1a. Project Name
|ARCHIVE VERSION: Patient Contributed Data|
1b. Project ID
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? (VL - yes we might. Trying to see the downside of this) (TR-Are we augmenting the headers in PGHD? see below)
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
TR - From PGHD IG - "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." Is this what a recommendation to make in white paper?
Also a white paper on PGHD integration into EHRs with Ken Mandl: https://www.nature.com/articles/s41746-020-0218-6 (VL-I think you should leave this field blank. Your contents here belongs in the white paper created by the project)
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? (VL - a white paper to be used to define patient contributed data and the work done to standardize interoperability in the field up to this point as well as consideration of gaps and needs and recommendations) (TR- Would it be possible to use findings in white paper to make recommendations to add to the PGHD implementation guide?|
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 (VL - pick one person for this. Its like the PM role)|
2e. Other Interested Parties (and roles)
|EHR Vendors, Providers (VL- this is the wrong form. Need to identify cosponsors and interested parties - two different things. Should be the names of workgroups only. Recommend at least CBCP) (TR - Digital Health vendors and researchers?). Data analytics groups|
2f. Modeling Facilitator
|Abigail Watson; Lloyd McKenzie|
2g. Publishing Facilitator
|Lloyd McKenzie, John Moe|
2h. Vocabulary Facilitator
2i. Domain Expert Representative
2j. Business Requirements Analyst
2k. Conformance Facilitator
Required for Implementation Guide projects
2l. Other Facilitators
Debi Willis (MyPatientLink); Abigail Watson (Symptomatic) (I do not know if this applies because its a white paper)
3a. Project Scope
|This is important|
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; implanted device identification information, 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 avoiding exposure to patient harm (MRI). 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. (VL - Need toclearly define the types of patient contributed data, understand what standards and implementation guides are already out there, and develop a plan based on what is discovered to provide recommendations on a way forward to ensure patient contributed data is communicated in a robust standard manner)|
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
Define Patient Contributed data
Conduct an environmental scan to identify and review standards and implementation guides that exist in this space.
Define a way forward based on result of the scan (this may include recommending using some existing standards, enhancing them, creating new implemntation guides, etc)
Publish white paper containing all of the above
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)|
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?
|CCD, CDA, N/A for v3 RIM (VL - Do not need to list specific standards - its a white paper)|
3l. Reason for not using current V3 data types?
|Using FHIR instead. |
3m. External Vocabularies
|SNOMED, LOINC, USCORE, |
3n. List of Vocabularies
|SNOMED, LOINC, USCORE|
3o. Earliest prior release and/or version to which the compatibility applies
4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?
4c. FHIR Profiles Version
4d. Please define your New Product Definition
|Patient Contributed Data Implementation Guide (TR - do we want to creata|
4d. Please define your New Product Family
|Patient Generated Data Products|
5a. Project Intent
|Exercising rights under the 21st Century Cures Act.|
5a. White Paper Type
|Gap Analysis, Implementation Guide|
5a. Is the project adopting/endorsing an externally developed IG?
|Patient Reported Outcomes (PRO), Personal Health Record Server (PHR-S)|
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
|Patient Reported Outcomes (PRO)|
6c. Content externally developed?
6d. List Developers of Externally Developed Content
6e. Is this a hosted (externally funded) project?
|Patient Advocacy Groups, Electronic Health Records, Clinicians, Practitioners. Researchers|
6f. Other Stakeholders
|Patient Families, Allied Healthcare, Medical Homes, Healthcare Supply chain, Digital Health|
6g. Other Vendors
6h. Other Providers
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