Fondazione Gianni Benzi published a new article on the special issue “Innovation and Healthcare” of the European Journal of Health Law.

The article is focused on Artificial Intelligence (AI), Machine Learning (ML) and Data Science, key areas of interest at the foundation, that are rapidly developing in healthcare, as well as on their translation into laboratory medicine and clinical practise.

The latest advances in the healthcare sector are represented by the growing ability to record massive amounts of health data. This kind of Big Data provides researchers with new tools and perspectives that have a crucial role in the development of novel therapies, early diagnosis, risk prediction and personalised medicine.

In this framework, Fedele Bonifazi, president of Fondazione Benzi, in close collaboration with Elisabetta Volpe, Viviana Giannuzzi, Giuseppe Digregorio, researchers at Fondazione Benzi and Professor Adriana Ceci, recently published the paper “Machine Learning Systems Applied to Health Data and System.

The authors highlight that the use of ML in medicine is becoming increasingly fundamental to analyse complex problems by discovering associations among different types of information and to generate knowledge for medical decision support. However, many regulatory and ethical issues should be considered. The regulatory framework for developing and marketing a new health technology based on ML and deep learning may be quite complex. Furthermore, if on the one hand ML algorithms are greatly helping the decision-making process in healthcare, on the other hand many patients may not feel comfortable with a machine making potentially important decisions on their life.

Some of the ethical and legal concerns could be, at least partially, resolved in case the ML software is classified as a ‘medical device’, because their marketing authorization is supported by a robust regulatory framework designed also to protect the rights of users. Therefore, the challenge is to understand how sustainable is the regulatory system in relation to the ML innovation and how legal procedures should be revised in order to adapt them to the current regulatory framework.

Discover more about this topic by reading the article that you can find here!

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