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

General Clinical Measurements

The General Clinical Measurements category includes requirements for all clinical vital signs measurements. Any assessment performed for other categories in clinical vital signs SHALL assess this category. The requirements of this category ensure that documentation of the method of measure and range of accuracy is documented for the device, and that the type of device can be determined.

Feature: Mechanism And Accuracy of Measurement is Documented

The mechanism and accuracy of measurements by the device **SHALL** be documented for each vital sign it can measure.

Scenario: Mechanism And Accuracy Documented

GIVEN

A <Device> that measures a vital sign

AND

<Documentation> for <Device>

WHEN

<Documentation> for <Device> is reviewed

THEN

the mechanism for measuring each vital sign is described and the range of accuracy of the measurement is reported.

Feature: Type of Device is Available

The type of device performing the measure SHALL be able to be determined from the NOTE: If a device can be associated with a Universal Device Identifier (UDI), it meets the criteria for this requirement, because this information is included in device metadata accessible via UDI.

Scenario: Type of Device

GIVEN

a <Device> that measures a vital sign

THEN

the <Device> must be able to be associated with <Metadata> about it

AND

that <Metadata> must describe the <Type> of device