Introduction
Medical tourism is a concept wherein people travel across international borders to access medical treatment, whether it be surgical or health services and care, mainly due to affordability, and/or access to technology not available in their resident country[1]. In the past few years, India has become a popular destination for medical tourism due to low costs, skilled manpower and rising standards. The setup, however, is heavily entangled with legal, ethical and policy considerations, including patient rights, service provider’s liability and regulations on cross-border medical treatments.
The legal regime concerning medical tourism in India does not exist in the form of an independent, overarching, codified statute; instead, it is scattered across multiple laws, including the Clinical Establishments (Registration and Regulation) Act, 2010; Medical Council of India Regulations; and associated consumer protection and immigration legislations.
Similarly, countries such as the United States of America have developed specific systems for regulating medical services provided to foreign patients with respect to liability, accreditation and ethical implications[2]. The objective of this research is to analyse the relevant Indian laws relating to medical tourism, particularly in regard to their implementation, extent and utility. This twofold emphasis provides for the domestic challenges as well as the international best practices in medical tourism.
The project primarily focuses on (i) conceptual analysis as to what medical tourism is and how it intersects with law; (ii) critically analysing the statutory/regulatory regime in India; (iii) discussion relating to landmark judicial decisions addressing the said issue, and, finally, (iv) a comparative analysis with the United States, followed by critical analysis.
The present work is divided into six sections. Section 1 provides an introduction, outlining the purpose, scope, and scheme of the study. Section 2 provides for research questions, while Section 3 sets out the research objectives. Section 4 contains the critical analysis of the concept, followed by Section 5 encapsulating the conclusion, and Section 6 compiles the references relied upon in the study.
Research Questions
- What is the legal framework and regulations which regulate medical tourism in India and the USA?
- What are some landmark judgments that have carved out a legal regime pertaining to medical tourism in India?
Research Objective
- To critically analyse the legal framework and regulations which regulate medical tourism in India and the USA
- To analyse landmark judgements that have carved out a legal regime pertaining to medical tourism in India
ANALYSIS
Conceptual Analysis
Medical Tourism is the process of travelling across international borders to receive medical treatment or care. Medical tourism, in contrast to leisure or business tourism, concerns itself with highly-specialised, cost-effective medical care, ranging from selective treatments (e.g., cosmetic surgery) and cutting-edge procedures to alternative medicine and wellness services[3].
The major reasons for medical tourism include economic, institutional and technological reasons. Patients travel for treatment or to obtain various types of medical procedures and receive care at a lower cost or shorter waiting time, including access to treatments not available in their home country[4]. In India, the cost of treatment, the presence of skilled manpower and a growing network of accredited hospitals are some reasons due to which it has become a leading destination. Yet this development raises important questions regarding the rights of patients, responsibilities and liabilities of professionals involved in providing services, accreditation of health centres, and ethical aspects related to cross-border healthcare delivery[5].
Legal Analysis
It is noteworthy that medical tourism is not governed by any codified law in India or the United States. Instead, it is regulated by an amalgamation of sectoral laws, professional licensing schemes, consumer protection regulations, immigration policy, and judicial pronouncements[6].
Indian legal framework concerning Medical Tourism
Clinical Establishments (Registration and Regulation) Act, 2010
This Act[7] regulates registration and regulation of all clinical establishments throughout India, including those treating foreign patients. Section 12[8] of this Act provides for the conditions to be fulfilled for registration, and Section 11[9] provides that unless the Act is complied with, no person shall run a clinical establishment. Hence, this Act serves as a parent legislation for the regulation of clinical establishments.
Indian Medical Council Act, 1956 (repealed and replaced by the National Medical Commission Act, 2019)
Under the erstwhile Act[10] and now the new Act[11] read with related regulations of the National Medical Commission (NMC) Act, 2019, only such persons who hold qualifications that are included in the statute can practice allopathic medicine in India.
Consumer Protection Act, 2019
Services provided or to be provided by the Medical professionals are within the meaning of “service” as defined under Section 2(42) of the Act[12]. Therefore, patients, including NRI patients, may file complaints against hospitals or doctors under the realm of deficiency in service/medical negligence, before the consumer forum.
The Indian Penal Code, 1860 / Bharatiya Nyaya Sanhita 2023
Criminal liability for medical negligence can be found under Section 304A (now Section 106 of the BNS), which provides punishment for causing death due to negligent acts[13]. Sections 336–338 (Now Section 125 of BNS) also punish acts endangering life or causing grievous hurt by rash/negligent acts[14]. These provisions also apply in cases of foreign patients, without any distinction.
Drugs and Cosmetics Act, 1940 and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
These Acts control the import, manufacture, sale and advertising of drugs and health products. As medical tourism is often directed to procedures which involve importing pharmaceuticals or other treatments, adherence to these laws is compulsory[15].
Immigration and Visa Regulations
The categories “Medical Visa” and “Medical Attendant Visa” are covered under the Visa Manual, 2019 of the Ministry of Home Affairs (MHA), Government of India[16]. These stipulations govern the entry and residence of foreign persons seeking treatment. Visa-related conditions (duration of stay and type of procedures that can be done) are a part of the regulations surrounding medical tourism.
Information Technology Act, 2000 and allied data protection rules
As the exchange of medical records is shared electronically for a number of medical tourists before they travel, rules with reference to sensitive personal data under Section 43A[17] and Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011[18] are applicable. Hospitals are bound by law to maintain patient confidentiality and protect their data.
The United States legal framework concerning Medical Tourism
The United States, although its focus is on exporting rather than importing patients, has a separate legal system governing the provision of treatment, which will be applicable when foreign nationals do opt to come within its sphere[19].
Health Insurance Portability and Accountability Act, 1996 (HIPAA)
Section 1177 imposes very strict requirements on health care providers to secure patients’ medical information[20]. These are procedures that are applicable to overseas patients receiving treatment in the United States of America.
Patient Protection and Affordable Care Act, 2010
This Act sets minimum levels of protection for health care providers and insurers[21]. Although this does not concern foreign patients per se, their provisions are complied with, thus assuring the quality of medical services for international patients as well.
State Medical Practice Acts
Physicians are licensed and regulated by the States. The Medical Board in each state makes sure only licensed personnel can treat and that standards of care are applied, irrespective of the patients’ nationality.
Tort law principles
Medical malpractice in the United States is governed largely through tort law legislation of the concerned State. Foreign patients possess equal standing to initiate civil claims for negligence or malpractice against healthcare providers.
Case Laws
Indian Medical Association v. V.P. Shantha, (1995) 6 SCC 651
Supreme Court held that Medical Service is included in the definition of “service” under Section 2(1)(o) Consumer Protection Act, 1986. The court held that a patient (be it the one who purchases treatment in a private hospital) has the right to relief under the Consumer Protection Act for deficient service. This consumerist understanding of healthcare also affects medical tourism, so that tourist patients in India have access to the same statutory remedies as domestic patients[22].
Kusum Sharma v. Batra Hospital and Medical Research Centre, (2010) 3 SCC 480
The Supreme Court laid down the guidelines on medical negligence. The court observed that negligence could not be presumed against the doctor for the mere happening of an untoward incident, so one has to prove that there was any departure from the standard of care by the doctor. It was observed that the warning “professional hazards attached” breaches of duty of care resulting in actionable negligence[23].
Spring Meadows Hospital v. Harjol Ahluwalia, (1998) 4 SCC 39
The Supreme Court observed that hospitals are also responsible for their doctors’ and employees’ negligence, continuing from the previous application of vicarious liability. The Court highlighted that hospitals have an independent duty to patients, which could be violated for services which their employees failed to perform. This finding is especially relevant for medical tourism, as patients tend to use institutional trust and assurances rather than the reputation of a specific doctor[24].
Comparative analysis
Medical tourism in both Indian and the US system is institutionally distinct, with India constituted by a patchwork of statutory measures emphasising registration and minimum standards along with consumer remedies and immigration control; in contrast, the USA is dominated by state‐based professional self‐regulation, a federal privacy regime, and rigorous tort liability. In India, the Clinical Establishments Act, 2010 requires registration as a “clinical establishment” with a defined minimum level of quality in services, and the notified standards are mandatory for hospitals and clinics catering to domestic as well as foreign patients[25].
Professional license and ethics are regulated under the National Medical Commission Act, 2019 (including professional conduct rule) and would apply regardless of the patient’s nationality. The patient’s complaint against medical negligence is largely redressed under the Consumer Protection Act, 2019 (s. 2(42)), thereby allowing even a foreigner to make complaints for deficiency of service before consumer forums. Further, a criminal complaint can also be filed in appropriate circumstances under relevant provisions of BNS.
In the United States, federal law does not establish any offence relating to “medical tourism”. Rather, patients from abroad seek treatment within the same healthcare-law framework that applies to domestic care. Licensing of physicians and facilities, scope of practice, and standards of care are dictated by State Medical Practice Acts and statutes concerning hospital licenses, with accreditation (e.g., The Joint Commission) serving as an issue rather than a statutory requirement[26].
Privacy and security of healthcare information in the United States is federally regulated through the Health Insurance Portability and Accountability Act (HIPAA), 1996, and the HITECH Act, 2009, which identify administrative, “physical”, and “technical” safeguards that apply equally to international patients. Emergency stabilisation duties are created under EMTALA (1986) that all Medicare hospitals must give medical screening examination and stabilising treatment irrespective of funds or immigration status[27].
Most malpractice civil liability is a matter of state tort law, with doctrines on informed consent, standard-of-care, causation, damages, and statutory damage caps, statutes of limitations, expert-affidavit requirements and pre-suit screening panels.
Critical Analysis
In India, various laws and legislations are present in bits and pieces, but there is no comprehensive statute to deal with the medico-legal complications in respect of foreign patients visiting India for treatment. However, various sectoral legislations regulate certain aspects of medical tourism, yet their application is indirect and characterised. This results in a “legal black hole” with respect to issues of cross-border liability, the enforceability of contractual undertakings and the convergence of professional standards. Judicial Pronouncements, such as those in Indian Medical Association vs V.P. Shantha and Spring Meadows Hospital vs Harjol Ahluwalia, have reinforced patients’ rights and outlined medical liability, but their regulation is irregular[28].
In contrast, the US government focuses more on the patient himself and has in place a tort-based liability regime. Federal privacy protections are offered by HIPAA (although no private right of action exists) and the licensing is at the state level. However, this leads to the parties incurring higher litigation costs, however, clarity is achieved over rights, remedies and professional accountability. India, on the other hand, is good for treatment and offers statutory Consumer Fora with low fees, but lacks in the implementation of punishments for malpractice, data protection and insurance[29].
Thus, India needs a dedicated legal framework for medical tourism which can harmonise the statute regulation, patient safety and cross-border enforcement to regulate domestic laws with international standards.
Conclusion
The aforementioned analysis shows that medical tourism, despite being an economic and health-related issue primarily, is firmly situated within the legal framework. In India, A combination of laws govern this sector, such as the Clinical Establishments (Registration and Regulation) Act, 2010, National Medical Commission Act, 2019, Consumer Protection Act, 2019, as well as immigration and data-protection laws. Judgments like Indian Medical Association v. V.P. Shantha and Spring Meadows Hospital v. Harjol Ahluwalia have strengthened the rights of patients and defined medical liability, which covers foreign nationals as well.
The comparative study with the United States’ divergent path, i.e., statutory regulation, consumer fora and visa mechanisms, to the US approach focusing on tort-based remedies, health privacy via HIPAA and state licensing regimes. Both jurisdictions are based on shared responsibility for patient safety, professional accountability and regulatory oversight[30].
Hence, the evolution of medical tourism must be viewed through a legal lens. Strong enforcement of the statute, consistent application of professional standards and judicial diligence in protecting the rights of patients remain essential for maintaining confidence in the industry. For India, the regulation of malpractices, data privacy and mechanisms for enforcement across borders would bring domestic practices on par with international standards and make it a secure and vibrant world destination in healthcare.
References
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[2] Han Teck Choo, ‘Medical Tourism: A Happy Holiday?’ (2025) 37 Singapore Academy of Law Journal 23.
[3] Kashish Dhawan, ‘Medical Tourism in India: Progress or Plight’ (2023) 6 International Journal of Law, Management and Humanities 3008
[4] Augustus Chow, ‘Patients with Passports: Medical Tourism, Law, and Ethics’ (2018) 14 Journal of Health and Biomedical Law 233
[5] Philip Mirrer-Singer, ‘Medical Malpractice Overseas: The Legal Uncertainty Surrounding Medical Tourism’ (2007) 70 Law and Contemporary Problems 211.
[6] Swati Gola, ‘Medical Tourism in India – In Whose Interest?’ (2016) 15 Journal of International Trade Law and Policy 115 https://doi.org/10.1108/JITLP-01-2016-0005.
[7] Clinical Establishments (Registration and Regulation) Act 2010.
[8] Clinical Establishments (Registration and Regulation) Act 2010, s 12.
[9] Clinical Establishments (Registration and Regulation) Act 2010, s 11.
[10] Indian Medical Council Act 1956.
[11] National Medical Commission Act 2019.
[12] Consumer Protection Act 2019, s 2(42).
[13] Indian Penal Code 1860, s 304A.
[14] Indian Penal Code 1860, ss 336-338.
[15] Drugs and Cosmetics Act 1940; Drugs and Magic Remedies (Objectionable Advertisements) Act 1954.
[16] Ministry of Home Affairs, Visa Manual 2019 (Government of India 2019).
[17] Information Technology Act 2000, s 43A.
[18] Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011, Gazette of India, Part II, sec 3(i).
[19] Levi Burkett, ‘Medical Tourism: Concerns, Benefits, and the American Legal Perspective’ (2007) 28 Journal of Legal Medicine 223 https://doi.org/10.1080/01947640701357763.
[20] Health Insurance Portability and Accountability Act of 1996, Pub L No 104–191, 110 Stat 1936 (1996).
[21] Patient Protection and Affordable Care Act of 2010, Pub L No 111–148, 124 Stat 119 (2010).
[22] Indian Medical Association v VP Shantha (1995) 6 SCC 651
[23] Kusum Sharma v Batra Hospital and Medical Research Centre (2010) 3 SCC 480.
[24] Spring Meadows Hospital v Harjol Ahluwalia (1998) 4 SCC 39.
[25] Hanis Wahed, ‘Ethical and Legal Issues in Medical Tourism’ (2015) 23 IIUM Law Journal 227 https://doi.org/10.31436/iiumlj.v23i2.130.
[26] Jeremy Snyder and Valorie A Crooks, ‘Medical Tourism and Bariatric Surgery: More Moral Challenges’ (2010) 10 American Journal of Bioethics 28 https://doi.org/10.1080/15265161.2010.528510.
[27] Felicitas Holzer and Ignacio Mastroleo, ‘Innovative Practice in Latin America: Medical Tourism and the Crowding out of Research’ (2019) 19 American Journal of Bioethics 42 https://doi.org/10.1080/15265161.2019.1602189.
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[30] Manohar Kumar, ‘From Exceptionalism to Non-Conformity: Pandemic Disobedience, Collective Irrationality, and Distributive Justice in India’ (2023) 31 Critical Criminology 601 https://doi.org/10.1007/s10612-023-09727-3.
