GDPR COMPLIANCE FOR MEDICAL DEVICE AND DIGITAL HEALTH TECHNOLOGY PROVIDERS

Privacy Policy for Medical Device and Digital Health Technology Providers

Effective: 1 May 2025

1. Introduction

We, the (“Entity”), process personal data in compliance with the General Data Protection Regulation (EU) 2016/679 (“GDPR”), the Medical Devices Regulation (EU) 2017/745, and applicable health technology laws. This policy outlines how we handle personal data collected through medical devices, health apps, and connected platforms.

2. Data Controller

The Entity is the Data Controller for data collected through direct sales, embedded software, connected services, or post-market surveillance. In cases of integration with healthcare providers, Joint Controller roles are clearly defined (Art. 26 GDPR).

3. What Personal Data We Collect

Depending on the product or service, we may process:

• Identification Data: Name, account ID, device serial number

• Health Data: Device usage logs, physiological measurements (e.g., heart rate, glucose, oxygen saturation)

• Technical and Sensor Data: Timestamped readings, user settings, environmental data

• Communication Logs: Customer support interactions, feedback

• Diagnostic and Maintenance Data: Internal logs, fault reports, software updates

• Children’s Data: Collected only where explicitly enabled by product configuration and with guardian consent

For implanted or Class III devices, data collection is carefully minimized and segregated.

4. Lawful Basis for Processing

Processing may be based on:

• Consent (Art. 6(1)(a), 9(2)(a)) – for digital health app accounts and advanced analytics

• Contractual Necessity (Art. 6(1)(b)) – for device delivery and support

• Legal Obligation (Art. 6(1)(c)) – post-market surveillance, MDR compliance

• Public Interest in Healthcare (Art. 9(2)(i)) – for population-level alerts

• Legitimate Interests (Art. 6(1)(f)) – product improvement, with minimized impact

5. Purposes of Data Processing

Data may be used to:

• Provide core medical functions and diagnostics

• Facilitate real-time monitoring and alerts

• Troubleshoot or improve device performance

• Comply with mandatory safety and effectiveness tracking

• Support post-market clinical follow-up (PMCF)

• Offer training, education, and customer support

6. Data Sharing and Recipients

We may share data with:

• Healthcare providers (if device is part of clinical care)

• Cloud service and software platform providers

• Regulatory authorities (e.g., notified bodies, EMA)

• Partners for joint development or support (under Article 28 contracts)

• Maintenance teams for servicing or device updates

No data is sold to marketers or advertisers.

7. Data Retention

• Device Data: Retained for the lifecycle of the device + 10 years (as per MDR)

• User Accounts: Until deactivation or as per local laws

• Support Tickets: Typically retained for 3–5 years

Anonymized data may be used for long-term studies or risk analysis.

8. Data Subject Rights

You have rights under GDPR:

• Access (Art. 15)

• Rectification (Art. 16)

• Erasure (Art. 17), with limitations for MDR compliance

• Restriction (Art. 18)

• Portability (Art. 20)

• Objection (Art. 21)

• Withdraw consent (Art. 7(3))

Contact our Data Protection Officer: [DPO Contact Information]

9. International Transfers

Data may be transferred outside the EEA only under:

• EU Standard Contractual Clauses (SCCs)

• Adequacy decisions

• Vendor risk assessments and encryption policies

10. Data Security

We employ:

• On-device encryption and secure boot

• Encrypted transmission and data-at-rest protocols

• Multi-layer authentication and secure APIs

• Security audits aligned with ISO 27001 and IEC 62304 standards

11. Data Breach Notification

Notifiable incidents will be reported within 72 hours to relevant Supervisory Authorities and users, depending on risk.

12. Automated Decision Making

Devices may automate measurements or alerts, but no legally significant decisions are made without user or clinician confirmation.

13. Data Protection Impact Assessments (DPIA)

DPIAs are conducted for:

• Implantable or AI-powered devices

• Remote patient monitoring systems

• High-risk consumer wearables

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