Gaps in the Global Regulatory Frameworks for the Use of Artificial Intelligence (AI) in the Healthcare Services Sector and Key Recommendations.

ABSTRACT

Artificial Intelligence (AI) has shown remarkable potential to revolutionise healthcare by enhancing diagnostics, improving treatment outcomes, and streamlining administrative processes. In the global regulatory landscape, several countries are working on regulating AI in healthcare. There are five key regulatory issues that need to be addressed (i) data security and protection-measures to cover the "digital health footprints" left unknowingly by patients when they access AI in health services; (ii) data quality-availability of safe and secure data and more open database sources for AI, algorithms, and datasets to ensure equity and prevent demographic bias; (iii) validation of algorithms-mapping of the explainability and causability of the AI system; (iv) accountability-whether this lies with the healthcare professional, healthcare organisation, or the personified AI algorithm; (v) ethics and equitable access-whether fundamental rights of people are met in an ethical manner. Policymakers may need to consider the entire life cycle of AI in healthcare services and the databases that were used for the training of the AI system, along with requirements for their risk assessments to be publicly accessible for effective regulatory oversight. AI services that enhance their functionality over time need to undergo repeated algorithmic impact assessment and must also demonstrate real-time performance. Harmonising regulatory frameworks at the international level would help to resolve cross-border issues of AI in healthcare services.