EGAF Health profile: L2 assurance for medical software

2026-08-30 · Assurance

The Health profile is L2. It extends Core for teams building medical-device software, electronic records under 21 CFR Part 11, or systems that handle protected health information. Administrative and physical safeguards, BAAs, and clinical validation stay with the organization.

Pre-release, founder-operated system; current capability labels describe the evidence boundary.

How the Evidence-Gated Assurance Framework works

The Evidence-Gated Assurance Framework (EGAF) is a spec-first assurance bar. It is in flight. A project claims conformance to EGAF L1, L2, or L3 at a given commit, with evidence attached. It is not a certification, an accreditation, or an authorization. Independent assessment of any organization remains a separate question.

Three parts make a run:

  1. A control catalog. Each control is either a machine check (an artifact an independent tool produced) or an evidence: attestation (a signed statement by a named principal). A named check with no backing artifact is DRIFT, never PROVEN. An empty-but-parsable file is not a verdict.
  2. A deterministic evaluator. Same inputs produce a byte-identical conformance report. The evaluator does not run tests or scanners. It reads artifacts other tools already produced and records their digests. An agent cannot manufacture PROVEN without producing the artifact the check names.
  3. A committed profile. .egaf/profile.yaml in the consumer repo is what CI evaluates. If that file is absent, the evaluator uses the bundled core profile, so L1 mandatory controls always apply. Profiles may only tighten a threshold; a loosening override is rejected at validation time.

Three levels. L1 Core is mandatory to claim any EGAF conformance: traceability, complexity and duplication caps, whole-codebase statement and branch coverage, mutation on changed files, verifier integrity, signed evidence, supply-chain hygiene. An EXCEPTION never satisfies an L1 control. L2 Regulated adds industry-profile controls (evidence packs, retention, model-risk records). L3 Safety-critical adds independence, structural coverage, tool-qualification inputs, and hazard linkage. Fail one applicable L1 control and the report's first line is L0.

Control status is derived from the seven check outcomes already used in Koinessa evidence bundles:

Check outcome Control status
PASS PROVEN
FAIL FAILED
SKIPPED-NOT-APPLICABLE with a recorded reason NOT-APPLICABLE
INFRASTRUCTURE-ERROR, TOOL-MISSING, EVIDENCE-INVALID, or ABSTAIN DRIFT
Missing evidence DRIFT

A level is achieved only when every applicable control at that level and below is PROVEN or NOT-APPLICABLE (L2/L3 may also count an unexpired EXCEPTION with an independent approver). The report always shows two honesty lists: Not proven (FAILED and DRIFT) and Accepted without proof (NOT-APPLICABLE and EXCEPTION). A clean badge over an empty honesty block is the failure the framework exists to prevent.

Frameworks are guidance. Controls are behavior. Evidence proves the behavior occurred. Organizational burdens — training, physical security, BAAs, a C3PAO assessment, DO-330 tool qualification, a SOC 2 Type II engagement — stay with the organization. The catalog cites clause identifiers and paraphrases; it does not reproduce normative text.

The catalog this series describes is a measured snapshot: 109 controls, vendored into Koinessa at pin 0.0.0-dev+98d08ef on 2026-08-30. The public specification repository is planned; until the operator creates its GitLab group, treat EGAF as a labeled pre-1.0 draft with publication pending. Koinessa's own first mainline conformance report is planned.

Read the Koinessa whitepaper for the surrounding Evidence-Gated Agentic Development thesis, and the verified-delivery report for what this system already publishes about itself.

The Health profile (id health, L2)

In flight. Source: vendor/egaf/catalog/profiles/health.yaml. Extends core.

Added frameworks:

EVD-08 (regime evidence pack per release) and EVD-06 (append-only, content-addressed evidence with audit-trail integrity) are catalogued at L2, so they are already active once this profile declares level: L2.

Applicability: agentic, services, data_store, and ui. Releases and deploys declared.

Retention is 72 months. Floor: 45 CFR 164.316(b)(2)(i) (Security Rule) and 164.530(j) (Privacy Rule) require six years of required documentation — policies, procedures, and records of required actions — from creation or last effective date, whichever is later. The Security Rule at 45 CFR 164.312(b) states no retention period for audit-trail logs themselves; the six-year figure is documentation, not logs, and must not be read as a HIPAA log-retention requirement. 21 CFR 11.10(c)/(e) sets no number for electronic records either: retention runs for the period the predicate rule sets (for example 21 CFR 820, 58, or 211). An adopter operating under Part 11 must name that predicate rule and use its period.

What the organization must still do: risk analysis, BAAs, clinical validation, CAPA, complaint handling, post-market surveillance, and any notified-body or FDA submission. EGAF can prove that a pipeline produced a signed evidence pack. It cannot write the quality-system file.

What this page does not claim

EGAF conformance is a per-commit statement a project makes about itself with evidence attached. It does not confer a certification, a SLSA level, or an authorization to operate. Citing a framework in a profile is a crosswalk, not a state the adopter has reached. Planned items carry no dates.

This article is one of ten in a series. Each page keeps the same mechanics and changes the profile.

The rest of the engineering blog covers the verification loop that EGAF sits on. The Koinessa home page states the product position.