Module 9 · Part 3 · Data Collection
EHR Integration, CCDA & FHIR
Understand how to extract structured clinical data from EHR systems using industry standards, reducing participant burden and improving data quality.
Patient Registries 101 · Dr. Danielle Boyce · EpilepsyLive
Why EHR integration is important
- Patient-reported data is invaluable, but it has limitations: participants may not know their exact lab values, may misremember medication doses, or may not be aware of diagnoses documented in their…
- The good news: federal law (the 21st Century Cures Act) now requires EHR vendors to provide patient access to their data, and your registry can leverage this.
What is C-CDA?
- The Consolidated Clinical Document Architecture (C-CDA) is an HL7 XML standard for clinical documents, the format EHRs have used for years to exchange participant records.
- C-CDA documents include sections for
- Problems (diagnoses, coded in SNOMED CT or ICD-10)
- Medications (RxNorm)
- Allergies
- Lab results (LOINC)
What is C-CDA? (cont.)
- Procedures
- Vital signs
- Immunizations
- Social history
C-CDA for registries
- Participants can download their C-CDA from their patient portal and upload it to your registry.
- Limitations of C-CDA
- Snapshot in time (not continuously updated)
- Inconsistent implementation across EHR vendors
- XML parsing requires technical infrastructure
- Requires participant action to download and upload
What is FHIR?
- HL7 FHIR (Fast Healthcare Interoperability Resources) is the modern standard for healthcare data exchange.
- FHIR represents data as Resources , discrete objects like Participant, Condition, Observation, Medication, and Procedure.
- FHIR R4 is the current stable version.
- hl7.org/fhir
FHIR for registries
- With FHIR APIs, your registry can
- Pull a participant's diagnoses, labs, and medications directly from their EHR in real time
- Receive automatic updates when new lab results are available
- Query across multiple participants at clinical sites that grant API access
- Submit data back to EHRs (e.g., registry-generated phenotype scores visible to the treating physician)
SMART on FHIR
- SMART on FHIR is a framework that enables third party apps (like your registry) to securely access EHR data with patient authorization.
- A participant can
- Visit your registry's patient portal
- Click "Connect my health records"
- Authenticate with their EHR's patient portal (e.g., MyChart)
- Authorize specific data types to be shared with your registry
SMART on FHIR (cont.)
- Your registry receives a FHIR access token and can pull their records
- smarthealthit.org
Site agreements
- Pulling FHIR data from clinical sites (rather than directly from participants) requires
- Data Use Agreement with the health system
- IRB approval covering EHR data access
- Possible Business Associate Agreement (BAA) under HIPAA
Bulk FHIR
- For population level data extraction (pulling data for many participants at once), use the FHIR Bulk Data Access specification, designed for exactly this use case.
- hl7.org/fhir/uv/bulkdata
Checklist
- [ ] Determined whether participant-initiated C-CDA upload or SMART on FHIR is the right approach
- [ ] Selected platform with FHIR R4 support
- [ ] Mapped registry data elements to FHIR resources
- [ ] Drafted site agreements for clinical site FHIR access
- [ ] Confirmed IRB protocol covers EHR data collection
- [ ] Tested SMART on FHIR patient authorization flow
Key resources
- HL7 FHIR R4 Specification
- SMART on FHIR
- FHIR Bulk Data Access
- CMS Interoperability Rule FHIR APIs
- ← Module 8 | Module 10: Patient-Reported Data & 21st Century Cures →
- Patient portal login , SMART on FHIR (covered above).
Key resources (cont.)
- Download & upload , a C-CDA file the person exports and re-uploads (covered above).
- HIPAA authorization , a signed release directing a provider to send records.
- Network exchange , TEFCA / Individual Access Services (see Module 10 ).
- EEG & imaging studies , large binary studies requested separately (see Module 10 ).