United States · Healthtech companies
ISO/IEC 27001 for US Healthtech Companies Selling Beyond the US
Why US healthtech companies selling abroad need ISO/IEC 27001, how it sits next to HIPAA, scope, audit focus and the accredited certification audit.
Did you know ISO 27001 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; an accredited certification body issues the certificate; 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 healthtech companies are asked for ISO/IEC 27001
The outcome: an ISO/IEC 27001 certificate from an accredited certification body that international and global buyers accept on sight, built on the same controls that already serve your US customers. We prepare you; the certification body audits and decides. Sterling does not certify.
Inside the United States, healthtech security talk starts with HIPAA and SOC 2. ISO/IEC 27001, the international standard for information security management systems[1], arrives from another direction.
- US companies expanding abroad. In Sterling's experience, telehealth, remote-monitoring and analytics platforms entering Europe, the Gulf, Australia or Asia meet buyers who name 27001 and have never read a SOC 2 report.
- US vendors to global life-sciences groups. Clinical-trial technology and patient-support platforms are reviewed by sponsors with international supplier standards.
- US companies wanting one backbone. One management system can sit behind HIPAA, SOC 2 and customer-specific questionnaires.
- Winning close deals. A certificate kept alive by yearly audits shows security managed all year, not just before renewal.
How ISO 27001 sits next to the US HIPAA Security Rule
The outcome: one set of controls and records that serves both, with no contradictions between them.
The certificate does not replace HIPAA. The Security Rule is federal regulation requiring covered entities and business associates to protect the confidentiality, integrity and availability of electronic protected health information[2], and a certificate does not discharge that duty. What the management system adds is governance: risk method, roles, internal audit and management review. Several US rule requirements map straight onto it.
- Access control. HIPAA requires technical policies limiting access to authorized people, with unique user identification[3].
- Audit logs and encryption. Audit controls are a HIPAA standard and encryption is addressable[3]; one evidence set serves both.
- Suppliers. HIPAA requires written contracts with business associates and their downstream vendors[4]; the same supplier register serves the certificate.
- Contingency. HIPAA lists backup, disaster recovery and emergency-mode plans[6].
- Records. HIPAA documentation is kept for six years[5]; we align your retention so one archive covers both.
What a US healthtech certificate should cover
The outcome: a scope that a buyer abroad recognizes as the service they are buying, so the certificate counts in procurement.
- Service. The platform named plainly: a remote-monitoring platform, virtual-care app or data-exchange service.
- People and locations. US and remote staff and contractors who build, run and support it.
- Technology. Cloud tenants, repositories, build systems, endpoints and customer interfaces.
- Data. Patient records, device readings and credentials, and where they are stored.
- Suppliers. What falls on each vendor's side of the line.
Where one product is a HIPAA business associate service and another is a consumer wellness feature, the scope and risk assessment can treat them differently, with the reasoning written down.
| Need | ISO/IEC 27001 | HIPAA Security Rule | SOC 2 |
|---|---|---|---|
| Nature | Management-system standard, audited by an accredited certification body | Federal regulation | Attestation report from a CPA firm |
| Typical buyer | International buyer or global health and life-sciences group | US health system, plan or other covered entity | US enterprise and mid-market buyer |
| Evidence you hold | Certificate and scope statement | Risk analysis and documentation | The report |
| Maintained by | Annual audits and recertification | Ongoing compliance and periodic evaluation | New report periods |
What auditors test in a US healthtech company
The outcome: every area has records an auditor can sample. These are Sterling's plain-English descriptions, not text from the standard.
1. Risk assessment and treatment. Including patient-data exposure and clinical workflow dependence, with a written statement of which controls apply and why. 2. Leadership. Policy, roles, objectives and dated management reviews showing real decisions. 3. Incident management. Detection, response and lessons learned; US health customers will ask how fast they hear from you. 4. People. Screening as appropriate, training and confidentiality commitments. 5. Internal audit and corrective action. The cycle that keeps the system alive after year one, with surveillance audits to follow.
Most US healthtech teams already hold much of this evidence in their cloud console, ticketing and HR tools. We help you export and organize it rather than re-create it.
Where US healthtech teams lose time
The outcome: we remove these before the certification body arrives.
- Calling the certificate HIPAA compliance. US customers who know the difference will ask for HIPAA records separately.
- The bought service scoped out. The certificate then proves little.
- No clinical impact in risk scoring. A care tool going down is a patient-safety matter.
- Three document sets. Separate HIPAA, SOC 2 and ISO binders contradict each other; we keep one control library with mappings.
How we take US healthtech companies to ISO 27001 certification
The outcome: a successful audit on schedule, with the work done for you. 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 service, data flows and controls, and give you a proposed scope with a HIPAA cross-reference. 2. Design. We draft policies, risk method, procedures and supplier rules around how your teams already work. 3. Evidence. Your team operates the system; Effivity, our GRC automation platform, holds the register and evidence trail. 4. Internal audit and management review. We test first and fix findings. 5. Certification body audit. We coordinate with the accredited body you select and support you to the decision. You deal with Sterling end to end.
Selling to buyers outside the US next year? Choose Get started and a Sterling expert will respond.
How Sterling delivers ISO certification
ISO management system standards such as ISO/IEC 27001, ISO/IEC 42001 and ISO 9001 are certified by an accredited certification body, not by a consultant[1]. Sterling never certifies. The certificate carries the name of the body that issued it, and that independence is what makes it credible to your buyers.
What Sterling does is prepare your company so that the certification body's audit goes smoothly. We coordinate:
- a gap assessment against the standard;
- the management system itself: scope, risk assessment, policies, procedures and records, sized for your company;
- training for your people and an internal audit before the certification audit;
- management review and corrective actions;
- the certification audit process, from choosing an accredited body to closing any findings.
Consulting and auditing are always separated. The people who consult never audit you, so the internal audit is a genuine test and the certification body's audit is independent.
Sterling has completed 8,100+ client engagements in 60+ countries over 20+ years, and our experts bring 30+ years of experience.
[1] About the IAF MLA (multilateral recognition arrangement). International Accreditation Forum (functions transferred to Global Accreditation Cooperation Inc., 1 Jan 2026). accessed October 23, 2026.
Sources
1. ISO/IEC 27001, Information security, cybersecurity and privacy protection, Information security management systems, Requirements. ISO. accessed October 23, 2026.
2. 45 CFR 164.306 Security standards: General rules. Electronic Code of Federal Regulations (HHS HIPAA Security Rule). accessed October 23, 2026.
3. 45 CFR 164.312 Technical safeguards. 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. 45 CFR 164.316 Policies and procedures and documentation requirements. Electronic Code of Federal Regulations (HHS HIPAA Security Rule). accessed October 23, 2026.
6. 45 CFR 164.308 Administrative safeguards. Electronic Code of Federal Regulations (HHS HIPAA Security Rule). 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
Is ISO/IEC 27001 required for US healthtech companies?
No. It is a voluntary international standard[1]. No US health regulation requires it, and the HIPAA Security Rule applies separately[2]. It becomes a practical requirement when a customer, tender or contract calls for it, which in Sterling's experience is most common when US healthtech companies sell outside the United States or to global life-sciences buyers.
Does an ISO 27001 certificate cover HIPAA?
No. The standard and the Security Rule are different instruments. The Security Rule requires the safeguards, risk analysis and contract terms it lists[2][3][4], and a certificate does not discharge those duties. A well-run management system does supply governance and evidence that your HIPAA effort can reuse, and we map one to the other.
Who issues the ISO 27001 certificate?
An accredited certification body audits your management system and decides whether to issue the certificate. Sterling prepares you, runs the internal audit and coordinates the process, but Sterling does not certify. Consulting and auditing are always separated, so the people who consult never audit you.
Should a healthtech start-up choose SOC 2 or ISO 27001 first?
It depends on who is buying. In Sterling's experience, US health systems and enterprise software buyers tend to request SOC 2 reports, while international customers request ISO certification. Many US healthtech companies need both eventually, and one control set can serve each. Our SOC 2 versus ISO 27001 guide helps you decide the order and plan the second one early.
Can one set of controls serve ISO 27001, SOC 2 and HIPAA?
Largely, yes. Access control, logging, supplier management, incident response and continuity appear in all three. The differences lie in documentation format, audit mechanics and a few specific obligations, such as business associate contract terms[4]. We keep a single control library with mappings.
What does the HIPAA Security Rule say about documentation we can reuse?
It requires written policies and procedures and written records of required actions and assessments, retained for six years[5]. A management system produces much of this naturally, because controlled documents and records are part of how it works. We align retention periods so one archive satisfies both.
How much of our existing work can we reuse?
Quite a lot if you already have HIPAA safeguards or a SOC 2 report: access control, change management, vendor review and incident handling transfer. The new elements are the formal scope, the risk method and statement of applicable controls, internal audit, and management review.
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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