Privacy Policy Lutastic+

1. Purpose

This document represents the currently valid version of the privacy policy of the company Minze NV.

2. Privacy Policy for the Lutastic+® App

With this Privacy Policy, we want to inform you about how we process personal data. Protecting your privacy is of utmost importance to us, which is why compliance with legal data protection regulations is a matter of course for us.

Lutastic+® is used as a Digital Health Application (DiGA) for patients with lower urinary tract symptoms.

This Privacy Policy applies to the mobile iPhone and Android app Lutastic+ (hereinafter "App"). It explains the type, purpose, and scope of data collection within the scope of App use. If the App is used on non-private devices or as part of shared accounts, there is a risk of data loss or unauthorized access. We point out that data transmission over the Internet may have security vulnerabilities. Complete protection of data against access by third parties is not possible.

2.1. Amendments to this Privacy Policy

We reserve the right to amend these data protection provisions at any time in compliance with legal requirements.

2.2. Name and Contact Details of the Controller

Minze NV
Represented by Tom Moore, CEO
Lange Gasthuisstraat 29, bus 15
2000 Antwerpen, Belgium
Email: info@minzehealth.com

2.3. Data Protection Officer

If you have questions about our data protection measures, the processing of your data, or concerning the protection of your rights as a data subject, you can reach us and our Data Protection Officer as follows:

Minze NV - DPO
Represented by Gilles Tas
Lange Gasthuisstraat 29, bus 15
2000 Antwerpen, Belgium
For all questions and concerns regarding your data, please contact dpo@minzehealth.com.

If you wish to communicate directly with our Data Protection Officer (for example, because you have a particularly sensitive concern), please contact us by email. This is the preferred method of communication. Please state in your request that your concern relates to the Lutastic+ App.

2.4. Data Collection

Various types of data are collected and processed within the scope of the application.

Personal Data

Personal data is all information about an identified or identifiable natural person.

The following data are collected for the purpose of providing access to the App and for billing purposes:

  • First and last name; also to label your care report, which you can create in the App (see section "Your Rights") and which is written to your electronic patient file with every export (see "Export to Your Electronic Patient File (ePA)" below)
  • Identification numbers (activation code, customer ID)
  • Email address
  • Date of birth; also shown on your care report, and part of the therapy document written to your electronic patient file (see "Export to Your Electronic Patient File (ePA)" below)
  • Gender; the App sets it to male when you set up your therapy, without asking you, because Lutastic+ is a therapy for men with lower urinary tract symptoms
  • Address (for shipping the Diary Pod)
  • Registration date
  • Data for login with Health ID and for writing to the electronic patient file (health insurance number, ePA document ID)
  • Consent logs (consent status, consent timestamp)
  • Activation codes
  • If applicable, contents of your correspondence with Lutastic+ customer support

Health Data

The following health data are collected within the scope of the digital therapy and use of the App:

  • IPSS (International Prostate Symptom Score)
  • IPSS-QoL (IPSS Quality of Life Question)
  • ICIQ-OAB (International Consultation on Incontinence Questionnaire – Overactive Bladder)
  • PGI-I (Patient Global Impression of Improvement)
  • Number of voids
  • Number of urge episodes
  • Nocturnal frequency (Nocturia)
  • Number of incontinence episodes
  • Voided volume
  • Bladder capacity
  • Voiding time intervals
  • Urge level of each void
  • Cause and trigger of a leakage
  • Pad change and pad weight
  • Catheter use
  • Post-void dribbling
  • Number of drinks
  • Type of drinks
  • 24h fluid intake
  • 24h urine output
  • Percentage of evening drinks per 24h
  • Percentage of nocturnal urine output per 24h
  • Weight and body length
  • Smoker or non-smoker
  • Activity level
  • Medication
  • Your usual wake-up and sleep times

Other Data (Content Data)

  • Number of daily opened tips per module
  • Number of completed challenges per module
  • Status of each challenge (pending, started, completed)
  • Status of the bladder diary (pending, started, completed)
  • Status of the symptom check (pending, started, completed)
  • Tracking of user logins

Export to Your Electronic Patient File (ePA)

At your request, the App writes your therapy data to your electronic patient file (ePA), so that they are available to you there. The data are written as a medical information object for digital health applications (DiGA MIO) in the format specified by the National Association of Statutory Health Insurance Physicians (KBV). With every export the App also writes your care report (PDF) to your ePA, next to the MIO document. Your ePA is provided by your health insurance fund; the documents are transmitted to it through the telematics infrastructure (TI), the secure network of the German healthcare system.

You can start the export yourself in the App at any time. You can also switch on the automatic export: the App then updates the documents in your ePA when you start a new module and when you complete your therapy. The automatic export is switched off by default, you can switch it off at any time, and it stops when your licence ends. Each export replaces the MIO document of the previous export in your ePA.

The export is only available if you sign in to the App with your Health ID (the digital identity of your health insurance fund), because your health insurance number is needed to find your ePA. In addition, you must have authorised Lutastic+ to write to your ePA in the ePA app of your health insurance fund. Your health insurance number is used only to address your ePA; it is not part of either document.

The MIO document contains:

  • Your date of birth and your gender
  • Your usual wake-up and sleep times, and your answers on medication, activity level, smoking, weight and body length
  • Your symptom checks with answers and scores (IPSS, IPSS-QoL, ICIQ-OAB)
  • Your bladder diary entries: voids with time, time of day (after waking up, during the day or after waking at night), voided volume, urge level, leakage trigger, pad change and pad weight; leakages; drinks with volume and type; and the values derived from them, such as bladder capacity
  • Your daily counts of voids, urges, leakages and drinks
  • Your progress through the modules and activities of the therapy
  • The name and current version of Lutastic+

The care report shows your name, your date of birth, your gender and the start date of your therapy together with your therapy data (see section "Your Rights"). Your name is only on the care report, not in the MIO document. Neither document contains your health insurance number, email address, postal address or any free-text comments.

An export takes place only when you start it in the App or have switched on the automatic export.

2.5. Purposes of Processing

We process your data for the following purposes:

  • For the intended use of our service and therapy offering
  • For the evidence of positive care effects within the scope of a trial
  • For evidence documentation in agreements according to § 134 paragraph 1 sentence 3 of the Fifth Book of the German Social Code (regarding certain (success-dependent) billing with health insurance funds)
  • For the export of your therapy data to your electronic patient file (ePA) at your request (see section "Data Collection")
  • For the continuous assurance of technical functionality, user-friendliness, and the further development of the App

In the App, you may grant us the following consents:

  1. I agree to the General Terms of Use. (mandatory)
  2. I agree to the Privacy Policy. (mandatory)
  3. I agree to the processing of my personal and health data for the purpose of the intended use of the DiGA, for the evidence of positive care effects within the scope of a trial, and for evidence documentation in agreements according to § 134 paragraph 1 sentence 3 SGB V in accordance with the Privacy Policy. (mandatory)
  4. I consent to the processing of my data for the improvement of the technical functionality, user-friendliness, and further development of Lutastic+. (optional)

The Terms of Use and this Privacy Policy are versioned separately. If one of them changes, the App asks you to agree to the new version of that document.

All consents can be withdrawn at any time.

2.6. Legal Basis

We rely on the following legal bases for the processing of your data:

For Statutory Health Insurance Patients within the Scope of DiGA

  • Your consent according to Article 6 (1) lit a GDPR for registration data
  • Article 9 (2) lit. a GDPR for health data

For Private Payers/Privately Insured Patients

  • Your consent according to Article 6 (1) lit a GDPR for registration data
  • Article 9 (2) lit. a GDPR for health data
  • The initiation or performance of a contract with you (Art. 6 (1) lit. b GDPR)

The health data serve the individual adjustment and performance of the training and thus the improvement of your health status. The data can also be used in anonymized form within the scope of demonstrating positive care effects.

2.7. Necessity or Obligation to Provide Data

Unless this is explicitly stated, providing your data is not necessary or mandatory.

Data Analysis

When you access our App, your behavior may be statistically evaluated and analyzed for the improvement and further development of our offerings. When using such tools, we ensure compliance with legal data protection regulations.

Your personal data is sent to:

Minze NV
Lange Gasthuisstraat 29, bus 15
2000 Antwerpen, Belgium

Sub Processors

When processing your data, we work with the following service providers who have access to your data:

Host Provider:

Amazon Web Services EMEA SARL (AWS)
38 Avenue John F. Kennedy,
L-1855 Luxembourg

We use the AWS service provided by Amazon Web Services EMEA SARL for data storage and the provision of our service. Therefore, we process your contact and medical data.

Billing within the Scope of DiGA is Performed by

Noventi HealthCare GmbH
Berg-am-Laim Str. 105
81673 München

We use the service of NOVENTI HealthCare GmbH for billing your entered DiGA code. All necessary data are processed in accordance with the currently valid version of the guideline of the National Association of Statutory Health Insurance Funds according to § 302 para. 2 SGB V and the associated annexes.

Further information about the provider can be found at https://www.noventi.de/datenschutz/.

Shipping of the Diary Pod is Performed by

SABEDA Logistik GmbH
Pappelallee 78-79
10437 Berlin, Germany

We use SABEDA Logistik GmbH to ship the Diary Pod to you. For this purpose SABEDA Logistik processes the recipient name, the delivery address and the email address you provided, so that the shipment can be dispatched and you can be notified about its delivery. No health data is transmitted.

Further information about the provider can be found at https://sabeda-logistik.de/datenschutz/.

Error and Crash Reporting is Performed by

Functional Software, Inc. d/b/a Sentry
45 Fremont Street, 8th Floor,
San Francisco, CA 94105, USA

We use Sentry to detect and diagnose technical faults in the App, which is necessary for us to keep a medical device safe and working. Sentry receives technical error reports: the fault itself, the app version, the device model and operating system, and a record of the steps that preceded it. Reports are stored in Sentry's European data region.

Before a report leaves your device we automatically remove personal data, health data, access credentials and authentication headers from it, and we instruct Sentry not to attach network or device identifiers. Where a report carries a recording of the screen shortly before a fault, all text, images and graphics in it are masked. We rely on our legitimate interest in the safety and reliability of the App (Art. 6 (1) (f) GDPR); this reporting cannot be switched off, because we would otherwise be unable to detect faults that affect your therapy. Performance measurement and session recording additionally require the optional usage-data consent described below.

Further information about the provider can be found at https://sentry.io/privacy/.

Usage Analytics and Push Notifications are Performed by

Google Ireland Limited
Gordon House, Barrow Street,
Dublin 4, Ireland

We use two services from Google's Firebase platform. Firebase Cloud Messaging delivers the push notifications the App sends you, such as therapy reminders. It receives a notification token identifying your installation; the token is removed when you log out and when you delete your account. Firebase Analytics records anonymous usage statistics — which functions are used and how the App performs. It is switched off by default and runs only if you give the optional usage-data consent (Art. 6 (1) (a) GDPR), which you can withdraw at any time under More → Privacy and data.

The analytics identifier is generated separately for each installation and is not linked to your patient identity, no advertising identifier is collected, and we use no other Firebase service.

Further information about the provider can be found at https://firebase.google.com/support/privacy.

Email Delivery is Performed by

Google Ireland Limited
Gordon House, Barrow Street,
Dublin 4, Ireland

All service email our systems send you is delivered through Google's Gmail SMTP relay. These are:

  • the confirmation of your email address when you register and when you change it, and a notice to your previous address after a change
  • a notice if someone tries to register again with your email address
  • security notices when a sign-in method of your account is added, changed or removed, when your account is signed in on a new device, and when a sign-in from another device is blocked
  • the confirmation of your deletion request, with the date on which your data will be anonymised
  • the notice that your licence has ended, with the date on which your data will be anonymised
  • the confirmation that your account has been deleted, if you delete it before your therapy has been set up

For the purpose of delivery the relay processes your email address and the content of the message.

Further information about the provider can be found at https://policies.google.com/privacy.

Support Requests are Handled with

Odoo S.A.
Chaussée de Namur 40,
1367 Grand-Rosière, Belgium

When you contact us through our support form, your request is recorded in Odoo, which we use to manage support tickets. Odoo processes the contact details and the content you provide in the request.

Further information about the provider can be found at https://www.odoo.com/privacy.

2.8. Data Storage

We store your personal data, health data, and other data,

  • for the duration of your licence. This is 365 days from the start of your therapy; 30 days after the end of the licence your personal data is anonymised (see section "Deletion and Retention Periods")
  • if you have consented to the processing, at most until you withdraw your consent
  • if we need the data for the performance of a contract, at most as long as the contractual relationship with you exists
  • if we use the data on the basis of a legitimate interest, at most as long as your interest in deletion or anonymization does not prevail
  • if legal retention obligations exist, until the end of the retention periods

Inquiries within the App (e.g., via email) are stored and processed by us, including all resulting personal data (e.g., name, request), for the purpose of processing your request. The processing of this data is based on Art. 6 (1) lit. b GDPR, provided that your inquiry is related to the performance of a contract or is necessary for the implementation of pre-contractual measures. In all other cases, the processing is based on your consent (Art. 6 (1) lit. a GDPR) and/or on our legitimate interests (Art. 6 (1) lit. f GDPR), as we have a legitimate interest in the effective processing of inquiries addressed to us. The data sent to us by you via contact inquiry remain with us until you request us to delete them, withdraw your consent to storage, or the purpose for data storage ceases to apply. Mandatory legal provisions – in particular legal retention periods – remain unaffected. We do not pass on your data without your consent.

2.9. Withdrawal of Consent and Deletion of Data

You can withdraw the consents you gave during registration (see section Purposes of Processing) at any time in the App under More → Privacy and data, or by email to dpo@minzehealth.com.

If you withdraw your consent for the mandatory purpose of data processing, you automatically lose access to the content of Lutastic+.

You can delete your account in the App under More → Delete account, or by email to dpo@minzehealth.com. Before you confirm the deletion, the App offers you an export of your data and your care report. After your request your account is blocked at once; 30 days later your personal data is anonymised and your account deleted. If your licence has already ended and its retention period (see section "Deletion and Retention Periods") ends earlier, the deletion takes place on that earlier date. Until the date of deletion you can ask our support to cancel it; your account is then unblocked. Data the App had stored on your device are not restored.

When an account is deleted, personal data are completely anonymized. Health data are retained to meet the regulatory requirements for medical devices and digital health applications. However, a personal reference is then technically no longer possible, and logging into the deleted account is no longer possible.

Your program and your data are no longer available to you from the moment of blocking. Once your data have been anonymised, Minze NV can no longer perform the services described in the Terms of Use, can no longer establish a reference to your account for you, and can no longer track whether you used a valid activation code. Any remaining, possibly already paid usage period then expires without the possibility of crediting or reimbursement.

Up to the blocking of your account, we can also transfer your data to you if you send this request to dpo@minzehealth.com.

Should other legal, contractual, tax, or commercial retention obligations or other legally anchored reasons conflict with the deletion, only the prolonged blocking of your account can be carried out instead of deletion.

2.10. Deletion and Retention Periods

Uniform deletion and retention periods apply to all users:

  1. Usage period: 365 days from the start of your therapy.
  2. End of the licence: On day 365 we inform you by email that your licence has ended and on which date your data will be anonymised. From then on, no new therapy can be started.
  3. Retention period after the end of the licence: For 30 days after the end of the licence you can still sign in to export your data, download your care report, withdraw your consent or delete your account. Your personal data is then anonymised and your account deleted.
  4. Deletion request: If you request the deletion of your account, it is blocked at once and your personal data is anonymised 30 days later, or earlier if the retention period after the end of your licence ends first (see section "Withdrawal of Consent and Deletion of Data").
  5. After anonymisation: Health data are retained without any personal reference to meet the regulatory requirements for medical devices and digital health applications.

Statutory retention obligations remain unaffected.

2.11. Device Permissions Used by the App

To deliver the therapy, the App uses certain functions of your device. Some of these your device asks you to allow, and you can decline them or withdraw them later in your device settings; others are technical permissions that your device grants when the App is installed, without asking. We list all of them below, each with the reason we request it. If you decline a permission, the App remains usable, but the function that depends on it is not available.

Permissions You Are Asked to Allow

  • Bluetooth (Android BLUETOOTH_SCAN and BLUETOOTH_CONNECT, iOS Bluetooth) – to find your Diary Pod, connect to it, read the void measurements it has recorded, and install firmware updates on it. We declare to your device that Bluetooth results are never used to determine your location.
  • Notifications (Android POST_NOTIFICATIONS, iOS notification authorisation) – to send you therapy reminders and messages about your programme.
  • Fingerprint or facial recognition (Android USE_BIOMETRIC and USE_FINGERPRINT, iOS Face ID) – to let you sign in to and unlock the App with the biometric feature of your device. The recognition is performed by your device; neither your fingerprint nor your facial data is transmitted to us or stored by us.

Technical Permissions Granted When the App Is Installed

  • Internet access (INTERNET) – to communicate with our servers, so that your therapy data can be saved, push notifications can be registered, and error reports can be sent.
  • Network status (ACCESS_NETWORK_STATE, ACCESS_WIFI_STATE) – to detect whether your device is online, so that entries you make offline are kept and transmitted later. We do not read the name of your network and do not search for networks around you.
  • Vibration (VIBRATE) – to vibrate for reminders and to give short feedback when you operate the App.
  • Delivery of push notifications (WAKE_LOCK) – to let the push service wake your device briefly so that a notification can be delivered.
  • Restoring reminders after a restart (RECEIVE_BOOT_COMPLETED) – to set your scheduled reminders up again after you restart your device.
  • Background activity on iOS (bluetooth-central, remote-notification) – to keep the connection to your Diary Pod while the App is in the background, and to receive notifications while the App is not open.
  • Confirming that the App is genuine on iOS (Apple App Attest) – to have Apple confirm to us that the App is an unmodified copy running on a genuine Apple device, which protects your health data against manipulated copies of the App. Apple receives a technical attestation of your installation for this purpose; it contains no personal data and no health data.
  • Checking for the Reminders app on iOS (LSApplicationQueriesSchemes) – to determine whether Apple's Reminders app is present on your device, so that the App can offer to create a reminder for you there. We do not read the contents of your reminders.

Permissions the App Does Not Request

The App requests no access to your location, camera, microphone, photos, contacts or calendar, and no access to the health data stored by Apple Health or Android Health Connect. It collects no advertising identifier.

2.12. App-Stores

The App is available via distribution platforms operated by third parties, so-called App Stores (Google Play and Apple AppStore). Downloading it may require prior registration with the respective App Store and the installation of the App Store software. We have no influence on the collection, processing, and use of personal data in connection with your registration and the provision of downloads in the respective App Store and the App Store software. The operator of the respective App Store is solely responsible in this regard. Please inform yourself directly with the respective App Store provider if necessary.

2.13. Transfer to Third Countries

Some of the service providers named in section "Necessity or Obligation to Provide Data" are based in the USA or belong to a group of companies based in the USA: Functional Software, Inc. (Sentry) for error and crash reporting, and Google (Firebase Cloud Messaging, Firebase Analytics and the Gmail SMTP relay), whose contracting party is Google Ireland Limited. Even where these providers store data in the European Union, access from the USA, and with it a transfer of data to the USA, cannot be ruled out.

Such transfers are based on the adequacy decision of the European Commission for the EU-U.S. Data Privacy Framework (Art. 45 GDPR), under which these providers are certified, and additionally on the standard contractual clauses of the European Commission (Art. 46 (2) (c) GDPR). Error reports and usage statistics contain no health data. Service emails delivered through Google's relay can, however, show that you use Lutastic+, a therapy for lower urinary tract symptoms. All other processing takes place within the European Economic Area.

2.14. Your Rights

As a data subject, you have the following rights:

  • To request information about the processing of your data, and to receive a copy of your personal data; you can request information about, among other things, the purposes of the processing, the categories of personal data that are processed, the recipients of the data (if disclosed), the duration of storage or the criteria for determining the duration
  • To receive the personal data concerning you in a structured, commonly used, and machine-readable format or to have it transmitted to another controller (Art. 20 GDPR)
  • To rectify your data; if your personal data is incomplete, you have the right to complete the data, taking into account the purposes of the processing
  • To have your data deleted or blocked
  • To have the processing restricted
  • To object to the processing of your data
  • To withdraw your consent to the processing of your data for the future
  • To lodge a complaint about unlawful data processing with a supervisory authority, in particular in the Member State of your habitual residence, your place of work or the place of the alleged infringement (Art. 77 GDPR). The supervisory authority responsible for Minze NV is the Belgian Data Protection Authority (Gegevensbeschermingsautoriteit / Autorité de protection des données), Brussels, https://www.dataprotectionauthority.be.

You can exercise some of these rights directly in the App:

  • Machine-readable export: you can download your therapy data as a structured, machine-readable file (Art. 20 GDPR). It is the same document that can be written to your electronic patient file, with the content listed in section "Data Collection" under "Export to Your Electronic Patient File (ePA)".
  • Care report: you can download a printable care report (PDF) that shows your name, your date of birth, your gender and the start date of your therapy together with your therapy data, such as your symptom-check scores and your bladder diary. The care report is created when you request it and is not stored by us.
  • Withdrawal of consent and deletion request: you can withdraw your consent and request the deletion of your account (see section "Withdrawal of Consent and Deletion of Data").

To protect your data, the App asks you to confirm your identity again before a download. For all other rights, write to dpo@minzehealth.com. We answer your request within one month of receiving it.

2.15. Reporting Security Vulnerabilities

If you believe you have found a security vulnerability in the Lutastic+ App or our services, we encourage you to report it to us so we can address it. You can reach our security team in either of the following ways:

The same details are also published in machine-readable form at security.txt in accordance with RFC 9116.

2.16. Status of the Privacy Policy

We adjust the information in case of changes to our processes.

Status of this Privacy Policy: 09.10.2026

Version of this Privacy Policy: V2.2