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1. INTRODUCTION

DigiDxDoc Health Solutions Private Limited ("DigiDxDoc," "we," "us," or "our") is committed to protecting the privacy and security of personal and health information. As a provider of digital pathology and radiology products (hardware, software, AI solutions) and services (detailed in services section in the website), we recognize the critical importance of maintaining the highest standards of data protection in healthcare.

This Privacy Policy describes how we collect, use, store, and protect your information in compliance with applicable privacy and healthcare regulations worldwide.

2. REGULATORY COMPLIANCE

This Privacy Policy ensures compliance with:

    General Data Protection Regulation (GDPR) - EU/EEA

    Health Insurance Portability and Accountability Act (HIPAA) - United States

    Personal Data Protection Act (PDPA) - Various jurisdictions

    Medical Device Regulations - FDA (US), CE Marking (EU), Health Canada

    Good Clinical Practice (GCP) guidelines

    ISO 27799 - Health informatics security management

    Local healthcare data protection laws in jurisdictions where we operate

3. DEFINITIONS

Controller: DigiDxDoc Health Solutions Private Limited, the entity that determines the purposes and means of processing personal data.

Processor: Third-party entities that process personal data on our behalf under our instructions.

Personal Data: Any information relating to an identified or identifiable individual.

Health Data/PHI: Protected Health Information including medical records, diagnostic images, pathology slides, test results, and any health-related information that can identify an individual.

Genetic Data: Personal data relating to inherited or acquired genetic characteristics of an individual.

Biometric Data: Personal data resulting from specific technical processing relating to physical, physiological, or behavioural characteristics.

Data Subject: The individual whose personal data is being processed.

Medical Device Data: Data generated, collected, or processed by our medical devices and software solutions.

4. SCOPE AND APPLICATION

This Privacy Policy applies to all processing of personal data by DigiDxDoc across our service offerings:

4.1 Technology Products

• Hardware deployment and maintenance

• Software licensing and support

• AI model development and deployment

• System integration services

4.2 Digital Pathology Services

• Telepathology consultations and second opinions

• Digital slide scanning and analysis

• AI-assisted diagnostic support

• Pathology reporting and case management

4.3 Digital Radiology Services

• Medical imaging analysis and interpretation

• Radiological consultations

• AI-powered image enhancement and analysis

• Radiology reporting services

4.4 Biopharma Services

• Sample processing and analysis

• Clinical trial support

• Research data management

• Biomarker analysis

4.5 Website and Digital Platforms

• Website interactions (www.digidxdoc.com)

• Customer portals and dashboards

• Mobile applications

• Marketing communications

5. CATEGORIES OF PERSONAL DATA COLLECTED

5.1 General Personal Data

Identity Information: Name, contact details, professional credentials

Technical Data: IP addresses, device information, system logs

Communication Data: Email correspondence, chat logs, support tickets

Financial Data: Billing information, payment details (processed by certified payment processors)

5.2 Health and Medical Data

Diagnostic Images: Pathology slides, radiology images, microscopy data

Medical Records: Patient history, symptoms, clinical notes

Diagnostic Reports: Pathology reports, radiology interpretations, second opinions

Genetic Information: Genomic data, biomarker information, hereditary data

Biometric Data: Image analysis results, morphometric measurements

5.3 Research and Development Data

Clinical Trial Data: Study participant information, trial results

AI Training Data: Anonymized datasets for machine learning model development

Performance Metrics: Diagnostic accuracy data, system performance indicators

Research Analytics: Statistical analyses, outcome measurements

5.4 Operational Data

User Activity: System usage patterns, feature utilization

Quality Metrics: Turnaround times, accuracy measurements

Audit Logs: Access records, system modifications, security events

6. SOURCES OF DATA COLLECTION

6.1 Direct Collection

Patient Portals: Information provided directly by patients

Healthcare Providers: Data submitted by referring physicians and institutions

User Registration: Account creation and profile setup

Service Requests: Consultation requests and case submissions

6.2 Indirect Collection

Partner Institutions: Healthcare organizations, laboratories, research centers

Medical Devices: Automated data collection from diagnostic equipment

Third-Party Systems: Integration with hospital information systems, PACS

Public Sources: Medical literature, published research (for AI training)

6.3 Automated Collection

System Logs: Technical performance and security monitoring

Device Telemetry: Equipment performance and maintenance data

Usage Analytics: Platform interaction and feature utilization

Quality Monitoring: Automated quality control measurements

7. PURPOSES OF PROCESSING AND LEGAL BASES

7.1 Healthcare Service Delivery

Purpose: Providing diagnostic services, consultations, and medical opinions

Legal Basis:

• Legitimate interest in healthcare delivery

• Consent for specific services

• Vital interests for emergency diagnostics

• Legal obligation under healthcare regulations

7.2 Research and Development

Purpose: AI model development, clinical research, product improvement

Legal Basis:

• Explicit consent for research participation

• Legitimate interest in medical advancement

• Compliance with research ethics approvals

7.3 Regulatory Compliance

Purpose: Meeting healthcare regulations, quality assurance, audit requirements

Legal Basis:

• Legal obligation under healthcare laws

• Compliance with medical device regulations

• Professional standards adherence

7.4 Business Operations

Purpose: Customer support, billing, contract management

Legal Basis:

• Contract performance

• Legitimate interest in business operations

• Legal obligation for financial record-keeping

8. CONSENT MANAGEMENT

8.1 Layered Consent Structure

We implement granular consent mechanisms allowing individuals to choose:

Essential Services: Core diagnostic and consultation services

Enhanced Analytics: AI-powered diagnostic assistance

Research Participation: Contribution to medical research and AI development

Marketing Communications: Educational content and service updates

Data Sharing: Collaboration with research institutions and partners

8.2 Consent Withdrawal

You may withdraw consent at any time through:

Patient Portal: Online consent management dashboard

Written Request: Email or postal communication

Healthcare Provider: Through your referring physician

Direct Contact: Our Data Protection Officer

Important: Withdrawal of consent may impact our ability to provide certain services, particularly ongoing medical consultations.

8.3 Emergency Situations

In urgent medical situations, we may process data based on vital interests without explicit consent, in accordance with healthcare emergency protocols.

9. DATA SHARING AND RECIPIENTS

9.1 Internal Recipients

Medical Professionals: Pathologists, radiologists, clinical specialists

Technical Teams: IT support, system administrators (with appropriate access controls)

Quality Assurance: Teams responsible for service quality and compliance

Research Teams: For approved research projects (with appropriate safeguards)

9.2 External Healthcare Partners

Referring Physicians: Diagnostic reports and clinical recommendations

Healthcare Institutions: Partner hospitals, clinics, and laboratories

Specialist Consultants: External medical experts for complex cases

Laboratory Networks: For additional testing or confirmation

9.3 Service Providers

Cloud Infrastructure: Certified healthcare cloud providers (AWS HIPAA, Azure Health)

Technology Partners: Medical device manufacturers, software developers

Support Services: Technical support, maintenance providers

Professional Services: Legal, audit, compliance consultants

9.4 Research Collaborators

Academic Institutions: Universities and research centers

Biopharma Companies: For clinical trial support and drug development

Medical Societies: For clinical guidelines and best practice development

Regulatory Bodies: For post-market surveillance and safety monitoring

9.5 Legal and Regulatory

Regulatory Authorities: FDA, EMA, local health authorities

Legal Authorities: Courts, law enforcement (with appropriate legal process)

Accreditation Bodies: For quality certification and compliance verification

Data Sharing Safeguards:

• All recipients are bound by confidentiality agreements

• Data sharing agreements include appropriate technical and organizational measures

• Access is limited to the minimum necessary for the specified purpose

• Regular audits ensure compliance with data sharing agreements

10. INTERNATIONAL DATA TRANSFERS

10.1 Data Residency

EU/EEA Data: Primarily stored in EU-based data centres

US Data: Stored in HIPAA-compliant US facilities

Multi-jurisdictional: Replicated across regions for business continuity

10.2 Transfer Safeguards

When transferring data internationally, we implement:

Adequacy Decisions: Utilizing European Commission adequacy findings

Standard Contractual Clauses (SCCs): For transfers to non-adequate countries

Binding Corporate Rules: For intra-group transfers

Certification Schemes: Healthcare-specific data protection certifications

10.3 Cross-Border Consultations

For international medical consultations:

• Explicit consent for cross-border data sharing

• Equivalent privacy protection guarantees

• Secure transmission protocols

• Clear data retention and deletion timelines

11. AI AND AUTOMATED DECISION-MAKING

11.1 AI-Assisted Diagnostics

Our AI systems provide:

Diagnostic Support: Assistance to medical professionals (not replacement)

Image Analysis: Pattern recognition and abnormality detection

Risk Assessment: Statistical analysis and outcome prediction

Quality Enhancement: Image optimization and artifact reduction

11.2 Human Oversight

• All AI-generated outputs are reviewed by qualified medical professionals

• Final diagnostic decisions always require human validation

• Patients have the right to request human-only analysis

• Clear distinction between AI assistance and human interpretation

11.3 AI Model Training

Data Minimization: Only necessary data used for training

Anonymization: Personal identifiers removed from training datasets

Bias Prevention: Regular testing for algorithmic bias and fairness

Performance Monitoring: Continuous evaluation of model accuracy and reliability

11.4 Transparency Rights

You have the right to:

• Know when AI is used in your diagnostic process

•Understand the logic and potential consequences of AI assistance

• Request human review of AI-generated recommendations

• Access information about AI model performance and limitations

12. DATA SECURITY MEASURES

12.1 Technical Safeguards

Encryption: AES-256 encryption for data at rest and in transit

Access Controls: Multi-factor authentication, role-based access

Network Security: Firewalls, intrusion detection, VPN access

Backup Systems: Encrypted, geographically distributed backups

12.2 Organizational Measures

Staff Training: Regular privacy and security awareness programs

Access Management: Principle of least privilege, regular access reviews

Incident Response: 24/7 security monitoring and response procedures

Vendor Management: Due diligence and ongoing monitoring of service providers

12.3 Healthcare-Specific Security

HIPAA Compliance: Administrative, physical, and technical safeguards

Medical Device Security: FDA cybersecurity guidelines implementation

Audit Logging: Comprehensive tracking of all data access and modifications

Business Associate Agreements: Contractual protections with all service providers

12.4 Physical Security

Data Centers: Biometric access controls, environmental monitoring

Equipment Security: Device encryption, secure disposal procedures

Facility Protection: Access controls at all DigiDxDoc locations

Transport Security: Secure courier services for physical media

13. DATA RETENTION

13.1 General Retention Principles

Minimum Necessary: Data retained only as long as required for specified purposes

Legal Compliance: Adherence to healthcare record retention requirements

Active Deletion: Automated deletion processes after retention periods

Anonymization: Conversion to anonymous data for long-term research use

13.2 Specific Retention Periods

Diagnostic Records:

• Patient diagnostic reports: 10 years (or as required by local law)

• Medical images and slides: 7 years minimum

• Emergency consultation records: As required by applicable healthcare laws

Research Data:

• Clinical trial data: As required by regulatory authorities (typically 15–25 years)

• AI training datasets: Until model retirement or regulatory requirement

• Published research data: Indefinitely in anonymized form

Operational Data:

• User account information: 3 years after account closure

• System logs: 1 year for security logs, 3 months for operational logs

• Communication records: 3 years for service-related communications

Financial Records:

• Billing and payment data: 7 years as required by financial regulations

• Contract and agreement records: Duration of contract plus 7 years

13.3 Deletion Procedures

Secure Deletion: NIST-compliant data destruction methods

Backup Purging: Removal from all backup systems

Third-Party Notification: Instruction to service providers for data deletion

Verification: Confirmation of successful data deletion

14. YOUR RIGHTS

14.1 Access Rights

Data Access: Copy of all personal data we hold about you

Processing Information: Details about how and why we process your data

Source Information: Where we obtained your data

Sharing Details: Who we've shared your data with

14.2 Correction and Updating

Data Accuracy: Right to correct inaccurate personal data

Completeness: Right to complete incomplete data

Medical Records: Right to add clarifications to medical records

Urgent Updates: Expedited processing for medically relevant corrections

14.3 Deletion Rights

Right to Erasure: Deletion of personal data under certain circumstances

Medical Records: Subject to legal retention requirements

Research Data: May be anonymized rather than deleted

Active Treatments: Deletion may be delayed for ongoing medical care

14.4 Processing Restrictions

Temporary Restriction: Pause processing while disputes are resolved

Selective Restriction: Limit processing to specific purposes

Medical Continuity: Essential medical services may continue

Legal Obligations: Processing may continue where legally required

14.5 Data Portability

Format: Machine-readable format for personal data

Medical Records: Standard healthcare formats (HL7 FHIR, DICOM)

Direct Transfer: To another healthcare provider where feasible

Scope: Limited to data provided directly by you

14.6 Objection Rights

Direct Marketing: Absolute right to opt-out

Processing Purposes: Right to object to specific processing activities

Research Participation: Right to withdraw from research studies

AI Processing: Right to request human-only analysis

14.7 Automated Decision-Making

Human Review: Right to human intervention in automated decisions

Explanation: Right to understand the logic of automated processing

Challenge: Right to contest automated decisions

Alternative Processing: Right to request manual processing

15. EXERCISING YOUR RIGHTS

15.1 How to Make Requests

Email: info@digidxdoc.com

Postal Address: DigiDxDoc Health Solutions Private Limited, Attention: Data Protection Officer
[3rd floor, 196/A, 4th Cross Rd, KHB Colony, 5th Block, Koramangala, Bangalore, Karnataka 560095 ]

Phone: 1800 8899 868

15.2 Request Requirements

Identity Verification: Government-issued ID or equivalent

Specific Request: Clear description of the right you wish to exercise

Relevant Information: Case numbers, dates, or other identifying information

Medical Proxy: Authorization for representatives or family members

15.3 Response Timeframes

Standard Requests: 30 days from receipt of valid request

Complex Requests: May be extended by 60 days with notification

Urgent Medical Requests: Within 48 hours where medically necessary

Free of Charge: No fee for reasonable requests

15.4 Request Limitations

We may decline requests that are:

• Manifestly unfounded or excessive

• Prohibited by law or regulation

• Inconsistent with ongoing medical treatment

• Technically impossible to fulfil

16. CHILDREN'S PRIVACY

16.1 Age Limitations

Our services are not intended for children under 13 years of age. We do not knowingly collect personal data from children under 13 without parental consent.

16.2 Pediatric Medical Services

For medical services involving minors:

Parental Consent: Required for children under 18 (or local age of majority)

Mature Minor Doctrine: Applied where legally recognized

Guardian Authorization: For children under legal guardianship

Emergency Treatment: Vital interests protection for urgent medical care

16.3 Parental Rights

Parents and legal guardians have the right to:

• Access their child's medical information

• Request correction of inaccurate data

• Withdraw consent for non-essential services

• Receive copies of privacy notices and consents

17. BREACH NOTIFICATION

17.1 Incident Response

In the event of a data breach:

Internal Assessment: Immediate risk evaluation and containment

Regulatory Notification: Within 72 hours to relevant authorities

Individual Notification: When high risk to rights and freedoms

Remedial Actions: Steps to mitigate potential harm

17.2 Notification Content

Breach notifications will include:

Nature of Breach: Types of data involved and circumstances

Potential Impact: Likely consequences for affected individuals

Measures Taken: Steps to address the breach and prevent recurrence

Contact Information: How to get more information and assistance

17.3 High-Risk Scenarios

We will notify individuals directly when breaches involve:

• Sensitive health data

• Financial information

• Identity theft risk

• Potential physical harm

• Discrimination risk

18. DATA PROTECTION OFFICER

18.1 Contact Information

Data Protection Officer, DigiDxDoc Health Solutions Private Limited

Email: dpo@digidxdoc.com

18.2 DPO Responsibilities

Our DPO is responsible for:

Privacy Compliance: Monitoring adherence to privacy laws

Training Programs: Staff education on data protection

Impact Assessments: Conducting privacy impact assessments

Stakeholder Communication: Liaison with regulators and individuals

18.3 Independent Authority

Our Data Protection Officer operates independently and reports directly to senior management, ensuring unbiased privacy oversight.

19. SUPERVISORY AUTHORITY

19.1 Complaint Rights

You have the right to lodge complaints with relevant supervisory authorities:

European Union: Your local Data Protection Authority

United States: Department of Health and Human Services (HIPAA complaints)

Other Jurisdictions: Local privacy commissioners or data protection authorities

19.2 Complaint Process

Before filing complaints with supervisory authorities, we encourage you to contact us directly so we can address your concerns promptly.

20. BUSINESS TRANSFERS

In the event of a merger, acquisition, or sale of assets:

Advance Notice: 30 days' notice to affected individuals

Privacy Protection: Successor entity bound by this Privacy Policy

Opt-Out Rights: Opportunity to object to the transfer

Data Deletion: Option to have data deleted rather than transferred

21. PRIVACY BY DESIGN

21.1 System Development

We integrate privacy considerations into:

Product Design: Privacy-friendly default settings

System Architecture: Data minimization and purpose limitation

Feature Development: Privacy impact assessments for new features

Third-Party Integration: Privacy evaluation of all integrations

21.2 Ongoing Monitoring

Regular Audits: Annual privacy compliance reviews

Risk Assessments: Continuous evaluation of privacy risks

Training Updates: Regular staff training on privacy requirements

Policy Reviews: Annual review and update of privacy policies

22. SERVICE-SPECIFIC PRIVACY NOTICES

22.1 Telepathology Services

Additional Considerations:

• Real-time video consultations may be recorded for quality assurance

• Digital slides may be stored for comparative analysis

• Cross-jurisdictional consultations subject to additional safeguards

22.2 AI-Powered Diagnostics

Additional Considerations:

• AI model training may use anonymized historical data

• Performance monitoring may involve statistical analysis

• Updates to AI models may affect processing methods

22.3 Research and Clinical Trials

Additional Considerations:

• Extended retention periods for regulatory compliance

• Potential publication of anonymized results

• International collaboration may involve data transfers

22.4 Biopharma Services

Additional Considerations:

• Strict confidentiality due to proprietary research

• Regulatory reporting requirements

• Long-term follow-up may be required

23. UPDATES TO THIS POLICY

23.1 Notification Process

We will notify you of significant changes through:

Email Notification: To registered users

Website Notice: Prominent display on our website

Service Notifications: In-app or portal notifications

Direct Mail: For material changes affecting your rights

23.2 Effective Date

Changes become effective 30 days after notification, unless:

Legal Requirements: Immediate compliance required

Enhanced Protections: Beneficial changes may be implemented immediately

User Consent: Additional consent required for expanded processing

24. CONTACT INFORMATION

24.1 General Inquiries

DigiDxDoc Health Solutions Private Limited

Website: www.digidxdoc.com

Email: info@digidxdoc.com

Phone: 1800 8899 868

24.2 Privacy-Specific Contacts

Privacy Questions: privacy@digidxdoc.com

Data Protection Officer: dpo@digidxdoc.com

Security Issues: security@digidxdoc.com

Patient Portal Support: support@digidxdoc.com

25. ACKNOWLEDGMENT

By using our services, you acknowledge that you have read, understood, and agree to this Privacy Policy. If you do not agree with any part of this policy, please do not use our services or contact us to discuss your concerns.

This Privacy Policy represents our commitment to protecting your privacy while delivering exceptional healthcare services. We encourage you to contact us with any questions or concerns about our privacy practices.

This document is available in multiple languages. If you need assistance understanding any part of this Privacy Policy, please contact our Data Protection Officer.