About ten types of solutions divided into four levels
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Concretely, the classification divides 11 types of digital solutions into four levels (A, B, C and D) “according to their purpose of use, their capacity to offer a personalized response and their decision-making autonomy”.
The level A includes “support services” for patients, caregivers or professionals within the framework of care or optimization of the care path or medico-administrative management and “without direct action on the health of patients”.
It includes the shared medical record (DMP), online appointment scheduling software or geolocation applications for public health purposes.
The level B includes tools for “general non-personalized user information” on living conditions, rules of hygiene, dietetics, pathologies or disabilities, “or any state of health”. This also includes “training materials or tools” for professionals.
The level C brings together the tools of “life support, prevention, screening, diagnosis, compliance, monitoring or treatment of a pathology”, a state of health or in the context of a situation of handicap, “without autonomy of the digital solution in the management of the therapeutic decision”.
There are no less than 8 categories of solutions at this level of the classification.
The HAS cited as concrete examples the audio description applications for the blind, remote monitoring systems that allow a professional to interpret and manage a patient’s data remotely, connected bracelets for alerting patients. help for the elderly, connected blood pressure monitors or respiratory pauses detection software for the diagnosis of sleep apnea.
Finally, the level D contains the tools proposing an “autonomous management of the decision” after analysis of the data and the diagnosis in order to automatically adjust a treatment to be administered without human intervention.
This is the case, for example, with solutions of the “artificial pancreas” type with continuous glucose monitors which automatically adjust the basal rate or trigger the administration of a bolus dose without the patient having to intervene.
The HAS specified that this classification grid constitutes a “basic tool of reference intended for the various potential actors for multiple uses”, but that it will find “its full utility” when it is “fed over time and over time. according to its uses by other parameters of a regulatory nature (medical device or not, data protection, level of risk according to the future European regulation, etc.), technical (need for interoperability or not, etc.) and economic (evaluation with a view to taking charge? by which actors? ect.) “.
The grid could also be used to “help structure exchanges” at European level on issues of autonomy and artificial intelligence.
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