HL7 CMHAFF Standard Sources of Regulations, Policies, Rules, and References

2.4.3 Use Case C

EHR-Integrated Disease Management App

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A diabetes management app allows a consumer to collect blood sugar readings through a Bluetooth-enabled glucometer. A healthcare provider offers the app to enable the patient’s blood sugar to be captured through devices, rather than relying on manual entry by the patient, and to electronically transmit the readings to the patient’s physician, rather than using paper or FAX. Activity data are collected through an activity tracker, and a consumer can open the app to record meals and snacks to enable estimates of caloric consumption.

2.4.4 Risks, Key Differences, and Environmental Scan

Use Case Impact Factors

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For some apps, especially those like Use Case C, there are several potential threats and vulnerabilities which should be assessed and mitigated, where necessary, by mHealth developers (see 3.2.2 Product Risk Assessment and Mitigation). 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.

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HL7 CMHAFF Glossary

Philosophically, the HL7 Mobile Health group favors using terms that are commonly accepted in the consumer mobile space, in preference to terms that are used only in the EHR space. Simply put, the target user for these devices are consumers, rather than clinicians. However, where terms are used differently in EHR vs consumer spaces, we take note of that, and acknowledge the various uses.

This does not purport to be an exhaustive set of mobile health definitions, but terms are included only to provide clarity within cMHAFF.

See British Standards Institution Publicly Available Specification (PAS) 277:2015 Health and wellness apps. Quality criteria across the life cycle. Code of practice (https://shop.bsigroup.com/forms/PASs/PAS-2772015/) which has a good set of Terms and Definitions (section 3).

Terms and Definitions

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