and potential HIPAA penalties. Your SOC 2 report provides documented evidence that the healthcare organization exercised due diligence in vendor selection.

2. Business Associate Agreement enforcement. HIPAA requires Business Associate Agreements (BAAs) between covered entities and their vendors, but a BAA is a contract — it does not verify security practices. SOC 2 provides the verification that the BAA promises are actually being fulfilled through operational controls.

3. Competitive differentiation. The healthtech market is crowded, and enterprise healthcare buyers use SOC 2 as a filtering criterion in procurement evaluations. Having SOC 2 Type II moves you past the security review stage faster and demonstrates compliance maturity that HIPAA alone does not convey.

Which Trust Service Criteria Matter for Healthtech

We recommend that healthtech companies consider a broader set of Trust Service Criteria than the minimum Security-only scope, because healthcare buyer expectations and the nature of health data create requirements across multiple criteria.

Trust Service Criterion	Relevance to Healthtech	Recommendation
Security	Required for all SOC 2 audits. Covers the controls that protect PHI and other sensitive data from unauthorized access.	Always include — mandatory
Availability	Critical for healthtech platforms that support clinical workflows, patient care, or time-sensitive health data access. Downtime in healthcare can affect patient safety.	Include for most healthtech companies
Confidentiality	Directly relevant given the sensitivity of PHI and the contractual confidentiality obligations in Business Associate Agreements.	Strongly recommended for healthtech
Privacy	Include if your platform collects consumer health information directly from patients, particularly for patient-facing apps, telehealth platforms, or consumer health tools.	Include for patient-facing platforms
Processing Integrity	Relevant for platforms that perform clinical calculations, process lab results, aggregate health data, or generate clinical decision support outputs.	Include if you process or transform health data

The most common healthtech SOC 2 scope includes Security, Availability, and Confidentiality. Patient-facing platforms often add Privacy. Clinical data analytics and decision support tools should consider Processing Integrity to address accuracy and completeness of data outputs.

How SOC 2 and HIPAA Overlap

SOC 2 and HIPAA share significant common ground. Understanding the overlap allows you to build a unified compliance program rather than maintaining two separate sets of controls.

Control Mapping: Where the Frameworks Align

Control Area	SOC 2 Requirement	HIPAA Requirement	Overlap
Access controls	CC6: Logical and physical access controls	§164.312(a): Access control	High — both require unique user IDs, role-based access, and access reviews
Encryption	CC6.1, CC6.7: Encryption in transit and at rest	§164.312(a)(2)(iv), §164.312(e)(1): Encryption and transmission security	High — both require encryption of sensitive data
Audit logging	CC7.1, CC7.2: System monitoring and detection	§164.312(b): Audit controls	High — both require logging of access to sensitive data
Incident response	CC7.3, CC7.4: Incident detection and response	§164.308(a)(6): Security incident procedures	Moderate — SOC 2 is more prescriptive about response documentation
Risk assessment	CC3.1-CC3.4: Risk identification and analysis	§164.308(a)(1)(ii)(A): Risk analysis	Moderate — both require formal risk assessments; HIPAA specifies PHI-specific risks
Workforce training	CC1.4: Competence commitment	§164.308(a)(5): Security awareness training	Moderate — both require security training for all workforce members
Vendor management	CC9.2: Vendor risk management	§164.308(b): Business associate contracts	Moderate — SOC 2 is broader; HIPAA focuses on BAAs specifically
Business continuity	A1.2: Recovery operations	§164.308(a)(7): Contingency plan	Moderate — both require backup and recovery capabilities

Where the Frameworks Diverge

Despite the overlap, each framework contains requirements that the other does not:

HIPAA requirements not covered by SOC 2:

• Designation of a HIPAA Privacy Officer and Security Officer
• Patient rights management (access, amendment, accounting of disclosures)
• Notice of Privacy Practices
• Breach notification to individuals, HHS, and media (specific HIPAA timelines and procedures)
• Minimum Necessary standard for PHI use and disclosure
• Business Associate Agreement management

SOC 2 requirements not covered by HIPAA:

• Formal change management controls with documented approval workflows
• Vendor security assessment beyond BAA requirements
• System description and boundary documentation
• Annual independent third-party attestation (HIPAA does not require external audits)
• Continuous monitoring and evidence collection across the full control environment

The practical takeaway: implementing SOC 2 gives you approximately seventy to eighty percent coverage of HIPAA's Security Rule technical safeguards. The remaining HIPAA-specific requirements — primarily around privacy rights, breach notification procedures, and BAA management — require dedicated attention.

Healthtech-Specific Controls Auditors Expect

Beyond standard SOC 2 controls, auditors experienced in healthtech focus on controls that address the unique risks of handling health data and integrating with healthcare systems.

PHI Access and Segregation Controls

Healthcare data demands stricter access controls than general business data:

• Role-based PHI access that restricts health data visibility to only those employees and system components that require it for their function
• Data environment segregation that isolates PHI processing from non-health-related data and from development and testing environments
• Break-glass procedures for emergency PHI access situations — documented processes that allow controlled access escalation with full audit trail capture
• Minimum Necessary enforcement that limits data access to the minimum amount of PHI needed for each operation or user role

EHR Integration Security

If your platform integrates with electronic health record systems (Epic, Cerner, Meditech, Allscripts), auditors pay close attention to:

• HL7 FHIR and API security for health data exchange, including OAuth 2.0 authentication, token management, and scope restrictions
• Integration credential management with rotation schedules and access logging for service accounts connecting to EHR systems
• Data validation controls that verify the integrity and completeness of health data received through integrations
• Connection monitoring with alerting for EHR integration failures, latency anomalies, and authentication errors

De-identification and Anonymization

If your platform handles de-identified health data for analytics, research, or secondary use:

• HIPAA Safe Harbor or Expert Determination method compliance documentation
• Re-identification risk assessment procedures
• Controls preventing linkage between de-identified datasets and patient identity data
• Access restrictions on de-identified data that prevent unauthorized re-identification attempts

Telehealth and Patient-Facing Platform Controls

For telehealth, patient portal, and consumer health applications:

• Session security including automatic session timeout, secure video transmission, and recording consent management
• Patient authentication that verifies patient identity before granting access to health records or clinical services
• Consent management for data collection, treatment, and sharing — including granular consent tracking for different data use purposes
• Mobile device security for patient-facing mobile applications, including secure data storage, certificate pinning, and jailbreak detection

What Healthcare Enterprise Buyers Expect

Healthcare enterprise buyers — hospital systems, health plans, and large provider networks — have some of the most demanding vendor security review processes of any industry.

Vendor Security Review Process

The typical healthcare enterprise procurement cycle includes:

1. Initial security questionnaire — Often based on the SIG (Standardized Information Gathering) framework or the institution's custom security questionnaire, frequently containing 300-500 questions
2. SOC 2 report review — Your Type II report is reviewed by the institution's information security team
3. HIPAA documentation review — BAA negotiation, HIPAA compliance attestation, and evidence of workforce training
4. Technical security assessment — May include penetration testing results, cloud security configuration review, or architecture documentation
5. Ongoing monitoring — Annual reassessment of your SOC 2 report and HIPAA compliance status

What Reviewers Prioritize

In our experience, healthcare security reviewers focus on several areas with particular intensity:

• PHI handling documentation: Clear documentation of how your platform collects, stores, processes, transmits, and disposes of PHI. Reviewers expect your SOC 2 system description to address PHI flows specifically.
• Encryption standards: AES-256 for PHI at rest and TLS 1.2 or higher for PHI in transit. Healthcare buyers may inquire about specific cipher suite configurations.
• Breach notification capabilities: Your incident response plan must address HIPAA breach notification timelines — sixty days from discovery for notification to individuals and HHS.
• Subprocessor transparency: Full disclosure of every third-party vendor that may access, process, or store PHI on your behalf, along with evidence that each vendor is HIPAA-compliant and covered by a BAA.
• Availability SLAs: For platforms supporting clinical workflows, healthcare buyers expect documented uptime commitments, typically 99.9% or higher, with evidence of historical uptime performance.

Planning Your Healthtech SOC 2 Audit

Recommended Approach: Unified SOC 2 + HIPAA Program

Rather than managing SOC 2 and HIPAA as separate compliance programs, we recommend building a unified program that satisfies both frameworks simultaneously. The implementation sequence:

1. Implement SOC 2 controls first — these provide the broadest coverage and the most structured framework for evidence collection
2. Layer HIPAA-specific requirements on top — add PHI-specific policies (Notice of Privacy Practices, patient rights procedures, breach notification procedures), designate HIPAA officers, and implement BAA management
3. Use your GRC platform to map controls across both frameworks — platforms like Vanta, Drata, and Secureframe support dual SOC 2 and HIPAA compliance with shared controls that map to both frameworks automatically

This approach reduces total effort by forty to fifty percent compared to implementing each framework independently.

Auditor Selection for Healthtech

Cost and Timeline for Healthtech

Healthtech SOC 2 audits are moderately more expensive than average due to expanded scope, HIPAA overlap requirements, and the complexity of health data handling controls.

Metric	Healthtech Range	Industry Average
Type I total cost	$35,000-$75,000	$25,000-$60,000
Type II total cost	$65,000-$180,000	$50,000-$150,000
Time to Type I report	3-5 months	2-4 months
Time to Type II report	10-16 months	8-15 months
Typical TSC scope	Security, Availability, Confidentiality	Security only or Security + Availability

Key Takeaways

• We consistently see that healthtech companies need both SOC 2 and HIPAA — HIPAA is the legal baseline, but SOC 2 provides the independent verification that enterprise healthcare buyers require before moving forward
• What we recommend for most healthtech companies is a SOC 2 scope that includes Security, Availability, and Confidentiality criteria
• In our experience, SOC 2 and HIPAA overlap seventy to eighty percent on technical security controls — we always advise building a unified program rather than managing them separately
• Healthcare-specific controls that we help clients implement include PHI access segregation, EHR integration security, de-identification procedures, and telehealth session security
• What we tell every healthtech client: hospital systems and health plans have some of the most demanding vendor security review processes — prepare your SOC 2 report with their specific priorities in mind
• We recommend selecting an auditor with explicit healthcare industry experience for more efficient fieldwork
• Based on what we see across our client base, healthtech SOC 2 costs run ten to twenty percent above average due to expanded scope and regulatory complexity

Frequently Asked Questions

If we are already HIPAA compliant, do we still need SOC 2?

What we tell clients is: yes, absolutely, for enterprise healthcare sales. HIPAA compliance is a legal requirement that addresses the minimum safeguards for PHI, but it does not include independent third-party attestation. SOC 2 provides that attestation through an audited report issued by a CPA firm. Based on what we see in every healthcare deal cycle, most hospital systems and health plans require both a signed BAA (HIPAA) and a current SOC 2 Type II report (independent verification) from their technology vendors. HIPAA alone does not satisfy the vendor security review requirements of enterprise healthcare buyers.

Which SOC 2 Trust Service Criteria do hospital systems require?

Based on what we see across our healthtech clients, most hospital systems expect Security and Availability at minimum. Availability is particularly important for platforms that support clinical workflows, because downtime can affect patient care. Confidentiality is frequently requested as well, given the sensitive nature of PHI. Privacy is expected for patient-facing platforms that collect health information directly from consumers. What we recommend is asking your prospective buyer's security team which criteria they require early in the procurement process — the specific requirements vary by institution.

How long does it take to get SOC 2 if we already have a HIPAA compliance program?

What we tell clients with a mature HIPAA compliance program is that they have a significant head start on SOC 2. Many HIPAA controls — access management, encryption, audit logging, workforce training, risk assessment — map directly to SOC 2 requirements. In our experience, SOC 2 readiness in this scenario typically takes six to ten weeks of incremental effort focused on formalizing change management, vendor management, and evidence collection processes that HIPAA does not address as explicitly. The total timeline to a Type I report is typically two to four months from the decision to pursue SOC 2.

Can a single audit cover both SOC 2 and HIPAA?

What we tell clients is: not exactly — SOC 2 and HIPAA are different frameworks assessed by different types of evaluators. However, many CPA firms that perform SOC 2 audits also offer HIPAA attestation services, and some offer combined engagements where both assessments occur during the same period using shared evidence. Based on what we see, this approach is more cost-effective than engaging separate firms for each framework. We recommend asking your auditor whether they offer combined SOC 2 and HIPAA engagements.

What is the most common SOC 2 finding specific to healthtech companies?

Based on what we see across our healthtech clients, the most common finding is inadequate segregation of PHI in non-production environments. Development teams frequently use real or insufficiently de-identified patient data in staging or testing environments, which violates both SOC 2 access control expectations and HIPAA's minimum necessary standard. What we recommend is implementing proper data masking or synthetic data generation for non-production environments — this resolves the finding and strengthens both your SOC 2 and HIPAA compliance posture.