The taskforce “Use of real-world data in decision making” presents its recommendations! Set up as part of the Strategic Contract for the Healthcare Industry and Health Technologies sectors, which was signed on 04 February 2019, the taskforce “Use of real-world data in decision making” presents now its recommendations. Co-led by Laurie Lévy-Bachelot...Read more
The “Artificial Intelligence & Health” program of the Strategic Contract for the Healthcare Industry and Health Technologies sectors (CST-ITS) includes two Task Forces (TF) for all stakeholders in the healthcare sector and government organizations to work together. They deal with cross-functional fundamental issues to implement and support in the best possible conditions the ecosystem that is most favorable to the development of the use of health data in France.
These two TF were set up as part of the Contract for the Healthcare Industry and Health Technologies sectors (CSF-ITS) which was signed on 04 February 2019.
TF1: Shared data valorization and economic model of the Health Data Hub
Background & objectives
The National Health Data System (SNDS) managed by the Health Data Hub is governed by the law of 24 July 2019 on the organization and transformation of the healthcare system. Article 41 of the law broadens the scope of the data included in the SNDS and provides for the setting up of a new governance with the creation of the Health Data Hub.
As part of the “AI & Health” Program, digital health companies and public authorities were asked to coordinate their positions on shared data valorization and the economic model of the Health Data Hub. In this context, a Taskforce (TF 1) was set up to make recommendations for an economic model for the provision of health data from the broadened SNDS.
This TF is co-led by Philippe Maugendre (Sanofi) and Frédérique Debroucker (Medtronic). About twenty stakeholders of the health ecosystem were involved, including digital health companies, startups, academic research organizations, healthcare professionals and facilities as well as public and regulatory authorities that are heavily engaged in this dialogue.
The analysis of the TF is particularly based on the expertise and experience of its members, examples of French and international public or private databases and some articles about economic models of databases.
The following roadmap was thus implemented:
- January 2020: Finalization of the recommendations by the taskforce
- 11 February 2020: Sharing of the recommendations with the Health Data Hub and the Department of research, studies, assessments and statistics (DREES)
- September 2020: Coordination with the DREES for the implementation of the recommendations according to regulatory publications (decrees, orders)
TF2: Use of real-world data in decision making
Background & objectives
Real-world data are key to the health system transformation. The main issue is to create the conditions for all stakeholders to generate evidence-based results to support decision making. It is therefore essential to:
- Be in line with objectives, methods and practices
- Identify common priorities and purposes concerning the use of real-world data
This taskforce is co-led by representatives of ARIIS with Laurie Lévy-Bachelot (MSD) and Luca Mollo (Pfizer) and a representative of the National Union of the Medical Technology Industry (SNITEM) with Anne Josseran (Resmed). About thirty stakeholders of the health ecosystem were involved, including digital health companies, startups, academic research organizations, patient organizations, healthcare professionals and facilities as well as public and regulatory authorities that are heavily engaged in this dialogue.
The aim of this taskforce is to implement:
- A guidance tool on the types of information sources: the objective of this tool is to guide stakeholders in the healthcare sector to relevant data types and sources to encourage knowledge-sharing between them and accelerate the learning curve of new entrants. This tool is part of a broader task carried out by the Ministry for Research and AVIESAN on database quality and identification in France.
- A guide to discovering algorithms in healthcare: the objective is to map and describe the various families of algorithms in healthcare to provide healthcare stakeholders with keys to data interpretation and build mutual understanding. This educative guide will help improve the quality of the methods applied to health data.
The development of deliverables helped achieve a consensus on areas for improvement to which all members of the healthcare sector must commit. In fact, three key issues bring together all stakeholders: data quality, method quality and data availability. These areas of consensus were addressed in a list of recommendations that was presented to the TF members on 02 September 2020.