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Stub - development will be led by Jan Oldenburg

Vital signs, PGHD, observations, anything originating from the patient universe vs provider generated.

Health concerns, goals, preferences

1a. Project Name

Patient Contributed Data

1b. Project ID

Assigned by the HL7 PMO via Project Insight

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

There is a 'PSS-Lite' process to define minimal information to initiate an 'investigative' project in HL7. Investigative projects will have two trimesters to either fully develop a project scope statement, or determine there is no need to advance the investigative project.

What is our goal here? Could we qualify as a PSS-Lite?

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

The Health Level Seven Version 3 (V3) Normative Edition—a suite of specifications based on HL7’s Reference Information Model (RIM)—provides a single source that allows implementers of V3 specifications to work with the full set of messages, data types, and terminologies needed to build a complete implementation. The 2015 Normative Edition represents the complete suite of V3 specifications. Each of these specifications has been balloted to formal approval as either a Normative Standard or a Draft Standard for Trial Use. It includes standards for communications that document and manage the care and treatment of patients in a wide variety of healthcare settings. As such, it is a foundational part of the technologies needed to meet the global challenge of integrating healthcare information, in areas such as patient care and public health

Do we think we will end up as a Normative project? What is our goal here? To create a set of guidelines? To update a set of standards? Do we think these will be standards for EHRs or standards that sit outside of EHRs?

Note there is already this as part of the Clinical Document Architecture; it's an implementation guide for patient-generated data (headers only, I think):

Also a white paper on PGHD integration into EHRs with Ken Mandl:

1e. Today's Date


1f. Name of standard being reaffirmed

1g. Project Artifact Information

Do we think we will create a project artifact? What would it look like or need to contain? 

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure


2a. Primary/Sponsor WG

Patient Empowerment Workgroup

2d. Project Facilitator

Jan Oldenburg & Maria D. Moen, Virginia Lorenzi

2e. Other Interested Parties (and roles)

EHR Vendors, Providers

2f. Modeling Facilitator

Abigail Watson; Lloyd McKenzie

2g. Publishing Facilitator

Lloyd McKenzie, John Moe

2h. Vocabulary Facilitator

Abigail Watson

2i. Domain Expert Representative


2j. Business Requirements Analyst

2k. Conformance Facilitator

Required for Implementation Guide projects

2l. Other Facilitators

Virginia Lorenzi

2m. Implementers

Debi Willis (MyPatientLink); Abigail Watson (Symptomatic)

3a. Project Scope


3b. Project Need

Patients and their caregivers are the closest observers of their own health and typically have information available to document their health status. Data related to this information includes observations; surveys; vital signs; readings from devices, wearables, and sensors; patient's own assessment of their health status; goals, preferences, priorities for care; mental health status; and non-prescription and prescription medication history including supplements, vitamins, OTC medications, prescribed medications, side effects, and actual patterns of medication ingestion. This data can be vital for physicians to have available in order to understand the patient's health condition between visits and during episodes of care, as part of understanding patterns and correlations in that critical information, and as a facilitator for empowering the collaboration between patients and their care teams. There are few standards governing how this data is collected, stored, transmitted, trended, or used, limiting the effectiveness of this genre of data. The standards that do exist are underused, potentially out-dated, and not well known.

3c. Security Risk


3d. External Drivers

Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors.

3e. Objectives/Deliverables and Target Dates

Review standards that exist. Identify whether the existing standards require update. Identify any additional standards that are required, if appropriate. Also identify what data needs context and trending.  

3f. Common Names / Keywords / Aliases:

Patient Generated Data (PGD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO)

3g. Lineage

3h. Project Dependencies

This project depends on clear consent for use of this data by patients or their caregivers/proxies, the ability to dictate who has access to it which will touch on "trust" issues in a technical sense, and clear definition as to intent of use.  It also requires providence tracking

3i. HL7-Managed Project Document Repository URL:

3j. Backwards Compatibility


3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

3l. Reason for not using current V3 data types?

3m. External Vocabularies

3n. List of Vocabularies

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?


4c. FHIR Profiles Version

R4; USCore

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

5c. Additional Ballot Info

5d. Joint Copyright

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.


6a. External Project Collaboration

6b. Content Already Developed

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

6f. Other Stakeholders

6g. Vendors

6g. Other Vendors

6h. Providers

6h. Other Providers

6i. Realm

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

7b. Sponsoring WG Approval Date

7c. Co-Sponsor Approval Date

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date