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

European Committee for Standardization (CEN)

Quality & reliability for health and wellness apps

Nathan E Botts 0 2919 Article rating: No rating

A new CEN Technical Specification for ‘Quality and Reliability of Health and Wellness Apps’ is being developed at the request and with the support of the European Commission. It is due to be completed in 2020. It will help to establish a common framework across Europe for the evaluation of these apps, giving users and health professionals confidence that the apps are fit for purpose, and providing app developers easier access to European markets.

Express Scripts Creates a Digital Health Formulary

Efforts to increase provider and patient safety

Nathan E Botts 0 2620 Article rating: No rating

Express Scripts is introducing what they propose is the industry’s first, stand-alone digital health formulary. Identifying that there are more than 300,000 health applications in the market, it is proposed that there is a great need to establish digital health formularies similar to medication formularies. 

HL7 Consumer Mobile Health Application Functional Framework (CMHAFF)

An HL7 Standard for Trial Use

HL7 Mobile Health Workgroup 0 12135 Article rating: 5.0

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.

Have you considered your privacy rights when using birth control apps?

Assessment of a Wired.com article by Megan Molteni

Nathan E Botts 0 9584 Article rating: 5.0

Abstract from the article titled, "Before Using Birth Control Apps Consider Your Privacy" posted on Wired.com: "Natural Cycles’ privacy policy states that in using the app each user grants the company and any of its partners broad rights to “use, reproduce, distribute, modify, adapt, prepare derivative works of, publicly display, publicly perform, communicate to the public, and otherwise utilize and exploit a user's anonymized information.”

2.4.2 Use Case B

Device-Connected Wellness App

HL7 CMHAFF 0 2880 Article rating: No rating

A weight management app helps consumers to systematically collect weight information, food consumption information and exercise information.  Weight can be entered manually, or a consumer can link a wireless scale to the app so that weight is automatically collected when using the scale.  Food consumption is entered manually, and the tool estimates calories consumed based on the consumer’s input. Exercise information may be entered manually or collected automatically through integration with a smart watch. 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).

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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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