@peerbits/fhir-observation-generator 1.0.0 → 1.1.0

package/README.md

@@ -34,7 +34,7 @@ This library provides a focused, auditable conversion layer for the supported vi
 
 ## 2. Features
 
-- **7 Core RPM Vital Types Supported:** Blood pressure, heart rate, body weight, SpO2, body temperature, blood glucose, and respiratory rate.
+- **Extended RPM coverage:** Blood pressure, heart rate, SDNN HRV, ECG events, weight/body composition, SpO2, postductal perfusion index, temperature, glucose/CGM, respiratory rate, spirometry, and sleep sessions.
 - **Component-Based Blood Pressure:** Generates exactly one Observation with systolic (`8480-6`) and diastolic (`8462-4`) components under panel LOINC `85354-9`.
 - **Verified UCUM Unit Conversion:** Converts raw units (e.g. °F to °C, lbs to kg, mg/dL to mmol/L) using standard reference formulas.
 - **Single Source LOINC Mapping:** Fully auditable table of codes (`http://loinc.org`) and FHIR categories (`vital-signs`).
@@ -60,7 +60,9 @@ npm ci
 npm run build
 ```
 
-## 4. Quick Start
+## 4. Demo and Quick Start
+
+[Peerbits HealthTech - Fhir Observation Generator Demo](https://healthcare.peerbits.com/demo/fhir-generator)
 
 ### Before (Raw RPM Device Reading JSON)
 

package/dist/bundle.d.ts

@@ -1,8 +1,15 @@
 /**
  * Batch / Bundle Generator for @peerbits/fhir-observation-generator.
  *
- * Converts an array of DeviceReading objects into a FHIR R4 transaction Bundle.
+ * Converts an array of DeviceReading objects into a FHIR transaction Bundle.
  * Formatted for direct execution with @peerbits/fhir-client's batch/transaction builder.
  */
-import { DeviceReading, FhirBundle, GeneratorConfig } from "./types.js";
+import { DeviceReading, FhirBundle, FhirR5Bundle, GeneratorConfig } from "./types.js";
 export declare function readingsToBundle(readings: DeviceReading[], config?: GeneratorConfig): FhirBundle;
+/**
+ * Converts readings into a FHIR R5 transaction Bundle.
+ *
+ * Vital-sign data generated by this package uses fields common to both FHIR R4
+ * and R5; this function provides an explicit R5-typed integration boundary.
+ */
+export declare function readingsToR5Bundle(readings: DeviceReading[], config?: GeneratorConfig): FhirR5Bundle;

package/dist/bundle.js

@@ -1,10 +1,10 @@
 /**
  * Batch / Bundle Generator for @peerbits/fhir-observation-generator.
  *
- * Converts an array of DeviceReading objects into a FHIR R4 transaction Bundle.
+ * Converts an array of DeviceReading objects into a FHIR transaction Bundle.
  * Formatted for direct execution with @peerbits/fhir-client's batch/transaction builder.
  */
-import { toObservation } from "./generators/index.js";
+import { toObservation, toR5Observation } from "./generators/index.js";
 export function readingsToBundle(readings, config) {
     if (!Array.isArray(readings)) {
         throw new Error("Invalid input to readingsToBundle: expected array of DeviceReading objects");
@@ -25,3 +25,25 @@ export function readingsToBundle(readings, config) {
         entry: entries,
     };
 }
+/**
+ * Converts readings into a FHIR R5 transaction Bundle.
+ *
+ * Vital-sign data generated by this package uses fields common to both FHIR R4
+ * and R5; this function provides an explicit R5-typed integration boundary.
+ */
+export function readingsToR5Bundle(readings, config) {
+    if (!Array.isArray(readings)) {
+        throw new Error("Invalid input to readingsToR5Bundle: expected array of DeviceReading objects");
+    }
+    return {
+        resourceType: "Bundle",
+        type: "transaction",
+        entry: readings.map((reading) => ({
+            resource: toR5Observation(reading, config),
+            request: {
+                method: "POST",
+                url: "Observation",
+            },
+        })),
+    };
+}

package/dist/generators/blood-pressure.d.ts

@@ -1,7 +1,7 @@
 /**
  * Blood Pressure Observation Generator.
  *
- * Grounded in FHIR R4 and US Core Blood Pressure Profile:
+ * Grounded in FHIR R4/R5 and the US Core Blood Pressure Profile:
  * Produces EXACTLY ONE Observation resource with systolic and diastolic
  * represented as component elements within the same Observation, NEVER as two separate Observations.
  */

package/dist/generators/blood-pressure.js

@@ -1,7 +1,7 @@
 /**
  * Blood Pressure Observation Generator.
  *
- * Grounded in FHIR R4 and US Core Blood Pressure Profile:
+ * Grounded in FHIR R4/R5 and the US Core Blood Pressure Profile:
  * Produces EXACTLY ONE Observation resource with systolic and diastolic
  * represented as component elements within the same Observation, NEVER as two separate Observations.
  */

package/dist/generators/extended.d.ts

@@ -0,0 +1,7 @@
+import type { DeviceReading, FhirObservation, GeneratorConfig } from '../types.js';
+export declare function extendedScalarToObservation(reading: DeviceReading, config?: GeneratorConfig): FhirObservation;
+export declare function continuousGlucoseToObservation(reading: DeviceReading, config?: GeneratorConfig): FhirObservation;
+export declare function bodyCompositionToObservation(reading: DeviceReading, config?: GeneratorConfig): FhirObservation;
+export declare function spirometryToObservation(reading: DeviceReading, config?: GeneratorConfig): FhirObservation;
+export declare function sleepToObservation(reading: DeviceReading, config?: GeneratorConfig): FhirObservation;
+export declare function ecgToObservation(reading: DeviceReading, config?: GeneratorConfig): FhirObservation;

package/dist/generators/extended.js

@@ -0,0 +1,126 @@
+import { formatCategory, getLoincMapping, LOINC_SYSTEM, UCUM_SYSTEM } from '../loinc-map.js';
+import { convertUnit } from '../units.js';
+import { validateObservation } from '../validate.js';
+const COMPONENTS = {
+    weight: { code: '29463-7', display: 'Body weight', unit: 'kg' },
+    bmi: { code: '39156-5', display: 'Body mass index', unit: 'kg/m2' },
+    bodyFat: { code: '41982-0', display: 'Percentage of body fat measured', unit: '%' },
+    fatMass: { code: '73708-0', display: 'Body fat mass calculated', unit: 'kg' },
+    muscleMass: { code: '73964-9', display: 'Body muscle mass calculated', unit: 'kg' },
+    boneMass: { code: '101685-6', display: 'Body bone mass', unit: 'kg' },
+    fev1: { code: '20150-9', display: 'FEV1', unit: 'L' },
+    fvc: { code: '19868-9', display: 'Forced vital capacity by spirometry', unit: 'L' },
+    pef: { code: '33452-4', display: 'Peak expiratory flow', unit: 'L/min' },
+    fev1FvcRatio: { code: '19926-5', display: 'FEV1/FVC', unit: '%' },
+    deepSleep: { code: '93831-6', display: 'Deep sleep duration', unit: 'min' },
+    lightSleep: { code: '93830-8', display: 'Light sleep duration', unit: 'min' },
+    remSleep: { code: '93829-0', display: 'REM sleep duration', unit: 'min' },
+    awakeTime: { code: '93828-2', display: 'Nighttime awakening duration', unit: 'min' },
+};
+function concept(code, display) {
+    return { coding: [{ system: LOINC_SYSTEM, code, display }], text: display };
+}
+function base(reading, config) {
+    if (!reading.patientRef?.trim())
+        throw new Error('FHIR Observation generation requires patientRef.');
+    if (!reading.timestamp || Number.isNaN(Date.parse(reading.timestamp)))
+        throw new Error('FHIR Observation generation requires a valid timestamp.');
+    const mapping = getLoincMapping(reading.deviceType);
+    return {
+        resourceType: 'Observation', status: config?.status ?? 'final', category: formatCategory(mapping.category),
+        code: concept(mapping.loincCode, mapping.display), subject: { reference: reading.patientRef }, effectiveDateTime: reading.timestamp,
+        ...(reading.deviceId ? { device: { reference: reading.deviceId } } : {}),
+        ...(reading.waveformRef ? { derivedFrom: [{ reference: reading.waveformRef.reference }] } : {}),
+    };
+}
+function checked(observation, config) {
+    if (config?.validate) {
+        const result = validateObservation(observation);
+        if (!result.valid)
+            throw new Error(`Structural validation failed: ${result.errors.join(', ')}`);
+    }
+    return observation;
+}
+function metric(reading, key, fallback, fallbackUnit) {
+    return reading.metrics?.[key] ?? (fallback === undefined || !fallbackUnit ? undefined : { value: fallback, unit: fallbackUnit });
+}
+function component(key, input) {
+    const definition = COMPONENTS[key];
+    if (!definition)
+        throw new Error(`No standard LOINC mapping for component '${key}'.`);
+    const converted = convertUnit(input.value, input.unit, definition.unit);
+    return { code: concept(definition.code, definition.display), valueQuantity: { value: converted.value, unit: converted.unit, system: UCUM_SYSTEM, code: converted.ucumCode } };
+}
+export function extendedScalarToObservation(reading, config) {
+    if (!['heart-rate-variability', 'perfusion-index'].includes(reading.deviceType) || typeof reading.value !== 'number')
+        throw new Error(`Invalid scalar reading for '${reading.deviceType}'.`);
+    if (reading.deviceType === 'heart-rate-variability' && reading.metadata?.hrvMethod !== 'sdnn') {
+        throw new Error(`HRV generation requires metadata.hrvMethod='sdnn'; no safe default can be inferred.`);
+    }
+    if (reading.deviceType === 'perfusion-index' && reading.metadata?.measurementSite !== 'postductal') {
+        throw new Error(`Perfusion-index generation requires metadata.measurementSite='postductal' for the default LOINC mapping.`);
+    }
+    const mapping = getLoincMapping(reading.deviceType);
+    const converted = convertUnit(reading.value, reading.unit, config?.targetUnit ?? mapping.defaultUcumUnit);
+    return checked({ ...base(reading, config), valueQuantity: { value: converted.value, unit: converted.unit, system: UCUM_SYSTEM, code: converted.ucumCode } }, config);
+}
+export function continuousGlucoseToObservation(reading, config) {
+    if (reading.deviceType !== 'continuous-glucose' || typeof reading.value !== 'object' || reading.value === null || !('glucose' in reading.value))
+        throw new Error('Invalid continuous-glucose reading.');
+    const value = reading.value.glucose;
+    if (typeof value !== 'number')
+        throw new Error('Continuous glucose value must be numeric.');
+    const converted = convertUnit(value, reading.unit, config?.targetUnit ?? 'mg/dL');
+    return checked({ ...base(reading, config), valueQuantity: { value: converted.value, unit: converted.unit, system: UCUM_SYSTEM, code: converted.ucumCode } }, config);
+}
+export function bodyCompositionToObservation(reading, config) {
+    if (reading.deviceType !== 'body-composition')
+        throw new Error('Invalid body-composition reading.');
+    const supported = Object.keys(COMPONENTS).filter((key) => ['weight', 'bmi', 'bodyFat', 'fatMass', 'muscleMass', 'boneMass'].includes(key));
+    const unsupported = Object.keys(reading.metrics ?? {}).filter((key) => !supported.includes(key));
+    if (unsupported.length)
+        throw new Error(`Body composition contains metrics without a safe default FHIR mapping: ${unsupported.join(', ')}.`);
+    const components = supported.flatMap((key) => reading.metrics?.[key] ? [component(key, reading.metrics[key])] : []);
+    if (!components.length)
+        throw new Error('Body composition has no FHIR-mappable metrics.');
+    return checked({ ...base(reading, config), component: components }, config);
+}
+export function spirometryToObservation(reading, config) {
+    if (reading.deviceType !== 'spirometry' || typeof reading.value !== 'object' || reading.value === null)
+        throw new Error('Invalid spirometry reading.');
+    const value = reading.value;
+    const components = ['fev1', 'fvc', 'pef', 'fev1FvcRatio'].flatMap((key) => {
+        const found = metric(reading, key, value[key], key === 'pef' ? 'L/min' : key === 'fev1FvcRatio' ? '%' : 'L');
+        return found ? [component(key, found)] : [];
+    });
+    if (!components.length)
+        throw new Error('Spirometry reading contains no measurements.');
+    return checked({ ...base(reading, config), component: components }, config);
+}
+export function sleepToObservation(reading, config) {
+    if (reading.deviceType !== 'sleep' || typeof reading.value !== 'object' || reading.value === null)
+        throw new Error('Invalid sleep reading.');
+    const value = reading.value;
+    const total = metric(reading, 'totalSleep', value.totalDuration, reading.unit);
+    if (!total)
+        throw new Error('Sleep reading requires total duration.');
+    const converted = convertUnit(total.value, total.unit, config?.targetUnit ?? 'min');
+    const components = ['deepSleep', 'lightSleep', 'remSleep', 'awakeTime'].flatMap((key) => {
+        const found = metric(reading, key, value[key], reading.unit);
+        return found ? [component(key, found)] : [];
+    });
+    const observation = base(reading, config);
+    if (reading.metadata?.periodStart && reading.metadata?.periodEnd && typeof reading.metadata.periodStart === 'string' && typeof reading.metadata.periodEnd === 'string') {
+        observation.effectivePeriod = { start: reading.metadata.periodStart, end: reading.metadata.periodEnd };
+        delete observation.effectiveDateTime;
+    }
+    return checked({ ...observation, valueQuantity: { value: converted.value, unit: converted.unit, system: UCUM_SYSTEM, code: converted.ucumCode }, ...(components.length ? { component: components } : {}) }, config);
+}
+export function ecgToObservation(reading, config) {
+    if (reading.deviceType !== 'ecg' || typeof reading.value !== 'object' || reading.value === null)
+        throw new Error('Invalid ECG reading.');
+    const value = reading.value;
+    if (!value.rhythmClassification)
+        throw new Error('ECG event requires rhythmClassification.');
+    return checked({ ...base(reading, config), valueCodeableConcept: { text: value.rhythmClassification } }, config);
+}

package/dist/generators/index.d.ts

@@ -1,7 +1,7 @@
 /**
  * Per-vital FHIR Observation generators index and generic dispatcher.
  */
-import { DeviceReading, FhirObservation, GeneratorConfig } from "../types.js";
+import { DeviceReading, FhirObservation, FhirR5Observation, GeneratorConfig } from "../types.js";
 import { bloodPressureToObservation } from "./blood-pressure.js";
 import { heartRateToObservation } from "./heart-rate.js";
 import { weightToObservation } from "./weight.js";
@@ -9,9 +9,18 @@ import { spo2ToObservation } from "./spo2.js";
 import { temperatureToObservation } from "./temperature.js";
 import { glucoseToObservation } from "./glucose.js";
 import { respiratoryRateToObservation } from "./respiratory-rate.js";
-export { bloodPressureToObservation, heartRateToObservation, weightToObservation, spo2ToObservation, temperatureToObservation, glucoseToObservation, respiratoryRateToObservation, };
+import { bodyCompositionToObservation, continuousGlucoseToObservation, ecgToObservation, extendedScalarToObservation, sleepToObservation, spirometryToObservation } from "./extended.js";
+export { bloodPressureToObservation, heartRateToObservation, weightToObservation, spo2ToObservation, temperatureToObservation, glucoseToObservation, respiratoryRateToObservation, bodyCompositionToObservation, continuousGlucoseToObservation, ecgToObservation, extendedScalarToObservation, sleepToObservation, spirometryToObservation, };
 /**
  * Generic dispatcher that maps any supported DeviceReading to a FHIR Observation
  * based on reading.deviceType.
  */
 export declare function toObservation(reading: DeviceReading, config?: GeneratorConfig): FhirObservation;
+/**
+ * Generates a FHIR R5 Observation for a device reading.
+ *
+ * The supported vital-sign elements are common to FHIR R4 and R5. This
+ * explicit R5 entry point preserves the existing R4 API while providing an
+ * R5-specific return type for R5 clients.
+ */
+export declare function toR5Observation(reading: DeviceReading, config?: GeneratorConfig): FhirR5Observation;

package/dist/generators/index.js

@@ -8,7 +8,8 @@ import { spo2ToObservation } from "./spo2.js";
 import { temperatureToObservation } from "./temperature.js";
 import { glucoseToObservation } from "./glucose.js";
 import { respiratoryRateToObservation } from "./respiratory-rate.js";
-export { bloodPressureToObservation, heartRateToObservation, weightToObservation, spo2ToObservation, temperatureToObservation, glucoseToObservation, respiratoryRateToObservation, };
+import { bodyCompositionToObservation, continuousGlucoseToObservation, ecgToObservation, extendedScalarToObservation, sleepToObservation, spirometryToObservation } from "./extended.js";
+export { bloodPressureToObservation, heartRateToObservation, weightToObservation, spo2ToObservation, temperatureToObservation, glucoseToObservation, respiratoryRateToObservation, bodyCompositionToObservation, continuousGlucoseToObservation, ecgToObservation, extendedScalarToObservation, sleepToObservation, spirometryToObservation, };
 /**
  * Generic dispatcher that maps any supported DeviceReading to a FHIR Observation
  * based on reading.deviceType.
@@ -32,7 +33,30 @@ export function toObservation(reading, config) {
             return glucoseToObservation(reading, config);
         case "respiratory-rate":
             return respiratoryRateToObservation(reading, config);
+        case "heart-rate-variability":
+        case "perfusion-index":
+            return extendedScalarToObservation(reading, config);
+        case "continuous-glucose":
+            return continuousGlucoseToObservation(reading, config);
+        case "body-composition":
+            return bodyCompositionToObservation(reading, config);
+        case "spirometry":
+            return spirometryToObservation(reading, config);
+        case "sleep":
+            return sleepToObservation(reading, config);
+        case "ecg":
+            return ecgToObservation(reading, config);
         default:
             throw new Error(`Unsupported deviceType: '${reading.deviceType}'`);
     }
 }
+/**
+ * Generates a FHIR R5 Observation for a device reading.
+ *
+ * The supported vital-sign elements are common to FHIR R4 and R5. This
+ * explicit R5 entry point preserves the existing R4 API while providing an
+ * R5-specific return type for R5 clients.
+ */
+export function toR5Observation(reading, config) {
+    return toObservation(reading, config);
+}

package/dist/loinc-map.js

@@ -28,6 +28,14 @@ export const LOINC_MAP = {
         defaultUcumUnit: "/min",
         defaultUnitDisplay: "beats/min",
     },
+    "heart-rate-variability": {
+        deviceType: "heart-rate-variability", loincCode: "80404-7", display: "R-R interval standard deviation (heart rate variability)",
+        category: VITAL_SIGNS_CATEGORY, defaultUcumUnit: "ms", defaultUnitDisplay: "ms",
+    },
+    ecg: {
+        deviceType: "ecg", loincCode: "8619-9", display: "Rhythm segment interpretation by EKG",
+        category: { ...VITAL_SIGNS_CATEGORY, code: "exam", display: "Exam" }, defaultUcumUnit: "1", defaultUnitDisplay: "",
+    },
     weight: {
         deviceType: "weight",
         loincCode: "29463-7",
@@ -36,6 +44,10 @@ export const LOINC_MAP = {
         defaultUcumUnit: "kg",
         defaultUnitDisplay: "kg",
     },
+    "body-composition": {
+        deviceType: "body-composition", loincCode: "43143-7", display: "Weighing device panel",
+        category: VITAL_SIGNS_CATEGORY, defaultUcumUnit: "1", defaultUnitDisplay: "",
+    },
     spo2: {
         deviceType: "spo2",
         loincCode: "59408-5",
@@ -44,6 +56,10 @@ export const LOINC_MAP = {
         defaultUcumUnit: "%",
         defaultUnitDisplay: "%",
     },
+    "perfusion-index": {
+        deviceType: "perfusion-index", loincCode: "73794-0", display: "Perfusion index by pulse oximetry",
+        category: VITAL_SIGNS_CATEGORY, defaultUcumUnit: "%", defaultUnitDisplay: "%",
+    },
     temperature: {
         deviceType: "temperature",
         loincCode: "8310-5",
@@ -60,6 +76,10 @@ export const LOINC_MAP = {
         defaultUcumUnit: "mg/dL",
         defaultUnitDisplay: "mg/dL",
     },
+    "continuous-glucose": {
+        deviceType: "continuous-glucose", loincCode: "99504-3", display: "Glucose in interstitial fluid",
+        category: { ...VITAL_SIGNS_CATEGORY, code: "laboratory", display: "Laboratory" }, defaultUcumUnit: "mg/dL", defaultUnitDisplay: "mg/dL",
+    },
     "respiratory-rate": {
         deviceType: "respiratory-rate",
         loincCode: "9279-1",
@@ -68,6 +88,14 @@ export const LOINC_MAP = {
         defaultUcumUnit: "/min",
         defaultUnitDisplay: "breaths/min",
     },
+    spirometry: {
+        deviceType: "spirometry", loincCode: "81459-0", display: "Spirometry panel",
+        category: { ...VITAL_SIGNS_CATEGORY, code: "exam", display: "Exam" }, defaultUcumUnit: "1", defaultUnitDisplay: "",
+    },
+    sleep: {
+        deviceType: "sleep", loincCode: "93832-4", display: "Sleep duration",
+        category: { ...VITAL_SIGNS_CATEGORY, code: "activity", display: "Activity" }, defaultUcumUnit: "min", defaultUnitDisplay: "min",
+    },
 };
 /**
  * Component LOINC mappings for blood pressure components.

package/dist/types.d.ts

@@ -1,14 +1,53 @@
 /**
  * Device reading and FHIR Observation types for @peerbits/fhir-observation-generator.
- * Grounded in US Core Vital Signs Profile and FHIR R4 Observation resource specification.
+ * Grounded in US Core Vital Signs Profile and the FHIR R4/R5 Observation resource specifications.
  */
-export type DeviceType = "blood-pressure" | "heart-rate" | "weight" | "spo2" | "temperature" | "glucose" | "respiratory-rate";
+export type DeviceType = "blood-pressure" | "heart-rate" | "heart-rate-variability" | "ecg" | "weight" | "body-composition" | "spo2" | "perfusion-index" | "temperature" | "glucose" | "continuous-glucose" | "respiratory-rate" | "spirometry" | "sleep";
 export declare const SUPPORTED_DEVICE_TYPES: DeviceType[];
 export interface BloodPressureValue {
     systolic: number;
     diastolic: number;
 }
-export type DeviceReadingValue = number | BloodPressureValue;
+export interface MetricValue {
+    value: number;
+    unit: string;
+}
+export interface BodyCompositionValue {
+    weight?: number;
+    bmi?: number;
+    bodyFat?: number;
+    fatMass?: number;
+    fatFreeMass?: number;
+    muscleMass?: number;
+    hydration?: number;
+    boneMass?: number;
+}
+export interface ContinuousGlucoseValue {
+    glucose: number;
+    rateOfChange?: number;
+    trend?: string;
+}
+export interface SpirometryValue {
+    fev1?: number;
+    fvc?: number;
+    pef?: number;
+    fev1FvcRatio?: number;
+}
+export interface SleepValue {
+    totalDuration: number;
+    deepSleep?: number;
+    lightSleep?: number;
+    remSleep?: number;
+    awakeTime?: number;
+    timeInBed?: number;
+    efficiency?: number;
+}
+export interface EcgValue {
+    averageHeartRate?: number;
+    rhythmClassification?: string;
+    durationSeconds?: number;
+}
+export type DeviceReadingValue = number | BloodPressureValue | BodyCompositionValue | ContinuousGlucoseValue | SpirometryValue | SleepValue | EcgValue;
 export interface DeviceReading {
     /**
      * The vital type of the device reading.
@@ -34,6 +73,15 @@ export interface DeviceReading {
      * Optional opaque device identifier (e.g. "Device/d-98765").
      */
     deviceId?: string;
+    metrics?: Record<string, MetricValue | undefined>;
+    metadata?: Record<string, unknown>;
+    waveformRef?: {
+        reference: string;
+        lead?: string;
+        sampleCount?: number;
+        samplingRateHz?: number;
+        checksum?: string;
+    };
 }
 export interface GeneratorConfig {
     /**
@@ -56,7 +104,7 @@ export interface FhirCoding {
     display?: string;
 }
 export interface FhirCodeableConcept {
-    coding: FhirCoding[];
+    coding?: FhirCoding[];
     text?: string;
 }
 export interface FhirQuantity {
@@ -68,23 +116,44 @@ export interface FhirQuantity {
 export interface FhirObservationComponent {
     code: FhirCodeableConcept;
     valueQuantity?: FhirQuantity;
+    valueCodeableConcept?: FhirCodeableConcept;
 }
-export interface FhirObservation {
+export interface FhirReference {
+    reference: string;
+}
+export interface FhirObservationBase {
     resourceType: "Observation";
     id?: string;
     status: string;
     category: FhirCodeableConcept[];
     code: FhirCodeableConcept;
-    subject: {
-        reference: string;
+    subject: FhirReference;
+    effectiveDateTime?: string;
+    effectivePeriod?: {
+        start: string;
+        end: string;
     };
-    effectiveDateTime: string;
     valueQuantity?: FhirQuantity;
     component?: FhirObservationComponent[];
-    device?: {
-        reference: string;
-    };
+    valueCodeableConcept?: FhirCodeableConcept;
+    derivedFrom?: FhirReference[];
+    device?: FhirReference;
+}
+/** FHIR R4 Observation produced by the existing generator API. */
+export type FhirR4Observation = FhirObservationBase;
+/**
+ * FHIR R5 Observation.
+ *
+ * The generated vital-sign fields are shared by R4 and R5. R5 additionally
+ * permits an ObservationDefinition reference and a BodyStructure reference.
+ */
+export interface FhirR5Observation extends FhirObservationBase {
+    instantiatesCanonical?: string;
+    instantiatesReference?: FhirReference;
+    bodyStructure?: FhirReference;
 }
+/** @deprecated Use FhirR4Observation or FhirR5Observation explicitly. */
+export type FhirObservation = FhirR4Observation;
 export interface FhirBundleEntry {
     resource: FhirObservation;
     request: {
@@ -97,6 +166,18 @@ export interface FhirBundle {
     type: "transaction";
     entry: FhirBundleEntry[];
 }
+export interface FhirR5BundleEntry {
+    resource: FhirR5Observation;
+    request: {
+        method: "POST";
+        url: string;
+    };
+}
+export interface FhirR5Bundle {
+    resourceType: "Bundle";
+    type: "transaction";
+    entry: FhirR5BundleEntry[];
+}
 export interface ValidationResult {
     valid: boolean;
     errors: string[];

package/dist/types.js

@@ -1,13 +1,20 @@
 /**
  * Device reading and FHIR Observation types for @peerbits/fhir-observation-generator.
- * Grounded in US Core Vital Signs Profile and FHIR R4 Observation resource specification.
+ * Grounded in US Core Vital Signs Profile and the FHIR R4/R5 Observation resource specifications.
  */
 export const SUPPORTED_DEVICE_TYPES = [
     "blood-pressure",
     "heart-rate",
+    "heart-rate-variability",
+    "ecg",
     "weight",
+    "body-composition",
     "spo2",
+    "perfusion-index",
     "temperature",
     "glucose",
+    "continuous-glucose",
     "respiratory-rate",
+    "spirometry",
+    "sleep",
 ];

package/dist/units.js

@@ -16,6 +16,15 @@ const SUPPORTED_UCUM_UNITS = new Set([
     "/min",
     "%",
     "mm[Hg]",
+    "ms",
+    "s",
+    "min",
+    "h",
+    "L",
+    "mL",
+    "L/min",
+    "kg/m2",
+    "1",
 ]);
 /**
  * Normalizes input unit strings into standard UCUM unit codes.
@@ -81,6 +90,33 @@ export function normalizeUcumUnit(unit) {
         case "mm[hg]":
         case "mm hg":
             return "mm[Hg]";
+        case "ms": return "ms";
+        case "s":
+        case "sec":
+        case "second":
+        case "seconds": return "s";
+        case "min":
+        case "minute":
+        case "minutes": return "min";
+        case "h":
+        case "hr":
+        case "hour":
+        case "hours": return "h";
+        case "l":
+        case "liter":
+        case "liters":
+        case "litre":
+        case "litres": return "L";
+        case "ml":
+        case "milliliter":
+        case "milliliters":
+        case "millilitre":
+        case "millilitres": return "mL";
+        case "l/min": return "L/min";
+        case "kg/m2":
+        case "kg/m^2": return "kg/m2";
+        case "1":
+        case "ratio": return "1";
         default:
             return unit;
     }
@@ -146,6 +182,17 @@ export function convertUnit(value, fromUnit, targetUnit) {
             ucumCode: targetUcum,
         };
     }
+    const durationInSeconds = { ms: 0.001, s: 1, min: 60, h: 3600 };
+    if (sourceUcum in durationInSeconds && targetUcum in durationInSeconds) {
+        const converted = value * durationInSeconds[sourceUcum] / durationInSeconds[targetUcum];
+        return { value: roundToFourDecimals(converted), unit: getUnitDisplay(targetUcum), ucumCode: targetUcum };
+    }
+    if (sourceUcum === "mL" && targetUcum === "L") {
+        return { value: roundToFourDecimals(value / 1000), unit: "L", ucumCode: "L" };
+    }
+    if (sourceUcum === "L" && targetUcum === "mL") {
+        return { value: roundToFourDecimals(value * 1000), unit: "mL", ucumCode: "mL" };
+    }
     // Temperature Conversions
     if (sourceUcum === "[degF]" && targetUcum === "Cel") {
         const converted = ((value - 32) * 5) / 9;

package/dist/validate.d.ts

@@ -1,8 +1,8 @@
 /**
  * Structural self-check for generated FHIR Observation resources.
  *
- * Verifies mandatory fields according to the FHIR R4 Observation specification
- * and US Core Vital Signs Profile requirements:
+ * Verifies generated vital-sign fields shared by the FHIR R4 and R5 Observation
+ * specifications and US Core Vital Signs Profile requirements:
  * - resourceType: "Observation"
  * - status
  * - category (containing vital-signs coding)
@@ -11,5 +11,12 @@
  * - effectiveDateTime
  * - valueQuantity OR component array (with valid values)
  */
-import { FhirObservation, ValidationResult } from "./types.js";
+import { FhirObservation, FhirR5Observation, ValidationResult } from "./types.js";
 export declare function validateObservation(observation: FhirObservation): ValidationResult;
+/**
+ * Validates the vital-sign subset emitted by this package for FHIR R5.
+ *
+ * The generated fields have the same shape in R4 and R5. This explicit entry
+ * point lets consumers validate R5 output without relying on the legacy R4 API.
+ */
+export declare function validateR5Observation(observation: FhirR5Observation): ValidationResult;

package/dist/validate.js

@@ -1,8 +1,8 @@
 /**
  * Structural self-check for generated FHIR Observation resources.
  *
- * Verifies mandatory fields according to the FHIR R4 Observation specification
- * and US Core Vital Signs Profile requirements:
+ * Verifies generated vital-sign fields shared by the FHIR R4 and R5 Observation
+ * specifications and US Core Vital Signs Profile requirements:
  * - resourceType: "Observation"
  * - status
  * - category (containing vital-signs coding)
@@ -27,9 +27,9 @@ export function validateObservation(observation) {
         errors.push("Missing required field: category (must be non-empty array)");
     }
     else {
-        const hasVitalSignsCategory = observation.category.some((cat) => cat.coding?.some((c) => c.code === "vital-signs"));
-        if (!hasVitalSignsCategory) {
-            errors.push("Missing required category coding with code 'vital-signs'");
+        const hasCategoryCoding = observation.category.some((cat) => cat.coding?.some((c) => c.system && c.code));
+        if (!hasCategoryCoding) {
+            errors.push("Category must contain at least one coding with system and code");
         }
     }
     if (!observation.code || !Array.isArray(observation.code.coding) || observation.code.coding.length === 0) {
@@ -44,8 +44,11 @@ export function validateObservation(observation) {
     if (!observation.subject || typeof observation.subject.reference !== "string" || !observation.subject.reference.trim()) {
         errors.push("Missing required field: subject.reference");
     }
-    if (!observation.effectiveDateTime || isNaN(Date.parse(observation.effectiveDateTime))) {
-        errors.push("Missing or invalid required field: effectiveDateTime (must be valid ISO date string)");
+    const validDateTime = !!observation.effectiveDateTime && !isNaN(Date.parse(observation.effectiveDateTime));
+    const validPeriod = !!observation.effectivePeriod && !isNaN(Date.parse(observation.effectivePeriod.start)) &&
+        !isNaN(Date.parse(observation.effectivePeriod.end)) && Date.parse(observation.effectivePeriod.start) <= Date.parse(observation.effectivePeriod.end);
+    if (!validDateTime && !validPeriod) {
+        errors.push("Observation requires a valid effectiveDateTime or effectivePeriod");
     }
     // Value check: Must have valueQuantity OR component array
     const hasValueQuantity = observation.valueQuantity &&
@@ -59,7 +62,9 @@ export function validateObservation(observation) {
             comp.valueQuantity &&
             typeof comp.valueQuantity.value === "number" &&
             Number.isFinite(comp.valueQuantity.value));
-    if (!hasValueQuantity && !hasComponents) {
+    const hasCodeableConcept = !!observation.valueCodeableConcept &&
+        (!!observation.valueCodeableConcept.text || !!observation.valueCodeableConcept.coding?.length);
+    if (!hasValueQuantity && !hasComponents && !hasCodeableConcept) {
         errors.push("Observation must contain either a valid valueQuantity or a valid component array with at least 2 components");
     }
     return {
@@ -67,3 +72,12 @@ export function validateObservation(observation) {
         errors,
     };
 }
+/**
+ * Validates the vital-sign subset emitted by this package for FHIR R5.
+ *
+ * The generated fields have the same shape in R4 and R5. This explicit entry
+ * point lets consumers validate R5 output without relying on the legacy R4 API.
+ */
+export function validateR5Observation(observation) {
+    return validateObservation(observation);
+}

package/package.json

@@ -1,7 +1,7 @@
 {
   "name": "@peerbits/fhir-observation-generator",
-  "version": "1.0.0",
-  "description": "Generate FHIR Observation resources from RPM device readings, with correct LOINC coding and unit conversion",
+  "version": "1.1.0",
+  "description": "Generate FHIR R4 and R5 Observation resources from RPM device readings, with correct LOINC coding and unit conversion",
   "license": "Apache-2.0",
   "author": "PeerbitsSolution",
   "homepage": "https://github.com/PeerbitsSolution/fhir-observation-generator#readme",