Edward Cash
The automating mundane processes, lowering healthcare costs, increasing access to healthcare delivery, better identifying patient requirements, and supporting doctors in their decision-making, the application of Artificial Intelligence (AI) has the potential to transform the healthcare system. Governments and health authorities must control AI and conduct adequate Health Technology Assessments for these advantages to emerge (HTA). The challenge posed by AI Health Technologies (AIHT) to conventional regulatory and review systems has been emphasised by numerous authors. We conducted a thorough evaluation of the literature on the difficulties presented by AIHTs in HTA and health regulation in order to inform and assist HTA organisations and regulators in adjusting their processes to AIHTs. Five dimensions are used to express this exceptionalism: 1) The unique characteristics of AIHT; 2) Their systemic effects on healthcare and the health sector; 3) The elevated expectations for AI in health; 4) The new ethical, social, and legal challenges that result from implementing AI in the health sector; and 5) The new evaluative constraints that AI poses to HTA. As a result, due to their technological features and possible effects on society as a whole, AIHTs are thought to be extraordinary. There are compelling arguments in favour of taking into account the exceptional features of AIHTs, particularly given that their effects on the healthcare system will be much greater than those of drugs and medical devices, as the implementation of AI by governments and health organisations carries the risk of creating new challenges and amplifying those already present. There is a window of opportunity for HTA agencies and scholars to evaluate AIHTs' exceptionalism and to strive towards exclusively deploying clinically, economically, and socially acceptable AIHTs in the healthcare system when AIHTs start to be more widely used.