MUMBAI, India, July 13 -- Intellectual Property India has published a patent application (202641083186 A) filed by Vellore Institute Of Technology on July 07, 2026, for A System And Method For Evidence-Anchored Clinical Safety Artefact Generation Using Constrained Claim Synthesis.
Inventors include Dr. V. Sivakumar; A. Mohan Babu; V. Dhivya Shree; and Hemanth R.
The application for the patent was published on July 10, 2026, under issue no. 28/2026.
Abstract: The present disclosure proposes a system (100) and method for generation of clinical safety artefacts from machine-learning model outputs using evidence-anchored claim synthesis, cryptographically verifiable traceability, explainable artificial intelligence (XAI)- based hazard mapping, and constrained evidence-validated generative processing for regulatory compliance in Software as a Medical Device (SaMD) environments under frameworks that include ISO 14971, IEC 62304, FDA SaMD guidance, EU MDR, and related clinical safety governance standards. The system (100) comprises a computing device (102) having a processor (104) and a memory (106). The computing device (102) is configured to execute processor-executed instructions stored in the memory for evidence ingestion, evidence validation, provenance-based evidence management, explainable artificial intelligence processing, evidence-linked regulatory evidence-validated claim processing, cryptographic traceability generation, and integrity-controlled evidence-bound clinical safety artefact generation.
Disclaimer: Curated by HT Syndication.
