Article
From Innovation to Market: Legal and Regulatory Challenges in Digital Health Entrepreneurship
Digital health entrepreneurship has expanded the routes through which software, connected devices, telehealth platforms, digital therapeutics and artificial intelligence-enabled tools enter healthcare. Unlike general consumer technology, products used for diagnosis, treatment, monitoring or clinical decision support may encounter overlapping requirements for medical-device regulation, clinical evidence, data protection, cybersecurity, professional responsibility and reimbursement. This narrative review examines the principal legal and regulatory challenges that arise as digital health ventures move from an initial concept to market adoption, with particular reference to India, the United States and the European Union. A targeted search of open-access peer-reviewed literature and publicly available regulatory documents was undertaken, prioritising material published or updated from 2017 to August 2026. The evidence indicates that regulatory difficulty is rarely confined to a single approval decision. Intended purpose and product claims may determine whether software is regulated as a medical device; evidence and quality systems influence market authorisation; privacy and cybersecurity obligations shape data architecture; and reimbursement, procurement and interoperability affect adoption after regulatory entry. Artificial intelligence-enabled products add questions concerning dataset relevance, software modification and post-market performance. India has strengthened its framework through the Medical Devices Rules, specific 2026 guidance on medical device software, the Digital Personal Data Protection framework and the Ayushman Bharat Digital Mission. The United States and European Union provide different but similarly layered regulatory pathways. For entrepreneurs, early integration of regulatory, clinical, technical and commercial planning may reduce avoidable redesign and improve readiness for market entry. Regulation is therefore better treated as a lifecycle consideration than as a final compliance step.