Citation:

Abdullah Mazharuddin Khaja, Iftikhar Bhatti, Tamoor Ali Sadiq, Michidmaa Arikhad. "Algorithms with a Bedside Manner: Regulating AI’s Social and Legal Impact on U.S. Healthcare" International Research Journal of Economics and Management Studies, Vol. 4, No. 9, pp. 55-67, 2025. Crossref. http://doi.org/10.56472/25835238/IRJEMS-V4I9P106

Abstract:

Artificial intelligence (AI) is rapidly entering routine clinical practice in the United States, with adoption accelerating across imaging, triage, clinical decision support, and operational management. Reported benefits include faster and more accurate diagnosis, improved workflow efficiency, and the potential to reduce healthcare costs. However, widespread implementation also introduces critical risks, including safety failures, algorithmic opacity, embedded bias, privacy breaches, and unresolved questions of liability. The current regulatory environment remains fragmented. While the Food and Drug Administration (FDA) has begun adapting device approval pathways to encompass software and machine learning applications, these frameworks are still evolving. Privacy protections under existing health law provide a foundation for safeguarding patient data, yet they are increasingly strained by large-scale data aggregation and cross-system linkages. Liability doctrines in malpractice and product law address some harms but leave significant gaps when autonomous algorithmic logic shapes medical decisions. Intellectual property policies further complicate matters by influencing transparency, disclosure, and oversight. This paper synthesizes interdisciplinary literature on clinical performance, social impact, and legal governance of AI in healthcare. It proposes an analytic method for regulatory assessment that emphasizes four core principles: safety, equity, privacy, and accountability. A consolidated risk-response matrix and supporting figures are presented to assist policymakers and health system leaders in evaluating emerging tools. The discussion recommends lifecycle validation processes, mandated bias audits, strengthened data governance protocols, clarified liability standards, and structured education for clinicians and patients. The overarching aim is the development of ethically aligned and legally compliant AI that enhances, rather than undermines, the quality of bedside care.

References:

[1] H. Rafi, H. Rafiq, and M. Farhan, “Agmatine alleviates brain oxidative stress induced by sodium azide,” 2023.
[2] S. I. Haider and M. Ali, “Mitigating the challenges of open and distance learning education system through use of information technology: a case study of Allama Iqbal Open University, Islamabad, Pakistan,” Pakistan Journal of Distance and Online Learning, vol. 5, no. 2, pp. 175–190, 2019.
[3] A. Raza, “AI and privacy – navigating a world of constant surveillance,” Euro Vantage Journal of Artificial Intelligence, vol. 1, no. 2, pp. 74–80, 2024.
[4] S. Khan, S. Mehmood, and S. I. Haider, “Child abuse in automobile workshops in Islamabad, Pakistan,” Pakistan Journal of Criminology, vol. 12, no. 1, pp. 61–74, 2020.
[5] T. Ghulam, H. Rafi, A. Khan, K. Gul, and M. Z. Yusuf, “Impact of SARS-CoV-2 treatment on development of sensorineural hearing loss,” Proceedings of the Pakistan Academy of Sciences: B. Life and Environmental Sciences, vol. 58, suppl., pp. 45–54, 2021.
[6] D. K. Mizouri et al., “Use of large language model chatbots in health care: privacy, cybersecurity, and ethical risks,” Journal of Medical Internet Research, vol. 25, p. e47617, 2023.
[7] H. Rafiq, M. Farhan, H. Rafi, S. Rehman, M. Arshad, and S. Shakeel, “Inhibition of drug-induced Parkinsonism by chronic supplementation of quercetin in haloperidol-treated Wistars,” Pakistan Journal of Pharmaceutical Sciences, vol. 35, pp. 1655–1662, 2022.
[8] A. Raza, “Trade secrets as a substitute for AI protection: a critical investigation into different dimensions of trade secrets,” 2024.
[9] G. Palmeri, “Divine disguises on the crossroads of Khotan: The iconographies from Dandan Oilik,” Journal of Asian Civilizations, vol. 44, no. 2, pp. 67–107, 2021.
[10] A. Ali, S. I. Haider, and M. Ali, “Role of identities in the Indo-Pak relations: a study in constructivism,” Global Regional Review, vol. 2, no. 1, pp. 305–319, 2017.
[11] A. Raza, “Equality before law and equal protection of law: contextualising its evolution in Pakistan,” Pakistan Law Journal, 2023.
[12] L. Notebaert, R. Harris, C. MacLeod, M. Crane, and R. S. Bucks, “The role of acute stress recovery in emotional resilience,” PeerJ, vol. 12, p. e17911, 2024.
[13] A. Raza and N. Bashir, “Artificial intelligence as a creator and inventor: legal challenges and protections in copyright, patent, and trademark law,” Dec. 2023.
[14] M. Farhan, H. Rafi, and H. Rafiq, “Dapoxetine treatment leads to attenuation of chronic unpredictable stress-induced behavioral deficits in rat model of depression,” Journal of Pharmacy and Nutrition Sciences, vol. 5, no. 4, pp. 222–228, 2015.
[15] Z. Ahmed, S. Khan, S. Saeed, and S. I. Haider, “An overview of educational policies of Pakistan (1947–2020),” Psychology and Education Journal, vol. 58, no. 1, pp. 4459–4463, 2021.
[16] A. Raza, “Credit, code, and consequence: how AI is reshaping risk assessment and financial equity,” Euro Vantage Journal of Artificial Intelligence, vol. 2, no. 2, pp. 79–86, 2025.
[17] S. I. Haider and F. M. Burfat, “Improving self-esteem, assertiveness and communication skills of adolescents through life skills-based education,” Journal of Social Sciences and Humanities (JSSH), vol. 26, no. 2, 2018.
[18] H. Rafi and M. Farhan, “Dapoxetine: an innovative approach in therapeutic management in animal model of depression,” Pakistan Journal of Pharmaceutical Sciences, vol. 2, no. 1, pp. 15–22, 2015.
[19] S. Zuberi, H. Rafi, A. Hussain, and S. Hashmi, “Upregulation of Nrf2 in myocardial infarction and ischemia-reperfusion injury of the heart,” PLOS One, vol. 19, no. 3, p. e0299503, 2024.
[20] A. Raza, B. Munir, G. Ali, M. A. Othi, and R. A. Hussain, “Balancing privacy and technological advancement in AI: a comprehensive analysis of the US perspective,” International Journal of Contemporary Issues in Social Sciences, vol. 3, no. 3, pp. 3732–3738, 2024.
[21] S. I. Haider and A. Waqar, “Projection of CPEC in print media of Pakistan from 2014–2019,” Global Strategic and Security Studies Review, vol. 1, pp. 45–64, 2019.
[22] H. Rafi, H. Rafiq, R. Khan, F. Ahmad, J. Anis, and M. Farhan, “Neuroethological study of AlCl₃ and chronic forced swim stress induced memory and cognitive deficits in albino rats,” The Journal of Neurobehavioral Sciences, vol. 6, no. 2, pp. 149–158, 2019.
[23] I. Bhatti, H. Rafi, and S. Rasool, “Use of ICT technologies for the assistance of disabled migrants in the USA,” Revista Española de Documentación Científica, vol. 18, no. 1, pp. 66–99, 2024.
[24] F. Rasool and S. I. Haider, “Exploitation and low wages of labor migrants in Gulf countries,” Global Management Sciences Review, vol. 1, pp. 32–39, 2020.
[25] M. Farhan, H. Rafiq, H. Rafi, S. Rehman, and M. Arshad, “Quercetin impact against psychological disturbances induced by fat-rich diet,” Pakistan Journal of Pharmaceutical Sciences, vol. 35, no. 5, 2022.
[26] U.S. Department of Health and Human Services, “Administrative simplification: proposed modifications to the HIPAA Security Rule to strengthen cybersecurity,” Dec. 2024. [Online]. Available: https://www.hhs.gov.
[27] H. Rafi, H. Rafiq, I. Hanif, R. Rizwan, and M. Farhan, “Chronic agmatine treatment modulates behavioral deficits induced by chronic unpredictable stress in Wistar rats,” Journal of Pharmaceutical and Biological Sciences, vol. 6, no. 3, pp. 80–85, 2018.
[28] Z. Zafar, I. Sarwar, and S. I. Haider, “Socio-economic and political causes of child labor: the case of Pakistan,” Global Political Review, vol. 1, no. 1, pp. 32–43, 2016.
[29] A. Raza, “Navigating the intersection of artificial intelligence and law in healthcare: complications and corrections,” 2024.
[30] M. Farhan, H. Rafi, and H. Rafiq, “Behavioral evidence of neuropsychopharmacological effect of imipramine in animal model of unpredictable stress-induced depression,” International Journal of Biology and Biotechnology, vol. 15, no. 22, pp. 213–221, 2018.
[31] A. Raza, “Trade secrets as a substitute for AI protection: a critical investigation into different dimensions of trade secrets,” 2024.
[32] J. N. Allen, “AI chatbots and HIPAA compliance: responsibilities for developers and health providers,” Harvard Law Review Blog, 2023.
[33] M. F. Muhammad, H. Rafiq, and H. Rafi, “Prevalence of depression in animal model of high-fat diet-induced obesity,” 2015.
[34] H. Rafi, H. Rafiq, and M. Farhan, “Pharmacological profile of agmatine: an in-depth overview,” Neuropeptides, vol. 105, p. 102429, 2024.
[35] S. I. Haider and N. K. Mahsud, “Family, peer group and adaptation of delinquent behavior,” Dialogue (Pakistan), vol. 5, no. 4, 2010.
[36] H. Rafi, F. Ahmad, J. Anis, R. Khan, H. Rafiq, and M. Farhan, “Comparative effectiveness of agmatine and choline treatment in rats with cognitive impairment induced by AlCl₃ and forced swim stress,” Current Clinical Pharmacology, vol. 15, no. 3, pp. 251–264, 2020.
[37] A. Raza, “Credit, code, and consequence: how AI is reshaping risk assessment and financial equity,” Euro Vantage Journal of Artificial Intelligence, vol. 2, no. 2, pp. 79–86, 2025.
[38] D. D. Farhud and S. Zokaie, “Ethical issues of artificial intelligence in medicine and health care,” Iranian Journal of Public Health, vol. 50, no. 11, pp. i–vi, 2021.
[39] M. Zubair, S. I. Haider, and F. Khattak, “The implementation challenges to women protection laws in Pakistan,” Global Regional Review, vol. 3, no. 1, pp. 253–264, 2018.
[40] H. Rafiq, M. Farhan, H. Rafi, S. Rehman, and M. Arshad, “Quercetin impact against psychological disturbances induced by fat-rich diet,” Pakistan Journal of Pharmaceutical Sciences, vol. 35, no. 5, 2022.
[41] S. Khan, S. I. Haider, and R. Bakhsh, “Socio-economic and cultural determinants of maternal and neonatal mortality in Pakistan,” Global Regional Review, vol. 1, pp. 1–7, 2020.
[42] H. Rafi, H. Rafiq, and M. Farhan, “Antagonisation of monoamine reuptake transporters by agmatine improves anxiolytic and locomotive behaviors commensurate with fluoxetine and methylphenidate,” Beni-Suef University Journal of Basic and Applied Sciences, vol. 10, no. 1, p. 26, 2021.
[43] A. Raza, “The application of artificial intelligence in credit risk evaluation: obstacles and opportunities in the path to financial justice,” Center for Management Science Research, vol. 3, no. 2, pp. 240–251, 2025.
[44] L. Gordon, M. Loeb, and W. Lucyshyn, “The economics of information security investment,” Information Systems Frontiers, vol. 17, no. 1, pp. 51–70, 2015.
[45] H. Rafi, H. Rafiq, and M. Farhan, “Inhibition of NMDA receptors by agmatine is followed by GABA/glutamate balance in benzodiazepine withdrawal syndrome,” Beni-Suef University Journal of Basic and Applied Sciences, vol. 10, no. 1, p. 43, 2021.
[46] A. Raza and N. Bashir, “Artificial intelligence as a creator and inventor: legal challenges and protections in copyright, patent, and trademark law,” Dec. 2023.
[47] I. H. Syed, W. A. Awan, and U. B. Syeda, “Caregiver burden among parents of hearing impaired and intellectually disabled children in Pakistan,” Iranian Journal of Public Health, vol. 49, no. 2, pp. 249–256, Feb. 2020.
[48] A. Raza, “Equality before law and equal protection of law: contextualising its evolution in Pakistan,” Pakistan Law Journal, 2023.
[49] S. Zuberi, H. Rafi, A. Hussain, and S. Hashmi, “Role of Nrf2 in myocardial infarction and ischemia-reperfusion injury,” Physiology, vol. 38, suppl. 1, p. 5734743, 2023.
[50] M. Farhan, H. Rafiq, H. Rafi, F. Siddiqui, R. Khan, and J. Anis, “Study of mental illness in rat model of sodium azide induced oxidative stress,” Journal of Pharmacy and Nutrition Sciences, vol. 9, no. 4, pp. 213–221, 2019.
[51] A. Raza, B. Munir, G. Ali, M. A. Othi, and R. A. Hussain, “Balancing privacy and technological advancement in AI: a comprehensive analysis of the US perspective,” International Journal of Contemporary Issues in Social Sciences, vol. 3, no. 3, pp. 3732–3738, 2024.
[52] S. I. Haider, B. A. Shah, and N. Jehan, “Socio-economic impact of emigration on the family members left behind: A case study of district Rawalpindi,” Global Regional Review, vol. 2, no. 1, pp. 241–252, 2017.
[53] H. Rafi, H. Rafiq, and M. Farhan, “Agmatine improves oxidative stress profiles in rat brain tissues induced by sodium azide,” Current Chemical Biology, vol. 18, no. 3, pp. 129–143, 2024.
[54] S. I. Haider and N. K. Mashud, “Knowledge, attitude, and practices of violence: A study of university students in Pakistan,” Journal of Sociology and Social Work, vol. 2, no. 1, pp. 123–145, 2014.
[55] A. M. Desai et al., “Generative AI in health systems: adoption and challenges,” Journal of the American Medical Informatics Association, vol. 31, no. 2, pp. 133–150, 2025.
[56] H. Rafi, H. Rafiq, R. Khan, F. Ahmad, J. Anis, and M. Farhan, “Neuroethological study of AlCl₃ and chronic forced swim stress induced memory and cognitive deficits in albino rats,” The Journal of Neurobehavioral Sciences, vol. 6, no. 2, pp. 149–158, 2019.
[57] D. J. Cullen and D. J. Nicholson, “Artificial intelligence and privacy in health care,” in Research Handbook on Health, AI and the Law, 1st ed., Cheltenham: Edward Elgar, 2023, ch. 8.
[58] M. Farhan, H. Rafiq, and H. Rafi, “Prevalence of depression in animal model of high-fat diet induced obesity,” Journal of Pharmacy and Nutrition Sciences, vol. 5, no. 3, pp. 208–215, 2015.
[59] F. Shafqat, S. I. Haider, A. R. Rao, and S. Waqar, “Depression, anxiety, and stress in rural and urban population of Islamabad,” The Rehabilitation Journal, vol. 2, no. 1, pp. 44–48, 2018.
[60] M. Zubair, S. I. Haider, and F. Khattak, “The Implementation Challenges to Women Protection Laws in Pakistan,” Global Regional Review, vol. 3, no. 1, pp. 253–264, 2018.
[61] A. Raza, “Credit, code, and consequence: how AI is reshaping risk assessment and financial equity,” Euro Vantage Journal of Artificial Intelligence, vol. 2, no. 2, pp. 79–86, 2025.
[62] S. I. Haider and A. Waqar, “Projection of CPEC in print media of Pakistan from 2014–2019,” Global Strategic and Security Studies Review, vol. 1, pp. 45–64, 2019.
[63] H. Rafi, H. Rafiq, and M. Farhan, “Pharmacological profile of agmatine: an in-depth overview,” Neuropeptides, vol. 105, p. 102429, 2024.
[64] M. Farhan, H. Rafi, and H. Rafiq, “Dapoxetine treatment leads to attenuation of chronic unpredictable stress-induced behavioral deficits in a rat model of depression,” Journal of Pharmacy and Nutrition Sciences, vol. 5, no. 4, pp. 222–228, 2015.
[65] L. Notebaert, R. Harris, C. MacLeod, M. Crane, and R. S. Bucks, “The role of acute stress recovery in emotional resilience,” PeerJ, vol. 12, p. e17911, 2024.
[66] M. Farhan, H. Rafiq, H. Rafi, R. Ali, and S. Jahan, “Neuroprotective role of quercetin against neurotoxicity induced by lead acetate in male rats,” unpublished.
[67] S. Khan and S. I. Haider, “Women’s education and empowerment in Islamabad, Pakistan,” Global Economics Review, vol. 5, no. 1, pp. 50–62, 2020.
[68] A. Raza, “AI and privacy – navigating a world of constant surveillance,” Euro Vantage Journal of Artificial Intelligence, vol. 1, no. 2, pp. 74–80, 2024.
[69] D. D. Farhud and S. Zokaie, “Ethical issues of artificial intelligence in medicine and health care,” Iranian Journal of Public Health, vol. 50, no. 11, pp. i–vi, 2021.
[70] S. I. Haider and N. K. Mahsud, “Family, Peer Group and Adaptation of Delinquent Behavior,” Dialogue (Pakistan), vol. 5, no. 4, 2010.
[71] A. Raza and N. Bashir, “Artificial intelligence as a creator and inventor: legal challenges and protections in copyright, patent, and trademark law,” Dec. 2023.
[72] Z. Ahmed, S. Khan, S. Saeed, and S. I. Haider, “An overview of educational policies of Pakistan (1947–2020),” Psychology and Education Journal, vol. 58, no. 1, pp. 4459–4463, 2021.
[73] A. Ali, S. I. Haider, and M. Ali, “Role of identities in the Indo-Pak relations: a study in constructivism,” Global Regional Review, vol. 2, no. 1, pp. 305–319, 2017.
[74] A. Raza, “Navigating the intersection of artificial intelligence and law in healthcare: complications and corrections,” 2024.
[75] D. K. Mizouri et al., “Use of large language model chatbots in health care: privacy, cybersecurity, and ethical risks,” Journal of Medical Internet Research, vol. 25, p. e47617, 2023.
[76] H. Rafi, F. Ahmad, J. Anis, R. Khan, H. Rafiq, and M. Farhan, “Comparative effectiveness of agmatine and choline treatment in rats with cognitive impairment induced by AlCl₃ and forced swim stress,” Current Clinical Pharmacology, vol. 15, no. 3, pp. 251–264, 2020.
[77] J. N. Allen, “AI chatbots and HIPAA compliance: responsibilities for developers and health providers,” Harvard Law Review Blog, 2023.
[78] M. Farhan, H. Rafiq, and H. Rafi, “Behavioral evidence of neuropsychopharmacological effect of imipramine in an animal model of unpredictable stress-induced depression,” International Journal of Biology and Biotechnology, vol. 15, no. 22, pp. 213–221, 2018.
[79] S. Khan, S. Mehmood, and S. I. Haider, “Child abuse in automobile workshops in Islamabad, Pakistan,” Pakistan Journal of Criminology, vol. 12, no. 1, pp. 61–74, 2020.
[80] A. M. Desai et al., “Generative AI in health systems: adoption and challenges,” Journal of the American Medical Informatics Association, vol. 31, no. 2, pp. 133–150, 2025.

Keywords:

Artificial Intelligence, Clinical Governance, Healthcare Regulation, Patient Safety, Algorithmic Bias.