Towards a framework for evaluating the safety, acceptability and efficacy of AI systems for health: an initial synthesis

The potential presented by Artificial Intelligence (AI) for healthcare has long been recognised by the technical community. More recently, this potential has been recognised by policymakers, resulting in considerable public and private investment in the development of AI for healthcare across the globe. Despite this, excepting limited success stories, real-world implementation of AI systems into front-line healthcare has been limited. There are numerous reasons for this, but a main contributory factor is the lack of internationally accepted, or formalised, regulatory standards to assess AI safety and impact and effectiveness. This is a well-recognised problem with numerous ongoing research and policy projects to overcome it. Our intention here is to contribute to this problem-solving effort by seeking to set out a minimally viable framework for evaluating the safety, acceptability and efficacy of AI systems for healthcare. We do this by conducting a systematic search across Scopus, PubMed and Google Scholar to identify all the relevant literature published between January 1970 and November 2020 related to the evaluation of: output performance; efficacy; and real-world use of AI systems, and synthesising the key themes according to the stages of evaluation: pre-clinical (theoretical phase); exploratory phase; definitive phase; and post-market surveillance phase (monitoring). The result is a framework to guide AI system developers, policymakers, and regulators through a sufficient evaluation of an AI system designed for use in healthcare.

From What to How. An Overview of AI Ethics Tools, Methods and Research to Translate Principles into Practices

The debate about the ethical implications of Artificial Intelligence dates from the 1960s. However, in recent years symbolic AI has been complemented and sometimes replaced by Neural Networks and Machine Learning techniques. This has vastly increased its potential utility and impact on society, with the consequence that the ethical debate has gone mainstream. Such debate has primarily focused on principles - the what of AI ethics - rather than on practices, the how. Awareness of the potential issues is increasing at a fast rate, but the AI community's ability to take action to mitigate the associated risks is still at its infancy. Therefore, our intention in presenting this research is to contribute to closing the gap between principles and practices by constructing a typology that may help practically-minded developers apply ethics at each stage of the pipeline, and to signal to researchers where further work is needed. The focus is exclusively on Machine Learning, but it is hoped that the results of this research may be easily applicable to other branches of AI. The article outlines the research method for creating this typology, the initial findings, and provides a summary of future research needs.