Personal Health Records, published by HL7 International / Patient Empowerment. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/personal-health-record-format-ig/ and changes regularly. See the Directory of published versions

Clinical Research

Clinical Research and Real World Evidence

This page documents how Personal Health Record data can contribute to clinical research, real-world evidence generation, and patient safety monitoring, with particular alignment to the HL7 Vulcan Accelerator initiatives.

Overview

Personal Health Records offer unique value for clinical research because they:

• Capture patient-reported outcomes and experiences
• Include data from consumer devices not connected to clinical systems
• Span multiple healthcare providers and systems
• Reflect the patient's complete health journey
• Enable longitudinal observational studies

Adverse Event Reporting

Adverse events in the context of a PHR may include:

• Medication side effects: Reactions to prescribed or over-the-counter drugs
• Vaccine reactions: Post-immunization adverse events
• Medical device problems: Issues with implants, wearables, or therapeutic devices
• Procedure complications: Unexpected outcomes from medical procedures
• Healthcare-associated events: Hospital-acquired infections, falls, etc.

FHIR Resources for Adverse Events

AdverseEvent Resource Example

{
  "resourceType": "AdverseEvent",
  "id": "adverse-event-medication",
  "status": "completed",
  "actuality": "actual",
  "category": [{
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/adverse-event-category",
      "code": "medication-mishap",
      "display": "Medication Mishap"
    }]
  }],
  "subject": {
    "reference": "Patient/example-patient"
  },
  "date": "2025-01-10T14:30:00Z",
  "detected": "2025-01-10T16:00:00Z",
  "recordedDate": "2025-01-10T18:00:00Z",
  "seriousness": {
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
      "code": "non-serious",
      "display": "Non-serious"
    }]
  },
  "suspectEntity": [{
    "instance": {
      "reference": "MedicationStatement/statin-therapy"
    },
    "causality": [{
      "assessment": {
        "coding": [{
          "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
          "code": "probably-likely",
          "display": "Probably/Likely"
        }]
      }
    }]
  }],
  "description": "Patient reports muscle pain in legs starting 2 weeks after beginning statin therapy."
}

Patient-Reported vs Clinician-Recorded

Distinguish data provenance using the recorder and meta elements:

Patient-reported:

{
  "resourceType": "AdverseEvent",
  "meta": {
    "source": "urn:phr:patient-reported"
  },
  "recorder": {
    "reference": "Patient/example-patient",
    "display": "Self-reported by patient"
  }
}

Clinician-recorded:

{
  "meta": {
    "source": "urn:ehr:hospital-xyz"
  },
  "recorder": {
    "reference": "Practitioner/dr-smith"
  }
}

Vulcan Accelerator Alignment

The Vulcan Accelerator initiative promotes standardized real-world data collection. For adverse event reporting aligned with Vulcan:

• Use standardized terminology (MedDRA for adverse event terms)
• Include severity grading (CTCAE for oncology contexts)
• Document temporal relationships clearly
• Capture concomitant medications
• Enable consent-based research sharing

Regulatory Reporting

For serious adverse events, PHR systems may facilitate reporting to regulatory bodies:

• FDA MedWatch (United States)
• PMDA (Japan - 医薬品医療機器総合機構)
• EudraVigilance (European Union)

Note: PHR systems should not automatically submit regulatory reports; they should facilitate patient or provider submission.

Real World Data Harmonization

Real World Data encompasses health data collected outside of traditional clinical trials, including:

• Electronic Health Records (EHR)
• Claims and billing data
• Patient registries
• Personal Health Records (PHR)
• Wearable devices and mobile health apps
• Social determinants of health data

Vulcan Accelerator Program

The HL7 Vulcan Accelerator works to harmonize standards for clinical research data. PHR implementations should consider alignment with:

Data Quality Considerations

Patient-contributed data requires attention to quality:

Provenance Tracking:

{
  "resourceType": "Provenance",
  "target": [{"reference": "Observation/bp-home-reading"}],
  "recorded": "2025-01-15T08:30:00Z",
  "agent": [{
    "type": {
      "coding": [{
        "system": "http://terminology.hl7.org/CodeSystem/provenance-participant-type",
        "code": "author"
      }]
    },
    "who": {
      "reference": "Patient/example"
    }
  }],
  "entity": [{
    "role": "source",
    "what": {
      "display": "Omron Blood Pressure Monitor Model HEM-7600T"
    }
  }]
}

Data Quality Flags:

• Device-captured vs manually entered
• Validated vs unvalidated measurements
• Professional vs consumer-grade devices
• Clinician-verified vs patient-reported

Consent for Research Use

PHR systems must implement consent management for research data sharing:

{
  "resourceType": "Consent",
  "id": "research-consent",
  "status": "active",
  "scope": {
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/consentscope",
      "code": "research"
    }]
  },
  "category": [{
    "coding": [{
      "system": "http://terminology.hl7.org/CodeSystem/consentcategorycodes",
      "code": "research"
    }]
  }],
  "patient": {
    "reference": "Patient/example"
  },
  "dateTime": "2025-01-01",
  "provision": {
    "type": "permit",
    "purpose": [{
      "system": "http://terminology.hl7.org/CodeSystem/v3-ActReason",
      "code": "HRESCH",
      "display": "Healthcare Research"
    }],
    "dataPeriod": {
      "start": "2020-01-01",
      "end": "2030-12-31"
    }
  }
}

De-identification Requirements

When contributing PHR data to research datasets:

Reference: HIPAA Safe Harbor

CDISC Alignment

For clinical research integration, PHR data may need transformation to CDISC standards:

Patient Data Registries

PHRs can contribute to condition-specific registries:

• Oncology registries (mCODE alignment)
• Rare disease registries
• Post-market device surveillance
• Long COVID tracking
• Pregnancy and birth outcome registries

References

• Vulcan Accelerator
• FDA Real World Evidence
• CDISC Standards
• FHIR AdverseEvent Resource
• MedDRA Terminology
• FDA MedWatch