India Regulatory Compliance

DPDP Act Compliance

Artexa guides medical device manufacturers and digital health software providers through India's Digital Personal Data Protection Act, aligning digital health architectures with national regulatory mandates.

100%

Health Data Lineage

2023

Act Enforcement Ready

Regulatory Scope

DPDP Impact on Medical Software

Software as a Medical Device processes sensitive patient health records, placing digital diagnostics under stringent data processing obligations enforced by the Data Protection Board of India.

Consent Architecture

Health Data Governance

Data Principal Rights

Explicit, verifiable consent mechanisms must be integrated directly into medical app onboarding, allowing patients granular control over clinical telemetry and personal health metrics.

Processing patient data mandates strict purpose limitation, data minimization, and secure audit logging across cloud servers, IoT monitors, and point-of-care diagnostic tools.

Medical platforms must build automated mechanisms for patients to access, rectify, or erase diagnostic logs, requiring deep integration with underlying software pipelines.

Artexa Solutions

DPDP Compliance Services

Our specialized medtech regulatory advisory bridges software engineering with legal data privacy requirements tailored specifically for Indian medical software vendors.

Audit & Strategy
Risk Management
Engineering Support

DPDP Readiness Assessment

DPIA for SaMD Platforms

Consent Workflow Design

Comprehensive evaluation of software architecture, data processing flows, consent mechanics, and vendor contracts against DPDP Act legal provisions.

Data Protection Impact Assessments tailored specifically for medical software, evaluating algorithmic privacy risks and clinical data safeguards.

Architecting compliant, legal-grade consent workflows and privacy notices directly into web, mobile, and embedded medical device software interfaces.

Structured Execution

Four Steps to DPDP Compliance

01
02
03
04

Data Flow Mapping

Gap & Risk Analysis

Architecture Remediation

Governance Setup

Cataloging personal health data ingress, storage, processing, and third-party API integrations across your software ecosystem.

Evaluating clinical data practices against DPDP Act legal parameters and CDSCO software validation mandates.

Implementing privacy-by-design frameworks, dynamic consent controls, and encrypted user audit logging.

Establishing Data Protection Officer oversight, breach response protocols, and ongoing regulatory documentation.

Regulatory Advisory

Schedule a DPDP Consultation

Speak with Artexa regulatory specialists to evaluate your digital health software or medical platform against India's DPDP Act requirements.

Address

New Delhi

Patna

Hyderabad

Contacts

+91 99051 95325
Contact@artexaglobal.com