Cardiac AI & Device Procurement: Trust & Regulation

𝐁𝐮𝐲𝐢𝐧𝐠 𝐓𝐫𝐮𝐬𝐭, 𝐍𝐨𝐭 𝐉𝐮𝐬𝐭 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲: 𝐖𝐡𝐚𝐭 𝐈𝐧𝐝𝐢𝐚'𝐬 𝐂𝐚𝐫𝐝𝐢𝐚𝐜 𝐏𝐫𝐨𝐠𝐫𝐚𝐦𝐬 𝐌𝐮𝐬𝐭 𝐀𝐬𝐤 𝐨𝐟 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 𝐚𝐧𝐝 𝐀𝐈

India's cardiac care programmes are moving beyond pilot projects. As STEMI hub-and-spoke networks connect smaller hospitals with specialist cardiac centres, the reliability of every ECG device and diagnostic algorithm becomes critical.

With 22 years of experience across medical devices, diagnostics, AI/ML-based Software as a Medical Device (SaMD) and digital health, Dr. Muthu Dhandapani, Vice President - Quality & Regulatory Affairs at Tricog Health India, highlights a fundamental challenge: when technology scales across thousands of facilities, a device-level risk can become a system-level risk.

Before adopting AI, healthcare leaders must assess whether it has been validated in relevant Indian populations, whether its intended use is clearly defined, how patient data is protected, and who is accountable for acting on its outputs.

Software updates and real-world performance also require continuous monitoring.

These safeguards are essential to ensure that AI supports clinical decisions without compromising patient safety.

The same rigour must guide procurement. Buyers should verify the applicable CDSCO authorisation, intended use, clinical evidence, quality standards and provisions for maintenance and software updates.

Regulatory authorisation and health technology assessment must work together: one addresses regulatory requirements for safety and performance, while the other evaluates whether a technology offers sufficient clinical and economic value for large-scale adoption.

Accountability must continue after deployment. India's Materiovigilance Programme, coordinated by the Indian Pharmacopoeia Commission, provides a mechanism for reporting and analysing medical device safety issues. Integrating such reporting into state programme dashboards could help identify emerging risks and support timely corrective action.

For India's cardiac care programmes, two priorities stand out: make verification of applicable regulatory authorisation mandatory in procurement, and integrate medical device safety reporting into programme monitoring.

Scaling cardiac care does not necessarily require new regulations; it requires existing safeguards to be applied consistently. Technology can expand access to care, but evidence, regulatory discipline and accountability are what make that expansion trustworthy.

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