Regulatory & Compliance

Government Approvals & Public Health Integration

MSR Health AI is built from the ground up to comply with CDSCO regulations, MoHFW Telemedicine Guidelines 2020, ABDM data standards, and DPDPA 2023 frameworks.

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Clinical & Hardware Regulatory (CDSCO)

Ensuring medical device safety, calibration, and legal import compliance.

📝 CDSCO MD-14 (Medical Device Import)Phase 0 Filing
📝 KMC API Connectivity (Doctor Verification)API Ready
📝 Ethics Board Review (Data Sets)Per Dataset
📝 ISO 13485:2016 (Device Quality)OEM Compliant
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Digital Public Infrastructure (ABDM)

Fully integrated with India's Ayushman Bharat Digital Mission and data privacy laws.

🔗 ABHA ID Generation & SDK IntegrationBuilt-in Phase 1
🔗 Consent Manager (HIE-CM) ComplianceMandatory
🔗 DPDPA 2023 Section 6 (Data Consent)AWS Mumbai
🔗 MoHFW Telemedicine Guidelines 2020Compliant e-Rx
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Intellectual Property & Patent Strategy

To protect the vast technological moat of this initiative, we are executing a phase-wise patent filing procedure starting from April. This comprehensive IP strategy secures the proprietary technology, hardware design, and integrated business model developed exclusively for the MSR Group.

📝 Hardware Design Patents (Kiosks & Pods)Filing April
📝 AI Diagnostic Algorithms & MSR Connect™ SystemFiling April
Timeline

Phase-Wise Approval & Procurement

Step-by-step strategy to transition from validation to mass government procurement.

Phase 0 — Foundation (Months 1-3)

Legal & Sandbox Clearances

Before physical deployment, laying the regulatory groundwork.

  • AWS Cloud Account & Security Audit: Setup in ap-south-1 (Mumbai) to ensure DPDPA 2023 data sovereignty compliance.
  • ABDM Sandbox Certification: Registering the MSR Connect platform on the National Health Authority (NHA) sandbox.
  • CDSCO MD-14 Filing: Initiating import licenses for hardware under Indian medical device rules.
  • KMC API Integration: Connecting to Karnataka Medical Council to verify RMP credentials natively during doctor onboarding.
Phase 1 — Market Entry (Months 4-7)

Validation & Pilot Implementations

Private deployments within the MSR Hospital network and 5 target rural districts (Ramanagara, Kolar, Tumkur, Mandya, Chikkaballapur).

  • Telemedicine Guidelines Enforced: System mandates synchronous live video for all first-time patient consults as per MoHFW 2020 rules.
  • e-Prescription Restrictions: Platform hard-codes Schedule X and Narcotic drug bans into the doctor's digital prescription pad.
  • Local Assembly Setup: Small-scale assembly of import CKD kits (Complete Knock-Down) in Bengaluru to optimize logistics.
Phase 2 — Scale-Up (Months 8-14)

KIADB Land Allotment & B2G Procurement

Shifting focus to localized manufacturing and government scheme integrations.

  • KIADB Manufacturing Facility: Applying for KIADB (Karnataka Industrial Areas Development Board) industrial land for localized component assembly.
  • PMJAY / Arogya Karnataka Integration: Syncing the platform with state nodal agencies to allow billing under government insurance schemes (unlocking 2.4 crore beneficiaries).
  • B2G Procurement (NHM & ZP): Bidding for district-level Zilla Panchayat tenders and National Health Mission funds for equipping PHCs.
Phase 3 — Full Make in India (Months 15+)

PLI Scheme & Nationwide Tenders

Transitioning to a highly localized, export-ready manufacturing base.

  • PLI Scheme Qualification: Achieving 80-85% domestic content to qualify for the Production Linked Incentive scheme (5% financial incentive).
  • Pan-India Expansion: Partnering with state governments outside Karnataka (e.g., Telangana Phase 2) using successful pilot data as proof of concept.
  • Data & Research Governance: IRB approvals for anonymized population health data sharing with pharmaceutical partners (e.g., Novo Nordisk, Sun Pharma).