| Package | hl7.fhir.uv.cmhaffr2 |
| Type | ImplementationGuide |
| Id | Id |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/uv/cmhaffr2/https://build.fhir.org/ig/HL7/cmhaff-ig/index.html |
| Url | http://hl7.org/fhir/uv/cmhaffr2/ImplementationGuide/hl7.fhir.uv.cmhaffr2 |
| Version | 2.0.1 |
| Status | active |
| Date | 2025-01-30T10:38:20+00:00 |
| Name | CMHAFFR2 |
| Title | Consumer Mobile Health Application Functional Framework, Release 2 |
| Experimental | False |
| Realm | uv |
| Authority | hl7 |
| Description | This is CMHAFF R2. |
No resources found
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Note: links and images are rebased to the (stated) source
Generated Narrative: ImplementationGuide hl7.fhir.uv.cmhaffr2
The official URL for this implementation guide is:
http://hl7.org/fhir/uv/cmhaffr2/ImplementationGuide/hl7.fhir.uv.cmhaffr2
This is CMHAFF R2.
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"grouping" : [
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"id" : "PDS",
"name" : "Product Development & Support Section",
"description" : "Prior to marketing a mobile app, the developer has a responsibility to ensure it meets Realm-specific rules and regulations.\nAlthough cMHAFF does not have guidelines for all aspects of the software product life cycle, cMHAFF still recommends\nthat the product development life cycle, for new apps and for upgrades to apps, ensure that requirements for functionality,\nreliability, performance, scalability, safety, compatibility, portability, and maintainability have been addressed, as well as any\nrequirements that relate to aspects that include these items previously described above:\n* Product Information for consumers (e.g., App Store descriptions, product disclosures)\n* Security\n* Privacy\n* Permission to use device features\n* Data Access\n* Data Sharing\n* Terms of Use, Conditions\n* Product Development, including risk management, user-centered design, compliance with applicable regulations,\nfunctions (product description), reliability, performance, scalability, safety, compatibility, and portability.\nThe security and privacy of information used by the app needs to be considered throughout the development\nphases of the app. Functionality must support the intended use of the app for the target users and stakeholders.\nThorough and iterative risk assessment and requirement analysis, testing, evidence collection, documentation, and\nconfiguration management ensures quality to satisfy the needs of the application’s various stakeholders 8 .\nAssessing the usability of the app helps ensure the app’s viability and adoption; testing must be population-\nrelevant and demonstrate reasonable product usability (accessibility) by people with visual, auditory and motor\ndisabilities within the intended target audience. Establishing a system of customer support enables product\ndefects and usability issues to be surfaced in a systematic way and helps problems related to use of the app to be\neffectively resolved and the developer to continually deliver the intended use of the app."
},
{
"id" : "PIM",
"name" : "Product Implementation Section",
"description" : "Apps are frequently marketed and downloaded through platform-specific “app stores.†Before an app can be housed within an app store, it must meet requirements set by the app store host. The app store is one primary source of product information for consumers to decide whether they want to install the app. In some realms, apps may also be obtained through an app registry."
},
{
"id" : "APU",
"name" : "App Use Section",
"description" : "This section addresses functionalities and considerations to be addressed while the user is operating\nthe app."
},
{
"id" : "AST",
"name" : "App Service Termination Section",
"description" : "Health apps may be used indefinitely or for a finite period of time and will consequently require the ability to terminate services with the app.Disuse may happen when a health condition improves, a new health habit is established, when motivation to use the app wanes, or when\nthe user determines a different app better meets their needs. Procedures for how data continues to be retained and used after account closure must be\nclear and understandable and give the app user options for relocation of their data to a new data repository."
},
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"name" : "Conditions and Agreements Section",
"description" : "This section of cMHAFF deals with nonfunctional, and usually nontechnical, aspects of mobile health apps. While not traditionally in scope for\nHIT standards oriented at large or small enterprise organizations, it is a very important and distinctive characteristic of apps targeted at consumers.Since one goal of cMHAFF is consumer protection, including their privacy and security, guidance in the area of “Conditions and Agreements†(CnA) is offered. CnA is not a formal or legal term, but an umbrella under which can be grouped various expressions of conditions that consumers to which are asked to agree before they start using a mobile health app. These may be called “Terms and Conditions,†“Terms of Use,†“Terms of Service,†“End User License Agreement (EULA),†and similar concepts. Typically, CnA are displayed and consumers are asked to click buttons to agree to terms, when they interact with “App Stores†(a generic term including wherever a consumer downloads a mobile health app). In addition to what the consumer agrees to, CnA may also commit the app supplier to certain behaviors or restrictions. While cMHAFF does not prescribe what these CnA must include, it provides guidance as to items that are important to disclose. In that respect, there is some precedent in the ONC 2015 Edition Certification, which contains disclosure and transparency requirements for EHR developers, e.g., about pricing and services that are not included in the base software."
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"name" : "PDS.1 Regulatory Considerations (Header)",
"description" : "This section is about the compliance of apps to applicable regulations for the domains (realms, locales,\nenvironments) in which they are intended to be used. CMHAFF is designed as a framework that can be\nfurther constrained (profiled) for these domains and does not require conformance to any specific\nlocale’s regulations.",
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"name" : "PDS.3 Usability and Accessibility Assessment (Header)",
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"name" : "Product Implementation",
"description" : "Apps are frequently marketed and downloaded through platform-specific “app stores.†Before an app can be housed within an app store, it must meet requirements set by the app store host. The app store is one primary source of product information for consumers to decide whether they want to install the app. In some realms, apps may also be obtained through an app registry.",
"isExample" : false,
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"groupingId" : "OTH"
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],
"reference" : {
"reference" : "Requirements/CMHAFFR2-PIM.1"
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"name" : "PIM.1 Product Information (Header)",
"description" : "This category is about providing information about the product to consumers and also other parties (e.g., governments, consumer or provider\norganizations) who have interest in potential purchase, use, endorsement, or recommendation of apps. The experience of installing an app begins at an\napp store and completes on a user device. See also the Conditions and Agreements section of this specification for guidance regarding Conditions and\nAgreements that usually appear as part of the app store experience. cMHAFF does not specify exactly how or where product information is conveyed, e.g., app store, web site, online help.",
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"groupingId" : "PIM"
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"reference" : {
"reference" : "Requirements/CMHAFFR2-PIM.1.2"
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"name" : "PIM.1.2 Payment (Header)",
"isExample" : false,
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"groupingId" : "PIM"
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"reference" : {
"reference" : "Requirements/CMHAFFR2-PIM.1.3"
},
"name" : "PIM.1.3 Evidence and Credentials (Header)",
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},
"name" : "PIM.1.4 Limitations and Warnings (Header)",
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},
"name" : "PIM.1.5 Technical Details (Header)",
"isExample" : false,
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"groupingId" : "PIM"
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"name" : "PIM.2 Launch App and Establish User Account (Header)",
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"name" : "App Use",
"description" : "This section addresses functionalities and considerations to be addressed while the user is operating\nthe app.",
"isExample" : false,
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],
"reference" : {
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},
"name" : "APU.1 Authentication (Header)",
"description" : "This category is about the system protecting against unauthorized access (e.g., by persons other than the consumer).",
"isExample" : false,
"profile" : [
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"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.2"
},
"name" : "APU.2 User Authorizations (Header)",
"description" : "This category is about personal data collection and use, including access to device features, being understood and explicitly\nauthorized (consented to) by the users of the app.",
"isExample" : false,
"profile" : [
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"groupingId" : "APU"
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],
"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.3"
},
"name" : "APU.3 Pairing or Syncing User Accounts with Devices and Data Repositories (Header)",
"description" : "This category is about consumer verification of all devices to which they wish to pair or sync data.",
"isExample" : false,
"profile" : [
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],
"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.4"
},
"name" : "APU.4 Security for Data at Rest and in Transport (Header)",
"description" : "This category is about providing assurance that the consumer’s stored data is secure, regardless of whether it is stored on the consumer’s\ndevices or elsewhere (e.g., in cloud-based servers for an app). It also provides assurance that consumer data is secure when it is moved between the\nconsumer’s device(s) and other locations.",
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],
"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.5"
},
"name" : "APU.5 Data Authenticity, Provenance, and Associated Metadata (Header)",
"description" : "This category is about providing assurance that consumer data is secure when it is moved between the consumer’s device(s) and other\nlocations. This category is about the attribution of sources of data (provenance) and assurance of data authenticity.",
"isExample" : false,
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],
"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.7"
},
"name" : "APU.7 Data Exchange and Interoperability (Header)",
"description" : "This category applies only if an app exchanges data with other devices, health apps, and/or HIT systems. If so, there are applicable\nstandards for data format, vocabulary, and transport, to increase interoperability and ease of connection.",
"isExample" : false,
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"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.8"
},
"name" : "APU.8 Notifications and Alerts (Header)",
"description" : "This category applies only if an app exchanges data with other devices, health apps, and/or HIT systems. If so, there are applicable\nstandards for data format, vocabulary, and transport, to increase interoperability and ease of connection.",
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],
"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.9"
},
"name" : "APU.9 Product Upgrades (Header)",
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],
"reference" : {
"reference" : "Requirements/CMHAFFR2-APU.10"
},
"name" : "APU.10 Audit (Header)",
"description" : "This category is about auditing, which is a mechanism for user and system accountability. Important events, such as logins and access to\nparticular functions and data, are recorded and can be used to detect instances of non-compliant behavior and to facilitate detection of improper\ncreation, access, modification, and deletion of personal health information. Any information technology including consumer health apps should follow\nbest practices in managing an audit trail. The audit trail should maintain a record of users who have accessed what data, from where, and when. Audit\nlogs should also record any attempts to access the system from an unauthorized terminal; expired usernames or passwords that try to access the\nsystem, unusual numbers of authentication attempts, and violations of an organizations security policy.",
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},
"name" : "App Service Termination",
"description" : "Health apps may be used indefinitely or for a finite period of time and will consequently require the ability to terminate services with the app.Disuse may happen when a health condition improves, a new health habit is established, when motivation to use the app wanes, or when\nthe user determines a different app better meets their needs. Procedures for how data continues to be retained and used after account closure must be\nclear and understandable and give the app user options for relocation of their data to a new data repository.",
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},
"name" : "AST.1 App and Data Removal (Header)",
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"groupingId" : "AST"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Requirements"
}
],
"reference" : {
"reference" : "Requirements/CMHAFFR2-AST.2"
},
"name" : "AST.2 Permitted Uses of Data Post Account Closure (Header)",
"description" : "This category is about what is done with consumers’ data if they close their account (terminate use of the app).",
"isExample" : false,
"profile" : [
"http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"
],
"groupingId" : "AST"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Requirements"
}
],
"reference" : {
"reference" : "Requirements/CMHAFFR2-CNA"
},
"name" : "Conditions and Agreements",
"description" : "This section of cMHAFF deals with nonfunctional, and usually nontechnical, aspects of mobile health apps. While not traditionally in scope for\nHIT standards oriented at large or small enterprise organizations, it is a very important and distinctive characteristic of apps targeted at consumers.Since one goal of cMHAFF is consumer protection, including their privacy and security, guidance in the area of “Conditions and Agreements†(CnA) is offered. CnA is not a formal or legal term, but an umbrella under which can be grouped various expressions of conditions that consumers to which are asked to agree before they start using a mobile health app. These may be called “Terms and Conditions,†“Terms of Use,†“Terms of Service,†“End User License Agreement (EULA),†and similar concepts. Typically, CnA are displayed and consumers are asked to click buttons to agree to terms, when they interact with “App Stores†(a generic term including wherever a consumer downloads a mobile health app). In addition to what the consumer agrees to, CnA may also commit the app supplier to certain behaviors or restrictions. While cMHAFF does not prescribe what these CnA must include, it provides guidance as to items that are important to disclose. In that respect, there is some precedent in the ONC 2015 Edition Certification, which contains disclosure and transparency requirements for EHR developers, e.g., about pricing and services that are not included in the base software.",
"isExample" : false,
"profile" : [
"http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMSection"
],
"groupingId" : "OTH"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Requirements"
}
],
"reference" : {
"reference" : "Requirements/CMHAFFR2-CNA.1"
},
"name" : "CNA.1 Specifications for Conditions and Agreements (Header)",
"isExample" : false,
"profile" : [
"http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FMHeader"
],
"groupingId" : "CNA"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Requirements"
}
],
"reference" : {
"reference" : "Requirements/CMHAFFR2"
},
"name" : "CMHAFF",
"isExample" : false,
"profile" : [
"http://hl7.org/fhir/uv/cmhaffr2/StructureDefinition/FunctionalModel"
],
"groupingId" : "OTH"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "CodeSystem"
}
],
"reference" : {
"reference" : "CodeSystem/change-info"
},
"name" : "Change Info",
"description" : "Requirement Change Indicator"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/requirements-actors"
},
"name" : "requirements-actors",
"description" : "Requirements Statement Actors"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/requirements-change-info"
},
"name" : "requirements-change-info",
"description" : "Requirements or Statement Criteria Change Indicator"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/requirements-dependent"
},
"name" : "requirements-dependent",
"description" : "Requirements Statement Criteria is dependent"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/requirements-example"
},
"name" : "requirements-example",
"description" : "Requirements Statement Example"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/FMFunction"
},
"name" : "FMFunction",
"description" : "This StructureDefinition represents the base EHR-S FM Function type"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/FMHeader"
},
"name" : "FMHeader",
"description" : "This StructureDefinition represents the base EHR-S FM Header type"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/FMSection"
},
"name" : "FMSection",
"description" : "This StructureDefinition represents the base EHR-S FM Section type"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/FunctionalModel"
},
"name" : "FunctionalModel",
"description" : "This StructureDefinition represents the base EHR-S FunctionalModel type"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/change-info"
},
"name" : "Requirement Change Indicators",
"description" : "Requirement Change Indicators"
}
],
"page" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"name" : "index.html",
"title" : "Home Page",
"generation" : "markdown",
"page" : [
{
"name" : "introduction.html",
"title" : "Introduction & Overview",
"generation" : "markdown"
},
{
"name" : "howtouse.html",
"title" : "How to Use this Guide",
"generation" : "markdown"
},
{
"name" : "examples.html",
"title" : "Exemplary Use Cases",
"generation" : "markdown"
},
{
"name" : "definitions.html",
"title" : "Definitions (Glossary)",
"generation" : "markdown"
},
{
"name" : "appendices.html",
"title" : "Appendices & Reference Documentation",
"generation" : "markdown"
},
{
"name" : "changes.html",
"title" : "IG Change History",
"generation" : "markdown"
}
]
},
"parameter" : [
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "releaselabel"
},
"value" : "CI build"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "copyrightyear"
},
"value" : "2025"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "shownav"
},
"value" : "true"
},
{
"code" : {
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"code" : "autoload-resources"
},
"value" : "true"
},
{
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"code" : "path-resource"
},
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},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/examples"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/extensions"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/models"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/operations"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/profiles"
},
{
"code" : {
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"code" : "path-resource"
},
"value" : "input/resources"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/vocabulary"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/maps"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/testing"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/history"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "fsh-generated/resources"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-pages"
},
"value" : "template/config"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-pages"
},
"value" : "input/images"
},
{
"code" : {
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"code" : "path-liquid"
},
"value" : "template/liquid"
},
{
"code" : {
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},
"value" : "input/liquid"
},
{
"code" : {
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"code" : "path-qa"
},
"value" : "temp/qa"
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{
"code" : {
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},
"value" : "temp/pages"
},
{
"code" : {
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"code" : "path-output"
},
"value" : "output"
},
{
"code" : {
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"code" : "path-tx-cache"
},
"value" : "input-cache/txcache"
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{
"code" : {
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"code" : "path-suppressed-warnings"
},
"value" : "input/ignoreWarnings.txt"
},
{
"code" : {
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"code" : "path-history"
},
"value" : "http://hl7.org/fhir/uv/cmhaffr2/history.html"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "template-html"
},
"value" : "template-page.html"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "template-md"
},
"value" : "template-page-md.html"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-contact"
},
"value" : "true"
},
{
"code" : {
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"code" : "apply-context"
},
"value" : "true"
},
{
"code" : {
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"code" : "apply-copyright"
},
"value" : "true"
},
{
"code" : {
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"code" : "apply-jurisdiction"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-license"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-publisher"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-version"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-wg"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "active-tables"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "fmm-definition"
},
"value" : "http://hl7.org/fhir/versions.html#maturity"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "propagate-status"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "excludelogbinaryformat"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "tabbed-snapshots"
},
"value" : "true"
}
]
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.