If your product touches protected health information (PHI), healthcare customers expect HIPAA compliance before they sign. We assess, build, and maintain your HIPAA program — risk assessment to remediation — so health data is handled correctly and deals close faster.
Four rules that protect patient data — and apply to you if you touch PHI
Requires administrative, physical, and technical safeguards for electronic PHI (ePHI). Includes the mandatory Security Risk Assessment — analyzing where ePHI lives, the threats against it, and the controls in place.
Defines how PHI may be used and disclosed, patient rights of access, and the minimum-necessary standard. Applies to covered entities and business associates alike.
Requires notification of individuals, HHS/OCR, and in large breaches the media — on strict timelines. You need an incident response plan that maps to these deadlines before a breach happens.
Extended HIPAA's reach to business associates — SaaS vendors included — and established the tiered penalty structure OCR enforces today, from reasonable-cause violations up to willful neglect.
A complete compliance program, built around your product
The foundation the Security Rule requires. We inventory where ePHI lives in your systems, identify threats and vulnerabilities, assess current safeguards, and document residual risk — the assessment OCR asks for first in any investigation.
Written, role-specific policies covering access management, encryption, device controls, data retention, and workforce sanctions — the documentation set auditors and customers expect.
Access controls, audit logging, encryption at rest and in transit, automatic logoff, and integrity controls — engineered for your stack and verified against the Security Rule's implementation specifications.
BAA review and drafting for your customer agreements, plus BAAs with your own sub-vendors. Every party that touches PHI on your behalf is contractually bound to safeguard it.
Role-based HIPAA awareness training for your team — what PHI is, how it's handled, how to spot and report a potential incident. Training records maintained for audit evidence.
A breach-response playbook aligned with the Breach Notification Rule: containment steps, risk-of-harm assessment, and notification timelines for individuals, OCR, and media.
HIPAA and SOC 2 share more than most vendors realize
If you're selling into healthcare, enterprise buyers often ask for both HIPAA compliance and a SOC 2 report. The good news: access controls, encryption, logging, change management, and risk assessment serve both frameworks. We build your program once, evidence both — cutting duplicate work roughly in half instead of running two separate compliance efforts.
• Start with the Security Risk Assessment (required by HIPAA, maps to SOC 2 risk assessment criteria)
• Build shared controls and evidence collection once
• Align policies to both frameworks' language
• Use readiness work for one audit to accelerate the other
• Maintain a single control register with dual mapping
From assessment to an operating program in four phases
PHI data-flow mapping, threat and vulnerability analysis, safeguard evaluation, and documented residual risk — the Security Rule's mandatory assessment.
Prioritized remediation plan addressing each risk-analysis finding: safeguards to implement, policies to write, contracts to update, and controls to engineer.
Technical safeguard implementation, policy rollout, BAA execution, workforce training, and incident response plan development — with our team guiding yours.
Periodic risk-assessment updates, training refreshers, policy reviews, and vendor BAA management. Compliance becomes an operating rhythm, not a one-time project.
Common questions answered
HIPAA applies to covered entities (health plans, clearinghouses, and providers who transmit health data electronically) and their business associates. If your product stores, processes, or transmits PHI on behalf of a healthcare customer, you are a business associate — and you must comply with the Security Rule, the applicable parts of the Privacy Rule, and the Breach Notification Rule.
A Business Associate Agreement is required whenever a business associate handles PHI for a covered entity. It must define permitted uses and disclosures, require appropriate safeguards, mandate breach reporting, and flow down to subcontractors. You need BAAs with your customers and with your own sub-vendors that touch PHI.
OCR enforces four penalty tiers based on culpability: from lack of knowledge up through reasonable cause, willful neglect that is corrected, and willful neglect that is not corrected. Per-violation penalties scale significantly by tier, and annual maximums per identical violation can reach into the millions — with recent OCR settlements regularly exceeding seven figures.
The Security Rule requires a risk assessment as an implementation specification — OCR treats it as the foundational compliance activity. Best practice is an annual assessment plus updates whenever there is a material change: new systems, new vendors, new product features that touch PHI, or any security incident.
They answer different questions. HIPAA is a legal requirement when you handle PHI — it's not optional. SOC 2 is a voluntary attestation that enterprise buyers use to evaluate your security posture. Most healthtech SaaS companies need HIPAA first, then add SOC 2 because hospital IT and procurement demand it. The two programs share substantial control overlap, so we build them together efficiently.
A working program — risk assessment, safeguards, policies, BAAs, training, and incident response — typically takes 6–10 weeks depending on company size and how much PHI infrastructure already exists. Ongoing maintenance (annual risk assessments, training refreshers, policy reviews) then keeps the program current.
Build a comprehensive security and compliance program
Pair HIPAA with the audit healthcare buyers want.
An international framework that maps well to HIPAA.
Executive oversight for your compliance program.
Let's assess your PHI risk and build a program that holds up to scrutiny.