GDPR COMPLIANCE FOR PHARMACY AND PHARMACEUTICAL SERVICES

Privacy Policy for Pharmacy Services

Effective: 1 May 2025

1. Introduction

We, the (“Entity”), are committed to handling your personal data with care, integrity, and in compliance with the General Data Protection Regulation (EU) 2016/679 (“GDPR”), national pharmacy laws, and the Falsified Medicines Directive. This policy explains how your personal information is processed in the course of providing pharmaceutical care.

2. Data Controller

The Entity acts as the Data Controller for all data processed when dispensing medications and offering pharmaceutical advice.

3. What Personal Data We Collect

We collect and process:

• Identification Data: Name, date of birth, ID or patient number

• Contact Details: Address, phone number, email (for home delivery or alerts)

• Health Data: Prescriptions, medical conditions, allergies, medication history

• Insurance and Payment Data: Insurer information, billing data, receipts

• Medication History: Data on prior and current medications for safety checks

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

We apply data minimization principles and process only data necessary for pharmacy operations and compliance.

4. Lawful Basis for Processing

Your personal data is processed based on:

• Consent (Art. 6(1)(a), Art. 9(2)(a)) – for optional services like reminders or home delivery

• Contractual Necessity (Art. 6(1)(b)) – for filling prescriptions and managing customer accounts

• Legal Obligation (Art. 6(1)(c)) – for regulatory and safety reporting (e.g., traceability)

• Vital Interests (Art. 6(1)(d)) – in emergencies or adverse drug reactions

• Provision of Healthcare (Art. 9(2)(h)) – for dispensing and advising on medicines

5. Purposes of Data Processing

Data is processed to:

• Dispense prescribed and over-the-counter medications

• Conduct drug interaction and contraindication checks

• Maintain medicine records and prescription logs

• Communicate with healthcare providers when needed

• Fulfill legal obligations related to controlled substances and traceability

• Provide reminder and delivery services (with consent)

6. Data Sharing and Recipients

Data may be shared with:

• Prescribing physicians and hospitals

• Health insurance providers and payers

• Wholesalers and distributors (for traceability compliance)

• Pharmacy software and IT service providers

All processors are subject to GDPR-compliant contracts under Article 28. We never sell personal data or use it for unsolicited marketing.

7. Data Retention

Retention periods comply with pharmacy regulations:

• Prescription Records: Retained for at least 10 years or as required by law

• Billing and Insurance Data: Retained for 6 years

• Delivery and Consent Forms: Retained only as long as necessary for service provision

8. Data Subject Rights

You may exercise your GDPR rights:

• Access (Art. 15)

• Correction (Art. 16)

• Erasure (Art. 17), unless restricted by pharmacy law

• Restriction (Art. 18)

• Portability (Art. 20)

• Objection (Art. 21)

• Withdraw consent at any time (Art. 7(3))

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

9. International Transfers

We do not typically transfer data outside the EEA. If required (e.g., for centralized prescription platforms), we ensure appropriate safeguards:

• Standard Contractual Clauses (SCCs)

• BCRs or adequacy decisions

10. Data Security

We apply the following technical and organizational measures:

• Segregated access controls for sensitive prescriptions

• Audit logging for medicine dispensing

• Encrypted patient communication systems

• Secure paper document storage (where applicable)

11. Data Breach Notification

In the event of a breach, we will notify the Supervisory Authority within 72 hours and notify individuals if there is a high risk to their rights.

12. Automated Decision Making

No automated decisions or profiling are used that would significantly affect your rights.

13. Data Protection Impact Assessments (DPIA)

We conduct DPIAs for high-risk processing, especially involving sensitive categories of health data.

14. Cookies and Website 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