HAS offers the 1st classification of digital health solutions

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To help all healthcare players in deploying solutions, the Haute Autorité de health publishes the 1st classification of digital solutions used in healthcare. Discovery.

In a context of increasing digital health tools, the Haute Autorité de health is offering a system of classification of digital solutions according to their purpose of use, their ability to provide a personalized response and their autonomy, that is to say their ability to act with or without human intervention. The objective: to help the actors to navigate and to contribute to a better integration of these tools in the health and medico-social sector.

Reduce travel, lighten the burden on the health system, help support at health home, facilitate follow-up after hospitalization … The Covid-19 pandemic has highlighted the enormous potential of digital solutions, which could be further strengthened through the integration of artificial intelligence.

However, the diversity of digital solutions goes hand in hand with their great heterogeneity, linked both to their technological nature, to their functionalities and to the audience for which they are intended (patients, caregivers, healthcare professionals, etc.). The digital solutions are also distinguished by other criteria such as their status (medical device or not), their evaluation process and / or the benchmarks imposed on developers, their possible coverage by Health Insurance, etc.

To respond to all these challenges, the Haute Autorité de health has therefore decided to offer a classification tool for digital solutions used in healthcare according to an approach by purpose of use supplemented by:

  • the ability of the digital solution to take into account user / patient parameters
    (which may lead to a personalization of the response),
  • whether or not the digital solution to human intervention is autonomous

4 categories, 11 types of digital solutions

To be as close as possible to the needs and expectations of healthcare stakeholders, the HAS submitted a draft classification for 3 months for public consultation with all stakeholders in the sectors involved in the development or use of digital solutions.

HAS then developed an easy-to-use classification, after analyzing the 76 contributions made. It has a total of 11 types of digital solutions classified into 4 levels (A, B, C, D), according to their purpose of use, their ability to offer a personalized response and their autonomy in decision-making (those requiring human intervention to implement a therapeutic, screening or diagnostic action, and those that generate by themselves, that is to say without prior human intervention, this same type of action).

Source: Haute Autorité de health – February 2021

  • Level A : Support services for patients, caregivers or professionals in the context of care or optimization of the care path or medico / socio-administrative management without direct action on the health of patients: shared medical file (DMP), software online appointment booking, geolocation application for public health purposes …
  • Level B : General non-personalized information for the user on living conditions, hygienic and dietary rules, pathologies / disabilities or any state of health (in the broad sense of the term), health, care or life paths, etc. . Also provides training materials or tools for healthcare professionals.
  • Level C : Life support, prevention, screening, diagnosis, compliance, monitoring or treatment of a pathology, a state of health or in the context of a situation of disability, without autonomy of the digital solution in the management of the therapeutic decision. This level alone comprises 8 categories according to the various functionalities of the solutions at this level. Some concrete examples: audio description application for the blind; application allowing people with disabilities to request assistance to solve a specific problem with smart health connected volunteer caregivers; remote monitoring system that allows a healthcare professional to interpret and manage patient data remotely; emergency alert smart health connected bracelet for the elderly, ovulation period prediction tool; gamification solution applied to the treatment of psychiatric pathologies; Wrist blood pressure monitoring smart health connected to the patient’s mobile phone, software associated with a chest band to detect breathing pauses in order to diagnose sleep apnea …
  • Level D : Autonomous management of the decision after data analysis and diagnosis in order to automatically adjust the treatment to be administered, without human intervention: for example a system which analyzes data from a continuous glucose monitoring used by a diabetic patient and which will automatically adjust the basal rate or deliver a bolus dose without patient intervention (artificial pancreas); Cardiac defibrillator implanted with a remote monitoring solution that analyzes data from a cardiac monitoring, delivers a shock in the event of cardiac arrest and can transmit alerts to the professional who follows the patient …

This classification grid was designed as a basic reference tool intended for the various potential actors and for multiple uses. For it to find its full utility, it must be supplied over time and according to its uses by other order parameters:

  • regulatory: medical device or not, data protection, level of risk according to the future European regulation, etc.
  • technical: need for interoperability or not, etc.
  • economic: evaluation with a view to taking charge? by which actors? etc.

By offering a functional approach supplemented by increasing levels of patient / caregiver / user personalization and autonomy of the digital solution, this classification grid, subject to additional matrix work, should, if the actors appropriate it, contribute to structure their exchanges (regulatory / technical / clinical / economic / evaluation) and ultimately contribute to increasing the efficient integration of digital solutions into the healthcare system, including the medico-social sector”Indicates the HAS.

Source: Haute Autorité de health

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