If you're building digital health software and selling into the US market, you've probably already typed "HIPAA compliance cost" into Google more than once. It's a fair question and a hard one to answer honestly, because most of what comes back is either a vendor selling a $50,000 platform subscription or a blog post with a suspiciously round number and no explanation of what's actually included. Here's a straighter answer, with the ranges we actually see and what drives them.
The short answer
For a typical early-stage or growth-stage digital health company, HIPAA readiness work runs somewhere between $8,000 and $35,000 depending on scope, team size, and how much of your infrastructure is already documented. Ongoing maintenance, once you're in a steady state, is usually a fraction of that per year. Full HITRUST certification is a different animal entirely and can run well into six figures, which is why most companies selling into US healthcare start with HIPAA readiness rather than jumping straight to HITRUST.
That range is wide on purpose. The number that matters to you depends on a handful of specific variables, not on which firm you hire.
What actually drives the price
Three things move the cost more than anything else.
How much you've already documented. If you have a risk assessment, business associate agreements with your vendors, and basic access control policies already in place, you're paying for a gap assessment and remediation plan. If you're starting from a blank folder, you're paying for someone to build your Security Rule and Privacy Rule documentation from scratch, which takes considerably more hours.
Your infrastructure complexity. A single-tenant app on AWS with a handful of engineers and one database holding protected health information (PHI) is a much smaller engagement than a multi-tenant platform with mobile apps, third-party integrations, and PHI flowing through five different subprocessors. Every subprocessor that touches PHI needs a BAA and a review of their own security posture, and that work scales with your architecture, not with your headcount.
Whether you're doing this alongside SOC 2. If a US healthcare enterprise customer is asking for both SOC 2 and HIPAA assurance (which is increasingly common), doing them together is genuinely cheaper than doing them as two separate projects. The access control, vendor management, and incident response evidence you build for SOC 2 largely satisfies HIPAA's Security Rule requirements too. We run these HIPAA readiness engagements alongside SOC 2 work specifically so you build the evidence once and use it twice, instead of paying two consultants to ask you for the same access logs.
Boutique consultant vs. compliance platform vs. solo consultant
The three paths to HIPAA readiness price out very differently, and the sticker price isn't the whole story.
Compliance automation platforms (the SaaS tools that monitor your AWS account and auto-generate policy templates) typically run $5,000 to $15,000 a year in subscription fees. That's attractive on paper, but the software doesn't write your risk assessment, negotiate your BAAs, or tell an auditor why your access review process is sufficient. Most companies that go this route end up hiring a consultant anyway to interpret the findings, which means you're paying twice.
Solo consultants are the cheapest option on an hourly basis and can be a reasonable fit if your scope is genuinely small and well-defined. The risk is bandwidth and continuity. If your solo consultant gets sick, takes another client, or simply doesn't have expertise in your specific stack (say, a healthcare API integration or a legacy on-prem component), your timeline slips and nobody else can pick it up mid-project.
Boutique firms sit in between a solo consultant and a large platform vendor: enough depth to handle complex infrastructure and audit-facing conversations, without the overhead (or the price tag) of a big-four advisory practice. This is where most digital health companies with real technical complexity land, because the engagement is scoped to your actual environment rather than a templated package.
There's no universally "right" answer here. A five-person startup with a simple SaaS product might do fine with a solo consultant. A company handling PHI across mobile, web, and a partner API integration usually needs more coverage than one person can reasonably provide.
How to scope the engagement without overpaying
The biggest cost overruns we see come from vague scoping, not from expensive consultants. A few things worth doing before you sign anything:
- Map your PHI flows first. Know exactly which systems, databases, and third parties touch protected health information before you get a quote. Vague answers here lead to vague quotes, which lead to change orders later.
- Separate "readiness" from "certification." HIPAA doesn't have a formal certification the way SOC 2 does. You don't need HITRUST to satisfy most enterprise buyers, and quotes that assume you're going straight to HITRUST will be inflated for what you actually need.
- Ask what's reused from SOC 2. If you're already SOC 2 compliant or working toward it, ask any HIPAA quote how much of that evidence carries over. If the answer is "none," you may be talking to someone who's going to duplicate work you've already paid for.
- Get the deliverable list in writing. A risk assessment, a policy set, a BAA review checklist, and a remediation plan are concrete deliverables. "We'll help you get compliant" is not a scope, it's a sales pitch.
What a realistic timeline looks like
Most HIPAA readiness engagements for a digital health company with a straightforward architecture take four to eight weeks from kickoff to a completed risk assessment and remediation plan. Companies running HIPAA alongside SOC 2 usually see the combined timeline stretch to ten to fourteen weeks, but that's still faster than running the two as sequential projects. If a firm quotes you a HIPAA readiness engagement that's expected to take six months, ask why. Either the scope is unusually large or the estimate is padded.
If you want a broader view of how HIPAA readiness fits alongside other compliance work like SOC 2 and ISO frameworks, our compliance solutions overview walks through how we sequence these engagements for companies selling into regulated US markets.
Get a real number for your situation
Ranges are useful for budgeting, but the only way to get an accurate quote is to walk through your actual PHI flows, your current documentation, and whether you're pairing this with SOC 2. Contact traztech for a scoping conversation and we'll give you a specific number, not a range, based on what your product and infrastructure actually look like.