Healthy Route Implementation Guide
0.1.0 - ci-build

Healthy Route Implementation Guide, published by Savannah Informatics. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/savannahghi/healthy-route-ig/ and changes regularly. See the Directory of published versions

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Official URL: https://fhir.savannahghi.org/ig/healthy-route/ImplementationGuide/org.savannahghi.healthyroute Version: 0.1.0
Draft as of 2026-09-04 Computable Name: HealthyRouteIG

OptimalHealth Healthy Route

Healthy Route Implementation Guide

Clinical data management profiles for the AstraZeneca Healthy Heart Africa validation study of a machine-learning algorithm predicting chronic kidney disease from digital retinal images.

The study runs in five countries under one approved protocol per country, with approximately 500 participants in each.

Each country's approved protocol takes precedence over this guide for that country. Where this guide and a protocol disagree, the protocol is correct.

Scope of this release

Area Status
Participant defined
Consent defined
Documents defined
Sites, people and study participation in preparation
Encounter, measurement and specimens in preparation
Imaging metadata and algorithm output in preparation
Referral, export and audit in preparation

Two principles carried through every profile

The de-identification boundary is expressed as cardinality. Participant data exists in two forms and this guide constrains both. Elements that may not leave a site tenant are set to a cardinality of 0..0 on the export profile, so a resource containing one fails validation rather than passing review. The boundary is enforced by the same tooling that validates every other conformance rule. See participant.

Country variance is instance data, never a profile. The participating countries differ in thresholds, eligibility and the split between cases and controls, and those differences belong in ResearchStudy and PlanDefinition instances. There is deliberately no country-specific profile in this guide.

This holds for everything modelled so far. The protocols also differ in procedures the guide does not yet cover, and whether those can be carried as instance data is settled by the measurement profiles rather than assumed here. See study and participation.

The participant identifier

A single opaque identifier, issued at registration, serves as the participant identifier within the tenant, the study identifier on the case report form, and the value entered on the retinal camera at image capture. It is retained unchanged across rescreening.

https://fhir.savannahghi.org/sid/optimalhealth-participant

Tenancy

Every resource holding participant data carries the tenant extension. Records are partitioned by site, and partition membership is a property of the record rather than of the storage location it happens to occupy.

The resources describing sites and staff do not carry it. They describe the partitions rather than sitting inside one: a site's tenant is the identity of its organisation, and a location or practitioner resolves to one through the organisation that manages or registered them. See sites and people.

Dependencies

IGPackageFHIRComment
.. Healthy Route Implementation Guideorg.savannahghi.healthyroute#0.1.0R5
... HL7 Terminology (THO)hl7.terminology.r5#7.3.0R5Automatically added as a dependency - all IGs depend on HL7 Terminology
.... FHIR Extensions Packhl7.fhir.uv.extensions.r5#5.3.0R5
... FHIR Tooling Extensions IGhl7.fhir.uv.tools.r5#1.1.2R5for example references

Package hl7.fhir.uv.extensions.r5#5.3.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sat, May 16, 2026 18:32+1000+10:00)

Package hl7.fhir.uv.tools.r5#1.1.2

This IG defines the extensions that the tools use internally. Some of these extensions are content that are being evaluated for elevation into the main spec, and others are tooling concerns (built Tue, Mar 24, 2026 11:13+1100+11:00)

Globals

There are no Global profiles defined

Terminology expansion parameters

Parameter Value
includeDesignations true
activeOnly false

Intellectual property

This publication includes IP covered under the following statements.