Towards the development of a methodological guide for the organisational assessment of digital medical devices
RetourThe French National Authority for Health (HAS) is developing a methodological guide for assessing the organisational impact of digital medical devices (DMDs) in order to provide a suitable framework for studies carried out by industry and, more broadly, by healthcare professionals, healthcare organisations and other evaluation structures.
Telemonitoring, therapeutic applications, digital support tools: digital medical devices (DMDs) are playing an increasingly important role in patient care. Beyond their clinical benefits, these technologies can change the way professionals coordinate their work, the way patients are followed up, and even the organisation of work within healthcare establishments.
These changes are now increasingly taken into account in the evaluations carried out by the HAS. However, it remains difficult to measure their impact on healthcare organisations in a robust and objective manner.
Based on a framework document, the HAS will produce a guide with a twofold objective:
- Produce a methodological guide for industries to enable them to substantiate their claims.
- More broadly, to provide a reference document for healthcare professionals, healthcare institutions and other assessment organisations wishing to implement procedures to assess the organisational impact of medical devices.
The SMATCH project
The HAS began work on this methodological guide as part of its research collaboration with the SMATCH project (‘Statistical and AI-based Methods for Advanced Clinical Trial Challenges in Digital Health’ ANR-22-PESN-003), a consortium funded under the France 2030 Digital Health research programme (PEPR SantéNum), co-led by Inria (the National Institute for Research in Digital Science and Technology) and Inserm (the National Institute of Health and Medical Research).
Coordinated by Sarah Zohar, head of the HeKa team, and Rodolphe Thiébaut, director of the BPH, SMATCH is based on a large national research collaboration bringing together 16 teams, mainly from Inria and Inserm centers. Each team brings unique and complementary expertise in statistics and the methodology of data science, digital technology and AI as applied to health issues and, specifically, to clinical trials.
Among these teams are several organisations from the Bordeaux public health department, including the BPH with its SISTM and PHARES teams, as well as the CIC EC 1401 and the EUCLID platform.
Bordeaux-based members of this major collaboration
Organised around four work packages (WPs), SMATCH proposes and tests statistical and AI methods to address the specific challenges posed by clinical trials in digital health (data heterogeneity, digital follow-ups, real-world data), areas in which the BPH and Bordeaux’s public health services are recognised for their expertise.
Led by Mélanie Prague, the members of our SISTM team, which leads WP1, are contributing to the development of mechanistic and statistical methods aimed at integrating pharmacological data, estimating models and determining optimal doses to accelerate the development of medicines and vaccines in Phase I and II clinical trials.
Florence Saillour, from CIC-EC EUCLID and the PHARES-BPH team, is tasked within WP3 to develop an innovative methodological framework for the evaluation of digital medical devices; The aim is to better characterise their components and applicability whilst assessing their clinical, organisational and public health impacts under real-world conditions of deployment within the healthcare system. Her initial investigations, focusing on remote monitoring digital medical devices, show that evaluation work has mainly focused on their effects on patient care, particularly in terms of preventing risky behaviour among patients, the early detection of certain diseases and improvements in quality of life.
«At SMATCH and within our multidisciplinary NewEvaDMN working group, we are continuing the work we have begun and will soon be able to offer an innovative, comprehensive, evidence-based and operational methodological framework for evaluating remote medical monitoring DMNs and supporting manufacturers in their application process for inclusion on the List of Medical Remote Monitoring Activities (LATM)».
Florence Saillour-Glenisson
Laura Richert, co-director of our BPH centre, is co-leader of WP4. The role of WP4 is to present the results from the other three work packages to the scientific community and regulatory authorities, taking into account acceptability, feasibility, ethical considerations and operational implications, in order to maximise their potential impact on health policy.
Expected results
With this guide, the HAS will set out a methodology for assessing the organisational impact of digital medical devices. In doing so, it will address a need expressed by manufacturers and help to lend greater validity to their arguments.
For SMATCH, this collaboration with the HAS, this guide and its recommendations will represent a major achievement and a significant contribution to health policies, fully in line with its objectives under the Digital Health Strategic Plan (PEPR Santé Numérique).
Stratégie IA et données de santé
Statistical and AI based Methods for Advanced Clinical Trial CHallenges in Digital Health | ANR
PEPR Santé numérique – (PEPR-SanteNum)
Plateforme méthodologique EUCLID :: Département DSP