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

Clinical Vital Signs

Clinical Vital Signs is a category that includes the measurements of other factors that can affect the primary measurement. When this category is assessed and reported, the Basic Vital Signs category must also be assessed and reported.

Clinical Vital Signs are distinct from Basic Vital Signs because this data includes that necessary to interpret the clinical impact of the primary measurement on the user without making other assumptions. This category focuses on the ability to measure these other factors rather than the primary measurement.

There are many factors that can influence the measured values. For example, a blood pressure measurement taken on the left arm can vary slightly, moderately or even severely from those taken on the right arm depending on many factors, including the presence of peripheral artery disease¹. The capture of laterality (left/right) of the measurement site can be used to help identify the presence of absence of disease. Other values, such as the body site where the measurement was taken (wrist, upper arm or leg), the method by which the measurement was taken (optic sensor, pneumatic cuff), the user’s position when the measurement was taken, time since recent physical activity, even the cuff size, can affect interpretation.

This section addresses the capture of additional data required to enable accurate clinical interpretation. The failure of a device to support these capabilities does not mean that its use for monitoring does not have clinical value, but it does mean that additional steps are likely needed to ensure consistency of results. User education and training, with written instructions, can sometimes substitute for being able to capture the all of the data necessary. Some devices or apps allow additional data to be captured when a measurement is taken (e.g., comment fields). These fields can often be used to substitute for missing device or application features, but may require additional effort when interfacing with these systems.

difference in systolic blood pressure between arms with vascular disease and mortality: a systematic review and meta-analysis](https://www.ncbi.nlm.nih.gov/pubmed/22293369/). Lancet. 2012 Mar 10;379(9819):905-914. doi: 10.1016/S0140-6736(11)61710-8. Epub 2012 Jan 30. Review. PubMed PMID: 22293369.

Category: 2 Clinical Vital Signs

The Category: 2 Clinical Vital Signs Category includes all requirements for from the following subcategories:

• Clinical Height And Weight The Clinical Height and Weight category supports additional requirements used in clinical settings for the interpretation of height and weight measures

• Clinical Blood Pressure The Clinical Blood Pressure category supports the reporting of additional measurements supporting clinical interpretation of results

• Clinical Heart Rate The Clinical Heart Rate Pressure category supports the reporting of additional measurements supporting clinical interpretation of results.

• Clinical Respiration The Clinical Respiration Category supports the reporting of additional measurements supporting clinical interpretation of results

• Clinical Spo2 The Clinical SPO2 category supports the capture of measurement site data when Oxygen Saturation is collected

• Clinical Temperature The Clinical Temperature Category supports capture of measurement site data when Temperature is collected

• General Clinical Measurements The General Clinical Measurements category includes requirements for all clinical vital signs measurements