The digital technology is progressively becoming an integral part of the health care systems. Since digital solutions cover a vast and diverse scope, they vary significantly by their operating nature, functionality, and principles. Furthermore, some are considered medical devices, and some are not; some are subject to evaluation, and others are not.
Given the extreme diversity of current and upcoming digital solutions, and in order to facilitate the exchange of information between the various stakeholders, the French High Authority for Health, HAS, proposes a draft classification of digital solutions based on:
- Digital solutions’ purpose
- The capacity of the digital solution to take into account user/patient parameters (leading to the personalization of the response)
- The functional autonomy of the digital solution
There are four levels of personalization and autonomy of the digital solution. They are ranged from A (low degree) to D (high degree), and the details are explained in the support document:
- Level A – No direct benefit to the health of users/patients
- Level B – General information and self-monitoring
- Level C – Prevention, screening, diagnosis, or treatment of the disease without autonomy in the decision management
- Level D – Prevention, screening, diagnosis, or treatment of the disease with autonomy in the decision management
This draft functional classification of digital solutions will help to bring clarity on what should be evaluated and what should not. This draft may help develop a framework for the assessment of digital solutions.
The call ends on June 30, 2020.
See the whole news and the link to the submission platform here.
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