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Integrated programme

ISO/IEC 27001, SOC 2 and HIPAA together: what US healthcare clients ask a provider to show: video

A film on giving US healthcare clients what they ask a health technology or service provider to show: a SOC 2 report, documented HIPAA compliance and ISO/IEC 27001.

  • Integrated programme
  • 3 min 14 s

Key takeaways

  • SOC 2 is a CPA firm's report; ISO/IEC 27001 is certified; HIPAA has no certificate.
  • One documented risk process can serve all three frameworks.
  • One control set meets Annex A, the Trust Services Criteria and the HIPAA safeguards.
  • Business associate agreements and breach procedures are HIPAA-specific additions.
  • Start the controls early: a SOC 2 Type 2 covers a period of operation.

The three documents healthcare buyers ask for

Health technology companies and healthcare service providers are commonly asked for three things: a SOC 2 report, evidence of HIPAA compliance and, for international clients, ISO/IEC 27001. They come from three different places. A licensed US CPA firm issues the SOC 2 report under the AICPA attestation standards, and it is a report, not a certificate. HIPAA is a US law with no government certification; compliance is shown through a documented risk analysis, safeguards, policies, training and agreements. ISO/IEC 27001 is certified by an accredited body.

This short film walks through how one programme prepares a provider for all three without running three projects.

These are the documents US healthcare buyers commonly ask a provider for during procurement.

Security is always in scope for SOC 2, and availability, confidentiality, processing integrity or privacy are added where clients rely on them; HHS does not recognise any private certification of HIPAA Security Rule compliance.

One risk process, one control set, two independent opinions

A single documented risk process serves all three frameworks: the HIPAA risk analysis, the ISO/IEC 27001 risk assessment and the risk assessment the SOC 2 criteria expect. One control set then meets ISO/IEC 27001 Annex A, the Trust Services Criteria and the HIPAA safeguards together, with HIPAA-specific items such as business associate agreements and breach procedures added where they apply.

The same evidence serves the certification body and the CPA firm, and supports the HIPAA documentation US healthcare buyers ask for in procurement. Because a SOC 2 Type 2 report covers controls operating over a period, the controls need to be running early, and the report period, the certificate's audits and the HIPAA risk reviews can then be planned together.

Sterling prepares the controls, evidence and SOC 2 system description and supports the provider through each review, with one consultant and one Effivity workspace under an all-inclusive proposal. The CPA firm and the certification body make their own decisions, and HIPAA has no certificate to issue.

ISO/IEC 27001 at a glance

Purpose
Information security management: protecting the confidentiality, integrity and availability of information through assessed risks and chosen controls
Relevant to
Any organisation holding client, personal or business-critical information, from technology and BPO to financial services, healthcare and public-sector suppliers
Edition
ISO/IEC 27001:2022 with Amendment 1:2024; 2013-edition certificates lapsed on 31 October 2025
Certification
Assessed and decided by an independent certification body accredited to ISO/IEC 17021-1 and ISO/IEC 27006-1
Sterling's role
Consulting with your team, Effivity, training, vulnerability assessment, internal audit and certification readiness, then Sustain™
Cost and timing
Total investment for an ISO/IEC 27001 ISMS depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 4 to 8 months

ISO/IEC 27001: the complete guide →

ISO/IEC 27001: questions people ask

Is ISO/IEC 27001 only for IT companies?

No. It applies to any organisation that holds information worth protecting, which is every organisation with clients, employees or a bank account. IT firms, BPOs and financial services feel the demand first because their clients ask; law firms, healthcare providers and public bodies certify for the same reasons.

What is the difference between ISO/IEC 27001 and SOC 2?

ISO/IEC 27001 is an international management system standard; an accredited certification body audits it and issues a certificate with a defined scope. SOC 2 is an attestation report on a service organisation's controls against the AICPA Trust Services Criteria, issued by a CPA firm and expected mainly by US clients. They overlap heavily in the controls examined, so one evidence base can serve both, but neither replaces the other; ask your clients which they accept.

How many controls does ISO/IEC 27001 have, and do we need all of them?

Annex A of the 2022 edition lists 93 reference controls in four themes: 37 organisational, 8 people, 14 physical and 34 technological. You are not required to implement every one. You must select controls from your risk treatment, compare the selection with Annex A so nothing necessary is missed, and record in the Statement of Applicability which controls apply, why, and whether they are implemented, with a justification for any you exclude.

Do we need a penetration test to get certified?

The standard requires you to manage technical vulnerabilities and assess risks; it does not prescribe a particular test. A vulnerability assessment is included in a Sterling ISMS engagement, and its findings feed the treatment plan. Whether a deeper penetration test is warranted depends on your risks, your clients' contracts and your regulator.

Does Sterling issue the ISO/IEC 27001 certificate?

No. Sterling consults, trains and prepares. An independent certification body accredited to ISO/IEC 17021-1 and ISO/IEC 27006-1 audits the ISMS in two stages and decides. A provider offering consulting and the certificate on one invoice is selling paper.

More ISO/IEC 27001 questions and answers →

The complete guide

Everything on ISO/IEC 27001

Start with the ISO/IEC 27001 page · SOC 2 · HIPAA, or go straight to the guide you need.

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