Auditors look for evidence that a healthtech company finds vulnerabilities, ranks them against risk to patient data, acts within stated times and records what it did. The HIPAA Security Rule asks for a thorough risk analysis and risk management measures. Dated records are what make your process credible.
This is general information, not legal advice.
What does the rule text say?
Under 45 CFR 164.308(a)(1), covered entities and business associates must implement a security management process to prevent, detect, contain and correct security violations. The implementation specifications include risk analysis, required: conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information. Risk management is also required: implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level. A required information system activity review asks you to regularly review records such as audit logs, access reports and security incident tracking reports.
The rule does not name a scanner, a patch window or a scoring system. That freedom is why your own written process matters.
What do auditors actually ask for?
Typically: your asset and system inventory, the date of your last risk analysis, how findings are ranked, the list of open findings with owners and dates, proof that a few chosen findings were fixed on time, and records of log review. They test whether the process is real by sampling.
Constructed example: an auditor picks one critical finding from a scan report and asks for the ticket, the fix commit and the redeploy date. If the three line up, the sample passes. If the ticket was closed with no link to the fix, it fails, even if the fix was real.
How do you rank findings in a way you can defend?
Write a short policy with severity classes and target times, for example faster targets for flaws that are known to be exploited or reachable in code that handles patient data. Use a consistent method: severity, exploitability, exposure and the data involved. Record the reasoning when you downgrade or accept a risk, with an owner and a review date. Untracked exceptions are the most common audit finding in this area.
What about third party code?
Most vulnerabilities in a modern app live in dependencies. Keep a software bill of materials per release so you can answer which version of which library runs in production. If your product is regulated as a medical device, FDA's postmarket guidance adds its own expectations on assessing controlled and uncontrolled risk and on timelines, so read it as well.
What to do
- Maintain an inventory of systems, services and dependencies that touch ePHI.
- Run and date a risk analysis at least on a schedule you set, and after major changes.
- Write a vulnerability policy with severity classes and target times.
- Link every finding to a ticket, a fix and a verification date.
- Document risk acceptances with owner, reason and expiry.
- Review audit logs and access reports on a schedule and keep proof.
- Rehearse sampling: pick three findings and trace each end to end.
Safeguard supports inventory, dependency scanning, reachability analysis and compliance automation that collects evidence. It does not certify HIPAA compliance, and auditors decide what satisfies them.
Quick check
Does HIPAA require a particular vulnerability scanner?
No. The Security Rule asks for an accurate and thorough risk analysis and risk management measures, and leaves methods to you.
What is the most common weak spot?
Records that do not connect: a finding, a ticket, a fix and a verification date that cannot be traced together.
Sources
- 45 CFR 164.308, administrative safeguards (eCFR)
- FDA, Postmarket Management of Cybersecurity in Medical Devices
Last reviewed: 18 October 2026.