Healthcare & clinical trials.
Advisory-only governance for clinical operations. The platform never produces a clinical decision; it governs the workflow and the audit trail around the clinician's authority.
01Advisory-only architecture
Healthcare is the cleanest test of the platform's architectural posture. The platform produces zero clinical decisions, makes zero diagnostic claims, and emits zero scores attached to patients. The clinical decision is the named clinician's. The platform's role is governance: validating that workflow preconditions are met, routing irreversible actions to the named clinical authority, and writing the entire workflow to the forensic chain.
02Avoiding SaMD classification under EU MDR
Software as a Medical Device (SaMD) classification under EU MDR carries substantial regulatory weight, and rightly so — software that drives clinical decisions ought to be regulated as a medical device. The architectural commitment of this vertical is to remain unambiguously outside that classification by design, not by interpretation.
Concretely, the platform: does not interpret medical images; does not produce diagnostic outputs; does not generate treatment recommendations; does not score patients on clinical risk; does not make clearance, eligibility, or escalation calls. Where any of these would otherwise sit in the workflow, H.A.R.I. routes the decision to a named clinician under DEFER, captures their signed authorization, and writes both the deferral and the resolution to the chain.
The platform is engineered for the institutional question — workflow correctness, audit trail, authorization integrity — and is engineered not to answer the clinical question. The two responsibilities are kept architecturally separate.
03Trial protocol governance
Clinical trial operations are governance-dense: protocol amendments, eligibility verification, randomization integrity, sample chain of custody, sponsor sign-offs, regulatory notifications. Each is a procedural step with hard preconditions and named authorities. The platform encodes the protocol in the CL, validates each step against its preconditions, routes amendments and exceptions to the named principal investigator and sponsor authorities, and writes the entire trial timeline to the forensic chain.
The institutional outcome is a trial whose procedural integrity is reproducible from the chain. A regulator reviewing the trial does not depend on a vendor's narrative or a sponsor's reconstruction; they replay the chain and read the procedural truth.
04Patient housing voucher integration via SLAM XP
The first SLAM XP pilot vertical is healthcare patient housing — accommodation provided to patients and family members during treatment that requires travel away from home. SLAM XP governs the voucher lifecycle (DRAFT → ISSUED → ACTIVATED → CONSUMED / EXPIRED / REVOKED) under the Five-Win constraint, with the platform recording the issuance, activation, and consumption events against the forensic chain.
The pattern matters because it activates dormant value (under-occupied accommodation capacity bought by sponsors) without requiring patients to be profiled, without their PII being retained, and without the sponsor obtaining a marketing surface. The mechanics are detailed on SLAM XP.
05Audit trail for clinical research
Every event in the clinical research workflow that crosses the H.A.R.I. layer is recorded: the input that produced the event, the policy version under which it was evaluated, the canonical output, and the signing authority where applicable. Reconstructing the trial's procedural history is the same operation as for any other vertical: walk the chain, verify the signatures, replay the policy.
Status
The healthcare vertical is architecture-validated for advisory-only governance and trial protocol governance, and is pilot-ready when scoped and authorized. The first SLAM XP healthcare pilot — patient housing voucher lifecycle — is engineered and pilot-ready when sponsors and operating partners are scoped.
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