A healthtech vendor should answer security questionnaires from a prepared evidence file organised around the HIPAA Security Rule, not from memory. Map each question to a safeguard, attach proof, state gaps plainly, and have standard answers for business associate contract terms. Honest answers close deals faster than polished ones that fall apart in review.
Why are healthtech questionnaires different?
If you handle electronic protected health information for a covered entity, you are likely a business associate, and the HIPAA Security Rule applies to you directly. The rule text, 45 CFR 164.308, opens with the requirement for covered entities and business associates to implement policies to prevent, detect, contain and correct security violations. Your buyer's questionnaire is mostly asking you to prove that.
Whether you are a business associate is a legal question. Have counsel confirm it.
What does the rule ask for, in questionnaire terms?
Section 164.308 contains the administrative safeguards. Four required items map to common questions:
- Risk analysis: an accurate and thorough assessment of risks and vulnerabilities to the confidentiality, integrity and availability of ePHI.
- Risk management: security measures sufficient to reduce risks to a reasonable and appropriate level.
- Sanction policy: sanctions against workforce members who fail to comply.
- Information system activity review: regular review of audit logs, access reports and incident tracking reports.
It also requires a named security official, workforce access procedures including termination, access authorization, and a security awareness and training program. Some specifications are labelled addressable. In HIPAA, addressable is not the same as optional. Read section 164.306 with counsel to see how to treat each one.
What do business associate contracts require?
Section 164.314 says the business associate contract must provide that you will comply with the applicable requirements of the Security Rule, ensure subcontractors that handle ePHI agree to comply through their own contracts, and report to the covered entity any security incident you become aware of, including breaches of unsecured protected health information.
Prepare answers for subcontractors: list your cloud host and key vendors, and show your flow down terms.
The playbook
- Build an answer bank. For each common question, write one accurate answer, an owner, an evidence link and a last reviewed date.
- Organise it by safeguard: governance, access, training, logging, incident response, vendor management, change management, and software supply chain.
- Keep a current risk analysis document. Many buyers ask for date and scope.
- Prepare a subcontractor list and your standard flow down language.
- Write an incident notification statement: who you notify, how fast, and through what channel.
- Keep evidence ready: policies, training completion, access review results, scan reports, penetration test summaries you are allowed to share.
- Answer "no" and "in progress" when true, with a dated plan. Reviewers see through vague yes answers.
- Never claim a certification you do not hold. Say exactly what is complete.
- Track every deal's special requests so the bank improves.
Constructed example: a buyer asks, "Do you scan third-party code for vulnerabilities?" A weak answer says "Yes". A strong one says: dependencies are scanned on every pull request, critical findings block release, the last report is attached, and two accepted exceptions are listed with owners and expiry dates.
Safeguard's compliance automation helps collect evidence and maintain answers, and its SBOM and dependency scanning supply software supply chain proof. Your answers still need human review.
How do you handle questions you cannot answer yet?
Write the gap down with a date and an owner. Offer a compensating control if you have one, and a milestone you can keep. Buyers in healthcare have seen many vague promises. A specific answer such as a named quarter and the person accountable tends to be accepted more readily than a general assurance.
Quick check
Are addressable specifications optional?
Not simply. Addressable is a defined HIPAA term, not a free pass. Check section 164.306 and have counsel confirm how it applies.
What must a business associate contract say about incidents?
Under 164.314, the associate must report to the covered entity any security incident it becomes aware of, including breaches of unsecured PHI.
Sources
- 45 CFR 164.308 Administrative safeguards, Legal Information Institute
- 45 CFR 164.314 Organizational requirements, Legal Information Institute
Last reviewed: 18 October 2026.
