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HAS proposes the first classification of digital solutions used in healthcare

Press release - Posted on Feb 17 2021
February 17, 2021

In a context of growth in digital tools suitable for use in health, the French National Authority for Health recently drafted a system for classifying digital solutions according to their intended use, their capacity to provide a personalised response, and their autonomy, i.e. their capacity to take action with or without human intervention. The objective: guide stakeholders and help improve the integration of these tools in the healthcare and medico-social sector.

Cutting down on travel, lightening the burden on the healthcare system, helping keep patients at home, facilitating post-hospitalisation follow-up, etc. The Covid-19 pandemic has highlighted the huge potential of digital solutions, which could be increased further by incorporating artificial intelligence. 
However, the diversity of digital solutions goes together with their substantial heterogeneity, associated with their technological nature, their functions, and their target population (patients, caregivers, healthcare professionals, etc.). Digital solutions are also differentiated by other criteria such as their status (medical device or not), their assessment process and/or the guidelines to be followed by developers, and their potential funding by the French Health Insurance scheme.
Therefore, on 1 April 2020, one year after its "prospective analysis on the digital (r)evolution"[1], the French National Authority for Health decided to propose a tool for classifying digital solutions used in healthcare.

 

4 categories, 11 types of digital solutions

HAS thus drew up a draft version, and subsequently submitted it for public consultation over a 3-month period by all stakeholders in the sectors involved in the development or use of digital solutions. Following the analysis of the 76 contributions, indicating strong interest in the draft classification, the French National Authority for Health has drawn up an easy-to-use classification. It includes a total of 11 types of digital solutions classified in 4 levels (A, B, C, D), according to their intended use, their capacity to provide a personalised response, and their autonomy in the decision process (those requiring human intervention to implement a therapeutic, screening or diagnostic action, and those generating this type of action themselves, i.e. without prior human intervention).

 

A grid to be supplemented with a matrix approach

This classification grid was devised as a reference foundation tool intended for the various potential stakeholders and for multiple purposes. To achieve its full potential, it should be fed over time and according to its use with other parameters of a regulatory (medical device or not, data protection, risk level according to the future European regulation, etc.), technical (need for interoperability or not, etc.), and economic (assessment with a view to funding? by which stakeholders? etc.) nature. On a national and European level, the digital framework is taking shape, particularly in terms of autonomy and artificial intelligence. The grid proposed by HAS could help structure interactions and, ultimately, help achieve effective integration of digital solutions in the healthcare system, in terms of healthcare and medico-social aspects.

  • Level A: System services for patients, caregivers or healthcare professionals within the scope of care or care pathway optimisation or medical/socio-administrative management with no direct action on patient health: shared medical record (SMR), online appointment software, geolocation app for public health purposes, etc.
  • Level B: General non-personalised user information on living conditions, healthy living, diseases/disabilities or any health state (in the broad sense of the term), health, care or life pathways, etc. Also provides healthcare professional training materials or tools.
  • Level C: Aid for living, for prevention, screening, diagnosis, compliance, monitoring or treatment of a disease, health state, or in the context of a disability, without autonomy of the digital solution in therapeutic decision management. This level alone includes 8 categories according to the wide range of functions of solutions of this level. Some concrete examples: audio description app for the visually impaired; app enabling persons with a disability to request assistance in solving an occasional problem from connected volunteer caregivers; telemonitoring system enabling a healthcare professional to interpret and manage patient data remotely; connected emergency service alert wristband for elderly persons, ovulation phase prediction tool; gamification solution applied to the treatment of psychiatric illnesses; wrist blood pressure monitor connected to the patient's smartphone, software associated with a chest band to detect breathing pauses with a view to diagnosing sleep apnoea, etc.
  • Level D: Autonomous decision management after data analysis and diagnosis with a view to automatically adjusting the treatment to be administered, without human intervention: for example, system that analyses data from a continuous glucose monitor used by a patient with diabetes and that will automatically adjust the basal rate or administer a bolus dose without the need for patient intervention (artificial pancreas); implantable cardiac defibrillator with a remote monitoring solution that analyses data from a heart monitor, delivers a shock in the event of cardiac arrest and can transmit alerts to the healthcare professional responsible for the patient's care, etc.

 

 

[1] HAS. 2019 prospective analysis report - Digital technology: what (R)evolution? 2019. https://www.has-sante.fr/upload/docs/application/pdf/2019-07/rapport_analyse_prospective_20191.pdf

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