Software as a Medical Device: Regulating AI in Healthcare via Responsible AI

Abstract

With the increased adoption of AI in healthcare, there is a growing recognition and demand to regulate AI in healthcare to avoid potential harm and unfair bias against vulnerable populations. Around a hundred governmental bodies and commissions as well as leaders in the tech sector have proposed principles to create responsible AI systems. However, most of these proposals are short on specifics which has led to charges of ethics washing. In this tutorial we offer a guide to help navigate through complex governmental regulations and explain the various constituent practical elements of a responsible AI system in healthcare in the light of proposed regulations. Additionally, we breakdown and emphasize that the recommendations from regulatory bodies like FDA or the EU are necessary but not sufficient elements of creating a responsible AI system. We elucidate how regulations and guidelines often focus on epistemic concerns to the detriment of practical concerns e.g., requirement for fairness without explicating what fairness constitutes for a use case. FDA's Software as a medical device document and EU's GDPR among other AI governance documents talk about the need for implementing sufficiently good machine learning practices. In this tutorial we elucidate what that would mean from a practical perspective for real world use cases in healthcare throughout the machine learning cycle i.e., Data Management, Data Specification, Feature Engineering, Model Evaluation, Model Specification, Model Explainability, Model Fairness, Reproducibility, checks for data leakage and model leakage. We note that conceptualizing responsible AI as a process rather than an end goal accords well with how AI systems are used in practice. We also discuss how a domain centric stakeholder perspective translates into balancing requirements for multiple competing optimization criteria.