KEYWORDS: artificial intelligence, AI, deep learning, digital health, healthcare, health-tech, machine learning, medical device, policy, regulation, SaMD, software as a medical device
As AI technology steadily advances and is more widely used in healthcare, regulators, healthcare professionals, and patients must be aware of and prepare for the resulting potential changes to the healthcare landscape and practice. While such technologies hold much promise of improving healthcare and offer novel solutions to existing and anticipated challenges, they also raise questions of safety, effectiveness, ethics, and governance that have yet to be fully explored and resolved.
This paper recognises that National Regulatory Authorities (NRAs) are a key element in the healthcare technology ‘ecosystem’, and thus seeks to inform regulators about the latest technological and regulatory developments of AI. It also aims to inform AI developers of the regulatory concerns they should be cognisant of while designing their products.
Authors
Ms Micaela Leong Hui Jin
A/Prof Silke Vogel
Dr Nokuthula Kitikiti
Mr Ananda P Muthalagu
With Contributions From
Prof John CW Lim
Mr Michael Gropp