Introduction:
Many small and large companies are working to gain an early lead in the growing use of Artificial Intelligence (AI) in India. Microsoft and Appollo Hospitals have announced a partnership for developing AI to early detect cardiac diseases. Moreover, the state government of Karnataka also announced that it will invest Rs. 40 crore to develop AI and Data Science. [1]
However, greater investment by existing players and, the entry of new players in the sector can only be incentivized through a robust and stable regulatory framework for these players to operate in.
Lack of Framework
The government though formed high-powered “Task Force on Artificial Intelligence” to explore how AI could be leveraged for India’s economic development across different sectors, it did not include any medico-legal expert to address the issues of law that are likely to arise with the integration of healthcare and AI.
- Doctors can be held liable for a breach of their duty of care and there have been instances of civil as well as criminal penalties being imposed in the existing laws. Where the liability arises solely due to an error attributable to the AI tool used by the doctors, it is unclear as to how the courts will decide the matter. Where the AI technology is faulty, who would be liable – the technology developer or the medical professional using such technology or both? What principle of liability would be applied in such a case – strict or absolute? It is imperative that these questions are definitively answered in order for the use of AI to scale.
- If the data entered at the primary level, on the basis of which recommendations are further given, is incorrect. As a result of this, the recommendations will be incorrect but the liability, in this case, is non-determinable.
- The tort law system holds these medical professionals liable in case of negligence on the basis of “foreseeability”. This principle will cease to exist with AI. Thus, establishing liability will become problematic.
- The use of AI in healthcare will also bring a change in the existing labor laws. This would happen as now “the definition of workmen” might have to include IT engineers, developers, managers, and trainers of Artificial Intelligence.
- The Intellectual Property Rights law will also have a significant impact. As of now, algorithms are not patentable as per section 3 (k) of India’s Patent Act. Copyright of such algorithms has to be done as per the existing law. AI uses a large set of data collected from the public and analyses such collected data to give recommendations and suggestions as the result. The reusability of the same set of data by other service providers of AI will be considered as an infringement of copyright by the developer or not is unclear.
- Data Privacy- The use of AI in healthcare involves a continual exchange and processing of data (often sensitive personal data or information) between the medical professional, patient, and the AI tool. There is no method to ensure the consent of the patient and the liability when it is not taken. The existing laws of the Information Technology Act, 2000 though allow the use of Artificial Intelligence does not stipulate rules with regards the same. The government is planning to introduce the Personal Data Protection Bill; hopefully, it will be able to address the raising privacy concerns arising out of the use of AI.
Conclusion
A study conducted by Nature Medicine utilized 101.6 million data points from electronic health records of over 1.36 million pediatric patients and demonstrated that artificial intelligence (AI) based models can have higher diagnostic accuracy than some doctors. It is important that governmental and regulatory bodies establish structures to monitor key issues and react in a responsible manner and establish governance mechanisms to limit the negative implications of the use of Artificial Intelligence.
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