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Section 1a: Clinical Document Architecture (CDA®)
Section 3: Implementation Guides

HL7 Implementation Guide for CDA® R2: Patient Generated Document Header Template, Release 1

DESCRIPTION

The integration of patient generated health data (PGHD) into HIT is an important change to the HIT ecosystem.  Although patients have long been the source of information recorded in the EHR, this information has been gathered orally or in paper forms, and transcribed by the provider in a way that is assessed, interpreted and summarized, and the original patient information may not be retained. Digital integration of PGHD provides the opportunity for patients to author data in a way that is consumable within the EHR.

Based upon recent testimony received by the HITSC and HITPC PGHD hearing, the successful inclusion of PGHD incorporates the following characteristics; information is material to the patient’s experience of their own condition, meaningful to the provider, contextually relevant, consumable by the EHR in a familiar way and correctly attributed to the patient or designee.  The ONC HITSC and HITPC have further directed that standards already directed in Meaningful Use (MU) should be reused, repurposed and harmonized.

The purpose of this implementation guide is to develop a standard way within the current framework of structured documents in the evolving health information ecosystem to capture, record and make interoperable, patient generated information. The goal is to enable patients to participate and collaborate electronically with care team members.

ALTERNATIVE NAMES

HL7 Implementation Guide for CDA® R2: Patient Generated Document Header Template, Release 1 may also go by the following names or acronyms:

"CDAR2 IG: Patient Authored Documents, R1", PGD Header, "HL7 Implementation Guide for CDA® R2: Patient Authored Documents, Release 1", Patient Authored Document

TARGETS

  • Patients
  • EHR, PHR Vendors
  • Healthcare Institutions (hospitals, long term care, home care, mental health)

BENEFITS

  • Create a CDA standard for patient generated data leveraging the existing Consolidated CDA standard
  • Enables patients to send structured data in a standardized format
  • Supports the integration of patient generated health data for health information technology

IMPLEMENTATIONS/CASE STUDIES

  • Intuit Health
  • Healthwise

DEVELOPMENT BACKGROUND

This Patient Generated Document (PGD) Header Template implementation guide is intended to provide implementation guidance on the header elements for documents authored by patients,representatives acting on their behalf or their devices. It is expected that the C-CDA document library will be expanded over time to include different types of patient generated documents. The PGD Header template defined in this implementation will be used to guide the header formation  of these patient generated documents.

The following will be 'in scope' for this implementation guide for Patient Generated Documents (PGD) and documents

  • Guidance and best practices for definition of the CDA header elements
  • A single PGD document template established to demonstrate the use of the PGD header and which requires one or more section(s) defined in the Consolidated CDA Implementation guide. This document templateID is 2.16.840.1.113883.10.20.29.1.1.
  • Guidance on use of the patient generated document headers (Universal realm & US realm) in a patient generated document
  • A set of 'patient' Use Cases to inform the best practices defined in this implementation guide

RELATED DOCUMENTS

HL7 Implementation Guide for CDA® R2: Patient Generated Document Header Template, Release 1

(Download) (532 KB)

ADDITIONAL DETAILS

The following will not be in scope for this implementation guide

  • Definition of patient generated C-CDA document types which contain specific sections. Even though the vision is for a new set of non-clinician generated consolidated document types, the new document types are NOT in scope for this implementation guide.

 

Implementers of this general Patient Generated Document Header Template should consider utilizing section and entry templates defined in the C-CDA Implementation Guide to maximize data interoperability. For example, a patient generated document which includes the same sections as a Continuity of Care Document would be a highly interoperable document because EHR systems that already exchange Consolidated CCD documents would be well positioned to consume the content generated by the patient.

The Patient Generated Document Header defines how to implement elements of the CDA header for documents that are generated by the patient or a person acting as a non-clinician and on behalf of the patient.

Like the General Header defined for C-CDA documents authored by clinicians, the Patient Generated Document Header is general and can be used with classes of documents where the information is authored by the patient or a person acting as a non-clinician as the patient's agent. The Patient Generated Document Header may be further constrained to fit narrower use cases requiring tighter constraints.

TOPIC

  • Patient Care

BALLOT TYPE

  • Informative

STATUS DATE

2013-10-02

RESPONSIBLE WORK GROUP

Structured Documents

PRODUCT TYPE

  • ANSI-registered Technical Report

STAKEHOLDERS

  • EHR, PHR Vendors
  • Healthcare Institutions

FAMILY

  • CDA

CURRENT STATE

  • Retired

REALM

  • US Realm