> ## Documentation Index
> Fetch the complete documentation index at: https://docs.encoreos.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Compliance Evidence Packages

> Last Updated: 2026-04-12

**Last Updated:** 2026-04-12

This directory contains compliance evidence packages — documents that tie specific feature implementations to their regulatory requirements. Evidence packages are required for any feature that touches a regulated area (CL, PM, HR, RH, GR, FA, IT, CE, PF).

## What is a Compliance Evidence Package?

A compliance evidence package proves that a specific implementation satisfies a specific regulatory requirement. It contains:

1. **Regulatory requirements table** — the specific clauses/requirements from the regulation
2. **Implementation evidence** — code references, schema elements, UI components, test names that satisfy each requirement
3. **Test evidence** — unit/integration/RLS test names that verify the implementation
4. **Gaps** — any requirements not yet implemented (with tracking references)

## When to Create an Evidence Package

Create an evidence package when:

* A spec targets a regulated requirement (42 CFR Part 2, HIPAA Security Rule, AHCCCS 320-O, FLSA, etc.)
* The feature is marked "implemented" or "partial" in the relevant compliance tracker
* Preparing for an audit, accreditation survey, or compliance review
* A regulator or payer requests documentation of compliance

Reference `docs/compliance/REGULATORY_COMPLIANCE_TRACKER.md` to find requirements that need evidence packages.

## How to Create an Evidence Package

1. **Identify the requirement:** Find the row in the relevant compliance tracker (e.g., `REGULATORY_COMPLIANCE_TRACKER.md`).
2. **Copy the template:** Use `specs/_templates/COMPLIANCE_SIGNOFF_TEMPLATE.md` as a starting point. For detailed evidence, use the `CL-11-EN-01-42cfr-part2-EVIDENCE.md` file in this directory as a model.
3. **Name the file:** `{SPEC-ID}-{REGULATION-ABBREVIATION}-EVIDENCE.md` (e.g., `CL-11-EN-01-42cfr-part2-EVIDENCE.md`)
4. **Complete each section:**
   * Regulatory requirements addressed (table with: Requirement, Implementation, Evidence)
   * Test coverage (list of test files/names)
   * Gaps (requirements not yet implemented, with spec/task references)
5. **Link from the compliance tracker:** Add a link to the evidence file in the corresponding tracker row.

## Coverage Audit

Run the evidence coverage audit to see which implemented/partial requirements lack evidence packages:

```bash theme={null}
npx tsx scripts/audit/audit-compliance-evidence.ts
```

This script cross-references the compliance tracker against existing evidence files and reports gaps.

## Priority: High-Risk Requirements (Create These First)

Based on audit risk and regulatory penalty severity, create evidence packages for these areas first:

| Priority | Regulation                                 | Tracker                                | Required Evidence                                |
| -------- | ------------------------------------------ | -------------------------------------- | ------------------------------------------------ |
| 1        | 42 CFR Part 2 (SUD data)                   | REGULATORY\_COMPLIANCE\_TRACKER.md     | Consent, disclosure, gating                      |
| 2        | HIPAA Security Rule technical safeguards   | IT\_SECURITY\_COMPLIANCE\_TRACKING.md  | Access control, audit logging, encryption, MFA   |
| 3        | AHCCCS Policy 320-O (clinical assessments) | REGULATORY\_COMPLIANCE\_TRACKER.md     | 18 required assessment elements                  |
| 4        | HIPAA Privacy Rule PHI handling            | REGULATORY\_COMPLIANCE\_TRACKER.md     | PHI classification, access controls, disclosures |
| 5        | FCRA adverse action notices                | FCRA\_TCPA\_COMPLIANCE\_TRACKING.md    | Background check workflow, adverse action        |
| 6        | FLSA overtime tracking                     | HR\_WORKFORCE\_COMPLIANCE\_TRACKING.md | Time/attendance, overtime calculation            |

## Current Evidence Packages

| File                                                                                           | Feature                           | Regulation            | Status     |
| ---------------------------------------------------------------------------------------------- | --------------------------------- | --------------------- | ---------- |
| [CL-11-EN-01-42cfr-part2-EVIDENCE.md](42cfr-part2-evidence-cl-11-en-01.md)                     | Electronic consent & redisclosure | 42 CFR Part 2         | ✅ Complete |
| [CL-02-EN-58-42cfr-part2-EVIDENCE.md](42cfr-part2-evidence-cl-02-en-58.md)                     | CL-02 Part 2 compliance           | 42 CFR Part 2         | ✅ Complete |
| [PM-15-P2-HIPAA-EDI-EVIDENCE.md](hipaa-edi-evidence.md)                                        | HIPAA EDI / clearinghouse         | HIPAA EDI (X12)       | ✅ Complete |
| [PM-25-HIPAA-CMS-VBP-EVIDENCE.md](hipaa-cms-vbp-evidence.md)                                   | CMS Value-Based Purchasing        | CMS-0057-F            | ✅ Complete |
| [CE-28-HIPAA-PART2-EVIDENCE.md](hipaa-part2-evidence.md)                                       | CE HIPAA/Part 2                   | HIPAA + 42 CFR Part 2 | ✅ Complete |
| [CE-29-HIPAA-PART2-320O-EVIDENCE.md](hipaa-part2-320o-evidence.md)                             | CE HIPAA/Part 2 320-O             | HIPAA + AHCCCS 320-O  | ✅ Complete |
| [HR-09-EN1-EEOC-TITLE-VII-EVIDENCE.md](en1-eeoc-title-vii-evidence.md)                         | EEOC Title VII compliance         | Title VII, ADA, GINA  | ✅ Complete |
| [HR-34-IRS-worker-classification-1099-EVIDENCE.md](irs-worker-classification-1099-evidence.md) | IRS 1099 worker classification    | IRS (26 USC)          | ✅ Complete |

## Related

* `docs/compliance/REGULATORY_COMPLIANCE_TRACKER.md` — master compliance status
* `specs/_templates/COMPLIANCE_SIGNOFF_TEMPLATE.md` — sign-off template
* `scripts/audit/audit-compliance-evidence.ts` — coverage audit script
* `AGENTS.md §Regulatory Compliance Decision Tree` — what regulations apply to each core
