HIPAA Security Rule — technical safeguards for systems holding ePHI (45 CFR Part 164, Subpart C)
This page is generated from the requirement table the AiSSAY engine ships for this framework. When the engine produces an evidence pack, each row below gets a status computed from the operator's own records at that moment. This page shows the table, not anyone's results.
Informational mapping prepared by the operator's own tooling. Not a legal opinion, not a certification, and not a substitute for advice of counsel. It organizes the operator's records against the cited requirements; whether those records satisfy the requirements is a determination for the operator, counsel, and the examiner.
This view maps the rule in force. The Security Rule update proposed in December 2024 was not final as of September 2026. A business associate agreement, the risk analysis and workforce training are the covered entity's. Records stay on the covered entity's own machines; we hold no copy.
The requirement table
9 rows: 6 mechanism, 1 organizational, 1 named gap, 1 computed
| Requirement | Mechanism, duty or gap | Type |
|---|---|---|
| 164.312(a)(1) — access control: only authorized persons or software reach ePHI | DELEGATED when the store is sealed by your key manager (the kms provider): whoever your key manager refuses cannot open the store at all, and every open appears in your key manager's own audit log. This store itself has no authentication, roles or permissions and refuses no read: once a key is unwrapped, the process holding it can read every record. Under any other provider, NOT IMPLEMENTED — the operating system's file permissions are the only access control. The status is computed from the provider this store declares, not assumed. | computed |
| 164.312(a)(2)(iv) — encryption and decryption of ePHI (addressable) | every record encrypted at rest under its own key (AES-256-GCM); the store key can be retired and replaced by a recorded ceremony | mechanism |
| 164.312(b) — audit controls: record and examine activity in systems containing ePHI | every read, export, hold and deletion is recorded in a hash-chained access log; every agent run is recorded step by step | mechanism |
| 164.312(c)(1) — integrity: protect ePHI from improper alteration or destruction | each record sealed into a hash chain with external anchoring; verification names any altered record; deletion leaves a tombstone | mechanism |
| 164.312(d) — person or entity authentication | computed from the store's declared read policy: with a policy in force the store refuses a read it cannot attribute to a key, and the refusal is logged. What it verifies is the key, not the person: who holds that key is established by your enrolment, and the status says so. | mechanism |
| 164.308(a)(1)(ii)(D) — regularly review information system activity | organizational: the review is the covered entity's. The access log, findings and flagged runs are what it reads. | organizational |
| 164.308(a)(6)(ii) — identify, respond to and document security incidents | injected instructions are scanned for and raised as findings in the record; interrupted capture is sealed as an explicit gap record; anchor verification detects a rewritten or forked chain. The response and its documentation are the covered entity's. | mechanism |
| 164.316(b)(2)(i) — retain required documentation six years | per-record retain-until dates (default seven years); deletion before that date is refused without a recorded override; legal hold blocks deletion outright | mechanism |
| Reliance on this tool — independent evaluation of its controls | NOT IMPLEMENTED. No penetration test, no third-party review of the cryptography and no independent report on this software's controls exist yet. Anyone relying on these records as evidence must evaluate the tool themselves, and this row says so first. | named gap |
How a status is earned
- Evidenced
- a deterministic check ran against your records and the counts support the row. A store holding no relevant records reads unevidenced — a true statement, not a passing one. Empty never counts as clean.
- Delegated
- the mechanism is enforced by a system you already trust — a store sealed by your own key manager delegates access control to it, and the pack says the enforcing log is your key manager's, not ours. The pack names the endpoint the key manager was reached at. An AWS endpoint other than AWS's own default for the region reads delegated to that endpoint, with a request that you confirm it is your key management service. One backend — AWS KMS — has run against the real AWS KMS service; no other backend has.
- Test seam
- sealed by an in-process test backend — a stub, or a stand-in for the AWS client — and the status names which. No key manager enforces access. The seam is built and tested, and the pack refuses to call that delegation.
- Partially evidenced
- the mechanism is built and some of your runs carry its evidence, but not all — usually because they were sealed before the mechanism existed. The pack says how many runs are in each group, and never counts the missing ones as passing.
- Organizational
- the requirement is a procedure only people can perform. The pack names it as yours instead of dressing a policy up as a mechanism.
- Named gap
- the pack cannot evidence it — either the mechanism is not built, or no software can supply it — and it says which. The gap is printed, because a reviewer should read it here rather than discover it.
No status is typed in by hand: every status is recomputed from the store each time a pack is produced, the requirement and mechanism text is written and reviewed as part of the engine, and the dependency evidence comes from our release scan. A failing mechanism can never be read as evidence that the control works.
Rows marked “computed” are the access-control rows. Their status is computed from the provider your store declares: a gap unless your key manager seals the store, “test seam” under a stub or stand-in backend, “delegated” only under a real one. Today they can never read evidenced, and marking them as a built mechanism would overstate them.