The UIZ.CARE Pilot Project is a clinical investigation of a new digital health platform designed to improve mental health care for Generation Z (young people aged approximately 15–24) in the Netherlands.

Our platform uses artificial intelligence (AI) to help General Practitioners (GPs) quickly assess mental health risks and make better-informed decisions. This pilot project aims to collect data and feedback to validate the platform’s safety, effectiveness, and regulatory compliance under EU Medical Device Regulation (MDR) Class II.

The pilot will run across 10–20 GP practices in the Brabant region and involve 100–300 Gen Z participants.

The Netherlands is experiencing a mental health crisis, particularly among young people. Over 40% of GP consultationsinvolve mental health concerns, yet most GPs lack tools to accurately assess psychological distress.

This results in:

1. Overloaded mental health services

2. Long wait times for patients

3. High costs for the healthcare system

4. Police and social services intervening in crises that could have been prevented

UIZ.CARE’s platform is intended to:

1. Reduce unnecessary specialist referrals by 20%

2. Save GPs 8–10 hours per week in administrative work

3. Enable faster, more personalized mental health support

4. Help transition from crisis management to proactive, equitable care

Unlike many digital tools that focus only on video consultations or basic mental health surveys, UIZ.CARE:

1. Integrates wearable data (e.g. Fitbit, Apple Health)

2. Uses advanced AI models to analyze mental health risks

3. Connects with Electronic Health Records (EHRs) used by Dutch GPs

Is being developed to meet MDR Class II certification, ensuring it qualifies as a regulated medical device

Is designed to align with Dutch and EU reimbursement systems for digital health

This makes UIZ.CARE unique in providing an evidence-based, certified clinical tool for GPs to manage mental health triage safely and efficiently.

We welcome participation from:

1. Individuals aged approximately 15–24 years old (Gen Z) who:

2. Live in the Netherlands

3. Are patients at one of the participating GP practices

4. Are willing to use digital tools and potentially share wearable data

5. General Practitioners (GPs) working in participating practices

6. If you meet these criteria and wish to contribute to improving mental health care,

We invite you to sign up.

If you join the pilot as a patient:

1. You will complete an initial sign-up form

You may be asked to:

1. Use a mobile app to answer questions about your mental health

2. Connect data from a wearable device (such as a Fitbit or Apple Watch)

3. Allow UIZ.CARE to access certain health information from your GP (with your consent)

You may participate in feedback interviews or surveys

Participation is voluntary. You can withdraw at any time without consequences to your health care.

To conduct the pilot safely and generate evidence for medical certification, we may collect:

1. Data from wearables (e.g. heart rate, sleep patterns)

2. Responses to mental health questionnaires

3. Latest physical health data

4. Feedback about your experience using the platform

This data will help us:

1. Test whether our AI models work reliably

2. Prepare documentation required for MDR Class II certification

3. Understand how the system fits into real GP workflows

4. Plan for integration into Dutch health insurance and reimbursement systems

We take data privacy extremely seriously. UIZ.CARE complies with the General Data Protection Regulation (GDPR)and all relevant Dutch laws.

Key protections include:

Secure storage on Google Cloud infrastructure with encryption (AES-256)

Role-based access control, limiting who can see your data

Use of anonymised or pseudonymised data wherever possible

Strict contracts with all partners and suppliers handling data

A clear right to withdraw your data at any time

We will never sell your personal data to third parties.

No. This pilot is a clinical investigation of a new digital tool. It is not a substitute for medical treatment or emergency care.

Your usual care will remain with your GP and any mental health specialists. UIZ.CARE does not provide direct medical treatment during the pilot.

At this stage, participants are not paid for participating in the pilot. However, your contribution helps shape a system that could significantly improve mental health care in the Netherlands.

In some cases, participating individuals and GP practices may receive incentives like gift cards or reimbursements for time or travel, depending on ethical committee approvals.

UIZ.CARE is developing a medical device software classified under MDR Class II. This means:

1. The software will be regulated as a medical device under EU law

2. It must meet strict safety, performance, and quality standards

3. Clinical evidence is required for CE marking, which certifies that the product is safe and effective for use in healthcare

The pilot generates:

1. Real-world data on the system’s safety and effectiveness

2. Evidence for regulatory submissions

3. Technical documentation needed for MDR compliance

4. Information for health insurers to support future reimbursement

No, participation in the pilot is free.

Your health insurance coverage will not be affected in any way. In the future, if the platform becomes certified and commercially available, UIZ.CARE will work with insurers like CZ and VGZ to integrate it into covered healthcare services.

Participation is voluntary. You can withdraw at any time by:

Emailing us at eHuisarts@uiz.care

Upon withdrawal, we will:

Cease collecting further data from you

Retain only the minimum data required for legal or regulatory purposes

Delete or anonymize your data if possible