Compliance & Legal
Self-declared regulatory positioning · Positionnement réglementaire auto-déclaré
Last updated: 30 September 2026 · compliance-1.4
1. Not a medical device reference only
EN. ChronoPill provides reference information about medicines from official sources. It is not a medical device and does not provide clinical decision support, diagnosis, prescription advice, or treatment recommendations. Always consult a qualified healthcare professional. This positioning is self-determined and documented, on the following basis:
- EU - Regulation (EU) 2017/745 (MDR) & MDCG 2019-11 software qualification: informational reference, not decision support.
- USA - ChronoPill's medication reminders and its verbatim display of official labeling are intended to fall outside device regulation under FDA's policy on Device Software Functions and Mobile Medical Applications and its General Wellness guidance. This self-assessment is pending legal review.
- UK - MHRA: informational reference, not a medical device.
- Japan - PMD Act: informational reference, not a medical device.
FR. ChronoPill fournit une information de référence sur les médicaments, issue de sources officielles. Ce n'est pas un dispositif médical et n'assure aucune aide à la décision clinique, diagnostic, ni recommandation de traitement. Consultez toujours un professionnel de santé.
2. Data protection & privacy by design
EN. ChronoPill is built privacy-first. Your medication data, schedules and health metrics (height and weight from Apple Health, and on iPhone the medications you choose to import from Apple Health) are stored locally on your device. Data stays on your device, except when you choose an online feature (account, Key points (AI) on tap, box photo recognition, caregiver sharing, prayer times in Fasting Mode, doctor search in a visit), as described in our Privacy Policy. Our reference/clinical database layer contains no personal or identifiable patient data (no PHI). We use no advertising SDK, and usage analytics run only if you opt in. ChronoPill holds no certification (see Section 3), and the Privacy Policy describes how it handles data. The data-protection laws that apply in each market where the app is offered:
| Market | Applicable data-protection framework |
|---|---|
| 🇪🇺 EU / 🇫🇷 France | GDPR / RGPD (health data = special category, Art. 9); EHDS / EU Data Act |
| 🇺🇸 USA | HIPAA (ChronoPill is not a covered entity), HITECH, CCPA/CPRA |
| 🇬🇧 United Kingdom | UK GDPR + Data Protection Act 2018 |
| 🇯🇵 Japan | APPI (health data = sensitive; consent-based) |
| 🇨🇦 Canada | PIPEDA + provincial (PHIPA Ontario, Law 25 Québec) |
| 🇲🇦 Morocco | Loi 09-08 + CNDP |
FR. Données de santé stockées localement sur l'appareil ; elles n'en sortent que si vous utilisez une fonction en ligne (compte, Points clés (IA) sur demande, reconnaissance de boîte par photo, partage aidant), décrite dans la Politique de confidentialité. La couche de référence ne contient aucune donnée personnelle. ChronoPill ne détient aucune certification ; le tableau ci-dessus liste les lois de protection des données applicables dans chaque marché.
3. Security & hosting
EN. ChronoPill's backend runs on Amazon Web Services (AWS) in the United States (US East, N. Virginia). AWS infrastructure is independently certified (ISO/IEC 27001, 27017, 27018, SOC 2). ChronoPill itself holds no certification, including no HDS certification and no HDS hosting contract. ChronoPill targets ISO/IEC 27001 and 27701 and SOC 2 Type II for its B2B / hospital offering; these are pursued through independent third-party audit and are not claimed as obtained unless a valid certificate is held.
4. Interoperability & source compliance
EN. The app displays official regulatory text verbatim, and every data value carries per-field provenance. Product identifiers used: dm+d (UK, paused), YJ code (Japan), NDC and UNII (US), CIS and CIP (France), DIN (Canada, paused), AMMPS registration (Morocco), and the ATC classification. Clinical coding terminologies (such as ICD-10 or SNOMED CT) are not used in the consumer app. Inferred or cross-country values are explicitly flagged, never presented as official source data.
5. Data sources and licences
EN. Medicine information in the app comes from the official sources below. Their text is shown verbatim and remains the property of each authority. Licence names and required attributions are quoted as published by each source; where no explicit licence is published, the source's terms of use apply and their review by counsel is pending.
| Country | Source | Licence or terms | Attribution |
|---|---|---|---|
| 🇺🇸 USA | NLM DailyMed, openFDA (U.S. FDA) | Public domain; openFDA: CC0 1.0 | Source: U.S. National Library of Medicine (DailyMed), U.S. Food and Drug Administration (openFDA) |
| 🇫🇷 France | ANSM, Base de données publique des médicaments (BDPM) | Licence Ouverte / Open Licence 2.0 (Etalab) | Source: ANSM, Base de données publique des médicaments (date of the installed data pack shown in the app) |
| 🇬🇧 United Kingdom | NHS Business Services Authority, dm+d; MHRA Products | dm+d: Open Government Licence v3.0; MHRA Products: terms of use (review pending) | Contains public sector information licensed under the Open Government Licence v3.0. |
| 🇨🇦 Canada | Health Canada, Drug Product Database (DPD) | Open Government Licence - Canada | Contains information licensed under the Open Government Licence - Canada. |
| 🇪🇸 Spain | AEMPS, CIMA | Terms of use (review pending) | Source: AEMPS, CIMA |
| 🇩🇪 Germany | BfArM | Terms of use (review pending) | Source: BfArM |
| 🇮🇹 Italy | AIFA | Terms of use (review pending) | Source: AIFA |
| 🇯🇵 Japan | PMDA, MHLW | Terms of use (review pending) | Source: PMDA, MHLW |
| 🇲🇦 Morocco | AMMPS | Terms of use (review pending) | Source: AMMPS |
| 🇪🇺 European Union | European Medicines Agency (EMA) | EMA legal notice: reuse allowed, including commercial, with EMA acknowledged as the source | Source: European Medicines Agency |
The United Kingdom and Canada sources are listed for reference: their packs are paused and not offered in the app while the licensing of their official texts is finalized.
ATC classification: WHO Collaborating Centre for Drug Statistics Methodology, Oslo (https://atcddd.fhi.no/). Use of ATC codes does not imply endorsement by the WHOCC.
Some fields are inherited from an identical product of another country and are labelled as such in the app. Optional Key points (AI) summaries are labelled AI and never replace the official text.
Open-source licences are listed in the app: Settings > About > Sources & Licenses.
Target markets & languages
Markets: European Union (incl. France, Germany, Spain, Italy), United States, Japan, Morocco. United Kingdom and Canada: paused while the licensing of their official texts is finalized.
Authoritative languages of this notice: English, Français. Localized versions (العربية / 日本語 and other market languages) are provided for convenience only and will be reviewed by qualified counsel; in case of discrepancy the English or French version prevails.
This notice is a good-faith self-declaration of ChronoPill's regulatory positioning and does not constitute legal advice. Questions: contact us via the app or website.
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