Application Data Exchange Assessment Framework and Functional Requirements for Mobile Health
1b. Project ID
1c. Is Your Project an Investigative Project (aka PSS-Lite)?
1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?
1e. Today's Date
1f. Name of standard being reaffirmed
1g. Project Artifact Information
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
2b. Co-Sponsor WG
Electronic Health Record
2c. Co-Sponsor Level of Involvement
Request formal content review prior to ballotRequest periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)
2c. Co-Sponsor Update Periods
Review prior to publication and at WGMs
2c. Co-Sponsor 2 Update Periods
Review prior to publication and at WGMs
2d. Project Facilitator
2e. Other Interested Parties (and roles)
US Office of the National Coordinator for Health IT
US National Institutes of Health, All of Us Research Project
2f. Modeling Facilitator
2g. Publishing Facilitator
2h. Vocabulary Facilitator
2i. Domain Expert Representative
2j. Business Requirements Analyst
2k. Conformance Facilitator
2l. Other Facilitators
3a. Project Scope
The scope of this project is to develop the assessment framework and functional requirements for consumer medical devices and applications required to support the exchange of observations and other data in support of consumer health monitoring. We will focus on vital signs (height, weight, blood pressure, O2 saturation, respiration and heart rate), and physical activity.
The scope of this project is Universal even though current leadership of the project is US based. We have had participation in project efforts from individuals in the US, Europe and Asia, and who serve markets internationally. We welcome greater international participation in this project.
3b. Project Need
Mobile apps and devices provide their own APIs and methods for collecting device data that can be communicated to EHR, PHR and research endpoints. Much of this data can (and has been) readily converted to FHIR resources. However, some limits have been encountered which demonstrate that essential data needed to generate, interpret and use the FHIR resources is sometimes missing. The purpose of this project is to develop functional requirements that can be used to assess devices, applications, and FHIR profiles to ensure that the essential data needed for clinical, patient and research uses is present in communications between applications.
3c. Security Risk
3d. External Drivers
All of Us Research program
3e. Objectives/Deliverables and Target Dates
Initial Ballot May 2020
Additional Ballot September 2020
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
FHIR Implementation Guide, FHIR Profiles
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
4d. Please define your New Product Family
5a. Project Intent
Implementation Guide (IG) will be created/modified
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
STU to Normative
5c. Additional Ballot Info
There are compatibility concerns, given that this specification could be used to assess existing FHIR and other implementation guides (e.g., US Core, Healthcare Devices FHIR IG specifications). However, these concerns are not material to the development of this guide.
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
IHE Mobile Health App Workgroup
6b. Content Already Developed
6c. Content externally developed?
6d. List Developers of Externally Developed Content
6e. Is this a hosted (externally funded) project?
Regulatory Agency, Standards Development Organizations (SDOs)
6f. Other Stakeholders
EHR, PHR, Equipment, Health Care IT
6g. Other Vendors
Healthcare Institutions (hospitals, long term care, home care, mental health)