Consultation for use of AI in medical devices

As more and more medical devices are assessed in France, and their technology advances, use of artificial intelligence (AI) is becoming prevalent, along with questions on how to reimburse such products.

The Haute Autorité de Santé (Health Authority – HAS) has announced its intention to establish evaluation criteria for products using connective and AI technology. Its current version is available for consultation until 15th January 2020.

HAS said:

“To conduct its evaluations, the CNEDiMTS uses the data provided by industry. In order to guide them in the constitution of their files, it provides them with several documents drawn up by the commission and which can be consulted on the HAS website, and in particular a guide for filing files.

“Today, this guide is enriched with a project for a new part dedicated to medical devices with one or more self-learning algorithm (s). In the form of a grid, this project scans 36 items covering 8 key areas, such as the algorithm learning process, the data involved in this learning or those that are involved in the decision of the medical device.”

Translated by Google Translate

Find the consultation documents and take part here.

See the consultation in our tracker here.

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Published on 25. November 2019 in News, News France