This is the third STU release of the Structured Data Capture (SDC) implementation guide. A list of changes from prior releases can be found here. Other versions of the specification can be found in the FHIR.org IG registry.

1.1 Scope

Forms permeate healthcare. They are used to capture administrative data, claims data, clinical information, research information, for public health reporting - every type of data that is manipulated by healthcare systems. They provide a user-friendly mechanism for capturing data in a consistent way. In FHIR, forms are represented using the Questionnaire resource and completed forms are represented using the QuestionnaireResponse resource. The base FHIR specification defines these resources but doesn't provide much guidance around how they should be used, nor does it set minimal expectations for interoperation. This implementation guide provides a set of guidance around the use of Questionnaire and QuestionnaireResponse. Specifically, it provides answers to - and conformance expectations around - questions like the following:

• What are the minimum capabilities a system should have to properly support FHIR-based forms?
• How do I present questions in a table?
• I want help text to appear in red - how do I do that?
• What's the mechanism to calculate and display a score for a completed form?
• I don't want to expose the logic of the questionnaire to other systems, but I still want to support form completion. How do I do that using FHIR?
• Most of the data in this form already exists in the patient's record. How can I save the time (and prevent the transcription errors) associated with re-entering it into a form?
• Once a form's complete, I want to import the data into other FHIR resources - is there an easy way to do that?

The implementation guide is structured to allow implementers to pick and choose the capabilities they need and combine them as necessary.

1.2 Navigation

This implementation guide follows the FHIR pattern of being published as a web-based specification. This allows easy navigation between the SDC-specific portion of the implementation guide and the resources, data types, value sets and other specification components leveraged from the FHIR core specification. This approach also allows implementers to easily navigate to the information needed to perform a particular task.

A Table of Contents page is provided that lists all of the pages defined as part of this implementation guide. (Do be aware that some pages have multiple tabs.) A table of contents is also available for the full FHIR specification if you really want to read absolutely everything. There's also an Artifact index that lists all formal FHIR artifacts defined within this implementation guide.

Bread-crumb navigation is provided in the gray bar just below the menu at the top of each page, allowing easy navigation back to the main SDC page.

This implementation guide is organized into several sections:

1. FHIR usage provides information about the FHIR and FHIRPath standards used by this IG and an overview of the resources used and base conformance expectations
2. Security sets base security expectations for systems claiming conformance with this implementation guide
3. Workflow describes the expectations for systems managing the creation, discovery and completion of questionnaires. Systems conforming to SDC are expected to conform to one of the CapabilityStatements defined in this section
4. Advanced Rendering describes how to use various questions and the base capabilities of Questionnaire to render different types of form elements
5. Form Behavior describes how to design 'active' forms that adjust what information is displayed and/or that perform calculations based on user input
6. Adaptive Forms describes an architecture to support completing forms where the questionnaire is not pre-defined and instead is dynamically developed based on the user's answers
7. Questionnaire Population describes how to design questionnaires to support pre-population of answers and how to use services that support pre-populating forms
8. Data Extraction describes how to design questionnaires to support converting completed forms into a FHIR resource or Bundle of FHIR resources for subsequent analysis
9. Artifact List provides a complete list of all of the profiles, extensions, capability statements, operations, value sets and other artifacts defined as part of this implementation guide

Of these, the first 3 are relevant to all SDC implementations. Sections 4-8 are optional - implementers can decide which are necessary for their purposes. Section 9 acts as an index and covers artifacts from all of the various sections.

1.3 Project

The original version of this implementation guide was prepared as a U.S. Realm Specification on behalf of the Structured Data Capture project - an effort under the U.S. Office of the National Coordinator (ONC)'s Standards and Infrastructure (S & I) Framework. Information about this original project can be found on the project wiki that contains development materials and records of project discussions.

The new version of this guide was developed by the FHIR Infrastructure work group in collaboration with the Lister Hill National Center for Biomedical Communications of the U.S. National Library of Medicine (NLM). As part of the revision of the implementation guide, the very limited potions of the implementation guide that were U.S. specific have been relaxed, making the guide applicable to all countries. Representatives from several non-U.S. jurisdictions were part of the project calls where the revisions to the implementation guide were determined. Project details, minutes and call information can be found on the project wiki. Additional participants are welcome to join as we further refine the implementation guide and work to increase adoption through connectathons, open source projects and other mechanisms.

1.4 Intellectual Property Considerations

While this implementation guide and the underlying FHIR are licensed as public domain, this guide includes examplse making use of terminologies such as LOINC, SNOMED CT and others which have more restrictive licensing requirements. Implementers should make themselves familiar with licensing and any other constraints of terminologies, questionnaires, and other components used as part of their implementation process. In some cases, licensing requirements may limit the systems that data captured using certain questionnaires may be shared with.