Regulatory Compliance Framework
Indian Healthcare Laws and Standards ComplianceCompliance Overview
The Maternal Health AI Platform operates under comprehensive regulatory compliance with Indian healthcare laws, data protection regulations, and international quality standards. This document outlines our adherence to all applicable legal frameworks.
Clinical Establishments Act
Act: Clinical Establishments (Registration and Regulation) Act, 2010
Rules: Telangana Clinical Establishments Rules, 2013
Status: Fully Compliant
Certificate: CE/TG/2024/MH-001
Valid Until: 31/12/2025
Data Protection
IT Act: Information Technology Act, 2000
Rules: Information Technology (Reasonable security practices) Rules, 2011
PDP Bill: Personal Data Protection Bill, 2019 (Draft Compliance)
Status: Substantially Compliant
Last Audit: 15/05/2024
Telemedicine Compliance
Guidelines: Telemedicine Practice Guidelines, 2020
MCI Regulations: Medical Council of India Regulations
Status: Fully Compliant
Registration: TM/TG/2024/SHC-001
Quality Standards
ISO 27001: Information Security Management
ISO 13485: Medical Devices Quality Management
NABH Standards: National Accreditation Board for Hospitals
Status: In Progress
Detailed Compliance Framework
Registration Requirements
- Registered under Clinical Establishments Act, 2010
- Compliance with Telangana Clinical Establishments Rules, 2013
- Valid license for healthcare service provision
- Regular inspections and compliance audits
Healthcare Service Standards
- Qualified medical professionals with valid registrations
- Adherence to medical protocols and guidelines
- Infection control and safety measures
- Patient rights and grievance mechanisms
Information Technology Act, 2000
- Reasonable security practices and procedures
- Data localization requirements for health data
- Breach notification procedures
- Cybersecurity framework implementation
Personal Data Protection Bill, 2019 (Draft Compliance)
- Consent management systems
- Data minimization principles
- Purpose limitation and data retention
- Cross-border data transfer restrictions
Telemedicine Practice Guidelines, 2020
- Doctor-patient relationship establishment
- Prescription guidelines for telemedicine
- Emergency care protocols
- Documentation and record-keeping requirements
Medical Council of India Regulations
- Professional conduct and ethics
- Continuing medical education requirements
- Malpractice insurance obligations
- Cross-state practice regulations
Responsible AI Framework
- Algorithmic transparency and explainability
- Bias detection and mitigation protocols
- Human oversight and intervention mechanisms
- Continuous monitoring and evaluation
Medical AI Validation
- Clinical validation studies
- Performance metrics and benchmarking
- Safety and efficacy assessments
- Regular model retraining and updates
Audit and Compliance Reports
| Compliance Area | Last Audit Date | Status | Next Review | Certificate/Registration |
|---|---|---|---|---|
| Clinical Establishments | 15/03/2024 | Compliant | 15/03/2025 | CE/TG/2024/MH-001 |
| Data Protection | 15/05/2024 | Substantially Compliant | 15/11/2024 | DP-AUDIT-2024-05 |
| Telemedicine | 01/04/2024 | Compliant | 01/04/2025 | TM/TG/2024/SHC-001 |
| ISO 27001 | 20/02/2024 | In Progress | 20/08/2024 | ISO-27001-2024-PRE |
| NABH Standards | 10/01/2024 | Assessment Phase | 10/07/2024 | NABH-ASSESS-2024-01 |
Regulatory Authority Contacts
Telangana State Health Department
Address: Secretariat, Hyderabad, Telangana
Phone: +91-40-2345-1234
Email: health@telangana.gov.in
Website: health.telangana.gov.in
Medical Council of India
Address: Pocket 14-15, Sector 8, Dwarka, New Delhi
Phone: +91-11-2589-3333
Email: mciindia@gmail.com
Website: mciindia.org
Compliance Commitment
SHC Technologies Pvt. Ltd. is committed to maintaining the highest standards of regulatory compliance. We conduct regular internal audits, engage with regulatory authorities, and continuously update our practices to ensure full adherence to all applicable laws and regulations.
Document Prepared By: Legal & Compliance Team
Last Updated: 07/06/2025
Next Review Date: 07/12/2025