Healthcare Compliance

1. Introduction

KaeroPrescribe is designed and operated with healthcare compliance at its core. As a healthcare management platform handling sensitive patient information, we adhere to the highest standards of data protection and security, meeting both Indian regulatory requirements and international healthcare standards including HIPAA (Health Insurance Portability and Accountability Act).

This document outlines our compliance framework, security measures, and the safeguards we implement to protect Protected Health Information (PHI) and ensure the integrity of healthcare data processed through our platform.

2. Indian Healthcare Regulatory Compliance

2.1 Information Technology Act, 2000

We comply with:

• Section 43A: Compensation for failure to protect sensitive personal data
• Section 72A: Disclosure of information in breach of lawful contract
• IT (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011

2.2 Digital Personal Data Protection Act, 2023 (DPDP Act)

Our compliance measures include:

• Consent Management: Clear, informed consent mechanisms for all data processing
• Purpose Limitation: Data used only for specified, legitimate purposes
• Data Minimization: Collection limited to what is necessary
• Data Principal Rights: Tools for access, correction, erasure, and portability
• Data Fiduciary Obligations: Robust security and accountability measures
• Cross-border Transfer: Compliance with transfer restrictions to notified countries
• Children's Data: Verifiable parental consent for minors

2.3 Clinical Establishments Act, 2010

• Support for registration and compliance requirements
• Maintenance of minimum standards for healthcare facilities
• Record-keeping as per prescribed formats and durations

2.4 Indian Medical Council Regulations

• Compliance with Professional Conduct, Etiquette and Ethics Regulations, 2002
• Support for telemedicine guidelines (Telemedicine Practice Guidelines, 2020)
• Prescription standards and documentation requirements

2.5 Drugs and Cosmetics Act, 1940

• Schedule H and H1 drug dispensing controls
• Narcotic and psychotropic substance tracking
• Pharmacovigilance reporting capabilities

3. HIPAA Compliance

While HIPAA is a U.S. regulation, we implement HIPAA-compliant safeguards as they represent global best practices for healthcare data protection. For clients handling U.S. patient data or requiring HIPAA compliance, we provide:

3.1 Administrative Safeguards

3.2 Physical Safeguards

3.3 Technical Safeguards

3.4 Business Associate Agreement (BAA)

For organizations requiring HIPAA compliance, we execute Business Associate Agreements that define our obligations as a Business Associate, including PHI handling, breach notification, and subcontractor requirements. Contact compliance@kaerogroup.com for BAA execution.

4. International Standards Compliance

4.1 GDPR Compliance (EU/EEA Users)

For users in the European Union or European Economic Area, we provide:

• Lawful basis for processing (consent, contract, legitimate interests)
• Data subject rights implementation (access, rectification, erasure, portability, objection)
• Data Protection Impact Assessments (DPIA) for high-risk processing
• Standard Contractual Clauses (SCCs) for international transfers
• 72-hour breach notification to supervisory authorities
• Records of processing activities

4.2 ISO 27001 Alignment

Our information security management system aligns with ISO 27001:2022 requirements:

• Information security policies and procedures
• Asset management and classification
• Access control and cryptography
• Operations security and communications security
• Supplier relationships and incident management
• Business continuity management

4.3 HL7 FHIR Standards

We support HL7 FHIR (Fast Healthcare Interoperability Resources) standards for healthcare data exchange, enabling seamless integration with other healthcare systems and ensuring data portability.

5. Security Controls

5.1 Encryption

5.2 Access Controls

• Role-Based Access Control (RBAC): Permissions based on job function and minimum necessary access
• Multi-Factor Authentication (MFA): Required for all users accessing PHI
• Session Management: Automatic timeout after inactivity, secure session handling
• Unique User Identification: Individual accounts with no shared credentials
• Password Policies: Strong password requirements, periodic rotation, no reuse

5.3 Audit Logging

• Comprehensive logging of all access to PHI
• User activity monitoring and anomaly detection
• Immutable audit trails with timestamps
• Log retention for minimum 7 years
• Regular audit log reviews

5.4 Network Security

• Web Application Firewall (WAF)
• Intrusion Detection and Prevention Systems (IDS/IPS)
• DDoS protection
• Network segmentation
• Regular vulnerability scanning and penetration testing

6. Breach Notification

In the event of a security breach affecting PHI, we follow strict notification procedures:

6.1 Indian Law Requirements

• Notification to CERT-In as required under IT Act
• Notification to Data Protection Board as required under DPDP Act
• Notification to affected data principals without unreasonable delay

6.2 HIPAA Requirements (for covered entities)

• Notification to covered entity within 24 hours of discovery
• Support for covered entity's 60-day notification to affected individuals
• Notification to HHS for breaches affecting 500+ individuals

6.3 GDPR Requirements (for EU data subjects)

• 72-hour notification to supervisory authority
• Without undue delay notification to affected individuals (for high-risk breaches)

6.4 Breach Response Process

7. Compliance Verification

7.1 Internal Audits

• Quarterly internal security assessments
• Annual comprehensive compliance audits
• Continuous monitoring and automated compliance checks

7.2 Third-Party Assessments

• Annual third-party security audits
• Regular penetration testing by certified professionals
• Vulnerability assessments and remediation tracking

7.3 Compliance Reports

Enterprise customers may request compliance reports and evidence of security controls. Contact compliance@kaerogroup.com for compliance documentation.

8. Customer Responsibilities

Compliance is a shared responsibility. Healthcare Providers using KaeroPrescribe are responsible for:

9. Data Center and Infrastructure

• Location: Primary data centers in India with geographic redundancy
• Certifications: SOC 2 Type II, ISO 27001 certified data centers
• Physical Security: 24/7 security, biometric access, CCTV surveillance
• Environmental Controls: Redundant power, cooling, fire suppression
• Disaster Recovery: Real-time replication, multiple availability zones
• Uptime SLA: 99.9% availability commitment

10. Data Retention and Disposal

10.1 Retention Periods

10.2 Secure Disposal

• Cryptographic erasure for digital data
• NIST SP 800-88 compliant media sanitization
• Certificate of destruction for physical media
• Documented disposal procedures

11. Training and Awareness

• Mandatory HIPAA/privacy training for all employees
• Role-specific security training
• Annual refresher training and certifications
• Phishing simulation and security awareness programs
• Incident response training and tabletop exercises

12. Contact Information