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GDPR COMPLIANCE FOR HOSPITAL OR HEALTHCARE INSTITUTION

HEREIN REFERRED TO AS THE (ENTITY)

Privacy Policy for Hospital or Healthcare Institution

Effective: 1 May 2025

1. Introduction

We, the (“Entity”), are committed to protecting the privacy and dignity of our patients, staff, and partners, in accordance with the General Data Protection Regulation (EU) 2016/679 (“GDPR”) and applicable healthcare regulations. This policy outlines how we manage personal data in our clinical and administrative operations.

2. Data Controller

The Entity is the Data Controller as defined by Article 4(7) GDPR and is responsible for all personal data processed within its care network.

3. What Personal Data We Collect

We may collect and process the following:

  • Patient Identification: Full name, date of birth, national ID/passport, medical record number

  • Contact Details: Home address, telephone, email

  • Health & Clinical Data: Medical history, diagnostics, care pathways, prescriptions, allergies, treatment outcomes

  • Admission & Discharge Data: Inpatient and outpatient details, emergency contacts

  • Family & Legal Data: Guardian/consent relationships, next of kin

  • Financial & Insurance Data: Billing, funding sources, claims information

  • Children’s Data: Collected under the lawful consent of parents/guardians

  • Employee Data (if applicable): Medical staff records, job performance, occupational health data

4. Lawful Basis for Processing

We process personal data under:

  • Consent (Art. 6(1)(a), Art. 9(2)(a)) – for elective procedures, research, or special consents

  • Contractual Necessity (Art. 6(1)(b)) – to provide care and services

  • Legal Obligation (Art. 6(1)(c)) – for mandatory health reporting and regulatory compliance

  • Vital Interests (Art. 6(1)(d)) – emergency care

  • Healthcare/Public Interest (Art. 9(2)(h), 9(2)(i)) – provision of medical treatment and management of public health risks

  • Legitimate Interests (Art. 6(1)(f)) – for safety audits, non-marketing communications (supported by documented LIAs)

5. Purposes of Data Processing

We process data to:

  • Deliver clinical treatment and emergency care

  • Maintain complete and accurate patient records

  • Facilitate lab tests, imaging, prescriptions, and referrals

  • Monitor patient outcomes and improve care quality

  • Comply with hospital reporting and public health obligations

  • Conduct medical research (with appropriate ethical approval)

  • Process payments, insurance claims, and audit trails

6. Data Sharing and Recipients

We may share your data with:

  • Licensed physicians and allied health professionals

  • Laboratories and diagnostic services

  • Insurers and public healthcare funders

  • Hospital affiliates and trusted subcontractors

  • Regulators, public health agencies, or the courts (as required by law)

All recipients are bound by strict contractual clauses under GDPR Article 28, with access based on the principle of least privilege.

7. Data Retention

Retention is in line with medical, legal, and regulatory requirements:

  • Patient Records: Retained for a minimum of 15–30 years, depending on national health law

  • Financial Data: Retained for 6 years

  • Imaging & Scans: Retained for the diagnostic and medico-legal period (varies by modality)

8. Data Subject Rights

Under GDPR, you may:

  • Access your data (Art. 15)

  • Rectify inaccuracies (Art. 16)

  • Request erasure (Art. 17)

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

  • Obtain data portability (Art. 20)

  • Withdraw consent (Art. 7(3))

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

9. International Transfers

Transfers outside the EEA are rare but may occur for second opinions or cross-border care. Where applicable, safeguards include:

  • Standard Contractual Clauses (SCCs)

  • Binding Corporate Rules (BCRs)

  • Adequacy decisions by the European Commission

10. Data Security

We maintain high standards of data protection, including:

  • Secure electronic health record systems

  • Role-based access controls and audit logs

  • Encrypted storage and communication channels

  • 24/7 IT monitoring and physical security of medical archives

11. Data Breach Notification

We follow Article 33 and 34 GDPR procedures:

  • Supervisory Authorities are notified within 72 hours

  • Patients are notified where there is a high risk to their rights or freedoms

12. Automated Decision Making

Automated tools may be used for triage support or appointment scheduling, but no legally significant decisions are made without human involvement.

13. Data Protection Impact Assessments (DPIA)

DPIAs are conducted for:

  • New healthcare technologies

  • AI diagnostics or predictive modeling

  • High-risk patient data systems

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

DATA SUBJECT RIGHTS

COMMUNICATION OPTIONS