INTEGRATING AI INTO HEALTHCARE PRACTICES: A LEGAL PERSPECTIVE

Learn the legal challenges for AI adoption in healthcare: across medical devices, negligence, and data protection.

- Ada Shaharbanu and Dhruvo Das

AI has revolutionized the healthcare industry in the last few years. As per the reports, the global AI in healthcare market is expected to reach $187.95 billion in the next six years. AI applications are increasingly being used for early detection and diagnosis of diseases, remote monitoring and diagnosis of patients, undertaking administrative tasks, making treatment decisions based on predictive analysis, and research and drug discovery.

In India, state governments have adopted AI-enabled applications to improve healthcare. For instance, in 2020, the Karnataka government launched AI driven pods for containing contagious diseases such as COVID-19. This article discusses some of the key legal issues that arise from the use of AI in the healthcare sector.

CLASSIFICATION AS A MEDICAL DEVICE

Since AI-driven software is equipped with algorithms designed to constantly learn from real-world applications, its recent use has increased significantly. Depending on the intended purposes for use, such software may qualify as a ‘medical device’ under Indian law, attracting registration and compliance requirements. For instance, if the software is intended to be used for diagnosis, prevention, monitoring, treatment, or alleviation of a disease, disorder, injury, or disability, or for the investigation, replacement or modification or support of the anatomy or of a physiological process, the underlying software may qualify as a medical device.