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      Artificial Intelligence and Healthcare Regulatory and Legal Concerns

      , M.Ch (NEURO) FACS FICS FAMS PhD , *

      Telehealth and Medicine Today

      Open Academia

      algorithm, artificial intelligence, Digital Information Security in Healthcare Act, regulatory requirements, software

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          Abstract

          We are in a stage of transition as artificial intelligence (AI) is increasingly being used in healthcare across the world. Transitions offer opportunities compounded with difficulties. It is universally accepted that regulations and the law can never keep up with the exponential growth of technology. This paper discusses liability issues when AI is deployed in healthcare. Ever-changing, futuristic, user friendly, uncomplicated regulatory requirements promoting compliance and adherence are needed. Regulators have to understand that software itself could be a software as a medical device (SaMD). Benefits of AI could be delayed if slow, expensive clinical trials are mandated. Regulations should distinguish between diagnostic errors, malfunction of technology, or errors due to initial use of inaccurate/inappropriate data as training data sets. The sharing of responsibility and accountability when implementation of an AI-based recommendation causes clinical problems is not clear. Legislation is necessary to allow apportionment of damages consequent to malfunction of an AI-enabled system. Product liability is ascribed to defective equipment and medical devices. However, Watson, the AI-enabled supercomputer, is treated as a consulting physician and not categorised as a product. In India, algorithms cannot be patented. There are no specific laws enacted to deal with AI in healthcare. DISHA or the Digital Information Security in Healthcare Act when implemented in India would hopefully cover some issues. Ultimately, the law is interpreted contextually and perceptions could be different among patients, clinicians and the legal system. This communication is to create the necessary awareness among all stakeholders.

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          Most cited references 26

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          Key challenges for delivering clinical impact with artificial intelligence

          Background Artificial intelligence (AI) research in healthcare is accelerating rapidly, with potential applications being demonstrated across various domains of medicine. However, there are currently limited examples of such techniques being successfully deployed into clinical practice. This article explores the main challenges and limitations of AI in healthcare, and considers the steps required to translate these potentially transformative technologies from research to clinical practice. Main body Key challenges for the translation of AI systems in healthcare include those intrinsic to the science of machine learning, logistical difficulties in implementation, and consideration of the barriers to adoption as well as of the necessary sociocultural or pathway changes. Robust peer-reviewed clinical evaluation as part of randomised controlled trials should be viewed as the gold standard for evidence generation, but conducting these in practice may not always be appropriate or feasible. Performance metrics should aim to capture real clinical applicability and be understandable to intended users. Regulation that balances the pace of innovation with the potential for harm, alongside thoughtful post-market surveillance, is required to ensure that patients are not exposed to dangerous interventions nor deprived of access to beneficial innovations. Mechanisms to enable direct comparisons of AI systems must be developed, including the use of independent, local and representative test sets. Developers of AI algorithms must be vigilant to potential dangers, including dataset shift, accidental fitting of confounders, unintended discriminatory bias, the challenges of generalisation to new populations, and the unintended negative consequences of new algorithms on health outcomes. Conclusion The safe and timely translation of AI research into clinically validated and appropriately regulated systems that can benefit everyone is challenging. Robust clinical evaluation, using metrics that are intuitive to clinicians and ideally go beyond measures of technical accuracy to include quality of care and patient outcomes, is essential. Further work is required (1) to identify themes of algorithmic bias and unfairness while developing mitigations to address these, (2) to reduce brittleness and improve generalisability, and (3) to develop methods for improved interpretability of machine learning predictions. If these goals can be achieved, the benefits for patients are likely to be transformational.
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            The potential for artificial intelligence in healthcare

            The complexity and rise of data in healthcare means that artificial intelligence (AI) will increasingly be applied within the field. Several types of AI are already being employed by payers and providers of care, and life sciences companies. The key categories of applications involve diagnosis and treatment recommendations, patient engagement and adherence, and administrative activities. Although there are many instances in which AI can perform healthcare tasks as well or better than humans, implementation factors will prevent large-scale automation of healthcare professional jobs for a considerable period. Ethical issues in the application of AI to healthcare are also discussed.
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              Overview of artificial intelligence in medicine

              Background: Artificial intelligence (AI) is the term used to describe the use of computers and technology to simulate intelligent behavior and critical thinking comparable to a human being. John McCarthy first described the term AI in 1956 as the science and engineering of making intelligent machines. Objective: This descriptive article gives a broad overview of AI in medicine, dealing with the terms and concepts as well as the current and future applications of AI. It aims to develop knowledge and familiarity of AI among primary care physicians. Materials and Methods: PubMed and Google searches were performed using the key words ‘artificial intelligence’. Further references were obtained by cross-referencing the key articles. Results: Recent advances in AI technology and its current applications in the field of medicine have been discussed in detail. Conclusions: AI promises to change the practice of medicine in hitherto unknown ways, but many of its practical applications are still in their infancy and need to be explored and developed better. Medical professionals also need to understand and acclimatize themselves with these advances for better healthcare delivery to the masses.
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                Author and article information

                Journal
                TMT
                Telehealth and Medicine Today
                Open Academia
                2471-6960
                23 April 2021
                2021
                : 6
                Affiliations
                Director, Apollo Telemedicine Networking Foundation, Chennai, India
                Author notes
                [* ]Correspondence: K. Ganapathy. Email: drganapathy@ 123456apollohospitals.com
                Article
                252
                10.30953/tmt.v6.252
                © 2021 The Authors

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for any purpose, even commercially, provided the original work is properly cited and states its license.

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