Indication¶
Dereferenced schema · Source · Referenced version
Regulatory approval text and its source, with contributions and documents embedded. Root type Indication with one subtype per organization, selected by the id prefix ind:{org}:. status is an extension; HSE indications additionally carry reimbursement_scheme and reimbursement_comment extensions.
Root type shared by every organization. Organization-specific types below extend it; the top-level schema closes the record with unevaluatedProperties.
Fields¶
| Field | Type | Required | Description |
|---|---|---|---|
id |
string matching ^ind:(fda|ema|hse|hc|hpra):.+$ |
yes | |
type |
always Indication |
yes | |
description |
string | yes | Regulatory approval text, verbatim. |
contributions |
array of Contribution | yes | |
reportedIn |
array of Document | yes | |
extensions |
array of extensions (see Extensions) | yes |
Extensions¶
Each extension is an object with a name, a value, and an optional description (see Extension).
| Name | Value | Required |
|---|---|---|
status |
one of Approved, Accelerated, Superseded, Withdrawn |
yes |
Subtypes¶
Every record matches exactly one subtype, which adds to the fields above.
| Subtype | Applies when | Description |
|---|---|---|
| FDA Indication | id matches ^ind:fda: |
Indication from the organization fda. reportedIn lists the evergreen FDA document (doc:fda:{drug}) first, followed by the dated, Deprecated FDA document (doc:fda:{drug}:{YYYY-MM-DD}) for the label in which the indication was initially approved. |
| EMA Indication | id matches ^ind:ema: |
Indication from the organization ema. |
| HC Indication | id matches ^ind:hc: |
Indication from the organization hc. |
| HPRA Indication | id matches ^ind:hpra: |
Indication from the organization hpra. |
| HSE Indication | id matches ^ind:hse: |
Indication from the Health Service Executive (HSE). Unlike other organizations, carries reimbursement information as extensions. |
FDA Indication¶
Indication from the organization fda. reportedIn lists the evergreen FDA document (doc:fda:{drug}) first, followed by the dated, Deprecated FDA document (doc:fda:{drug}:{YYYY-MM-DD}) for the label in which the indication was initially approved.
Builds on Indication.
| Field | Type | Required | Description |
|---|---|---|---|
id |
matching ^ind:fda: |
||
extensions |
array of extensions: status (one of Approved, Accelerated, Superseded, Withdrawn, required) |
||
reportedIn |
array of (Document with id matching ^doc:fda:[^:]+$, Document with id matching ^doc:fda:[^:]+:\d{4}-\d{2}-\d{2}$, extensions containing status extension with value always Deprecated) (exactly 2 items) |
The evergreen document, then the dated document for the initial approval. |
EMA Indication¶
Indication from the organization ema.
Builds on Indication.
| Field | Type | Required | Description |
|---|---|---|---|
id |
matching ^ind:ema: |
||
extensions |
array of extensions: status (one of Approved, Accelerated, Superseded, Withdrawn, required) |
HC Indication¶
Indication from the organization hc.
Builds on Indication.
| Field | Type | Required | Description |
|---|---|---|---|
id |
matching ^ind:hc: |
||
extensions |
array of extensions: status (one of Approved, Accelerated, Superseded, Withdrawn, required) |
HPRA Indication¶
Indication from the organization hpra.
Builds on Indication.
| Field | Type | Required | Description |
|---|---|---|---|
id |
matching ^ind:hpra: |
||
extensions |
array of extensions: status (one of Approved, Accelerated, Superseded, Withdrawn, required) |
HSE Indication¶
Indication from the Health Service Executive (HSE). Unlike other organizations, carries reimbursement information as extensions.
Builds on Indication.
| Field | Type | Required | Description |
|---|---|---|---|
id |
matching ^ind:hse: |
||
extensions |
array of extensions: status (one of Approved, Accelerated, Superseded, Withdrawn, required), reimbursement_scheme (one of CDS, ODMS, Incomplete Reimbursement, Hospital, N/A, Hybrid, required), reimbursement_comment (string or null, required) |
JSON Schema¶
Full JSON Schema
{
"$schema": "https://json-schema.org/draft/2020-12/schema",
"$id": "https://moalmanac.org/schemas/dereferenced/indications.schema.json",
"title": "Indication",
"description": "Regulatory approval text and its source, with contributions and documents embedded. Root type `Indication` with one subtype per organization, selected by the id prefix `ind:{org}:`. `status` is an extension; HSE indications additionally carry `reimbursement_scheme` and `reimbursement_comment` extensions.",
"$ref": "#/$defs/Indication",
"allOf": [
{
"if": {
"required": [
"id"
],
"properties": {
"id": {
"pattern": "^ind:fda:"
}
}
},
"then": {
"$ref": "#/$defs/FDA Indication"
}
},
{
"if": {
"required": [
"id"
],
"properties": {
"id": {
"pattern": "^ind:ema:"
}
}
},
"then": {
"$ref": "#/$defs/EMA Indication"
}
},
{
"if": {
"required": [
"id"
],
"properties": {
"id": {
"pattern": "^ind:hc:"
}
}
},
"then": {
"$ref": "#/$defs/HC Indication"
}
},
{
"if": {
"required": [
"id"
],
"properties": {
"id": {
"pattern": "^ind:hpra:"
}
}
},
"then": {
"$ref": "#/$defs/HPRA Indication"
}
},
{
"if": {
"required": [
"id"
],
"properties": {
"id": {
"pattern": "^ind:hse:"
}
}
},
"then": {
"$ref": "#/$defs/HSE Indication"
}
}
],
"unevaluatedProperties": false,
"$defs": {
"Indication": {
"type": "object",
"properties": {
"id": {
"type": "string",
"pattern": "^ind:(fda|ema|hse|hc|hpra):.+$"
},
"type": {
"const": "Indication"
},
"description": {
"type": "string",
"description": "Regulatory approval text, verbatim."
},
"contributions": {
"type": "array",
"items": {
"$ref": "contributions.schema.json"
}
},
"reportedIn": {
"type": "array",
"items": {
"$ref": "documents.schema.json"
}
},
"extensions": {
"type": "array",
"items": {
"$ref": "extension.schema.json"
},
"allOf": [
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
}
]
}
},
"required": [
"id",
"type",
"description",
"contributions",
"reportedIn",
"extensions"
],
"description": "Root type shared by every organization. Organization-specific types below extend it; the top-level schema closes the record with unevaluatedProperties."
},
"FDA Indication": {
"description": "Indication from the organization `fda`. `reportedIn` lists the evergreen FDA document (`doc:fda:{drug}`) first, followed by the dated, Deprecated FDA document (`doc:fda:{drug}:{YYYY-MM-DD}`) for the label in which the indication was initially approved.",
"allOf": [
{
"$ref": "#/$defs/Indication"
},
{
"properties": {
"id": {
"pattern": "^ind:fda:"
},
"extensions": {
"type": "array",
"items": {
"anyOf": [
{
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
]
},
"allOf": [
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
}
]
},
"reportedIn": {
"type": "array",
"minItems": 2,
"maxItems": 2,
"prefixItems": [
{
"$ref": "documents.schema.json",
"properties": {
"id": {
"pattern": "^doc:fda:[^:]+$"
}
}
},
{
"$ref": "documents.schema.json",
"properties": {
"id": {
"pattern": "^doc:fda:[^:]+:\\d{4}-\\d{2}-\\d{2}$"
},
"extensions": {
"contains": {
"type": "object",
"properties": {
"name": {
"const": "status"
},
"value": {
"const": "Deprecated"
}
},
"required": [
"name",
"value"
]
}
}
}
}
],
"description": "The evergreen document, then the dated document for the initial approval."
}
}
}
]
},
"EMA Indication": {
"description": "Indication from the organization `ema`.",
"allOf": [
{
"$ref": "#/$defs/Indication"
},
{
"properties": {
"id": {
"pattern": "^ind:ema:"
},
"extensions": {
"type": "array",
"items": {
"anyOf": [
{
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
]
},
"allOf": [
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
}
]
}
}
}
]
},
"HC Indication": {
"description": "Indication from the organization `hc`.",
"allOf": [
{
"$ref": "#/$defs/Indication"
},
{
"properties": {
"id": {
"pattern": "^ind:hc:"
},
"extensions": {
"type": "array",
"items": {
"anyOf": [
{
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
]
},
"allOf": [
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
}
]
}
}
}
]
},
"HPRA Indication": {
"description": "Indication from the organization `hpra`.",
"allOf": [
{
"$ref": "#/$defs/Indication"
},
{
"properties": {
"id": {
"pattern": "^ind:hpra:"
},
"extensions": {
"type": "array",
"items": {
"anyOf": [
{
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
]
},
"allOf": [
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
}
]
}
}
}
]
},
"HSE Indication": {
"description": "Indication from the Health Service Executive (HSE). Unlike other organizations, carries reimbursement information as extensions.",
"allOf": [
{
"$ref": "#/$defs/Indication"
},
{
"properties": {
"id": {
"pattern": "^ind:hse:"
},
"extensions": {
"type": "array",
"items": {
"anyOf": [
{
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
},
{
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "reimbursement_scheme"
},
"value": {
"enum": [
"CDS",
"ODMS",
"Incomplete Reimbursement",
"Hospital",
"N/A",
"Hybrid"
]
}
}
},
{
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "reimbursement_comment"
},
"value": {
"type": [
"string",
"null"
]
}
}
}
]
},
"allOf": [
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "status"
},
"value": {
"enum": [
"Approved",
"Accelerated",
"Superseded",
"Withdrawn"
]
}
}
}
},
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "reimbursement_scheme"
},
"value": {
"enum": [
"CDS",
"ODMS",
"Incomplete Reimbursement",
"Hospital",
"N/A",
"Hybrid"
]
}
}
}
},
{
"contains": {
"$ref": "extension.schema.json",
"properties": {
"name": {
"const": "reimbursement_comment"
},
"value": {
"type": [
"string",
"null"
]
}
}
}
}
]
}
}
}
]
}
}
}