Functional requirements to mitigate the Risk of Harm to Patients from
Artificial Intelligence in Healthcare
- URL: http://arxiv.org/abs/2309.10424v1
- Date: Tue, 19 Sep 2023 08:37:22 GMT
- Title: Functional requirements to mitigate the Risk of Harm to Patients from
Artificial Intelligence in Healthcare
- Authors: Juan M. Garc\'ia-G\'omez, Vicent Blanes-Selva, Jos\'e Carlos de
Bartolom\'e Cenzano, Jaime Cebolla-Cornejo and Ascensi\'on
Do\~nate-Mart\'inez
- Abstract summary: This study proposes 14 functional requirements that AI systems may implement to reduce the risks associated with their medical purpose.
Our intention here is to provide specific high-level specifications of technical solutions to ensure continuous good performance and use of AI systems to benefit patients in compliance with the future EU regulatory framework.
- Score: 0.0
- License: http://creativecommons.org/licenses/by-nc-sa/4.0/
- Abstract: The Directorate General for Parliamentary Research Services of the European
Parliament has prepared a report to the Members of the European Parliament
where they enumerate seven main risks of Artificial Intelligence (AI) in
medicine and healthcare: patient harm due to AI errors, misuse of medical AI
tools, bias in AI and the perpetuation of existing inequities, lack of
transparency, privacy and security issues, gaps in accountability, and
obstacles in implementation.
In this study, we propose fourteen functional requirements that AI systems
may implement to reduce the risks associated with their medical purpose: AI
passport, User management, Regulation check, Academic use only disclaimer, data
quality assessment, Clinicians double check, Continuous performance evaluation,
Audit trail, Continuous usability test, Review of retrospective/simulated
cases, Bias check, eXplainable AI, Encryption and use of field-tested
libraries, and Semantic interoperability.
Our intention here is to provide specific high-level specifications of
technical solutions to ensure continuous good performance and use of AI systems
to benefit patients in compliance with the future EU regulatory framework.
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