AI is creating an impact in every field it touches. The Healthcare sector across the world advanced with the intervention of AI. Technology aids in predicting health risks and events, enables drug development, supports the personalization of care management and much more. 

According to a report by Allied Market Research, AI in the healthcare market was valued at $8.23 billion in 2020 and is projected to reach $194.4 billion by 2030. Furthermore, it is growing at a CAGR of 38.1% from 2021 to 2030. AI is used in healthcare to research the connection between treatment techniques and patient outcomes.  

However, the World Health Organization has put forward certain concerns AI may perpetuate if left unchecked. It might undermine the quality of health and social care that older people receive. The data can be unrepresentative of older people by past ageist stereotypes, prejudice or discrimination. 

Apart from the concerns put forward by the WHO, there are some internal technical factors that must be taken into consideration by health professionals and technicians. For instance, doctors and technicians largely depend on machines for generating patient data. As a result, there is an uncertainty in the determination of liability when AI-induced machines and technologies commit errors which might result in radical miscalculation in analysis.  

Role of AIMD 

With developments in technology, AIMD can help predict, diagnose and manage the well-being of a patient. In addition, this innovation can aid in simulating cognitive human intelligence and can save a number of applications across the healthcare industry. 

However, it is significant to first study the functioning of AI in the medical field and the machine errors it commits. Any such errors or miscalculations ought to be readdressed by having a framework to determine legal accountability.

Legal recognition 

In India, AIMD has been recognized through the Medical Devices Rules 2017, which identifies ‘software’ as a medical device by expanding the scope of the definition of the drug under the Drugs and Cosmetics Act, 1940. In addition, an amendment was brought to the Rules in 2020 by which all medical devices, excluding 37 specific categories such as nebulizers, BP monitoring devices, CT scan equipment etc., are registered with the Central Licensing Authority.  

Various tests are positioned in the form of registration, and a certificate board would check the efficiency of the devices. However, the obligation for medical devices manufactured or imported in India is on the importer or manufacturer of the device. 

The registration and certificate procedure under the Medical Devices Rules 2017 do not ensure the permanent safety of those devices. It rather lays down a grievance redressal mechanism through which malfunctions or complaints can be tackled.  

Medical malpractice claims 

Medical malpractice claims are legal claims made by or on behalf of a patient when a case of medical negligence transpires. However, this lacks any provision to address the claims when AI is involved.  

‘Black box algorithms’, also known as the model of the device, is present in all AI medical devices, including the ones that require human efforts to perform. It does not include inputs or outputs but is known for its probability-based results as the only logic behind the model. Here, the processing that takes place within the device is hidden even from its builder, making it nearly impossible to trace the source of any mistake that occurs. 

According to experts, the efficiency and safety of an AIMD can only be observed by randomized clinical trials showing positive results. Such results would be compared to human-made results to test the accuracy.  

When people across the world are reaping the benefits of AI in healthcare, it is important to understand its limitations.