Organizations operating in today's digital landscape face mounting pressure to demonstrate robust security and compliance practices. Healthcare technology companies face multiple compliance requirements as they work with both healthcare providers and general business customers.
Rather than approaching these certifications separately, combining SOC 2 and HITRUST e1 assessments presents a strategic opportunity. This approach streamlines compliance efforts while maximizing business value.
Understanding the synergy between SOC 2 and HITRUST e1
SOC 2 and HITRUST e1 serve complementary purposes in the compliance ecosystem. SOC 2, developed by the American Institute of CPAs, provides a flexible framework for demonstrating security, availability, processing integrity, confidentiality, and privacy controls. HITRUST e1 offers a prescriptive approach specifically tailored to healthcare information security.
The remarkable overlap between these frameworks means preparing for SOC 2 controls can accomplish up to 90% of the work required for HITRUST e1 certification. Both frameworks fundamentally address similar security concerns. They require organizations to implement controls around access management, data protection, incident response, and vendor management.
The primary difference lies in their approach and specificity. SOC 2 allows organizations to tailor controls to their specific business model and risk profile. HITRUST e1 provides explicit requirements designed for healthcare data protection. By pursuing both simultaneously, organizations avoid duplicating effort while ensuring comprehensive coverage of security controls.
The business case for combined compliance
The decision to pursue SOC 2 and HITRUST e1 together extends beyond operational efficiency. Modern healthcare technology vendors serve diverse customer bases spanning traditional healthcare providers, insurance companies, and corporate wellness programs. Each customer segment brings different compliance expectations.
Healthcare providers increasingly require HITRUST certification as a baseline for vendor relationships. Technology companies and enterprise clients typically expect SOC 2 reports as standard documentation of security practices.
Consider a health technology startup developing a patient engagement platform. This company serves hospitals directly while offering white-label solutions to employee benefits companies. The hospitals require HITRUST certification to ensure HIPAA compliance and alignment with their security programs. The benefits companies demand SOC 2 reports to satisfy their enterprise risk management requirements.
By obtaining both certifications through a combined audit process, this startup positions itself to serve both markets. It avoids doubling its compliance investment.
Financial advantages
The financial advantages become clear when examining the typical audit process. Separate assessments would require two distinct preparation phases, two sets of evidence collection, and two audit engagements. This duplication increases direct costs and creates significant operational burden.
Staff members must repeatedly demonstrate similar controls to different assessors. A combined approach consolidates these efforts. It reduces both the financial investment and time commitment required from internal teams.
Navigating the combined assessment process
The journey toward dual certification begins with understanding both frameworks' requirements. Organizations must map their existing controls against both SOC 2 criteria and HITRUST e1 requirements. This mapping exercise reveals gaps needing attention and highlights areas where single control implementations satisfy both frameworks.
Implementing multi-factor authentication for system access simultaneously addresses SOC 2's logical access controls and HITRUST's authentication requirements. This efficiency demonstrates the value of the combined approach.
Documentation standards
The preparation phase demands careful attention to documentation standards. Both frameworks require evidence of control implementation, but they may have different presentation expectations. Organizations should develop documentation practices satisfying the most stringent requirements from either framework.
This might mean maintaining logs for the longer retention period if frameworks differ. It could also mean documenting procedures with the greater level of detail required by one framework.
Selecting the right assessment firm
Selecting an assessment firm experienced in both frameworks is critical for success. Not all auditors possess the expertise or authorization to conduct both SOC 2 audits and HITRUST assessments. Working with a qualified firm that can perform both assessments simultaneously eliminates coordination challenges.
The assessor's familiarity with both frameworks provides valuable insights. They can help structure controls and evidence efficiently to meet dual requirements.
Practical implementation strategies
The readiness assessment phase serves as the foundation for successful dual certification. Organizations should conduct a gap analysis evaluating current practices against both frameworks simultaneously. This combined analysis prevents addressing SOC 2 requirements only to discover additional HITRUST gaps later.
The readiness assessment should produce a unified remediation plan. This plan should prioritize controls offering the greatest coverage across both frameworks.
Real-world example
Consider a digital therapeutics company preparing for expansion into hospital systems. During their readiness assessment, they discover their incident response procedures meet SOC 2 requirements. However, these procedures lack the specific healthcare breach notification timelines required by HITRUST.
Rather than creating separate procedures, they enhance their existing incident response plan. They incorporate HITRUST's healthcare-specific requirements while maintaining SOC 2 compliance. This integrated approach ensures procedures work effectively for both healthcare and non-healthcare incidents.
Evidence collection
Evidence collection represents another area where strategic planning yields significant benefits. Organizations should establish procedures capturing the most comprehensive data required by either framework. Automated evidence collection tools significantly reduce the burden of maintaining compliance documentation.
Configure these tools to collect evidence at the frequency and detail level required by the more stringent framework. This ensures sufficiency for both assessments.
Monitoring and continuous improvement
Implementing internal controls requires ongoing monitoring to ensure effectiveness. Both SOC 2 and HITRUST emphasize continuous monitoring, though they may specify different review frequencies or testing methodologies.
Organizations should develop monitoring programs satisfying both frameworks' requirements while avoiding redundant testing. This might involve scheduling control tests at the more frequent interval if requirements differ. It could also mean combining test procedures to evaluate multiple control objectives simultaneously.
Addressing different reporting periods
The monitoring program must address different reporting periods associated with each framework. SOC 2 Type 2 reports typically cover a minimum period of six months. HITRUST e1 assessments evaluate controls at a point in time with some looking back at historical evidence.
Organizations must ensure monitoring activities provide sufficient coverage for both assessment types. Maintain consistent control operation throughout the SOC 2 review period. Also be prepared for HITRUST's validation requirements.
Leveraging dual certification for business growth
Successfully achieving both certifications positions organizations for accelerated business development. Dual certification immediately expands addressable markets by removing compliance barriers. Sales cycles often accelerate when organizations can promptly provide both certifications.
This eliminates lengthy security reviews and compliance discussions that delay deal closure. The foundational compliance work also establishes a platform for future growth.
Building on the foundation
Organizations achieving HITRUST e1 certification complete substantial groundwork toward higher HITRUST assurance levels. These include i1 and r2 certifications, which become increasingly important when working with larger healthcare systems.
The SOC 2 foundation enables easier adoption of additional compliance frameworks. These might include ISO 27001 or specific regulatory requirements like GDPR.
Conclusion
Pursuing SOC 2 and HITRUST e1 certification simultaneously represents a strategic investment in organizational maturity and market positioning. The combined assessment requires careful planning and coordination. However, the benefits far exceed the incremental effort required beyond pursuing a single certification.
Organizations successfully navigating this dual certification process achieve greater efficiency in their compliance programs. They also position themselves as serious players in the healthcare technology ecosystem.
The overlapping nature of these frameworks makes joint pursuit logical. Combined with expanding market demand for both certifications, this approach makes sense for organizations committed to excellence in security and compliance.
FAQs about SOC 2 & HITRUST e1
What is HITRUST e1?
HITRUST e1 is the essentials-level, prescriptive information security assessment and certification. It establishes a solid baseline of security controls, especially for organizations handling healthcare-related data.
It focuses on core controls such as access management, data protection, incident response, and vendor management. It's quicker to achieve than higher assurance levels and serves as a practical stepping stone to HITRUST i1 and r2.
Does HITRUST cover SOC 2?
No. HITRUST and SOC 2 are separate programs with different outputs and audiences. HITRUST provides certification against the HITRUST CSF. SOC 2 is an independent auditor's attestation report against the AICPA Trust Services Criteria.
However, substantial overlap exists in controls like access, data protection, incident response, and vendor management. Work done for one can satisfy much of the other. You still need a separate SOC 2 engagement to obtain a SOC 2 report. A combined assessment with a firm qualified in both can produce both outcomes efficiently.
What is the difference between HITRUST e1 and r2?
Scope and rigor: e1 is the essentials-level, prescriptive baseline with a smaller, standardized control set. r2 is the most comprehensive, risk-based assessment tailored to your environment and risk factors.
Assurance level: e1 provides foundational assurance suited to lower-risk use cases and early-stage programs. r2 provides high assurance typically required by large healthcare organizations and for handling highly sensitive data.
Effort and timing: e1 is faster and less resource-intensive. r2 requires deeper evidence, testing, and maturity.
Validity: e1 certifications are generally valid for 1 year. r2 certifications are typically valid for 2 years with an interim review at year 1.
Use case: e1 serves as an on-ramp and stepping stone toward i1/r2. r2 is the gold standard when maximum assurance is needed.
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