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Abstract

AI can prove to be a valuable tool in healthcare. It can assist in tasks like analysis of medical imaging, data management, drug discovery, and even help in diagnosing diseases. The emergence of AI in recent years has raised the question of using it in the healthcare sector as well, which calls for rules and regulations in order to regulate AI’s application. However, the rapid emergence of AI also comes with various challenges, such as data privacy and security concerns, ethical considerations, and questions of liability and accountability in the event of AI generated errors. Therefore, rules and regulations become necessary to ensure compliance of safe and legal practices in healthcare. As AI continues to redefine healthcare, striking a balance between utilising its potential and ensuring patient safety remains of utmost importance.

Introduction

The healthcare industry is undergoing a transformative shift as Artificial Intelligence (AI) rapidly integrates into its core functions, offering unprecedented tools for diagnosis, treatment, and patient care. There are various advantages of integrating AI into the healthcare such as assistance in clinical decision-making, substantial reduction in human error, diagnosis etc. Moreover, AI has the potential to reach even to the remote areas, making healthcare accessible to all sections of society.

However, there are also various challenges and issues that needs to be addressed before deploying AI into healthcare sector. The rapid emergence of AI into healthcare presents critical issues concerning data privacy and security, ethical considerations related to patient’s consent and transparency, as well as questions regarding the liability and accountability in cases of errors committed by AI. Moreover, there is the concern about loss of employment in healthcare due to introduction of AI in healthcare. This article discusses the significant advantages of AI in healthcare and the various challenges and ethical considerations that need to be addressed before integration of AI into the healthcare sector. It also discusses the emerging legal implications and regulations surrounding AI usage in the healthcare sector.

Advantages in using AI in healthcare

AI is rapidly transforming the healthcare industry in India, bringing unprecedented tools for diagnosis, treatment and patient care. AI expenditure in India is expected to reach $11.78 billion by 2025 and add $1 trillion to India’s economy by 2035, as per a World Economic Forum report. The AI in Healthcare Market is projected to grow from $14.6 Billion in 2023 to $102.7 Billion by 2028[1]. AI has various advantages as well as consequences related to its application in the healthcare sector.

AI can be used for prompt and accurate diagnosis as well as can analyze medical images, such as X-rays, MRIs, and CT scans, with remarkable accuracy, helping healthcare providers detect diseases and conditions at an earlier stage. By integrating technology with health care will ensure quality and prompt clinical decision making such as it can predict patient outcomes and disease progression, allowing for proactive interventions and personalized treatment plans. Further, AI can automate routine administrative tasks, reducing the administrative burden on healthcare professionals and allowing them to focus more on patient care. Due to integration AI in healthcare, there will also be a reduction in human error and more precision. Due to the shortage and unavailability of doctors in various rural and urban or remote areas, AI can prove to be a boon to the healthcare sector by making healthcare available to all the strata of the society effectively and efficiently. While the advantages of AI in healthcare are significant, it’s important to implement these technologies responsibly, addressing data privacy, ethical, and regulatory considerations to ensure that patient well-being and safety remain paramount.

Challenges in utilising AI in healthcare

The rapid advancement of AI technology brings along several challenges such as data privacy and security. World Health Organization’s (WHO) first global report on AI in health titled- ‘Ethics and Governance of artificial intelligence for Health’ cautions against overemphasizing the benefits of AI in the health sector. It points out the risks linked to unethical collection and utilization of health data, patient safety, and biases encoded in algorithms. As mentioned in a news release, the Director-General of WHO, Dr Tedros Adhanom Ghebreyesus, said, “Like all new technology, artificial intelligence holds enormous potential for improving the health of millions of people around the world, but like all technology, it can also be misused and cause harm[2].” Numerous AI systems utilize intricate deep learning models capable of delivering precise outcomes, yet they often lack transparency in elucidating the rationale behind their findings. In healthcare, where human lives are on the line, it’s imperative for both physicians and patients to comprehend the logic behind the recommendations generated by AI. Hence, the usage of AI in healthcare also comes with various challenges and consequences that needs to be addressed before deploying AI.

a. Data Privacy and Security

When deploying AI in healthcare, data privacy and security issues are paramount concerns due to the sensitive and personal nature of medical information. These issues can have far-reaching consequences, and it’s crucial to address them effectively. The increase in cyber related crimes can pose serious threat to the sensitive information provided by the patients to AI as it often require access to patient records and medical history. Maintaining the confidentiality of this information is critical to protect patient privacy. Protecting patient data from unauthorized access, data breaches, and cyberattacks is a significant concern which needs to be addressed before deploying AI in the healthcare sector. Many a times healthcare organisations tie up with third party AI vendors. When working with such vendors, there is a necessity to ensure that these vendors adhere to data privacy and security standards.

b. Ethical considerations in AI driven healthcare

Healthcare providers are entrusted with the life and well- being of a patient. There are various ethical considerations as well to be kept in mind while using AI in healthcare sector. Some patients may have very strong preference for human healthcare providers, and in many cases they may not trust AI for making critical healthcare decisions . A patient’s consent is a must while employing AI in healthcare sector. A patient should be thoroughly informed and explained about the process and application of AI. Transparency in AI algorithms and their decision-making processes is essential to ensure patients and healthcare providers understand the basis for AI-generated recommendations. AI systems can inadvertently perpetuate biases in healthcare if not trained and tested properly. This can lead to disparities in care. Hence, the consequences of AI also needs to be explained to the patients. Ethical considerations should be at the forefront of AI development for healthcare. The decision for using AI or not should lie with the patients and in case the patient does not agree to such application of AI, it cannot be used.

c. Liability and accountability

The prospect of patient harm caused by the decisions made by an artificial intelligence based clinical tool is something to which current practices of accountability and safety worldwide have not yet adjusted. Just like any other diagnostic tool, AI based solutions themselves cannot be held accountable for its decisions and judgments. It is therefore important to have assignment of accountability and responsibility at all stages of development and deployment of AI for health. Determining who is responsible for errors made by AI in healthcare is a complex ethical issue. Patients should have avenues for recourse if AI related errors occur. Legal frameworks need to clarify liability issues, particularly in cases where AI systems are involved in clinical decisions and treatment. Developers and vendors of AI systems used in healthcare may share liability when their systems are involved in clinical decisions or patient care. They have a responsibility to ensure that their AI solutions are safe, effective, and compliant with regulatory standards. Hence, it becomes crucial while deploying AI in healthcare sector, who shall share liability and accountability in case of any error and to what extent.

d. Loss of employment

There is an apprehension that application of AI in healthcare sector would result in huge losses in employment, however, it is pertinent to note that even for operating AI humans are needed. Although AI will make ordinary tasks that were done by humans more quick and easy, it cannot completely replace humans. However, it cannot be denied that emergence of AI in healthcare sector can replace certain healthcare providers involved in tasks that does not require much human intelligence or involvement. It is most likely to be very few in number. Further, doctors who use AI may be able to replace the doctors who are not very well versed with high tech equipment. However, no level of technology can replace the human touch, empathy and emotional support provided to the patients by healthcare providers. It is impossible for AI to replicate the same level of emotional connection that a human can establish with a patient.

Healthcare often deals with unpredictable situations and rapidly changing patient conditions. Humans have the ability to adapt to these situations, while AI may struggle when confronted with something it hasn’t been explicitly trained for. Moreover, medical decisions often involve complex ethical and legal considerations for which human involvement is a must. AI may assist in such decision making but it cannot be completely entrusted with the life of a patient. AI can only be used as a tool in the healthcare sector for assisting, and the healthcare sector cannot completely depend on the usage of AI without any human involvement. AI is to be used for the purpose of making tasks easier and more effective and not to eradicate humans from the sector.

Hence, it can be concluded that human involvement cannot be completely eradicated by the emergence of AI in healthcare sector.

Legal implications and regulations of using AI in healthcare

The emergence of AI in recent years has raised the question of using it in the healthcare sector as well, which calls for rules and regulations in order to regulate AI’s application. Rules and regulations become necessary to ensure compliance of safe and legal practices in healthcare. As healthcare deals with various issues such as data privacy and security, ethical issues, liability and accountability in case of errors, it becomes more necessary to have regulations for the application of AI in healthcare sector.

Recently, Indian Council of Medical Research (ICMR) released ethical guidelines for AI usage in healthcare. Through this, they hope to make “AI-assisted platforms available for the benefit of largest section of common people with safety and highest precision possible,”[3]. As per the guidelines, the ethical review process for AI in health comes under the domain of the ethics committee[4]. The document notes that the regulation of AI technologies in healthcare is still in its nascent stage even in developed countries. It underlines the importance of regular internal and external audits to ensure optimum functioning of AI systems which must be made available to the public. It aims for a smooth integration between humans and technology. Consent of patients in using AI is also given prime importance in the regulations released by ICMR. Further, it ensures privacy and personal data protection at all stages of development and deployment of AI has to be maintained. The ICMR regulations further deals with a variety of issues such as misuse, exploitation, safety concerns of using AI in healthcare sector.

India already offers streamlining of AI technologies in various sectors including healthcare through the National Health Policy (2017), National Digital Health Blueprint (NDHB 2019), and Digital Information Security in Healthcare Act (2018) proposed by the Health Ministry which will pave the way for the establishment of the National Data Health Authority and other health information exchanges.

Conclusion

AI can be a valuable tool in healthcare. It can assist in tasks like medical imaging analysis, data management, drug discovery, and even help in diagnosing diseases. It can help healthcare providers make more informed decisions by providing data-driven insights. However, it should be seen as a complement to human healthcare providers, enhancing their capabilities rather than replacing them. The ideal scenario is often a collaboration between healthcare professionals and AI systems to ensure an efficient healthcare system. As the landscape of AI in healthcare continues to evolve, it is imperative that stakeholders, including healthcare providers, policymakers, technologists, and legal experts, work in concert to make regulations and laws in order to ensure a safe, transparent and efficient usage or integration of AI into the healthcare sector.

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Written by- Amrita Rout

[1] Jayapriyanka J, ‘Rapid transformation. Artificial intelligence in Indian healthcare: A promising future with challenges, The Hindu business line, June 30, 2023, https://www.thehindubusinessline.com/news/science/artificial-intelligence-in-indian-healthcare-a-promising-future-with-challenges/article67015361.ece#:~:text=AI%20expenditure%20in%20India%20is,to%20%24102.7%20Billion%20by%202028.

[2] AI in Healthcare: The regulations conundrum, financial express, June 19, 2023 09:00, https://www.financialexpress.com/healthcare/healthtech/ai-in-healthcare-the-regulations-conundrum/3131045/

[3] BINDU SHAJAN PERAPPADAN, ‘ICMR releases ethical guidelines for AI usage in healthcare’, The Hindu, March 24, 2023, https://www.thehindu.com/sci-tech/health/icmr-releases-the-countrys-first-ethical-guidelines-for-application-of-ai-in-biomedical-research-and-healthcare/article66657158.ece#:~:text=The%20Indian%20Council%20of%20Medical%20Research%20(ICMR)%20has%20released%20the,based%20solutions”%20in%20the%20fields

[4] Ethical guidelines for application of artificial inteliigence in biomedical research and healthcare, https://main.icmr.nic.in/sites/default/files/upload_documents/Ethical_Guidelines_AI_Healthcare_2023.pdf