This page is part of the Application Data Exchange Assessment Framework and Functional Requirements for Mobile Health (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Functional Requirements

This section describes the top level requirement categories identified for this guide. You can navigate to the sub-categories listed below, or select a specific category in the Table of Contents.

Category: 10 Functional Requirements

The Category: 10 Functional Requirements Category includes all requirements for from the following subcategories:

• Attribution Features in the Attribution category ensure that metadata about reported measurements are included to identify the device creating a measurement, the author creating manually entered data, and that devices are not permanently linked to a given user and can be readily replaced at need

• User Data User data, including demographics and other user attributes, are used to configure the device or app, and associate it with the current user of the device.

• System Data System data includes configuration, capabilities and attributes of a device, application or infrastructure that describes the essentials to ensure proper operation of the system

• Observations The Observations Category supports recording of measurement of vital signs, physical activity and sleep, and data associated with those measurements

• Data Sharing The Data Sharing category supports requirements that enable users to share (or not share) data with other systems and users

• General Requirements The Clinical Vital Signs Category describes requirements supporting additional data needed for accurate interpretation of device measurements in a clinical setting.