The integration of artificial intelligence (AI) in healthcare has the potential to enhance quality and accessibility. However, it also brings forward critical considerations regarding patient safety and the upholding of ethical standards, particularly in terms of data privacy and accountability. Photo: Suriyo Munkaew

In October 2024, Claes Granmar, Associate Professor of European Law, and Henricus Verhagen, Associate Professor at the Department of Computer and Systems Sciences (DSV), embarked on a two-week research visit to India as part of the SPARC (Strategic Partnership for Artificial Intelligence Research and Collaboration) project. Funded by India’s Ministry of Education since 2023, SPARC aims to promote patient safety and develop regulatory guidelines for the deployment of AI in the Indian healthcare systems.

"An EU regulation regarding access to personal data in healthcare and medical research is underway, and India faces similar regulatory challenges. Given the current flow of health data between the EU and India for diagnostics, which must align with EU standards, there is a clear interest in fostering closer coordination,” says Claes Granmar, the European Primary Investigator (PI) for SPARC.

The SPARC project addresses key issues in AI diagnostics and patient record management, focusing on distribution of responsibilities, data protection, informed consent, and ethical considerations. The objective is to provide Indian lawmakers with the necessary groundwork to shape the forthcoming Digital India Act, which aims to regulate digitalization and the deployment of high-risk AI. Researchers from Stockholm University, Symbiosis Law School in Pune, and the University of Milan have joined forces to shoulder this task.

Launch of SPARC Partnership at Stockholm EU Conference

In India, the project is spearheaded by Professor Dr. Shashikala Gurpur, a distinguished law academic and researcher, who serves as the Director of Symbiosis Law School and Dean of the Faculty of Law in Pune. With a notable career in both Indian and international law, Dr. Gurpur plays a pivotal role in the project.

The partnership was initiated at an EU conference in Stockholm in 2018, where Claes Granmar and Dr. Gurpur established contact. This led to a collaborative project proposal in 2019, co-developed with Angelica Bonfanti, Associate Professor at the University of Milan. Their goal was to secure funding for a multidisciplinary international research initiative focused on AI diagnostics, automated decision-making, and data privacy.

As the assessment of the project proposal was delayed by the pandemic, SPARC could secure funding only in late 2023, and the project became a reality the same year.

Common Ground and Divergent Views on AI Regulation

Claes Granmar who has extensive experience in international collaborations, including research residencies at esteemed institutions in the U.S. and Germany, is joined by Ph.D. candidate Giorgi Parulava and Henricus Verhagen in the Swedish core team of SPARC.

Claes Granmar, Associate Professor of European Law.

Reflecting on his recent visit to India, Granmar observed that Indian experts largely align with Swedish perspectives on the role of AI in healthcare. However, some Indian AI researchers, particularly those focused on diagnostic and treatment applications, exhibit skepticism towards extensive regulatory frameworks - a sentiment also observed among tech companies in the EU.

"For professionals dedicated to advancing diagnostics and treatment, the emphasis on data privacy and mandatory human oversight in decision-making processes can be challenging. These requirements are sometimes seen as ‘disruptions’ to machine learning and costs in terms of reduced AI efficiency. This underscores the importance of open, constructive discussions to strike a balance between innovation and ethical/legal standards" says Granmar.

Indian Regulatory Approaches Shaping Project Focus

Throughout their visit, Granmar and Verhagen engaged in a series of faculty seminars and workshops across Pune and Nagpur, where they shared insights, supervised doctoral students, and held lectures. The visit was concluded with a focus group discussion on AI applications in healthcare, attended by prominent medical experts and representatives from India’s Medical Ethics Council.

During the seminars, it became clear that India places significant emphasis on overarching international frameworks, such as those established by the UN and WTO, whereas the EU typically translates international agreements into detailed legislation. As a result, India often operates on broader principles, while the EU Member States implement more specific, regulatory frameworks.

"This distinction is crucial for our project. Understanding India’s reliance on private standardization bodies rather than government oversight helps us focus on formulating principles for secure and ethical AI deployment in healthcare, rather than on creating detailed normative systems,” Granmar concludes.

Text: Natalie Oliwsson