HAS proposes the first classification of digital solutions used in healthcare
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", 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.
 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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