United States · Healthtech companies
SOC 2 for US Healthtech Companies: What Hospital and Payer Reviews Require
What US hospitals and payers require from healthtech vendors in a SOC 2 report: scope, controls, HIPAA mapping and the CPA-firm examination.
Did you know SOC 2 can cost less than US$10,000, all-inclusive? If you've been quoted more, talk to us before you sign.
100% success, on time: the Sterling Promise
We stay with you until your agreed outcome is achieved, through consulting, audit preparation and the resolution of audit findings. The engagement defines the standard, scope, outcome and responsibilities; your organization puts the agreed controls into use; a US-licensed CPA firm issues the SOC 2 report; an independent assessor reviews your HIPAA program, and that decision stays independent.
Done for you, end to end
We write the policies, set up the controls and evidence, run the internal audit and coordinate the independent audit. You deal with one team from first call to final report.
Simple and quick
A free gap assessment, then one plan with dates from day one. Effivity, our GRC automation platform, is included to keep the evidence moving.
8,100+ client engagements
In 60+ countries over 20+ years, with experts who bring 30+ years of experience.
Under US$10,000, all-inclusive
For most start-ups and SMEs: SOC 2, ISO 27001, ISO 42001, HIPAA or ISO 9001, including the independent audit. A fixed quote follows a free gap assessment.
Included in every engagement
Every Sterling consulting engagement comes with the following, so you are not buying extras to get to the finish line:
- Effivity, Sterling's GRC automation platform, with a full-year subscription, to run your controls, evidence, tasks and audits in one place.
- Sterling Academy: preferential course access, with complimentary awareness training for your people.
- Internal auditor training for your audit team, as applicable to your standard.
- For information-security engagements, a vulnerability assessment.
These are part of the engagement, not a separate purchase. The details depend on the standard you are working toward, which we confirm during the free gap assessment.
Consulting and auditing are always separated: the people who consult never audit you. That keeps your internal audit objective and protects the independence of the CPA firm, Qualified Security Assessor or certification body that performs the final step.
Behind this are 8,100+ client engagements in 60+ countries over 20+ years, led by experts with 30+ years of experience.
All-inclusive pricing for start-ups and SMEs
Did you know SOC 2 or ISO 27001 can cost less than US$10,000, all-inclusive? If you've been quoted more, talk to us before you sign.
Sterling's all-inclusive fee for SOC 2, ISO 27001, ISO 42001, HIPAA or ISO 9001 is under US$10,000 for most start-ups and SMEs. It covers our done-for-you consulting and the independent audit: the SOC 2 report from a US-licensed CPA firm, as AICPA standards require, or the certification audit by an accredited certification body. For HIPAA, it covers HIPAA compliance consulting and an independent HIPAA assessment. Effivity, training and a vulnerability assessment are included. That's less than a month's cost of an in-house security hire: the US Bureau of Labor Statistics puts the national median annual wage for information security analysts at $129,180 (May 2025), about $10,765 a month in pay alone[1].
A fixed quote follows a free gap assessment.
What the fee covers, and what it doesn't:
- It is the fee for your first SOC 2 report or your first certification only.
- Annual work is always additional and billed the following year: later SOC 2 report periods, and ISO surveillance and recertification audits.
- It assumes a typical start-up or SME scope: one product or service and one main location.
- Larger or multi-site scopes get a fixed quote after the gap assessment.
- PCI DSS is quoted separately: a fixed quote follows a free gap assessment.
[1] Occupational Employment and Wage Statistics, May 2025: 15-1212 Information Security Analysts, national annual median wage. US Bureau of Labor Statistics. accessed October 23, 2026.
Why US hospitals and payers ask healthtech vendors for a SOC 2 report
The outcome: a SOC 2 report that US health-system vendor-risk teams can file in one pass, so your deal stops waiting on a two-hundred-question spreadsheet. We do the preparation for you; the SOC 2 report is issued by a US-licensed CPA firm, as AICPA standards require.
A signed business associate agreement tells a US hospital you accepted a legal duty. It does not show that your controls work. A SOC 2 report does, as an independent CPA's examination of controls at a service organization[1][2].
- US health systems. In Sterling's experience, large provider groups review many vendors each quarter and prefer a report over custom answers.
- US payers and digital-health platforms. Their reviews cover access, change management, monitoring and incident response across your whole stack at once.
- Your counsel and theirs. The HIPAA Security Rule lets you choose measures reasonable and appropriate to your size and risks[3]; a SOC 2 report gives an independent view of how that judgment works in practice.
SOC 2 next to the US HIPAA Security Rule
The outcome: one control set mapped to both, so nothing legally required is assumed to be covered by a report.
HIPAA is federal regulation with required and addressable specifications and contract duties for business associates[3][4]. SOC 2 is an attestation framework. No health-privacy rule requires a SOC 2 report, and a report does not by itself establish HIPAA compliance. Most US healthtech companies end up holding both; we keep a separate HIPAA mapping beside the SOC 2 controls.
- Where they overlap. Access control, audit logging, encryption, vendor review, incident response and backups appear in both, so one set of evidence can serve each.
- Where HIPAA goes further. The documented risk analysis, the reasoning behind each addressable specification and the business associate contract terms[4] need their own records.
- What US customers receive. The report for their vendor-risk team, and HIPAA documents for their privacy and compliance office.
| Topic | SOC 2 (attestation) | HIPAA Security Rule (regulation) |
|---|---|---|
| Nature | Independent CPA firm examines controls and issues a report[2] | Federal rule that applies to covered entities and business associates[3] |
| Scope set by | You choose the system boundary and categories[5] | Where electronic protected health information is created, received, maintained or transmitted[3] |
| Vendor agreements | Vendor management is examined | Business associate contracts are a stated requirement[4] |
| Output | A report buyers can request | No report is produced by the rule itself; you keep documentation[3] |
What a US healthtech SOC 2 report should cover
The outcome: a system boundary that includes what US clinical customers actually worry about.
- Application. Patient and clinician apps, APIs and services that process health data.
- Cloud and pipeline. Production, the build pipeline and how code reaches production.
- Integrations. EHR, lab, pharmacy, payer and device connections, described by the data crossing each.
- Identity. How clinicians, patients, staff and support authenticate.
- Vendors. Hosting, messaging, monitoring and analytics providers and how you review them.
The Trust Services Criteria cover security, availability, processing integrity, confidentiality and privacy[5]. What we recommend for most US healthtech companies (Sterling's recommendation): start with security, add availability once you sign uptime commitments to clinical customers, and take on privacy only when customers name it.
The controls US health-system reviewers sample first
The outcome: each control runs and leaves a record from day one of your observation period.
1. Access to patient data. Unique accounts, MFA, role-based permissions, prompt removal, a break-glass process and signed access reviews. 2. Logging and monitoring. Tamper-resistant logs with alerts someone answers, and proof of review. 3. Change management. Reviewed, tested, approved releases; enforced pull-request rules work for daily shipping. 4. Vendor management. A vendor list that lines up with your business associate agreements. 5. Incident response. A plan whose notification timing matches your US customer contracts, plus a recorded exercise. 6. Data protection and continuity. Encryption, key management, tested restores, retention and disposal. 7. Risk and governance. An annual risk assessment aimed at the same data flows as your HIPAA analysis.
Where US healthtech teams lose time
The outcome: we remove these before the CPA firm starts testing.
- Integration layer scoped out. The hospital connection is the most scrutinized part.
- Skipped reviews in a Type 2 period. One missed quarter shows up as an exception.
- Contract promises stricter than practice. Reconcile breach-notice terms first.
- Loose status claims. Say Type 1 or Type 2, and only what is true.
- Support and clinical staff left out. Their access and training evidence is often the thinnest in the file.
How we take US healthtech companies to a clean SOC 2 report
The outcome: a successful, on-time report with the work done for you, while your engineers keep building. Sterling's record is 100% success and on-time completion across 8,100+ client engagements in 60+ countries over 20+ years, led by experts with 30+ years of experience. The people who consult never audit you.
1. Free gap assessment. We review your system, data flows, agreements and evidence, and propose a boundary and categories. 2. Policies and controls. We write documents that match how your team works and build missing controls with you, HIPAA mapping alongside. 3. Evidence. Effivity, our GRC automation platform, collects tasks, approvals and artifacts. 4. Readiness review. We test the way an examiner would; your team closes findings. 5. The examination. The SOC 2 report is issued by a US-licensed CPA firm, as AICPA standards require. We coordinate requests and follow-up; you deal with Sterling throughout.
A US hospital questionnaire waiting on your desk? Choose Get a proposal and a Sterling expert will respond.
How Sterling delivers SOC 2
A SOC 2 engagement has one deliverable that no consultant can hand you: the report. The SOC 2 report is issued by a US-licensed CPA firm, as AICPA standards require[1]. What Sterling does is make sure you get there ready, and that nothing between today and the report lands on your desk.
With Sterling, you deal with one team from start to finish. We coordinate:
- a readiness review and a gap assessment against the Trust Services Criteria;
- the policies, procedures and controls you need, written for how your company actually works;
- evidence collection, so the examination does not become a scramble;
- an internal audit before the examiner arrives, carried out by people who did not advise you on the controls;
- the Type 1 or Type 2 path that fits your deal timeline, and the examination itself, including scheduling, requests and follow-ups.
Our experts bring 30+ years of experience, and the firm has completed 8,100+ client engagements in 60+ countries over 20+ years. You get a single plan, a single point of contact and a clear view of what happens next.
[1] SOC (System and Organization Controls) Suite of Services. AICPA & CIMA. accessed October 23, 2026.
Sources
1. System and Organization Controls: SOC Suite of Services. AICPA & CIMA. accessed October 23, 2026.
2. SOC 2 Reporting on an Examination of Controls at a Service Organization Relevant to Security, Availability, Processing Integrity, Confidentiality, or Privacy. AICPA & CIMA. accessed October 23, 2026.
3. 45 CFR 164.306 Security standards: General rules. Electronic Code of Federal Regulations (HHS HIPAA Security Rule). accessed October 23, 2026.
4. 45 CFR 164.314 Organizational requirements. Electronic Code of Federal Regulations (HHS HIPAA Security Rule). accessed October 23, 2026.
5. 2017 Trust Services Criteria (With Revised Points of Focus - 2022). AICPA & CIMA. accessed October 23, 2026.
Information only
The information on this page is provided for general informational purposes only. It is not legal advice, and it is not a substitute for advice from a qualified attorney about your own situation.
Requirements depend on your scope, your customers' contracts, your industry and the regulations that apply to you. Two companies asking for the same standard can have very different obligations. We confirm yours during a gap assessment, and we update our content as standards change, but you should check the current text of any standard or rule that matters to you.
Sterling consults and prepares. It does not decide whether you meet a standard. That decision belongs to the independent party that performs the final step: the US-licensed CPA firm for a SOC 2 report, the Qualified Security Assessor or acquirer for PCI DSS, and the accredited certification body for ISO certificates. Timelines and outcomes depend on your readiness and on those parties.
Standards and marks named on this site belong to their respective owners.
FAQs
Frequently asked questions
Do US hospitals require SOC 2 from healthtech vendors?
No rule makes it universal. In Sterling's experience, many US health systems and payers request it in vendor reviews, while others accept a completed questionnaire. Check the documents your largest prospects have sent. A SOC 2 report is an independent CPA firm's examination of your controls[2], so for buyers who request it, it often shortens the review considerably.
Is SOC 2 the same as HIPAA compliance?
No. SOC 2 is an attestation framework examined by a CPA firm[1][2]. HIPAA is a federal rule with its own specifications and contract requirements[3][4]. A SOC 2 report can provide supporting evidence, but it does not by itself establish compliance with the Security Rule. Many healthtech companies maintain both.
Which Trust Services categories should a healthtech company include?
Start with security. The criteria also cover availability, processing integrity, confidentiality and privacy[5]. Add availability if you commit to uptime for clinical customers, confidentiality if contracts require specific data handling, and privacy only when customers ask for it. That is Sterling's recommendation, not an AICPA rule.
Who issues the SOC 2 report?
The SOC 2 report is issued by a US-licensed CPA firm, as AICPA standards require. Sterling prepares your controls, runs the internal readiness review and coordinates the examination. Consulting and auditing stay separate, so the people who consult never audit you.
Type 1 or Type 2 for a US healthtech start-up?
As commonly described, a Type 1 report speaks to the design of controls at one date, and a Type 2 covers whether they operated over a period. In Sterling's experience, US health buyers often prefer Type 2. If a deal needs something sooner, a Type 1 can be a first step, followed straight away by an observation period so the Type 2 follows without a gap.
Will a SOC 2 report answer our customers' business associate questions?
Partly. It supports answers on access, monitoring and vendor management. The business associate agreement itself has its own content, including incident reporting and flow-down to downstream vendors[4], and your customers may still ask for HIPAA-specific documents. We prepare both sets from one control library.
What should we have ready before a gap assessment?
A diagram of how health data moves through your product, a list of cloud accounts and vendors, your current policies, signed business associate agreements and any questionnaires you have received. None of it needs polishing; the assessment shows what is missing.
What is included when we work with Sterling?
Every engagement includes a full-year subscription to Effivity, our GRC automation platform; preferential Sterling Academy course access, with complimentary awareness training for your people; and internal auditor training for your audit team, as applicable to your standard. For information-security engagements we add a vulnerability assessment.
Keep exploring
More in Compliance for Healthtech companies in the US
Compliance for Healthtech companies in the US
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