Comparative Regulatory Frameworks for Digital Therapeutics in India, the United States, and the European Union: Regulatory Challenges and Opportunities for Global Harmonisation

Background: Digital therapeutics (DTx) represent an emerging category of software-driven interventions intended to prevent, manage or treat medical conditions through evidence-based therapeutic functions. Their increasing adoption has created regulatory challenges concerning product qualification, risk classification, clinical evidence, software quality management, cybersecurity and post-market surveillance. Although India, the United States and the European Union regulate qualifying DTx through established medical device frameworks, differences in regulatory interpretation and implementation complicate international market access. Objective: To critically compare the regulatory frameworks governing digital therapeutics in India, the United States and the European Union, identify major regulatory gaps and propose strategies for strengthening international regulatory harmonisation. Methods: A comparative narrative review was undertaken using primary regulatory legislation, official guidance documents, international standards and peer-reviewed literature. Regulatory requirements were analysed across seven domains: product qualification, risk classification, market authorisation, clinical evidence, software quality management, cybersecurity and data protection, and post-market surveillance. Results: The three jurisdictions share risk-based regulatory principles but differ substantially in their regulatory procedures. The United States applies established FDA pathways, including 510(k), De Novo classification and Premarket Approval, supported by software-specific guidance and the Quality Management System Regulation effective February 2026. The European Union regulates qualifying DTx under Regulation (EU) 2017/745, incorporating software classification rules, clinical evaluation, conformity assessment and lifecycle surveillance. India applies the Medical Devices Rules, 2017, supplemented by CDSCO's July 2026 medical device software guidance. Major challenges include differences in classification, variability in clinical evidence transparency, software change management, cybersecurity obligations and post-market performance monitoring. Conclusion: Regulatory convergence should prioritise common software terminology, risk-proportionate clinical evidence, harmonised technical documentation and lifecycle-oriented surveillance rather than identical national approval procedures. Supplementary DTx-specific guidance could strengthen India's regulatory preparedness while facilitating international alignment.