Open Access Research Article

AI IN HEALTHCARE: LEGAL REGULATION OF AI-BASED DIAGNOSIS AND TREATMENT IN INDIA — A COMPARATIVE STUDY WITH THE EUROPEAN UNION AND THE UNITED STATES

Author(s):
ARPIT MEENA YUVRAJ SINGH DERWAL KAUSHAL KISHOR MEENA
Journal IJLRA
ISSN 2582-6433
Access Open Access
Volume 3
Issue 7
Download PDF Open PDF Citation Search Scholar

Abstract

Abstract Artificial intelligence (AI) has moved from the margins of medicine to its working core. Algorithms now read radiological images, flag deteriorating patients, triage emergency cases and recommend treatment pathways, and regulators have authorised well over a thousand AI-enabled medical devices. Legal systems built around the individual clinician and the static medical device are strained by technologies that are opaque, that may change after deployment and that can fail systematically rather than accidentally. The central question is who bears legal responsibility when AI-assisted diagnosis or treatment injures a patient, and which regulatory architecture is best placed to prevent that injury. This paper examines the legal regulation of AI-based diagnosis and treatment in India and compares it with the European Union and the United States. India has no AI-specific statute; the field is governed by the professional-negligence doctrine developed in Jacob Mathew v State of Punjab and Indian Medical Association v VP Shantha, the Consumer Protection Act 2019, the Medical Devices Rules 2017, the Telemedicine Practice Guidelines 2020, the ICMR ethical guidelines of 2023, the Digital Personal Data Protection Act 2023 and the CDSCO’s draft guidance on medical device software of October 2025. The European Union has adopted a horizontal, risk-based statute in the AI Act, layered on the Medical Device Regulation, the General Data Protection Regulation and a revised Product Liability Directive, although the application dates for high-risk systems have recently been deferred. The United States regulates through device law administered by the Food and Drug Administration, a statutory carve-out for certain clinical decision support software, state tort law and an emerging body of state legislation. The paper draws on decisions including Canterbury v Spence, Riegel v Medtronic, Taylor v Intuitive Surgical, Estate of Lokken v UnitedHealth Group, SCHUFA Holding (Scoring) and SNITEM and Philips France. It argues that India should neither wait for a comprehensive AI statute nor transplant a foreign model wholesale. Instead, it should adopt a calibrated, sector-specific framework that preserves the clinician’s non-delegable professional duty, recognises an independent institutional duty on hospitals that procure and deploy clinical AI, extends product liability to software, and imposes transparency, logging, consent and bias-audit obligations proportionate to risk. The paper concludes by proposing legislative and regulatory reforms that allocate responsibility among developers, hospitals and clinicians in a manner that protects patients without chilling beneficial innovation.

Published Paper

PDF Preview
Download Open

Author Details

Authors: ARPIT MEENA, YUVRAJ SINGH DERWAL & KAUSHAL KISHOR MEENARegistration ID: 1013282 | Published Paper ID: IJLRA13282, IJLRA13283 & IJLRA13284Year: Oct-2026 | Volume: 3 | Issue: 7Approved ISSN: 2582-6433 | Country: Delhi, IndiaPage No.: 373-391

Article Information

AI IN HEALTHCARE: LEGAL REGULATION OF AI-BASED DIAGNOSIS AND TREATMENT IN INDIA — A COMPARATIVE STUDY WITH THE EUROPEAN UNION AND THE UNITED STATES

Authors: ARPIT MEENA, YUVRAJ SINGH DERWAL, KAUSHAL KISHOR MEENA

  • Journal IJLRA
  • ISSN 2582-6433
  • Volume 3
  • Issue 7
Citation Download Paper Full Details Search on Google Search on Google Scholar

About Journal

International Journal for Legal Research and Analysis

  • AbbreviationIJLRA
  • ISSN2582-6433
  • AccessOpen Access
  • LicenseCC 4.0

All research articles published in International Journal for Legal Research and Analysis are open access and available to read, download and share, subject to proper citation of the original work.

Creative Commons

Disclaimer: The opinions expressed in this publication are those of the authors and do not necessarily reflect the views of International Journal for Legal Research and Analysis.

Current Issue

Ethics and Policy

For Authors