ISO & Healthcare Compliance for Hospitals, Pharma & Health-Tech in India

HIPAA is a US law and is not directly mandatory for Indian hospitals unless they handle protected health information (PHI) of US patients — common in medical tourism, telemedicine with US-based patients, or health-data outsourcing. We help you assess your HIPAA exposure and implement required controls.

ISO 9001 provides the QMS framework that underpins WHO GMP, Schedule M and export regulatory compliance. Many pharma exporters use ISO 9001 certification as the baseline quality signal for international buyers and distributors.

At minimum, ISO 27001 (for patient data security) and alignment with India's DPDP Act 2023. If processing data of EU or US patients, GDPR and HIPAA applicability must also be assessed. ISO 42001 is relevant for AI-driven clinical decision tools.

Yes. We provide integrated QMS consulting that covers both ISO 9001 and ISO 15189 (medical laboratory) requirements, minimizing duplication and audit burden for diagnostic labs and pathology centers.