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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): https://www.hl7.org/implement/standards/product_brief.cfm?product_id=316

Also a white paper on PGHD integration into EHRs with Ken Mandl: https://www.nature.com/articles/s41746-020-0218-6

1e. Today's Date

4/27/2020

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

Metric

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

EPatientDave

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


Attachments


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

No

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

No

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?

R4

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.

no

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