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What the service is for

An implementation guide is not documentation: it is the conformance contract.

FHIR keeps its resources deliberately flexible so they can serve any country and any clinical domain. That same flexibility is why two «FHIR-compatible» systems can still fail to understand each other. An implementation guide closes the gap: it fixes which resources are used, which elements are mandatory, which terminologies apply, which identifiers are recognized, how information is searched and what a system must satisfy to be considered conformant. At Meddyg we build those guides as executable specifications — profiles, ValueSets, examples, rules and tests published as an installable package — not as documents each implementer reads their own way.

Scopes

Two scopes, the same technical rigor

The method is the same. What changes is who governs the specification, how many implementers depend on it and how much a mistake costs.

Institutional / organizational

One organization and the systems operating under its authority.

National / regional

A whole jurisdiction, or several countries reporting under one shared format.

Who governs it
Institutional / organizationalAn internal technical committee. Agreements are reached between areas of the same organization: clinical, IT, quality and information security.
National / regionalA health authority, a national technical board or a regional body, with institutions that do not report to one another and still have to converge.
Who implements it
Institutional / organizationalYour own systems and those of your direct vendors: EHR, laboratory, imaging, pharmacy, billing, patient portals.
National / regionalThe entire ecosystem: public and private institutions, software vendors and exchange networks, at very different levels of maturity.
How decisions get made
Institutional / organizationalShort cycles. You can iterate with the actual implementers within the same week and correct against concrete cases.
National / regionalLong cycles, public consultation and formal review. Every profiling decision affects dozens of implementers at once.
How it is published
Institutional / organizationalInternally or on your own domain, with the package available to vendors. No balloting or external consultation required.
National / regionalFormal publication: stable canonical URLs, declared jurisdiction, version history and a package available in public registries.
How it is versioned
Institutional / organizationalAligned to the release calendar of the organization's own systems — a calendar the organization controls.
National / regionalSemantic versioning with a compatibility policy and announced transition periods. Breaking a national guide takes years to recover from.
How conformance is enforced
Institutional / organizationalAs a contractual clause and an acceptance criterion: a vendor is conformant when their implementation validates against the published package.
National / regionalAs a condition for connecting at all, with conformance testing, a certification environment and, where it applies, connectathons.
Who maintains it
Institutional / organizationalThe internal team, with Meddyg alongside while the organization builds its own profiling capability.
National / regionalA standing process: intake of change requests, planned releases and sustained support for implementers.

Both scopes share the same technical pipeline and the same conformance artifacts. What differs is governance, versioning policy and the cost of a breaking change.

Methodology

How we build an implementation guide

Seven stages. Each one produces artifacts that get validated and published — not interim deliverables that stay inside a document.

Where the guide comes from: the WHO SMART Guidelines

An implementation guide does not start from a blank document. The WHO defines a five-level ladder for bringing a narrative clinical guideline down to software that executes it and can be tested, and a FHIR guide is exactly level L3. Where the domain already has a published DAK — level L2 — its personas, processes, data elements, indicators and requirements are the input profiling starts from, rather than being rebuilt from scratch in every country.

The five levels
  1. L1Narrative: the guideline as published
  2. L2DAK: personas, processes, data elements, logic, indicators and requirements
  3. L3Machine-readable: FHIR profiles, terminology and logic in CQL
  4. L4Executable: tested against reference cases and data
  5. L5Continuous improvement: evidence of use feeds back into the guideline

We use the SMART Guidelines as a reference model and a way of working. It is not a project delivered to the WHO: it is the model we organize the work around when there is a clinical guideline behind the guide.

  1. 01

    Use cases and scope

    We define which exchanges the guide covers and which are explicitly out of scope. Actors, scenarios, triggers and the full path of each transaction, end to end.

    Artifacts
    • Scope document
    • Actors and participating systems
    • Exchange scenarios
    • Success criteria
    In an institutional guide

    The use cases come from concrete pain: a result that never arrives, a duplicated encounter, a report someone assembles by hand every month.

    In a national or regional guide

    The use cases come from a mandate: a notifiable-disease regulation, a public health program or a regional reporting commitment.

  2. 02

    Information model and FHIR mapping

    Before profiling, we agree on what each data point means. We model the domain's clinical information and decide which FHIR resource represents it — and when the right answer is an extension rather than forcing a resource.

    Artifacts
    • Logical model
    • Data dictionary
    • Data → resource and element mapping
    • Design decision log
    In an institutional guide

    The mapping runs against the models already living in the organization's systems, historical quirks included.

    In a national or regional guide

    The mapping runs against the regulation and the national core, so the new guide depends on it instead of redefining it on its own.

  3. 03

    Profiling and extensions

    We constrain resources to what the use case requires: cardinalities, must-support, slicing, allowed types and invariants expressed in FHIRPath. Extensions are defined only when the data does not fit the base resource.

    Artifacts
    • StructureDefinition (profiles)
    • StructureDefinition (extensions)
    • FHIRPath invariants
    • Identifier conventions
    In an institutional guide

    Tight profiling: you can constrain firmly because the universe of systems is known and bounded.

    In a national or regional guide

    Careful profiling: every mandatory element leaves some implementer out, so what is required today is kept separate from what is announced for the next release.

  4. 04

    Terminology and semantics

    Sharing structures is not sharing meaning. We define the vocabularies bound to each element, the binding strength and the equivalences with the local codes already in use.

    Artifacts
    • CodeSystem
    • ValueSet
    • ConceptMap
    • Binding strength per element
    • Terminology versioning rules
    In an institutional guide

    Each system's own code tables are reconciled against the standard vocabulary, without forcing an immediate replacement.

    In a national or regional guide

    It is settled who publishes and maintains the national ValueSets, and on what terms licensed vocabularies such as SNOMED CT® are distributed.

  5. 05

    Conformance and capability

    The guide states what a conformant system must be able to do: which operations it exposes, which searches it supports, which profiles it accepts and what it must reject. Without this, «conformant» is verifiable by no one.

    Artifacts
    • CapabilityStatement
    • SearchParameter
    • OperationDefinition
    • Valid examples and examples that must fail
    • Conformance rules per actor
    In an institutional guide

    Conformance becomes a contractual clause and the acceptance criterion for a vendor delivery.

    In a national or regional guide

    Conformance becomes an eligibility requirement: without it, a system does not connect to the ecosystem.

  6. 06

    Publication

    We author the guide in FSH and build it with SUSHI and the IG Publisher, inside a continuous integration pipeline that runs the QA report on every change. The output is a browsable site and an installable package.

    Artifacts
    • FSH sources and sushi-config
    • CI pipeline with QA report
    • Published guide site
    • Versioned FHIR package
    • Canonical URLs
    In an institutional guide

    It is published on an organizational domain and handed to vendors as part of their integration documentation.

    In a national or regional guide

    It is published with a declared jurisdiction, version history and presence in public registries, with the canonical URL as each artifact's permanent identity.

  7. 07

    Validation, adoption and maintenance

    A guide nobody manages to implement is worthless. We validate examples with the official validator, prepare material and tests for implementers, walk the first integrations through and leave the change cycle open.

    Artifacts
    • Validated examples
    • TestScript and test plan
    • Implementer guide
    • Change request process
    • Versioning policy
    In an institutional guide

    We stay with the first real integration until it validates end to end in production, not just in the test environment.

    In a national or regional guide

    Connectivity testing and connectathons get organized, and implementer support is sustained throughout the adoption period.

Version strategy

R4 and R5: the version is an ecosystem decision

The right question is not which version is better, but who your system needs to talk to and for how long. We work in both and, when the ecosystem demands it, sustain the two at once.

R4

FHIR R4 · 4.0.1

The version with the largest installed base.

  • It is the version implemented by most servers, libraries and commercial products running in production today.
  • It is what many tenders and already-contracted integrations require, and those will not be renegotiated over a version change.
  • A large share of the published guide ecosystem and of the testing tooling is built on it.
  • It is the natural choice when the guide has to work against systems your organization does not control.
R5

FHIR R5 · 5.0.0

More mature resources for domains where R4 fell short.

  • Resources and elements that were insufficient in R4 arrive more complete, which cuts down the custom extensions you have to invent.
  • It is the version on which Meddyg designed, profiled and published the guides for Costa Rica's health ecosystem.
  • It is the natural choice when a new ecosystem is being defined and you control the implementers' calendar.
  • Worth verifying the actual version support in the project's servers and tooling before committing it in a specification.

Coexistence and migration

Almost no ecosystem switches versions overnight. R4 and R5 normally coexist for years, and that coexistence is designed rather than improvised.

  • Declare the guide's reference version and which FHIR versions each endpoint accepts, explicitly and verifiably.
  • Use cross-version extensions when data that exists in only one version has to travel in the other, instead of inventing a custom extension nobody else will understand.
  • Keep the mapping between the equivalent profiles in each version, so migrating does not mean redesigning the guide.
  • Publish the guide in both versions when the ecosystem justifies it, from one information model and one pipeline.
  • Announce the transition with a real overlap period, so no implementer drops out of the exchange between one release and the next.
  • Isolate version translation in the integration layer rather than in every client system, so that cost is paid once.
Results

What your organization receives

Everything an implementer needs to build, validate and demonstrate conformance without depending on a meeting with us.

Publishable FHIR package

The guide, built and versioned, installable with the ecosystem's standard tooling.

Profiles and extensions

StructureDefinitions with documented cardinalities, must-support, slicing and invariants.

ValueSets and ConceptMaps

Terminologies, binding strength and equivalences between local codes and the standards.

Validated examples

Instances that pass the validator, including edge cases and examples that must fail.

CapabilityStatement and searches

What a conformant system exposes: operations, search parameters and accepted profiles.

Sources and pipeline

A repository with FSH, configuration and CI, so the guide stays alive without us.

Versioning policy

Compatibility rules, numbering and the transition between releases of the guide.

Implementer material

Onboarding documentation, a test plan and support through the first integrations.

Experience

Guides we have built

Published specifications in real use, not lab exercises. Each one defines the conformance contract for an exchange that happens today.

NationalR5

Core IG — Costa RicaOpens in a new tab

The base FHIR resources and core profiles for national clinical exchange: the guide every other one depends on.

Meddyg's roleCollaboration on design, profiling and publication.

National

Notifiable diseases, vaccines and lab results — EDUS/CCSS

A guide for reporting notifiable diseases, vaccines and laboratory results. Meddyg implemented and deployed to production the first FHIR server to receive these reports from EDUS/CCSS, later extended to other health providers.

Meddyg's roleParticipation in the design, profiling and publication of the guide, plus implementation of the receiving infrastructure.

Regional

Regional AEFI reporting

The first HL7® FHIR® implementation guide for regional AEFI (Adverse Events Following Immunization) reporting, together with the design of the infrastructure that would receive those reports.

Meddyg's rolePart of the Meddyg team acted as a consultant on the design of the guide and on the design and implementation of the receiving infrastructure.

National

Digitally signing FHIR resources — Central Bank of Costa Rica

Integration of the JAdES format into GAUDI, the BCCR's digital signature and sealing platform. Not a guide in itself: it is exactly the kind of conformance rule — how a resource is signed and how that signature is verified — a guide must declare for non-repudiation to be enforceable.

Meddyg's roleTechnical assistance so the BCCR's teams could enable signing of FHIR resources.

The guides above are national and regional in scope. The same method — information model, profiles, terminology, conformance and publication — is what we apply to institutional guides, with shorter cycles and internal governance.

Profile

Who is this service for?

The method is the same; what changes is what is at stake when the specification is left ambiguous.

National health authorities

Ministries and regulators that must set how the country reports and exchanges information. The guide turns written regulation into something verifiable.

Social security and public networks

Nationwide systems with many facilities and vendors. The guide defines what is required of each, without negotiating it case by case.

Regional bodies and multi-country programs

Initiatives where several countries must report under one shared format without giving up what is specific to each.

Health information exchanges

Ecosystems onboarding new participants that need a repeatable technical contract rather than a separate agreement per connection.

Hospitals and hospital networks

Organizations running several clinical systems that want to stop negotiating the format on every new integration.

Laboratories and imaging centers

Results and reports that must reach multiple external receivers with the same structure and the same codes.

Health software vendors

Products that must demonstrate conformance with a national guide, or build their own to bring order to client integrations.

Self-assessment

Do any of these sound familiar?

We say we are «FHIR-compatible», but every integration is negotiated from scratch.
Every vendor reads the standard their own way and every reading is defensible.
We have a reporting regulation written in prose and nobody can turn it into structures.
We cannot tell whether a system is conformant without an expert reviewing messages by hand.
We publish profiles, but no examples or tests implementers can actually run.
Our guide lives in a document that no longer matches what the systems do.
Every institution defines its own codes for the same clinical concept.
We need to choose between R4 and R5 and internal opinion is split.
Our guide is on R4 and the ecosystem we must connect to moved to R5.
Nobody knows who approves a change to the specification or when the next version ships.
Every release of the guide breaks integrations that were already working.
A vendor passed review and then sends data in production that we cannot process.

If any of these describe your organization, an implementation guide is how the agreement becomes a rule that can be validated.

Do you need «conformant» to mean something verifiable?

An implementation guide turns regulations and agreements into rules a system can validate before it reaches production.