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HL7 CMHAFF Standard Introduction and Purpose

1. Introduction

Acknowledgements, Background, Intended Audience, and Instructions

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The Consumer Mobile Health Application Functional Framework is an HL7 Standard for Trial Use (STU). The primary goals of the Consumer Mobile Health Functional Framework (cMHAFF) are to provide a standard against which a mobile app’s foundational characteristics -- including but not limited to security, privacy, data access, data export, and transparency/disclosure of conditions -- can be assessed.

2. Overview

Goals, Scope, Conformance Design Principles

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The primary goals of cMHAFF are to provide a standard against which a mobile app’s foundational characteristics -- including but not limited to security, privacy, data access, data export, and transparency/disclosure of conditions -- can be assessed. The framework is based on the lifecycle of an app, as experienced by an individual consumer, from first deciding to download an app, to determining what happens with consumer data after the app has been deleted from a smartphone. It is important to note that the Framework does not speak directly to the specific health or clinical functionality of an app but can be extended to do so through the use of profiles (with constraints and/or extensions) developed on top of cMHAFF.

2.4.1 Use Case A

Simple, Standalone

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A walking app collects data based on how far someone walks, using GPS technology. A consumer can view a history of walks taken and summary statistics related to distance walked and estimated calories burned. App developer is not a HIPAA-covered (see reference below) entity (CE) such as a healthcare provider, nor is the app sponsored by a CE (such as a hospital or physician).

3.2.1 Regulatory Considerations

Compliance of Apps to Applicable Regulations

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This section is about the compliance of apps to applicable regulations for the domains (realms, locales, environments) in which they are intended to be used. CMHAFF is designed as a framework that can be further constrained (profiled) for these domains and does not require conformance to any specific locale’s regulations.

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