Healthcare & HealthTech

The compliance stack every hospital system requires of their vendors.

Hospital systems, health plans, and digital health networks will not sign with a technology vendor — however good your product is — until you can prove your security meets their standards. For most HealthTech companies, that means SOC 2, HIPAA, and increasingly HITRUST. We build your entire compliance programme on a single coordinated timeline.

 
timeline

10–14 weeks (SOC 2 + HIPAA combined)

Pass rate

98% first-time audit pass rate

Scope

Frameworks: SOC 2 · HIPAA · HITRUST

advisory

Senior practitioner on every engagement

Pricing

PHI data flow mapping included

Why it matters

What healthcare enterprise buyers actually require from technology vendors.

Healthcare enterprise procurement is among the most security-conscious in any industry. Most HealthTech companies try to tackle these requirements one at a time as they come up in sales conversations. We build a unified programme that addresses all of them systematically.

01

SOC 2 Type 2 — the baseline requirement

SOC 2 Type 2 is required for any vendor handling clinical, claims, or member data. It provides independent third-party validation that your security controls actually work. HIPAA compliance alone is not sufficient — enterprise healthcare buyers want both.

02

HIPAA compliance documentation

Your HIPAA programme covers the Security Rule and Privacy Rule, your Risk Analysis, all policies, and your Business Associate Agreement template. We build documentation that satisfies both regulatory requirements and the commercial expectations of healthcare enterprise procurement teams.

03

HITRUST i1 or r2 certification

Increasingly required by large hospital systems and national health plans. The three HITRUST assessment tiers (e1, i1, r2) confuse most companies approaching certification for the first time. We scope the right level based on your actual buyer requirements — not a generic recommendation.

04

Combined programme — one timeline, not three

HIPAA and SOC 2 share substantial control overlap: access controls, encryption, audit logging, incident response, vendor management. We build your compliance programme to satisfy both simultaneously, giving you two compliance deliverables from one programme and saving 30–40% in time and cost.

What We Cover

Scoped specifically for platforms that handle patient and clinical data.

We build every control specifically for your company’s architecture and team capacity — not a generic checklist designed for a different type of organisation.

 
PHI scoping & Trust Service Categories

If your platform handles Protected Health Information — patient records, claims data, clinical notes, appointment information, lab results — your SOC 2 scope must reflect this correctly. An incorrectly scoped SOC 2 report is worse than no report at all in a healthcare procurement context. We define your PHI data flows precisely and ensure the right Trust Service Categories are included.

Availability — the category healthcare buyers prioritise

For clinical and care delivery platforms, downtime can affect patient care. Healthcare enterprise buyers scrutinise the Availability category closely. We help you build robust uptime monitoring, documented SLA commitments, incident management procedures, and business continuity plans that satisfy the most demanding procurement teams.

Subprocessor and cloud security in a PHI context

Healthcare buyers will ask about every tool that touches their data — your cloud provider, monitoring tools, analytics stack, communication platforms. We map your subprocessor relationships, obtain their compliance documentation, and build the vendor oversight programme that enterprise healthcare procurement teams expect.

BAA-ready documentation

We prepare all Business Associate Agreement documentation and pre-built responses to the vendor security questionnaires your enterprise buyers send before they will sign a BAA. When the questionnaire arrives, you have an answer package ready.

Our Process

From kick-off to certified report — in a straight line.

Weeks 1–2
Gap Assessment & Scope Definition

We audit your existing controls, define your PHI data flows, and establish your SOC 2 and HIPAA programme scope. You receive a gap report that maps every finding to both frameworks simultaneously — so you see exactly what needs to be built once for both.

Weeks 3–8
Control Implementation & Policy Development

We implement the controls required for SOC 2 and HIPAA simultaneously, using the overlapping control areas to avoid duplicating work. We produce your HIPAA Risk Analysis, Security Rule policies, Privacy Rule documentation, and SOC 2 control framework in a single coordinated workstream.

Weeks 9–10
Readiness Testing

We conduct a full pre-audit review against both frameworks. Every gap discovered here is closed before your formal auditor arrives. Your HIPAA compliance documentation is reviewed against HHS requirements. Your SOC 2 evidence package is compiled and organised.

Audit & Certification
Audit & Compliance Certification

Your SOC 2 auditor conducts the formal assessment. Your HIPAA compliance programme is documented and ready for review. We manage both processes simultaneously where possible. You receive your SOC 2 report and HIPAA compliance documentation — ready to share with every healthcare enterprise prospect.

"We needed SOC 2 and HIPAA compliance to close our first hospital system contract. The combined approach saved us four months and roughly half the budget we had set aside for doing them separately."
CTO — Series B HealthTech

SOC 2 Type 2 + HIPAA · 14 weeks

14 wks

SOC 2 + HIPAA combined timeline

40%

Cost saving vs running separately

1st

Passed SOC 2 audit on first attempt

FAQs

Common questions about healthcare & healthtech compliance.

If your question is not here, book a free consultation — a senior advisor will give you a direct answer in 30 minutes.

For most enterprise healthcare buyers, yes. HIPAA compliance is a legal requirement and a baseline expectation — but it is self-assessed and not independently certified. Enterprise healthcare procurement teams increasingly require SOC 2 as independent, third-party validation that your security controls actually work. HIPAA compliance alone is typically not sufficient for a hospital system or health plan vendor assessment.
It depends on your data model. If your platform receives data from healthcare organisations — even indirectly through APIs, data pipelines, or integrations — you likely handle PHI and are subject to HIPAA as a Business Associate. If you operate only on de-identified data, HIPAA may not apply. But your healthcare enterprise buyers will still expect SOC 2 as evidence of security maturity.
 
For a HealthTech company building both programmes simultaneously, the combined timeline is typically 10–14 weeks to achieve SOC 2 Type 1 and HIPAA compliance. The two programmes share enough overlap in controls and documentation that running them together is significantly more efficient than doing them sequentially.
HITRUST i1 takes 4–6 months from project start to certificate issuance. HITRUST r2 takes 12–18 months. If you have existing SOC 2 and HIPAA work in place, the HITRUST implementation is substantially faster because many controls and policies already exist. We recommend starting HITRUST scoping as soon as you have a healthcare enterprise customer asking for it — the timeline is the most common surprise.
Yes. We can help you draft accurate, defensible responses to healthcare vendor security questionnaires that reflect your current security posture honestly — without overstating compliance you do not yet have. We can also help you draft a roadmap letter explaining your compliance programme timeline, which many healthcare procurement teams will accept as a bridge while certification is in progress.
Work With Us

Book a free 30-minute consultation. A senior advisor — not a sales rep — will talk honestly about your compliance situation and exactly what it will take to get you where you need to be.

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Related Services

The natural next steps after your gap assessment.

Framework

HIPAA Compliance

A detailed overview of HIPAA Security Rule and Privacy Rule compliance — what it requires, what it involves, and how it differs from SOC 2.

Framework

HITRUST Certification

HITRUST CSF certification — e1, i1, and r2 explained. When healthcare enterprise buyers require it and how to scope it correctly.

Framework

SOC 2 Compliance

The core SOC 2 framework — Trust Services Criteria, Type 1 vs Type 2, and what the full advisory process involves.