Experiment to measure the budget impact of digital medical devices launched in France

On March 24, 2023, the French National Authority for Health (HAS) announced a three-year experiment on the health economic evaluation of digital medical devices (DMD).

This experiment should make it possible to evaluate the budget impact (changes in the distribution of Social Insurance expenses, quantifying future savings) of DMDs.

Manufacturers claiming levels of added clinical value (ASA) ranging from major (I) to minor (IV) and an impact on the organization of care can voluntarily accompany their request for registration or renewal of registration of their DMD on the list of reimbursable products and services (LPPR) with a budget impact analysis.

This will allow manufacturers to provide the Economic Committee on Health Products (CEPS) with a budget impact analysis, validated by the HAS Economic and Public Health Evaluation Commission (CEESP), to present savings generated to the healthcare system to define the fairest possible pricing of their innovation.

See the details in French here.

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