Highlights
- •Challenges: Data governance, algorithm robustness, stakeholder consensus and legal liability.
- •General Data Privacy Regulation has been published to ensure high quality of data governance.
- •Model transparency, robustness and fairness are important for AI development to increase trust.
- •WHO and FDA published ethical AI technology regulatory framework to ensure safety of the AI system.
Abstract
Keywords
Introduction

Data governance
Véliz C. Wellcome Trust–Funded Monographs and Book Chapters. Medical privacy and big data: A further reason in favour of public universal healthcare coverage. In: de Campos TC, Herring J, Phillips AM, editors. Philosophical Foundations of Medical Law. Oxford (UK): Oxford University Press © Carissa Véliz 2019.; 2019.
Algorithm robustness
Stakeholder consensus
- Kortesniemi M.
- Tsapaki V.
- Trianni A.
- Russo P.
- Maas A.
- Källman H.-E.
- et al.
Legal liability
Current guidelines for ethical AI development
FDA. Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback. Available at: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device. Accessed at Dec 01, 2021.
- (i)Humans should have autonomy over the system and intervention is possible to monitor the decisions made by the system;
- (ii)Robust and reliable algorithm. The AI system should be able to withstand adversarial attacks;
- (iii)Ensuring data privacy and good governance;
- (iv)Model transparency. The data and algorithms used to create an AI system should be transparent, and the decisions made by the systems are justifiable.
- (v)Fair output and results, in which all decisions made by an AI system must be diverse and not biased;
- (vi)Environmentally sustainable, where the output must take ecological and societal well-being into account to enhance positive social change; and,
- (vii)Model accountability, in which AI systems should be auditable.
Conclusion
Funding
Declaration of Competing Interest
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