Family Health History Quick App Review

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The FHH Quick App Review is an abbreviated quality assessment process based on the ISO/TS 82304-2 eHealth app quality label standard. It is designed to assist healthcare providers in choosing quality FHH digital tools for patient care and patient use.

An email is required so that a copy of your responses will be emailed to you. Your email is not used for any other purpose.

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E-Mail-Adresse *

What is the formal name of the FHH app you are reviewing?

Who are the intended users of the FHH app? (Health professionals, patients, researchers, genetic/genomic/testing labs) Check all that apply.

Health professionals

Patients

Researchers

Genetic/Genomic test labs

Sonstiges:

Are potential customers and users provided with adequate product information about the FHH app? (Full pedigree functionality or just a form, general or single disease focus, and use of personal data by the app, etc.)

No product information

Comprehensive product information

Auswahl löschen

What product information is missing?

What is the intended use or purpose of the FHH app? Check all that apply.

To Inform – learning the value of FHH in genetic-based care

For Simple Monitoring – personal health tracking that may benefit both the patient and their family members

To Communicate – between family members, between patient and doctor or genetic counselor, and other health services

For Research – consenting and sharing FHH data and information with one or many research organizations

To Calculate – FHH app generates a heritable risk assessment, a percentage risk of a genetic mutation for a relative yet to be sequenced, and relatives indicated for cascade testing

To Diagnose – determine heritable risk, provide validated information and clinical interpretation on genetic variants, recommend appropriate genetic/genomic testing, all under physician and genetic counselor guidance

To Treat – order, schedule, and track testing, genomics and pharmacogenomics, indicated clinical surveillance, and genetic counseling

For Preventative Behavior Change – makes recommendations and tracks lifestyle changes

To Self-Manage – provides tools for patients who collect and examine their medical, ‘Omic, and family health history data, along with patient generated data (wearables, other devices)

Sonstiges:

For which health issue(s) and/or health need(s) is the FHH app intended? (a specific gene, disease?)

In which languages is the FHH app available?

Are the health risks of the health app analyzed? (Health risks may include over-reliance on the app, misinterpretation of information, medical judgments made without input from a medical professional, etc.)

No analysis of health risks

Comprehensive analysis of health risks

Auswahl löschen

List the health risks analyzed in the app

Are measures in place to control the health risks of the FHH app? (Is there information covering user safety, including warnings and limitations of use. Is user training offered? Is there documented verification and validation of risk reports and algorithms used by the app, etc.)

No measures in place to control the health risks

Comprehensive measures in place to control the health risks

Auswahl löschen

List the measures to control health risks in the app

Are the residual risks of using the health app found to be acceptable? Is a consent system in place for patient privacy and security (data sharing options explained, data hiding or limiting options available with family members, healthcare providers, medical systems, protecting paternity confidences, how is de-identified data created, etc.)? Check all that apply.

Data sharing options explained

Data hiding or limiting options available between family members

Data hiding or limiting options available with healthcare providers, medical systems

Protecting paternity confidences

How de-identified data is created

Sonstiges:

Is a process in place to collect and review safety concerns and incidents for the FHH app? (how can users report incidents or issues)?

Yes

Not clear

Auswahl löschen

Are ethical challenges of the health app assessed with intended users and health professionals? (information not used for health insurance qualification, being sensitive to cultural issues, how to report medically actionable health risks without causing undue concern, understanding the role of biological relationships vs. non-biological and chromosomal sex for risk assessment purposes, respecting the privacy of the user’s family members, etc.)?

Ethical challenges not assessed

All ethical challenges not assessed

Auswahl löschen

List ethical challenges not assessed by the app

Describe the health benefits of using the FHH app. Are potential users made aware of the health interventions applied to achieve the health benefits? Is there a review of possible interventions that could be ordered or performed by the Primary Care physician?

Health benefits not described

Health benefits fully described

Auswahl löschen

List the health benefits that are described

Are potential users made aware of the need for support of a health professional to achieve the health benefits?

Yes

Not sure

Auswahl löschen

Are potential users made aware of the financial costs to achieve the health benefits? (out-of-pocket costs for laboratory testing and other interventions)

Yes

Not sure

Auswahl löschen

Are there maintenance processes for the health information in the FHH app by the app developer? Are all sources for the health information disclosed to users?

Yes

Not sure

Auswahl löschen

Does the FHH app encourage and track the user by keeping the pedigree and FHH information up to date?

Yes

Not sure

Auswahl löschen

Is the design of the FHH app driven and refined by user-centered evaluation? Is the app design based on an explicit understanding of users, tasks and environment? (Share your opinion)

No, not at all

Yes, completely

Auswahl löschen

Are measures in place to avoid user error and reasonably foreseeable misuse of the health app? (Input error detection, context-sensitive help, etc.)

No error detection

Complete error detection

Auswahl löschen

Share one or more example(s) of missing error detection

Are instructions for use readily available for users? Are appropriate resources available to adequately help users who experience problems with the app?

No instructions

Complete instructions

Auswahl löschen

Share an example of instructions

Is a privacy statement readily available to potential users of the FHH app? Is an appropriate retention policy established to erase or review the data stored?

Yes

Not sure

Auswahl löschen

Is a secure by design process followed? (Security by design ensures that information security is designed and implemented within the development lifecycle of the app.)

Yes, it appears so

No, it doesn't look like it

Not sure

Auswahl löschen

Is user authentication, authorization and session management implemented to secure access to the health app? (The identity of an app user is authenticated prior to access of any personal identifying information.)

Yes

Not sure

Sonstiges:

Auswahl löschen

Are security vulnerabilities reported, identified, assessed, logged, responded to, disclosed, and quickly and effectively resolved?

Yes, it appears so

No, it doesn't look like it

Not sure

Auswahl löschen

Is the information security policy readily available to potential users?

Yes

Not sure

Auswahl löschen

Is data interoperability achieved via published FHH data standards like HL7 FHIR (Fast Healthcare Interoperability Resources) and GA4GH (Global Alliance for Genomics and Health)? Are certified interoperable systems listed (what other apps, data repositories, and major medical systems does the app communicate with)?

Standards used are listed

Interoperable systems are listed

No information about wither question is given (previous two answers should not be checked)

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