Artificial Intelligence and Healthcare Regulatory and Legal Concerns

We are in a stage of transition as artificial intelligence (AI) is increasingly being used healthcare across the world. Transitions offer opportunities compounded with difficulties. It universally accepted that regulations and law can never keep up exponential growth technology. This paper discusses liability issues when AI deployed healthcare. Ever-changing, futuristic, user friendly, uncomplicated regulatory requirements promoting compliance adherence needed. Regulators have to understand software itself could be medical device (SaMD). Benefits delayed if slow, expensive clinical trials mandated. Regulations should distinguish between diagnostic errors, malfunction technology, or errors due initial use inaccurate/inappropriate data training sets. The sharing responsibility accountability implementation an AI-based recommendation causes problems not clear. Legislation necessary allow apportionment damages consequent AI-enabled system. Product ascribed defective equipment devices. However, Watson, supercomputer, treated consulting physician categorised product. In India, algorithms cannot patented. There no specific laws enacted deal DISHA Digital Information Security Healthcare Act implemented India would hopefully cover some issues. Ultimately, interpreted contextually perceptions different among patients, clinicians legal communication create awareness all stakeholders.