Section 500.8 requires written procedures, guidelines and standards for secure development of in-house applications, plus procedures for evaluating, assessing or testing the security of externally developed applications. The CISO or a qualified designee must review and update them at least annually. The text names no tools, so you choose the practices.
This is general information, not legal advice.
Two audiences, one document set
The rule has two halves, and teams often write only the first.
| Half | Covers | Typical content |
|---|---|---|
| In-house applications | Code you write and ship | Code review, testing, dependency checks, secrets handling, release approval |
| Externally developed applications | Software you buy or install | Pre-adoption review, testing in your environment, update and exit handling |
The phrase "within the context of the Covered Entity's technology environment" means an external product is judged by how you deploy it, not only by the vendor's marketing.
Writing the in-house standard
Keep it short enough that developers read it. A workable outline:
- Design review for changes that touch nonpublic information.
- Peer review required before merge.
- Automated checks in the pipeline: static analysis, dependency scanning, and tests.
- Rules for how findings are triaged and by when they are fixed, linked to your risk assessment.
- Release approval and a record of who approved.
- Handling of third party components, including how new dependencies are added.
Standards that state a duty and name an owner are easier to defend than standards that describe a hope.
Writing the external software procedure
Ask the same questions each time. What data will it process? Where does it run? How is it updated? What is it built on? Has it been tested against your environment? A one page form plus a dated result, for each product, is enough evidence that a procedure exists and was used.
Include open source packages. They are externally developed applications in the plain sense of the words, and a procedure for adding one that includes a license and vulnerability check closes a common gap.
The annual review
The rule says review, assess and update as necessary at least annually, by the CISO or a qualified designee. Evidence is a dated record: who reviewed, what changed, what was left alone and why. A calendar entry and a short change log do the job.
Mistakes to avoid
Procedures fail the same ways again and again. They are written once and never matched to how the team really ships. They list tools by name, then go stale when a tool is replaced. They cover custom code but ignore open source packages and bought software. And they are reviewed on paper by the CISO without any check that practice matches. State duties, not product names, include third party components explicitly, and sample a few recent releases each year to confirm the procedure was followed.
Where Safeguard fits
Safeguard offers SBOM and dependency scanning, reachability analysis, and policies, gates and guardrails for pull requests, which can enforce parts of a written standard. You can try a free scan at gold.safeguard.sh/scan.
Quick check
Does 500.8 require a particular scanner type?
No. It requires written procedures for secure development and for evaluating external applications. Tool choice follows your risk assessment.
Who must do the annual review?
The CISO or a qualified designee, under 500.8(b).
Sources
Last reviewed: 19 October 2026.
