v0.5.0-rc

This is the final RC before our first stable version (v0.5.0) is released.

Changes

⚠️= breaking change

General

• ⚠️The system element must be set to https://smarthealth.cards/ial when specifying meta.security
• IAL1 for meta.security SHOULD no longer be populated
• Updated example links pointing at GitHub to lead to the correct lines
• Prefixed invariants with vc- (does not affect resources; only changes display of invariants in the IG)
• Substantial cleanup of terminology
• Removed most warnings about IG Validator issues as these have been resolved (🎊). There is still a note about a possible warning related to the FHIR security labels value set, but this is a minor issue.
• Improved guidance on conformance page for when Resource.meta should/shouldn't be populated
• Added note on home page that this IG does not describe resources meant to be the representation of canonical data in an EHR
• Added note on home page about our approach to cardinality constraints and terminology bindings
• Add unit tests for the IG (see README on GitHub for details)

Immunization

• Added substantial documentation to the beginning of the AD Immunization profile
• ⚠️vaccineCode is now required (technically a breaking change, but should not affect implementers as this was already MS)
• Add support for manufacturer, which is required if the system used for vaccineCode does not identify the manufacturer
• Add warning when performer.actor.display is longer than 30 chars
• Added support for other code systems in addition to CVX
• Added CVX-specific profiles to assist implementers using this code system for vaccineCode
• Removed temporary code system URI for CVX
• Remove reportOrigin, site, route, and fundingSource value set bindings as these are not MS elements and SHOULD NOT be populated
• Improved guidance for isSubpotent

Lab results

• ⚠️Disallowed category
• ⚠️Made value[x] required (this was already MS, so while technically a breaking change it should not affect implementers)
• ⚠️Add invariant requiring status to have a value meaning "completed" (technically a breaking change, but should not affect implementers as this element was already required)
• Added support for valueQuantity, and for referenceRange (which SHOULD be populated with valueQuantity)
• Added support for valueString when a computable representation of lab results is not available (this replaces our use of valueCodeableConcept.text for this)
• Add warning when performer.display >30 chars
• Add LOINC answer list options for lab results (previously only SNOMED codes were allowed)

Patient

• Remove reference to "animals" from short and definition
• Added guidance for partially known or missing birth dates in comment on birthDate element
• ⚠️Disallow contact, and portions of address to protect privacy

Bundles

• ⚠️Make slicing of entry closed, which limits the types of resources that can be included
• ⚠️Improved consistency of DM constraints
• Removed id from example Bundles
• Shortened slice names (does not affect resources, just how slices are displayed in the IG)
• Removed note on the conformance page about combining both lab test results and immunization resources into a single Bundle: this is no longer allowed now that the slice is closed for entry.

v0.4.0-rc

Breaking changes

• Settle on resource:# syntax for fullUrl and reference based on guidance from FHIR-I. This is a SHALL requirement to match the SMART Health Card spec. fullUrl is now required.
• Address- and telecom-related changes in Patient profiles
  • Entirely disallow including exact address (address.line and address.text) in the AD profile.
  • The other address elements are marked as “SHOULD NOT populate” in the AD profile. Accordingly, removed MS from address.country and address.postalCode in AD profile.
  • address is entirely disallowed in the DM profile.
  • telecom is now “SHOULD NOT populate” in the AD profile. It was already entirely disallowed in the DM profile.
  • We should discuss whether address and telecom should be entirely disallowed in the AD profile. These are mutable data which may have little long-term value for verification, but has significant privacy downsides.
• Patient.gender is now disallowed in AD and DM profiles.
• Make DM profiles match the MS flags on the AD counterparts. There were a number of inadvertent inconsistencies which have been resolved.
• Make naming consistent through the IG. This should not break implementations, but could break validation tools. vaccine has been replaced with vaccination throughout, and covid-19 replaced with covid19 in StructureDefinition IDs.
• Make Observation.category 1..1 rather than 1.. for lab result profiles. This is not expected to break any implementations, but if it does please let us know.
• FixImmunization.status to #completed and disallow statusReason entirely. This is technically a breaking change, but shouldn’t affect implementers unless Issuers are issuing credentials for incomplete vaccinations.
• Patient.photo is now 0..0, which is technically a breaking change but should not affect implementers.

Other changes

• Omit id throughout for data minimization purposes. However, this is technically not allowed (id can only be omitted when sending a resource to a server with a create request), so we may want to revisit this from a conformance perspective.
• Add note that validation with the FHIR validation tool is currently broken and an explanation about why (this is on the Conformance page). We are working on a functional validation workflow.
• Add example links in the expected place within the FHIR IG (a tab on each profile page).
• Move examples out of the FHIR IG in favor of linking to the files on GitHub. This may be a temporary change, but is necessary to avoid spurious errors when publishing the IG.
• Remove all the profile-specific examples in favor of linking to a section within the bundle examples. The content was identical with the profile-specific examples, so this change avoids the possibility of these getting out of sync.
• Update examples to match changes in IG.
• Ability to link to the differential, snapshot, and snapshot (must support) tabs on the profile pages
• Add definition and comments to Immunization.occurrence
• Add guidance for representing lot number in Immunization.lotNumber
• Add guidance on providing string laboratory results vs. computable results in value[x] comment
• Explain using display to identify the responsible organization for performing an immunization or lab test.
• Add headers on all the AD and DM profiles with a link to the explanation of this pattern, and to their AD/DM counterpart.
• Removed the Excel data dictionary for now. It doesn’t seem to be used and there’s some burden associated with updating it.

v0.3.0-rc

This is the Release Candidate for our first stable release! Thanks to @nkarip co-authoring this, and to everyone who reviewed the IG for their suggestions.

General

• Added meta.security proof of concept to Immunization profile, and their examples (please provide feedback on the implementation of this).
• Substantial improvements to content on index.html and conformance.html.
• Added dropdown menu for profiles and value sets.
• Added invariant to warn when element strings are >20 chars for MS elements and id.
• Changed realm from US to Universal.
• Added scripts to facilitate validating examples against the IG in the scripts/ folder (only needed for IG authors, not implementers).

Patient profiles

• Removed MS label from Patient.gender.
• Fixed consistency issues with MS labels (Patient.address).
• Changed Patient.name from 1..\* to 1..1 in DM profile; we believe more than 1 patient name is an edge case that should rarely, if ever occur. See the details for Patient.name for more information.
• Made Patient.address.id and Patient.address.extension 0..0 in the DM profile.

Lab result (observation) profiles

• Made category[labortory].coding, .coding.code, and .coding.system MS for consistency.
• Removed 0..0 for category.id and category.text to fix validation issue.

Bundle profiles

• Switched to separate Bundle profiles for COVID lab results and generic lab results to facilitate validation; added DM versions of both of these bundles as well.
• Added DM version of the VaccineCredentialBundle to facilitate validation.
• Made Bundle.type MS since it is 1..1.

Immunization profiles

• MS consistency fixes: Immunization.patient and Immunization.vaccineCode, Immunization.performer.actor, Immunization.status.
• Added guidance about use of CVX codes.
• Added explanation for handling of isSubpotent.

Examples

• Removed telecom from Patient examples.
• Made id consistently use the resource:x format across examples.
• Removed extraneous content from Scenario2Bundle example.

Value sets

• Attempted to correct URLs for PHIN VADS and VSAC value sets (see below).
• Removed value sets that were no longer used.
• Added value set for identity assurance.

Known issues

• We are using a temporary value set for CVX codes to avoid valdiator errors. The FHIR CVX value set is being updated, and we will switch back to this before our stable release.
• Other value sets based on PHIN VADS and VSAC are not being expanded. We are working to resolve this.
• The COVID-specific LOINC codes identifying lab tests are not being expanded. This is causing validation errors related to invalid codes. We are working to resolve this.
• We are not providing a way to identify the device/method used to generate the laboratory result. This is a TODO in the FSH code, and needs to either be implemented or removed.

v0.2.1-dev

Bug fixes

• Adds MS to Patient.address.country and Patient.address.postalCode in the AD profile
• Removes 0..0 for Patient.address in the DM profile, and adds 0..0 for all the Address elements that are not country and postalCode

Other changes

• Remove sushi-config.yaml dependency on US Core (no longer used in this IG)

v0.2.0-dev

v0.2.0 release

Initial release

Initial development release of the IG