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1a. Project Name

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

Mobile Health

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

Christina Caraballo

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
Open mHealth

2f. Modeling Facilitator

Keith Boone

2g. Publishing Facilitator

Keith Boone

2h. Vocabulary Facilitator

2i. Domain Expert Representative

Nathan Botts

2j. Business Requirements Analyst

2k. Conformance Facilitator

Keith Boone

2l. Other Facilitators

2m. Implementers

Reliant Medical
Open mHealth
Audacious Inquiry
Health eServices

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

3f. Common Names / Keywords / Aliases:

mHealth ADE Assessment Framework

3g. Lineage

mHealth App Data Exchange investigative project

3h. Project Dependencies

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

IEEE 11073

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

4a. Products

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

Open mHealth
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?


6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6f. Other Stakeholders

6g. Vendors

EHR, PHR, Equipment, Health Care IT

6g. Other Vendors

6h. Providers

Healthcare Institutions (hospitals, long term care, home care, mental health)

6h. Other Providers

6i. Realm


7d. US Realm Approval Date

7a. Management Group(s) to Review PSS


7b. Sponsoring WG Approval Date

Dec 20, 2019

7c. Co-Sponsor Approval Date

Dec 17, 2019

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

Jan 22, 2020

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date