The Platform
Clinical Grounding
Every rule traces to an authoritative source through a five-layer hierarchy. Higher layers override lower. Enforced programmatically at pack-load time, not by policy.
Clinical Grounding
A compliance substrate is only as credible as its evidence base. When a reviewer asks "why does the system flag this as a gap?", the answer cannot be "because we programmed it that way." It must be: the regulatory floor requires X, the society that writes the Standards classifies this as a Class I recommendation, and the institutional protocol layers a local restriction consistent with both.
Every rule in Regain Accreditation carries that level of traceability, not as metadata added after the fact, but as a structural requirement enforced at the point of rule authoring.
The five-layer source hierarchy
Clinical evidence is not monolithic. A regulatory contraindication carries different authority than an institutional formulary preference. A Class I society recommendation carries different weight than a preliminary finding from a recent trial. The substrate encodes the distinction as a five-layer hierarchy where higher layers always override lower:
Layer 1, Regulatory floor. Hard safety facts: regulatory product labeling, contraindications, mandated warnings, risk-management requirements. These are non-negotiable. Rules at Layer 1 produce hard-stop findings. No downstream layer can weaken them.
Layer 2, Standards published by the societies that write them. Society guidelines, society Standards for Accreditation, multi-society consensus documents. Class I, II, and III recommendations with documented evidence grades. This is the layer that captures the Standards programs are accredited to.
Layer 3, Local site protocols. Institutional formulary, escalation procedures, scope-of-practice definitions. These rules reflect the specific clinical environment of a facility. They can add restrictions beyond Layers 1 and 2; they cannot weaken them. The constraint is enforced programmatically, the pack loader rejects any site rule that would reduce the stringency of a higher-layer rule.
Layer 4, Governance and accreditation policy. Regulatory standards, AI risk-management frameworks, quality-management requirements, medical-device lifecycle standards. These rules govern how the substrate itself operates, not just what it evaluates.
Layer 5, Emerging evidence. Recent trials, meta-analyses, safety signals, post-market findings. These carry the lowest override priority but serve a critical function: surfacing new information that may eventually move up the hierarchy as consensus forms.
The hierarchy is not advisory. It is enforced by the evaluation engine. A Layer 3 site protocol that contradicts a Layer 1 safety fact is rejected at load time. A Layer 5 emerging-evidence rule cannot override a Layer 2 society standard. The substrate cannot be misconfigured into an unsafe state through rule-pack composition.
Evidence base
The rule packs cite published sources directly. Each rule carries:
- A reference to the specific section of the authoritative source
- The publication that section appears in
- The evidence grade the source assigns
- The next scheduled review date for the source
The source registry tracks review schedules across every cited source, flags overdue reviews, detects orphaned citations when a source is superseded, and generates validation reports for governance review. When the evidence base changes, the rules that depend on it are surfaced for re-evaluation. Nothing falls through silently.
Structured provenance
Every rule's provenance record is machine-readable. The schema covers source type, source layer, citation, source URL, evidence grade, jurisdiction, clinical domain, the named clinical reviewer who authorized the rule, the effective date, the review interval, and the next review due date.
This is not documentation attached to the rule. It is a functional component of the substrate. The source registry uses it to track review freshness. The Reviewer Surface uses it to generate rule-fire explanations. The governance module uses it to produce audit-ready validation reports.
Cross-layer provenance unity
The provenance schema is unified across the substrate. The same shape appears in the supervisory layer, the compliance evaluator, and the governance module. A single provenance query can trace a compliance finding from the source observation that triggered it, through the FHIR mapper that processed it, through the rule that evaluated it, to the published source that authorizes the rule.
This is what separates clinical grounding from clinical documentation. Documentation says "we based this on guidelines." Grounding produces a machine-verifiable chain of evidence that a reviewer, an auditor, or a regulatory body can follow from finding to source in a single query.
Why this matters for accreditation
The accreditation cycle increasingly scrutinizes the evidence basis of compliance claims. It is no longer sufficient to demonstrate that a program meets a Standard, the program must demonstrate that the assessment methodology is itself grounded in authoritative sources, current, and consistently applied.
A substrate where every rule carries structured, versioned, review-tracked provenance with evidence hashing does not just pass that scrutiny. It produces compliance evidence in a shape the cycle can read directly.