Deep fluency across the frameworks your auditors and clients expect.

HIPAA compliance is where most healthcare organizations begin — and where most compliance failures ultimately surface. The Privacy Rule, Security Rule, and Breach Notification Rule establish baseline requirements for any entity that creates, receives, maintains, or transmits protected health information. The HITECH Act extended these obligations to business associates and significantly increased enforcement penalties.

Our HIPAA advisory work goes beyond the standard risk assessment checklist. We conduct comprehensive Security Rule risk analyses examining all three safeguard categories — administrative, physical, and technical — with specific attention to the distinction between required and addressable implementation specifications. Where an addressable specification is not implemented, we document the rationale and alternative measures that provide equivalent protection, creating a defensible compliance position.

For healthcare SaaS organizations, HIPAA compliance intersects directly with your technical architecture: encryption at rest and in transit, access control granularity, audit logging completeness, and incident response capabilities. We translate between your engineering team and regulatory requirements to ensure controls are both technically sound and regulatory-compliant.

HITRUST CSF has become the de facto standard for healthcare organizations that need to demonstrate comprehensive security maturity to enterprise clients and partners. The R2 certification, in particular, is increasingly required in healthcare SaaS procurement processes — replacing the "send us your SOC 2" approach with a healthcare-specific, independently validated assessment.

We prepare organizations for HITRUST assessment across all three tiers. For organizations new to HITRUST, we typically begin with an e1 readiness assessment to establish baseline maturity, then build toward i1 or R2 certification based on the organization's client requirements and timeline. Our preparation includes complete control mapping across all 19 domains, policy alignment, evidence collection system design, and mock assessment exercises.

A critical advantage of our approach is multi-framework mapping. HITRUST CSF incorporates requirements from HIPAA, NIST, ISO 27001, PCI DSS, and other standards. We leverage this overlap deliberately — implementing controls that satisfy HITRUST requirements while simultaneously addressing SOC 2 criteria and HIPAA safeguards. This compresses your total compliance investment and reduces the operational burden of maintaining multiple independent compliance programs.

SOC 2 has become table stakes for SaaS organizations selling to enterprise healthcare customers. A Type I report attests that your controls are suitably designed at a point in time. A Type II report goes further, attesting that those controls operated effectively over an observation period — typically six to twelve months.

We support organizations through the complete SOC 2 lifecycle: scoping the appropriate Trust Services Categories (Security is always in scope; Availability, Confidentiality, Processing Integrity, and Privacy are selected based on your service and client commitments), designing controls that satisfy criteria while remaining operationally practical, building evidence collection mechanisms, and managing the audit process itself.

Our audit support includes Information Request List management — the detailed evidence inventory your CPA firm will require. We prepare evidence packages, coordinate auditor walkthroughs, draft management responses to any identified exceptions, and ensure your team is prepared for every aspect of the examination. The goal is a clean report with zero surprises.

NIST SP 800-53 provides the most granular and comprehensive control catalog available, organizing over 1,000 security and privacy controls across 20 families. While not mandatory for all healthcare organizations, NIST alignment is increasingly valued by enterprise clients, government-adjacent payers, and organizations pursuing FedRAMP authorization.

We provide crosswalk mapping between NIST 800-53 and your existing HIPAA, HITRUST, or SOC 2 compliance programs — identifying where you already satisfy NIST requirements through existing controls and where incremental effort is required. This prevents the common mistake of treating NIST as a separate compliance initiative when substantial overlap already exists.

CMS regulations impose specific obligations on organizations that process Medicare and Medicaid data, operate as claims clearinghouses, or serve Medicare Advantage plans. These requirements layer on top of HIPAA obligations and address operational concerns that HIPAA alone does not cover — including offshore data access restrictions, clearinghouse independence requirements, and attestation obligations.

We advise organizations navigating the intersection of CMS requirements and SaaS operations, particularly around the increasingly scrutinized question of offshore PHI access in development and support environments.

21 CFR Part 11 establishes requirements for organizations that use electronic records or electronic signatures in FDA-regulated contexts. For healthcare software companies, this means ensuring that clinical data systems, electronic health records, and laboratory information systems maintain appropriate audit trails, access controls, and validation documentation.

We advise on the practical implementation of Part 11 requirements within modern software architectures — addressing system validation approaches, audit trail integrity, electronic signature reliability, and the documentation practices that FDA expects during inspection.