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Legal System and Implementation of Artificial Intelligence into Healthcare




Abstract



Although artificial intelligence has become a prominent part of today’s world, it is still in its infancy in healthcare in India. Robotic surgical devices are currently acting as the main driver of emerging technologies for performing surgical procedures. Healthcare is constantly encountering new conditions and evolving it’s therapeutic gradually. However, it comes with risks and atrocious repercussions that may possibly take away life than saving a life. In India, the Supreme Court held that the protection of life is a fundamental right under Article 21 of the Indian Constitution. The same government also granted permission for the usage of robotic devices prone to malfunctioning and involvement of illegal procurement of these devices in surgical methods. Obliquely, the government has violated the patient's right to protection by not implementing mandatory laws to regulate the mishaps of robotic devices. Individuals are so dependent on technology in the present scenario that it has become an integral part of their judgement. Similarly, few surgeons are dependent on robotic devices that impel critical misjudgement endangering the patient’s life. Furthermore, this article includes relevant case laws supporting these arguments and suggestions to resolve the raised issues.



1. Introduction:



Surgery is a medical specialty that revolves around treating various maladies with invasive procedures. As technological innovation is taking over all disciplines, lately with the development of digital imaging technology, ultrasounds, and electrosurgical units combined with optical engineering, robotics made its way into the health sector. Robotic-assisted surgery known for its minimally invasive method has irrevocably changed the surgical treatment of various diseases significantly. Artificial intelligence-powered analytics can potentially identify certain ailments rapidly than a doctor, however it fails to make a safe decision making.


While the benefits of robotic surgery outshine the deterrent effects, it has paved the way for some undesirable events. In a report, Challen et al argue that robotic units are able to take corrective measures when a mistake is made with or without human intervention. On the other hand, during a surgical procedure, a single mistake by these robotic devices will have a direct effect on the safety of the patient. At this point a question arises as to who is accountable for such mishaps, will it be considered as medical negligence or ignored due to malfunction of the robotic device.

The fourth-generation industrial revolution, first coined by Klaus Schwab[1] became a model of economic acceleration. Schwab believed that technological advancement can alter the operations undertaken by the companies and the government for economic growth. While Artificial intelligence is apt from an economic point of view, absolute reliability on it is still criticized for safety reasons in healthcare. As far as diagnostic tools are concerned, technology implementation is encouraged. However, few factors like malfunction of the robotic device, illegality in the procurement of these devices, and extreme dependency of healthcare professionals on these devices can cause one’s life. While the government has allowed the use of such devices, it has not implemented any laws to regulate the procurement and usage of these devices. This leads to questioning the reliability of the legal decisions for overlooking the subsequent consequences of introducing artificial intelligence in healthcare.

1.1 Research problem:


Technological development has influenced the government to an extent that it has failed to scrutinize the possible deterioration these advancements can cause in healthcare. Article 21 of the Indian Constitution guarantees protection of life but with the advancement of robotic surgery in healthcare. However the legal system did not implement any strict laws to control the mishaps of applying artificial intelligence into surgical procedures, which can potentially cause threat to life.



1.2 Scope and Limitation:


This critique draws attention to the reliability of robotic devices used in surgical procedures. Relevant arguments are used to arraign the non-authentic usage of robotic devices. It further scrutinizes the tendency of surgeons to depend on artificial intelligence leading to appalling consequences. However, the case laws are limited to Indian case laws and related to the health sector.



1.3 Methodology:


Artificial intelligence is budding over the past decade and is a new discipline to the current literature. This article incorporates exploratory design and descriptive design to explore the possible outcomes by the introduction of latest technology into traditional medical practice and further building up the argument with supportive case laws. Additionally, this paper follows the doctrinal research method as the data has been collected from primary (legal documents) and secondary sources (credible websites and periodicals).



2. Data Analysis:

2.1 Malfunction of the Robotic Device while Performing a Surgery:

The US Food and Drug Administration reported a hundred and forty-four deaths associated with robot-assisted surgery, a thousand three hundred and ninety-one injuries, and eight thousand and sixty-one cases of device malfunctions. Additionally, Rush University Medical Center and the University of Illinois also reported two deaths and fifty-two injuries that were caused when the mechanical surgeon either spontaneously powered down mid-operation or made an incorrect movement. Overall, ten and a half percent of cases recorded malfunctions like electrical sparks which burned patients, resulting in a hundred and ninety-three injuries.[2] India being a developing country has recently adopted the implementation of technological advancement in healthcare. However, these innovations are not well regulated as seen in the case, Kumar Mohammed Rafique V. Municipal Corporation[3] of Greater Bombay, malfunctioning of an artificial device ultimately cost the life of an eleven-year-old victim. The victim namely Mohamed Rafiq Haji Umar fell off a bus and was semi-conscious while taken to the hospital. The victim was reported having a condition called hematoma and was operated at the Bombay Hospital by inserting a Ventriculoatrial Shunt that is placed to enable the flow of cerebrospinal fluid to the atrium of the heart from the cerebral ventricular system.[4] This shunt device was reported of being repaired twice earlier and still, the hospital continued using it. The failure of this shunt caused hydrocephalus to raise the intracranial tension resulting in loss of life.[5] Article 21 which provided for protection of life has obliquely been violated as the government was negligent in ceasing a device that had a potential risk of malfunctioning. Failure to evaluate these medical robotic devices assisting in surgical procedures can claim many innocent lives. The government must implement strict laws to assess the functioning of artificial robotic devices. Introducing such laws will also enable the hospitals to keep a check on the robotic devices regularly.


2.2 Illegality in the Procurement of Artificial Intelligence:

Medical devices are very crucial as their malfunctioning can cause injury to the patient. The indispensable reason for causing such malfunctioning of robotic devices is impaired regulation in the procurement of medical devices. However, in India, the manufacture, sale, and distribution of these medical devices are secured and regulated under the provision of the Drug and Cosmetic Act of the 1940 & Rules 1945.[6] There are only fifteen devices that are regulated under the government, while other devices can be imported from a firm and an enterprise.

In the case, Sanjay Shyamsundar Sharma vs State of Gujarat,[7] the applicant filed against the illegalities and irregularities in the procurement of the "Robotic Assistant Surgery Instrument" at Civil Hospital, Ahmedabad. Sanjay also requested the court to undertake the necessary procedure for replacing the instrument in question to enable the general public at large to have the benefits of the modernized instrument for knee and hip replacement surgery. Advocate Mr. Majmudar referred to various documents related to the case and revealed that public money of eleven crores rupees has been spent in biding the instrument. In spite of the purchase of such a costly instrument, only three surgeries were performed during the period of 6 to 7 years. Therefore, the instrument was presented before the Additional Director of Medical Education and Research for examining the device. Since it did not belong to any particular brand of equipment, the instrument was discontinued. This is one case where such an incident was brought to notice, many people may overlook these facts when they lose their loved ones, believing it was due to the severity of the patient’s condition. The government should mandate the hospitals to inform not only the procedure of the surgery but also the authenticity of the devices used in the surgery to ensure more safety measures.


2.3 Extreme Dependency on Robotic Surgery:


Today’s world is so dependent on technology that they entrust artificial intelligence more than their own intelligence. Artificial has no doubt increased the efficiency and accuracy of the diagnosis, however that should not take over the judgement of the surgeon while performing surgery. Some experts have opined that artificial intelligence will augment the role of physicians.[8] Here is an instance of extreme dependency on robotic surgery that cost a life. In the case, Prem Kishore vs Union Of India And Ors,[9] Urmila Devi underwent "Robotic Ureterolysis", a surgery performed for removing the fibroid in the ureter in Shri Ganga Ram Hospital. The petitioner claimed that while operating the patient, the doctor erroneously cut the external iliac artery, and instead of addressing the same immediately, the concerned doctors put the hemoclips & suture on it and further continued with the Robotic surgery for another three hours. It is claimed that due to the aforesaid act of the concerned doctors, the petitioner‟s wife suffered heavy blood loss, which resulted in acute kidney failure. The patient suffered two cardiac arrests but she was revived. Thereafter, she suffered a third cardiac arrest after thirty minutes and was declared dead. The extreme dependency on robotic surgery led to the error of judgment on the part of the surgeon as he converted to open surgery at a later stage during the operation which led to excessive blood loss and eventually cardiac arrest. This is a medical negligence case that could have been prevented by the implementation of strict laws that mandates training the doctors and licensing them to perform surgeries including robotic devices.



3. Suggestion:


The legal body has to set a standardized law to evaluate these robotic devices from time to time by an appointed government official. To prevent the illegality in the procurement of the robotic surgical devices, the government can take up an initiative by creating an online portal to check if the device brand has been registered under the government. This also establishes transparency and disciplinary procurement. Artificial intelligence developments are still in their infancy and the legal bodies should partially restrict the usage of robotic devices in healthcare. There must be a law that allows only experienced doctors who are well-trained to use these advanced devices in the surgical procedure by the supervision of the Medical Council of India. The government must look into introducing a new licensing exam to qualify surgeons to use these complex devices. This can filter out the accomplished certified doctors in order to prevent loss of life due to extreme dependency on robotic devices.

4. Conclusion:


The government must realize that along with economic growth in the aegis of artificial intelligence advancement, it also has to ensure the protection of life provided under Article 21 of the Constitution, especially under healthcare. With all the innovations, traditional surgical methods must not be controlled by robotic devices that can pose a vulnerability in critical situations. The government has the ability to deploy new technological aspects into relevant disciplines. However, with great decisions comes great responsibilities. The primary responsibility of the government is the safety of its people.

Transparency of government in the procurement of the surgical devices along with the transparency of firm handling in the manufacturing of these devices is necessary to establish trust among the clinicians and the patients. As seen in the cases resulting in loss of life due to malfunctioning of robotic devices which may be due to illegality in the procurement of these devices - the government should take up steps to stop these negligent acts. Therefore, it is the duty of the government to list out the possible atrocious repercussions brought by the introduction of artificial intelligence as it is evidenced to have an equal threat to life. The legal entity must ensure implementation of regulatory laws to demonstrate its reliability and retain the trust bestowed on the government. Therefore, the usage of artificial intelligence must not increase health inequality, rather should be adopted for social benefit ensuring all safety measures.



References



Ahuja A. S. (2019). The impact of artificial intelligence in medicine on the future role of the physician. PeerJ, 7, e7702. https://doi.org/10.7717/peerj.7702


Clinical Development Service Agency contributors. FAQs for medical devices regulations. Clinical Development Services Agency. From https://thsti.res.in/cdsa/faqs-for-medical-devices-regulations/#menu


Hankinson, T. C. (2020, March 23). Ventriculoatrial Shunt Placement. E-Medicine. From https://emedicine.medscape.com/article/1895753-overview#:~:text=Background,conditions%20encountered%20in%20neurosurgical%20practice.


Kumar Mohammed Rafique V. Municipal Corporation. (14.08.1985 - BOMHC)


Prem Kishore vs Union Of India And Ors. (29.04.2019 - DELHC)


Sanjay Shyamsundar Sharma vs State of Gujarat. (26.12.2017 - GUJHC)


Schulze, E., Everything you need to know about the Fourth Industrial Revolution, CNBC (January 17, 2019) https://www.cnbc.com/2019/01/16/fourth-industrial-revolution-explained-davos-2019.html


Thomson, I. (2015, July 21). Robot surgeons kill 144 patients, hurt 1,391, malfunction 8,061 times. The Register. From https://www.theregister.co.uk/2015/07/21/robot_surgery_kills_americans/

End notes:


[1] https://www.cnbc.com/2019/01/16/fourth-industrial-revolution-explained-davos-2019.html Accessed on 01 June, 2020

[2] https://www.theregister.co.uk/2015/07/21/robot_surgery_kills_americans/ Accessed on 16 april, 2020

[3] https://indiankanoon.org/doc/1154351/ Accessed on 18 april, 2020

[4]https://emedicine.medscape.com/article/1895753-overview#:~:text=Background,conditions%20encountered%20in%20neurosurgical%20practice. Accessed on 23 april, 2020

[5] Ibid

[6] https://thsti.res.in/cdsa/faqs-for-medical-devices-regulations/ Accessed on 28 April, 2020

[7] https://www.casemine.com/judgement/in/5a9548f84a93260d852ce7c1 Accessed on 06 May, 2020

[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6779111/ Accessed on 12 May, 2020

[9] https://indiankanoon.org/doc/82071084/ Accessed on 18 May, 2020



Author: Moulya Reddy (Student, ISBR Law College affiliated to Karnataka State Law University)

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