| Περίληψη: | This dissertation deals with mHealth applications, the regulations, and standards that apply, in cases where they are classified as medical devices, as well as their tools and methods of evaluation. The term Mobile health (mHealth) apps refer to self-contained pieces of software coded for a specific purpose and usually optimized to run on tablet or a mobile device. This work first refers to key concepts such as what is defined as health technology and medical device as well as what is health technology evaluation. Next, the market for mobile health applications today, their evaluators and the corresponding regulatory frameworks in Europe and the USA are investigated. Finally, a systematic review of the literature is performed in order to examine the number of economic evaluations that are available to support the adoption and reimbursement of mobile health applications by National authorities and payers.
The majority of mHealth, applications that are available today, although they are widely used for healthcare purposes, are not placed on the market under any regulatory framework, as they are not characterized as medical devices by their developers. Therefore, they are not controlled and may cause harm to their users’ health, by providing misleading or inaccurate results, or, disclosure of sensitive personal information related to medical confidentiality.
The Food and Drug Administration and the European Commission that are responsible for Medical Devices regulations in the US and EU respectively, provide guidance on whether or not a mHealth application is falling under the medical device regulatory framework and therefore should be considered as such. However, the large majority of mHealth apps are offered the same way as all other apps under the wellbeing category. Due to the critical character of their nature and the fact that they may influence their users concerning their health conditions, there is a need for formal evaluation. In the case of mHealth applications that are placed on the market as medical devices, an assessment it would be very valuable to inform any reimbursement decision by national health authorities. The Health Technology Assessment (HTA) paradigm, and more specifically Cost-effectiveness/Cost-utility analyses, should form the basis for reimbursement decisions if one aims to maximise the health of the population under a fixed budget.
As part of this Master thesis, a systematic literature review was performed in order to provide the general picture of the economic evaluation studies (cost-effectiveness and cost-utility analyses) that are available to support the HTA of mHealth applications. The findings show there are still few studies available and the literature to support the related decision-making process on these technologies is still scant.
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