Question 1

Which HITRUST level should I start with?

Accepted Answer

Most pre-revenue MedTech innovators start with e1 (Essentials, 1-year certification, ~44 controls) to prove baseline cyber hygiene to first hospital customers. Step up to i1 once you have hospital traction, and to r2 if a large IDN or AMC explicitly requires it. We make the recommendation based on your actual customer pipeline, not the most expensive option.

Question 2

How is HITRUST different from SOC 2?

Accepted Answer

SOC 2 is an attestation against principles you scope yourself. HITRUST is a certification against a prescriptive control framework, and it includes inheritance from your cloud provider's existing certifications. Large hospital systems and IDNs increasingly prefer HITRUST because the comparison across vendors is apples-to-apples, where SOC 2 reports vary widely in scope and quality.

Question 3

Do you do the validated assessment yourselves?

Accepted Answer

No - HITRUST validated assessments must be performed by an authorized HITRUST External Assessor. We run readiness, control build, evidence collection, and assessor coordination. We work with several External Assessors we trust, or we can work with one you bring.

Question 4

Can SOC 2 evidence be reused for HITRUST?

Accepted Answer

A large portion of it, yes. SOC 2 covers most of HITRUST e1 and i1, especially in access control, change management, and operations. We map every SOC 2 control to the HITRUST CSF in week 1 so you only build the gap, not the whole framework twice.

Question 5

How long does HITRUST take?

Accepted Answer

e1: 6-9 months end to end. i1: 9-12 months. r2: 12-18 months for a first certification, then 2-year cycles after. The biggest variable is how much existing security maturity you have - teams already running SOC 2 cut 3-6 months off these timelines.

Question 6

Does HITRUST cover the device itself or just the cloud?

Accepted Answer

Both. We scope HITRUST to the system-of-systems: the device, its wireless interfaces, the update pipeline, and the cloud back-end. The risk analysis treats loss of availability or integrity as potential clinical events, aligned with your ISO 14971 hazard analysis - not just IT-flavored confidentiality risk.

Question 7

How do I know whether to start with e1, i1, or r2?

Accepted Answer

Three rules of thumb. (1) Starting commercial traction with community hospitals and regional systems: HITRUST e1 (~44 controls, 1-year certification) closes most procurement reviews and signals real cyber hygiene. (2) Selling SaMD/PHI workloads to large IDNs and AMCs: i1 (~182 controls, 1-year) is increasingly the floor. (3) Multi-product platform vendor or a national IDN explicitly requires r2: 200-500+ controls, 2-year certification. Picking one level too high wastes 6-12 months and $50-100k; picking too low loses the deal you were trying to close. We give an honest recommendation in the 30-min call based on your actual buyer list.

Question 8

What does the HITRUST MyCSF subscription actually cost, and is it included?

Accepted Answer

MyCSF is a HITRUST-billed subscription (not from Blue Goat) that you need to scope, document, and submit your assessment. List pricing for the level of MyCSF you'll need typically runs $13k-$40k annually depending on tier and number of in-scope assessments. The External Assessor's validated-assessment fee is also separate - typically $25k-$75k for e1/i1 and $75k-$200k for r2. Our fixed-fee engagement covers everything else: scoping, control build, evidence collection, MyCSF data entry, internal pre-assessment, and assessor coordination. We confirm all third-party costs in writing during scoping so there are no surprises.

Question 9

How does cloud-provider inheritance reduce HITRUST scope?

Accepted Answer

HITRUST is one of the few frameworks with a formal inheritance model: if your cloud provider has a current HITRUST CSF certification covering the controls in scope, you can inherit those control statements rather than implementing and evidencing them yourself. AWS, Azure, and GCP each maintain inheritance packages. For a typical SaaS or SaMD on a major cloud, inheritance can remove 25-40% of the operational evidence burden, especially around physical security, hypervisor controls, and data-center operations. We model the inheritance opportunity in week 1 so you only build the gap.

Question 10

What's the recertification cycle and ongoing cost?

Accepted Answer

e1 and i1 are 1-year certifications - you re-assess every 12 months. r2 is a 2-year certification with an interim assessment in year 1. Annual recertification typically runs 40-60% of the initial engagement cost because the control build and MyCSF setup are already done; you're refreshing evidence and re-running the validated assessment. Most clients keep us on a small annual retainer to refresh evidence, run the internal pre-assessment, and handle assessor coordination - then absorb the rest internally. We size the retainer to your team's bandwidth, not a fixed package.

HITRUST for MedTech. The certification IDNs actually ask for.

Why MedTech teams pick the wrong HITRUST level

Over-scoped certification

Wrong MyCSF factors

Generic SaaS HITRUST

Controls we build for the level you need

Access & identity

Device & SDLC

Operations & monitoring

Risk & vendor

How the HITRUST program runs

1. Level selection & MyCSF scoping

2. Gap assessment & build

3. Operating evidence

4. Validated assessment

Reviewer-ready deliverables in one engagement

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Backed by MedTech leaders.

HITRUST Readiness (e1 / i1 / r2) - scoped, fixed-fee, FDA-ready.