UIZ.CARE Pilot Project – Frequently Asked Questions (FAQ)
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1. What is the UIZ.CARE Pilot Project?
The UIZ.CARE Pilot Project is an observational, non-interventional study carried out in Dutch general practice. It evaluates whether UIZ.CARE, a digital health platform, can reduce GP administrative workload, improve usability for both GPs and patients, ensure safe-by-design use, and integrate wearable data (Fitbit/Google Fit).
The pilot does not provide diagnoses, test clinical outcomes, or replace medical judgment. Instead, it tests the platform as an operational support system in real-world practice.
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2. Why is this pilot being conducted?
The Netherlands faces an escalating mental health crisis among young adults. Over 40% of GP consultations involve mental health concerns, and 30–40% of GP time is spent on administration. This results in:
1. Long waiting times for patients.
2. Overloaded mental health services.
3. Rising costs across the system.
The pilot’s primary goal is to determine if UIZ.CARE can reduce GP administrative workload by 8–10 hours per week (30–40%).
Secondary goals include assessing usability (target SUS ≥75), data interoperability (≥90% successful wearable data ingestion), and safety-by-design (no serious device-related incidents).Referral patterns will be explored descriptively, but diagnostic accuracy is not part of this study.
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3. What makes UIZ.CARE different from other digital health tools?
Unlike many apps that focus only on video consultations or basic self-assessment, UIZ.CARE is designed for GPs and patients together:
1. It integrates self-reported symptoms and wearable data (Fitbit, Google Fit).
2. It provides AI-supported summaries to streamline documentation, communication, and triage support.
3. It connects with Dutch GP workflows and EHR systems (e.g., via FHIR APIs).
4. It is being developed to meet EU MDR Class IIa requirements and CE certification standards.
This makes UIZ.CARE one of the few digital platforms designed to operate as a regulated, evidence-based GP support tool.
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4. Who can participate in the pilot?
Participation is open to:
1. GP practices in the Netherlands that wish to test UIZ.CARE.
2. Adult patients (≥18 years old) registered with a participating GP practice.
The study focuses especially on young adults (18–24, “Gen Z”), but all adults may be included. Patients need access to a smartphone and may optionally share wearable data (Fitbit or Google Fit).
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5. What does participation involve for patients?
If you join as a patient:
You will use UIZ.CARE during routine GP visits.
You may fill in short questionnaires about symptoms or daily routines.
You may choose to share wearable data (e.g., activity, sleep, heart rate).
You will complete short surveys about your experience.
No extra GP visits are required. Participation is voluntary and you can withdraw at any time without consequences for your regular care.
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6. What data will UIZ.CARE collect?
For this pilot, UIZ.CARE will collect:
Self-reported health and symptom data.
Survey responses about usability and workload.
Wearable data from Fitbit or Google Fit (if patients choose to share).
GP workload diaries and EHR portal logs (for efficiency measurement).
No experimental procedures or additional medical data are collected.
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7. How will my data be protected?
Data protection is a top priority.
All study data are stored on EU-based server (ISO 27001 / NEN7510 certified).
Data are encrypted with AES-256 and transferred securely (TLS).
Each participant is assigned a unique study code; identifiers (like names or emails) are stored separately.
Analyses use only pseudonymised datasets.
Data are retained for 5 years after study completion and then deleted or irreversibly anonymised.
No data will ever be sold to third parties.
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8. Will I receive medical treatment or advice through UIZ.CARE during the pilot?
No. UIZ.CARE is a support tool, not a treatment or diagnostic system. Your GP remains responsible for all medical care. The pilot does not provide new treatment, alter your usual care, or replace your GP’s judgment.
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9. Will I be paid to participate?
There is no payment for participation.
However, your contribution helps co-create a system that could reduce GP workload and improve youth mental health care. In some cases, practices may receive modest support for their time, depending on ethics approvals. -
10. How does this pilot relate to MDR Class II and CE certification?
UIZ.CARE is being developed as software classified under MDR Class IIa. CE marking requires evidence of safety, performance, and usability.
This pilot provides:
Data on workload reduction, usability, interoperability, and safety.
Documentation needed for MDR compliance.
Real-world validation of safe and effective use.
Important: This pilot does not assess diagnostic accuracy or clinical outcomes. Those will be part of later clinical validation studies.
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11. Will this affect my health insurance or cost me anything?
No. Participation is free and does not
affect your health insurance coverage. In the future, UIZ.CARE aims to work with Dutch insurers (e.g., CZ, VGZ) to ensure reimbursement.
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12. How can I withdraw from the pilot if I change my mind?
Participation is voluntary. You can withdraw at any time by emailing Pilot@uiz.care.
When you withdraw:
No new data will be collected.
Existing data will be deleted or anonymised unless legally required to retain.
Your healthcare will continue as usual.
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13. Is UIZ.CARE only for mental health?New List Item
No. The platform supports both mental and physical health indicators, especially where they overlap (e.g., sleep, stress, physical activity). In this pilot, the focus is primarily on workflow efficiency, usability, and safe data integration, not on specific diagnostic categories.
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14. What if I don’t own a wearable device?New List Item
Participation is still possible. Patients without a wearable can still contribute via questionnaires and surveys. Wearable integration is optional but helps us test interoperability.
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15. Will my answers be anonymous?
Yes. All research data are pseudonymised. Reports and publications will never contain names or personal identifiers.
This project has been made possible in part by a contribution from the Stimuleringsfonds Metropoolregio Eindhoven.
This project has been made possible in part by a contribution from the Stimuleringsfonds Metropoolregio Eindhoven.
If you have questions about the pilot, your data, or your rights as a participant, please contact:
UIZ.CARE Pilot Team
✉️ Pilot@uiz.care
🌐 www.uiz.care
For independent advice about your rights as a research participant, you can also contact a local ethics committee or data protection authority.
Why This FAQ is Important
Meets MDR Class II requirement to inform participants adequately before consent.
Covers all the technical, legal, and practical aspects of the pilot.
Protects UIZ.CARE legally and ethically.
Builds trust with users, regulators, and partners.
Positions UIZ.CARE as a serious medical device innovator, not merely a health app.
Final Note
We are grateful for your interest in shaping the future of mental health care. Together, we aim to deliver a certified, scalable solution that reduces wait times, supports GPs, and helps young people thrive.
Last updated: 01 October 2025 — Some answers are currently being finalized and will be updated soon.

