Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India

The digital transformation of healthcare, driven by electronic health records, together with the IoT-enabled medical devices and AI-driven analytics, has provided the healthcare with more care and innovation but also created unprecedented levels of cybersecurity vulnerabilities in medical informatics ecosystem. Recent incidents, such as ransomware attacks on pharmaceutical companies, breaches at the European Medicines Agency, and the Indian Council of Medical Research, are just a couple of examples of how the incident that was restricted by one jurisdiction can spread to the research, manufacturing, and data networks around the globe. The study gives a comparative overview of cybersecurity regulation across the United States, the European Union, and India, and examines how the three approaches to risk-based, rights-based, and hybrid regulatory models affect the resilience of the system as a whole. The analysis also indicates structural imbalances in breach notification, medical-device regulation and cross-border data management that disrupts global interoperability. The study ends with recommendations on harmonized international standards, secure-by-design, empower breach-response networks, and improved cooperation by WHO, ITU, and GDHP to make the global health cybersecurity resilient. The paper concentrates on the fact that by redefining cybersecurity as a networked socio-technical challenge, there is a need to have collaboratively designed, globally consistent governance policies to protect digital health systems and deliver continuity, trust, and innovation across jurisdictions.