Deliverable 4.9 - Final report

Deliverable 4.9 – Final report – Ethical Lessons Learned – a deep dive in mHealth for diabetes

Deliverable 4.9 - Final report - Ethical Lessons Learned   -  a deep dive in mHealth for diabetes
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  • Create Date February 17, 2022

The ethical values highlighted in the mHealth Hub Quick Guide to Ethics must be appropriately tailored to each use case to have any real value.  This means that it must be adapted to the local setting and the medical need.  While the questions outlined in this mHealth Hub Diabetes App Ethics Checker do not purport to address the application of the Quick Guide to any one country or use setting, they explore the way the Quick Guide can apply to apps developed for use by people with diabetes. This condition has been chosen to align with Hub Knowledge Tool 2, which focusses explicitly on diabetes.

The present text provides a template of core questions that helps implement the mHealth Hub Ethics Guide as a functional assessment for a given set of solutions. It is presented here as an analogue tool that could be developed as a simple checklist. In its present format it provides a manual check list of questions, which could be simply implemented by a person undertaking a manual check. It could however be integrated into a more automated tool in which some answers could be generated automatically.

It could also be used as a basis for commissioning mHealth solutions and be used as part of a specification in a call for tenders, and as such be used to drive conformity and interoperability across several solution providers. This would be especially useful if an mHealth programme is being developed to support a range of patients with different healthcare needs, or patients with co-morbidities who need to use more than one mHealth solution. It also provides the core elements that will need to be addressed by the service implementors, which may be a national health care programme, an insurer, a care provider group, or any other actor who may be part of the ecosystem in which the mDiabetes solution is operated.

While the present deliverable is developed in the framework of an mDiabetes solution, it serves as baseline that could be further developed for other chronic conditions or other healthcare needs. Its purpose is to demonstrate a practical application of the four quadrants of the mHealth Hub Ethics Guide.  It could also be used as an ex-ante guidance for app developers.

Where the solution is a commercial product purchased directly by a patient, rather than a solution reimbursed or part financed by a public body or insurer, a simplified version of the schema could also be used to support purchaser decision making. As such it could be used in complement with the newly developed CEN-ISO standard ISO/TS 82304-2, Health software – Part 2: Health and wellness apps – Quality and reliability.

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