GDPR COMPLIANCE FOR DIAGNOSTIC AND PATHALOGY LABS

Privacy Policy for Diagnostic and Pathology Laboratory

Effective: 1 May 2025

1. Introduction

We, the (“Entity”), are committed to processing your personal and health-related data in full compliance with the General Data Protection Regulation (EU) 2016/679 (“GDPR”), relevant health laws, and laboratory standards (e.g., ISO 15189). This policy describes how we handle your data when providing diagnostic testing and related services.

2. Data Controller

The Entity is the Data Controller for personal data collected in the course of diagnostic services.

3. What Personal Data We Collect

We collect and process:

• Identification Data: Name, date of birth, national ID, gender

• Contact Details: Address, email, phone number

• Health and Clinical Data: Test requisitions, biological samples, diagnostic findings, physician referrals

• Sample Metadata: Time of collection, sample type, test parameters

• Payment/Insurance Data: Billing information, insurer details

• Children’s Data: Collected with verified parental or guardian consent

We also process pseudonymized/anonymized data for quality control and research under strict safeguards.

4. Lawful Basis for Processing

We process your data based on:

• Consent (Art. 6(1)(a), Art. 9(2)(a)) – for elective or non-reimbursed tests

• Contractual Necessity (Art. 6(1)(b)) – where testing is part of medical care

• Legal Obligation (Art. 6(1)(c)) – mandatory disease reporting, accreditation compliance

• Vital Interests (Art. 6(1)(d)) – urgent or emergency testing

• Healthcare Provision (Art. 9(2)(h)) – diagnosis and treatment support

• Public Health (Art. 9(2)(i)) – infectious disease monitoring, national health programs

5. Purposes of Data Processing

Your data is used to:

• Conduct diagnostic tests and issue reports

• Communicate results with referring physicians or health authorities

• Ensure traceability and chain-of-custody of specimens

• Maintain quality assurance and accreditation records

• Provide internal training and anonymized research, where applicable

6. Data Sharing and Recipients

We may share data with:

• Healthcare professionals involved in your care

• Public health authorities (e.g., infectious disease surveillance)

• External laboratories or subcontracted test providers (with patient consent or contractual agreement)

• IT system providers (e.g., Laboratory Information Management Systems – LIMS)

All third-party processors are under GDPR-compliant Data Processing Agreements.

7. Data Retention

In line with diagnostic and medical retention rules:

• Test Reports and Metadata: Retained for at least 10 years (or longer for genetic/pathology testing)

• Sample Storage: As specified by test type (e.g., 1–5 years for blood, 20+ for slides/biopsy blocks)

• Consent Forms: Retained as long as linked tests or results are stored

8. Data Subject Rights

You have the right to:

• Access your data (Art. 15)

• Correct errors (Art. 16)

• Request erasure (Art. 17), subject to regulatory limits

• Restrict or object to processing (Art. 18, 21)

• Port your data to another provider (Art. 20)

• Withdraw consent (Art. 7(3))

Requests can be made via the DATA SUBJECT ACCESS REQUESTS below.

9. International Transfers

If a specialized test requires international shipment, your data will only be shared under:

• EU Standard Contractual Clauses

• Adequacy decisions by the European Commission

• Explicit consent, where applicable

10. Data Security

We use:

• Encrypted LIMS and result distribution platforms

• Sample tracking and role-based access systems

• Secure biohazard and sample storage protocols

• Annual risk assessments and penetration testing

11. Data Breach Notification

We notify the Supervisory Authority within 72 hours of any breach involving personal data and inform affected individuals where applicable.

12. Automated Decision Making

Diagnostic tools may support interpretation, but final results are always validated by qualified laboratory professionals.

13. Data Protection Impact Assessments (DPIA)

DPIAs are conducted for:

• Genetic testing programs

• Population screening initiatives

• New IT platforms or lab services

14. Cookies and Tracking

We use cookies and similar tracking technologies strictly for essential website functionality, security, and analytics. No profiling or advertising cookies are used without your prior explicit consent.

15. Complaints

You may lodge a complaint with your Supervisory Authority if you believe your rights are infringed via CONTACT SUPERVISORY AUTHORITY below.

16. Use of Artificial Intelligence (AI) and Automated Tools

We may use Artificial Intelligence (AI) or automated technologies to support the delivery, analysis, or improvement of our services. Any deployment of AI is conducted in accordance with applicable laws, including the GDPR and forthcoming EU AI Act, and is subject to the following safeguards:

• Transparency: Where AI tools are used to process personal data (e.g., chatbots, service optimization, fraud detection), individuals are clearly informed at the point of interaction.

• Human Oversight: All AI-supported functions are subject to human review and final decision-making. No fully automated decisions with legal or similarly significant effects are taken without human intervention.

• Fairness and Accuracy: AI systems used by the Entity are regularly monitored to ensure outputs are non-discriminatory, accurate, and aligned with intended purposes.

• Data Minimization: Personal data used in AI models is limited to what is strictly necessary, and anonymization or pseudonymization is applied wherever feasible.

• Third-Party AI Providers: If AI services are sourced from external vendors, they are required to comply with our data protection standards and are bound by GDPR-compliant agreements (Art. 28).

• Rights of Individuals: Data subjects retain all applicable GDPR rights, including the right to object to automated processing (Art. 21) and to receive meaningful information about the logic and implications of any AI-supported decisions (Art. 22).

This clause will be updated as legal frameworks governing AI continue to evolve.

17. Updates
This policy is reviewed annually and updated to reflect changes in law or service station operations.

We the ENTITY take your privacy seriously and treat your personal information with the same care and respect we would expect for our own. This policy has been developed to comply with relevant data protection laws in our jurisdiction and, where necessary, with those of other applicable regions. If you have any concerns or identify areas where you feel we may not be meeting our responsibilities, please don’t hesitate to get in touch using the contact methods listed at the end of this policy. We are committed to addressing any issues promptly and transparently.

A specialized compliance team has created this policy

1. Data Protection Officer (DPO) – Regulatory Oversight

• Ensures all policies strictly adhere to GDPR principles (lawfulness, transparency, data minimization, etc.)

• Coordinates legal review of lawful basis, data subject rights, international transfers

• Leads DPIA structure and breach protocols

2. Healthcare Compliance Specialist – Clinical & Sector-Specific Accuracy

• Aligns policies for clinics, hospitals, diagnostic labs, and CROs with EU healthcare-specific laws (e.g., MDR, IVDR)

• Validates handling of health data, pseudonymization, and patient consent

3. Cybersecurity Expert – Data Security & Technical Controls

• Reviews and enhances sections on encryption, access controls, breach response

• Assesses vulnerabilities in telemedicine, HealthTech, and device ecosystems

4. Clinical Trials Legal Advisor – Research & Ethics Governance

• Provides expert review of consent models, data minimization, and pseudonymization in CRO/trial sponsor contexts

• Validates retention and secondary use of trial data

5. Insurance & Claims Data Analyst – Financial & Claims Compliance

• Reviews insurance provider policy to ensure lawful processing of medical + financial data

• Checks fraud detection profiling, cross-border reinsurance handling

6. Social Care & Safeguarding Expert – Care Facilities Privacy

• Ensures care home, mental health, and disability service policies reflect safeguarding, social care, and public interest standards

7. Occupational Health Specialist – Employment Health Interface

• Validates lawful employer data access, fitness for work processing boundaries, and health/safety recordkeeping

8. Medical Device Regulatory Consultant – MDR/IVDR Alignment

• Ensures policies for device providers include obligations under EU Medical Device Regulation and post-market surveillance practices

9. Digital Health & AI Legal Advisor – Emerging Tech Compliance

• Checks AI/algorithmic decision-making disclaimers in telemedicine & HealthTech

• Ensures policies reflect EU AI Act intersections where applicable

10. Cross-Border Transfers Specialist – International Data Governance

• Verifies compliance mechanisms for SCCs, BCRs, and adequacy decisions across all entities transferring data internationally