Bélisle-Pipon Jean-Christophe, Couture Vincent, Roy Marie-Christine, Ganache Isabelle, Goetghebeur Mireille, Cohen I Glenn
Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada.
Faculty of Nursing, Laval University, Quebec, QC, Canada.
Front Artif Intell. 2021 Nov 2;4:736697. doi: 10.3389/frai.2021.736697. eCollection 2021.
The application of artificial intelligence (AI) may revolutionize the healthcare system, leading to enhance efficiency by automatizing routine tasks and decreasing health-related costs, broadening access to healthcare delivery, targeting more precisely patient needs, and assisting clinicians in their decision-making. For these benefits to materialize, governments and health authorities must regulate AI, and conduct appropriate health technology assessment (HTA). Many authors have highlighted that AI health technologies (AIHT) challenge traditional evaluation and regulatory processes. To inform and support HTA organizations and regulators in adapting their processes to AIHTs, we conducted a systematic review of the literature on the challenges posed by AIHTs in HTA and health regulation. Our research question was: What makes artificial intelligence exceptional in HTA? The current body of literature appears to portray AIHTs as being exceptional to HTA. This exceptionalism is expressed along 5 dimensions: 1) AIHT's distinctive features; 2) their systemic impacts on health care and the health sector; 3) the increased expectations towards AI in health; 4) the new ethical, social and legal challenges that arise from deploying AI in the health sector; and 5) the new evaluative constraints that AI poses to HTA. Thus, AIHTs are perceived as exceptional because of their technological characteristics potential impacts on society at large. As AI implementation by governments and health organizations carries risks of generating new, and amplifying existing, challenges, there are strong arguments for taking into consideration the exceptional aspects of AIHTs, especially as their impacts on the healthcare system will be far greater than that of drugs and medical devices. As AIHTs begin to be increasingly introduced into the health care sector, there is a window of opportunity for HTA agencies and scholars to consider AIHTs' exceptionalism and to work towards only deploying clinically, economically, socially acceptable AIHTs in the health care system.
人工智能（AI）的应用可能会给医疗系统带来变革，通过将日常任务自动化和降低与健康相关的成本来提高效率，扩大医疗服务的可及性，更精准地满足患者需求，并协助临床医生进行决策。为了实现这些益处，政府和卫生当局必须对人工智能进行监管，并开展适当的卫生技术评估（HTA）。许多作者都强调，人工智能健康技术（AIHT）对传统评估和监管流程构成了挑战。为了为HTA组织和监管机构提供信息并支持他们使流程适应AIHT，我们对关于AIHT在HTA和卫生监管中所带来挑战的文献进行了系统综述。我们的研究问题是：在HTA中，是什么让人工智能与众不同？当前的文献似乎将AIHT描绘为在HTA中具有特殊性。这种特殊性体现在五个方面：1）AIHT的独特特征；2）它们对医疗保健和卫生部门的系统性影响；3）对健康领域人工智能的期望增加；4）在卫生部门部署人工智能所引发的新的伦理、社会和法律挑战；5）人工智能给HTA带来的新的评估限制。因此，AIHT因其技术特性以及对整个社会的潜在影响而被视为特殊。由于政府和卫生组织实施人工智能存在产生新挑战并放大现有挑战的风险，所以有充分理由考虑AIHT的特殊方面，特别是因为它们对医疗系统的影响将远大于药物和医疗设备。随着AIHT开始越来越多地被引入医疗保健领域，HTA机构和学者有一个机会窗口来考虑AIHT的特殊性，并努力仅在医疗系统中部署临床、经济、社会可接受的AIHT。
