Frequently asked questions
Is Brustkrebs-Kompass a medical device under the MDR?
No. Brustkrebs-Kompass is an information and self-management app. It does not provide diagnoses, does not give individual therapy or dosing recommendations and does not perform any medical evaluation of individual findings. The functional description follows the criteria of MDCG 2019-11. A final legal qualification will be obtained before market launch via external legal counsel.
Which indications are addressed?
Breast cancer across all therapy phases: diagnosis, primary therapy, adjuvant and neoadjuvant therapy, anti-hormone therapy and follow-up. The estrogen-modulating nutrition strategy is scientifically particularly relevant for hormone-positive tumours (ER+/PR+) and is rated in the app per food with source references.
Which personal data is processed?
Personal entries (symptoms, blood values, medication, appointments, emergency profile, journal entries, favourites, meal history and tolerance feedback) are processed exclusively on the user's device. AES-GCM encryption, master key in the iOS Keychain or the Android Keystore. Outbound connections to Supabase (public content), Open Food Facts, PubMed E-Utilities and Semantic Scholar contain no user ID, no tracking ID and no user-entered health data. The operator does not process personal data of users.
Why does the app use Supabase, Open Food Facts and PubMed?
Network requests are used only for public content: Supabase serves the curated food, recipe and medication databases; Open Food Facts returns product information for a scanned barcode; PubMed and Semantic Scholar return public study information. These requests contain no user-entered health data, no account, no advertising ID and no tracking ID. Personal entries stay local on the device.
Who is the target audience?
Adult patients aged 18 and older with the indications mentioned, and their relatives. Content is offered in German and English. The app is not intended as a decision tool for medical professionals; clinicians may, however, recommend it as a complementary patient- education tool.
How is content quality-assured?
Food assessments, interactions and recommendation tags carry a source and evidence level (e.g. strong, moderate, weak evidence) per record. Sources include the German S3 guideline (AWMF), peer-reviewed publications, WCRF-CUP, EFSA assessments and EU regulations. Content is reviewed manually when guidelines are updated.
Which reminder and tracking functions exist?
Medication reminders with adherence score, symptom and blood-value trends, therapy-cycle overview (chemo, radiotherapy, anti-hormone), journal and mindset modules. All data stays on the device. Push notifications are opt-in and contain no sensitive data in their payload.
How much does the app cost?
Nothing. Brustkrebs-Kompass is and remains free for all users. There is no premium tier, no subscription, no in-app purchases, no advertising and no data business. Development and operation are financed exclusively through voluntary donations.
Why is the app not listed as a DiGA?
Conscious decision. A DiGA classification under § 33a SGB V would be reimbursable through the German statutory health insurance, but would exclude or hinder numerous groups: privately insured patients with limited tariff coverage, men with breast cancer, breast cancer patients with comorbidities outside narrow DiGA indications, German citizens living abroad and EU citizens without German statutory insurance, and patients without a medical prescription. Rather than lose these groups, the app stays free, low-barrier and internationally accessible.
If not a DiGA: what about CE marking and MDR?
The MDR classification process is carried out regardless of DiGA status. Every software placed on the EU market must be classified under Regulation (EU) 2017/745. The decisive guidance is MDCG 2019-11. Possible outcomes: (1) not a medical device (likely, since the app offers information and self-management features, no diagnosis or therapy), (2) medical device Class I with self- declaration of conformity and CE marking, or (3) higher class with notified-body assessment (not currently expected). The actual outcome will be documented on this page once the external legal assessment is finalised.
How is the app funded?
Exclusively through voluntary donations. These cover ongoing curation of the food, recipe and interaction database, integration of new versions of the S3 guideline, translations, legal counsel for the MDR classification procedure, external clinical review and server operation. There is no advertising revenue and no data sales. Donations and grants, including from institutions, are welcome; content and assessments stay independent and follow the evidence only. See the "Funding & support" section for donation options.
How can I get test access?
Before launch in the app stores, we provide test access for medical and legal professionals, patient representatives and selected testers. On iPhone this runs through TestFlight with an invitation to your Apple ID, on Android through the internal test of Google Play with an invitation to the address of the Google account you are signed in with on your phone. Another address will not work there. Please contact us via the section on the home page; with a short note about your role or area of interest. A short guide is available at brustkrebs-kompass.de/anleitung-en.