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Elderwise

© 2026 Elderwise. Tous droits réservés.

    Legal, Risque & Compliance

    Informations sur nos normes de conformité, certifications, contrôles et pratiques de protection des données

    Certification Overview

    Elderwise is committed to achieving and maintaining compliance with key industry certifications. Our strategic roadmap outlines our journey toward full certification, with timelines tailored to the complexity and requirements of each standard.

    Certification Strategy & Timeline

    Compliance Roadmap

    Elderwise follows a structured approach to meeting healthcare compliance standards. Target completion dates are subject to change.

    Certification Process

    Documentation Phase

    Creation of policies, procedures, and controls documentation

    Gap Analysis

    Assessment of current practices against certification requirements

    Implementation

    Deploying necessary controls and remediation activities

    Internal Audit

    Verification of control effectiveness before external assessment

    External Assessment

    Official certification audit by accredited third parties

    Certification

    Receipt of formal certification and continuous monitoring

    Current Implementation Status

    While formal certifications are in progress, Elderwise has already implemented key security and privacy controls aligned with healthcare standards. Our approach follows industry-standard continuous compliance methodology, emphasizing automated evidence collection, regular assessments, and security by design.

    Pre-certification Assurances

    We provide interim compliance documentation to customers, including security questionnaire responses, SOC 2 readiness assessments, and draft BAAs/DPAs while formal certification is underway.

    Continuous Compliance Monitoring

    Following compliance best practices, Elderwise employs continuous monitoring tools to automatically detect and remediate compliance drift, ensuring our systems maintain compliance between formal assessment periods.

    Santé Standards & Elderwise Compliance

    Last Mis à jour: 2026-04-13
    HIPAA
    Objectif: Opérationnel

    Santé Insurance Portability and Accountability Act (HIPAA)

    U.S. santé privacy and security law governing PHI.

    Santé Relevance:

    U.S. santé privacy and security requirements governing PHI handling by covered entities and business associates.

    Exigences clés:

    • Accords de partenariat commercial (BAA)
    • Role-based access and MFA (FR)
    • Audit logging and surveillance
    • Minimum necessary access (FR)
    • Encryption in transit and at repos
    • Procédures de notification des violations
    • Periodic risque évaluations and workforce training

    Comment Elderwise se conforme:

    BAA en place avec les sous-traitants, RBAC/MFA/SSO appliqués, journaux d'audit centralisés, privilèges minimaux par défaut, chiffrement AES-256/TLS 1.3, procédures de réponse aux incidents et formations HIPAA récurrentes.

    GDPR
    Objectif: Opérationnel

    Règlement général sur la protection des données de l'UE (RGPD)

    Réglementation européenne de protection des données couvrant le traitement licite et les droits des personnes.

    Santé Relevance:

    Cadre de l'UE/EEE pour la protection des données, le traitement licite et les droits des personnes concernées.

    Exigences clés:

    • Lawful basis and consent management (FR)
    • Droits des personnes concernées (accès, effacement, portabilité)
    • Accords de traitement des données
    • Protection des données dès la conception et par défaut
    • Records of processing activities (FR)
    • International transfer safeguards (FR)

    Comment Elderwise se conforme:

    Consent capture and audit trails, DPA addenda with vendors, privacy by design reviews, DSR workflows, and transfer impact évaluations where applicable.

    PDPA
    Objectif: Opérationnel

    Loi sur la protection des données personnelles (PDPA, Singapour)

    Loi singapourienne de protection des données mettant l'accent sur le consentement et la limitation des finalités.

    Santé Relevance:

    Obligations de protection des données de Singapour pour le consentement, la limitation des finalités, la notification et l'accès/correction.

    Exigences clés:

    • Consentement et notification
    • Purpose limitation (FR)
    • Access and correction rights (FR)
    • Protection and retention limits (FR)
    • Notification de violation de données

    Comment Elderwise se conforme:

    Déclarations de consentement localisées, calendriers de conservation, canaux d'accès/correction et procédures de notification de violation alignées sur les directives du PDPC.

    ISO27001
    Objectif: Q2 2026 (FR)

    ISO/IEC 27001 Système de management de la sécurité de l'information

    International ISMS standard for managing information security risques.

    Santé Relevance:

    Norme internationale pour l'établissement, la mise en œuvre, la maintenance et l'amélioration continue d'un SMSI.

    Exigences clés:

    • Risque management program
    • Gouvernance et documentation du SMSI
    • Contrôles de sécurité selon l'Annexe A
    • Continuous improvement cycle (FR)

    Comment Elderwise se conforme:

    Formal ISMS scope definition, risque register, policies and control mapping, internal audits, and readiness for certification.

    SOC2
    Objectif: Q2 2026

    SOC 2 Type II (Sécurité, disponibilité, confidentialité)

    Attestation de l'efficacité des contrôles de sécurité sur une période (Type II).

    Santé Relevance:

    Attestation de l'efficacité des contrôles sur une période d'examen selon les critères de services de confiance de l'AICPA.

    Exigences clés:

    • Documented policies and procedures (FR)
    • Security surveillance and alerting
    • Change and incident management (FR)
    • Vendor risque management

    Comment Elderwise se conforme:

    Control mapping to TSC, evidence collection automation, continuous surveillance, quarterly control testing, and external audit readiness.

    HITRUST
    Objectif: 2026

    Norme HITRUST CSF

    Santé-centric certifiable security framework harmonizing multiple standards.

    Santé Relevance:

    Santé-focused certifiable framework harmonizing HIPAA, ISO, NIST, and other requirements.

    Exigences clés:

    • Risque-based control selection
    • Policy/procedure implementation (FR)
    • Validation and scoring (FR)
    • External évaluation

    Comment Elderwise se conforme:

    Scope definition for PHI systems, control inheritance where applicable, and staged readiness toward validated évaluation.

    HITECH
    Objectif: T1 2026

    Loi HITECH (Notification de violation)

    Améliorations américaines de notification de violation et d'application de la loi HIPAA.

    Santé Relevance:

    Améliorations américaines de notification de violation et d'application de la loi HIPAA.

    Exigences clés:

    • Breach risque évaluation
    • Notifications en temps opportun
    • Seuils de déclaration des médias et du HHS

    Comment Elderwise se conforme:

    Procédures de réponse aux incidents, préservation des preuves, arbres de décision pour la matérialité et les délais de signalement.

    FHIR
    Objectif: Opérationnel

    HL7 FHIR (Interopérabilité)

    Modern interoperability standard for structured clinique data exchange.

    Santé Relevance:

    Modern santé interoperability standard for structured clinique data exchange.

    Exigences clés:

    • Ressources et profils FHIR
    • RESTful APIs and conformance (FR)
    • Sécurité et autorisation (SMART sur FHIR)

    Comment Elderwise se conforme:

    Modélisation de données FHIR-first pour les entités principales, profils versionnés, et OAuth2/OpenID Connect pour un accès sécurisé.

    HL7
    Objectif: Opérationnel

    Messagerie HL7 v2/v3

    Santé messaging standards used by EHRs and labs.

    Santé Relevance:

    Legacy and current santé messaging standards widely used by EHRs and labs.

    Exigences clés:

    • Formats et segments des messages
    • Ack/error handling (FR)
    • Transports et sécurité

    Comment Elderwise se conforme:

    Adaptateurs pour l'intégration HL7 v2.x si nécessaire, normalisation vers les schémas internes et transport sécurisé.

    ISO42001
    Objectif: 2026

    ISO/IEC 42001 Système de management de l'IA

    Norme de système de gestion de l'IA pour une gouvernance responsable de l'IA.

    Santé Relevance:

    Cadre pour la gouvernance responsable des systèmes d'IA tout au long de leur cycle de vie.

    Exigences clés:

    • AI risque management and controls
    • Gouvernance et transparence des données
    • Surveillance and continuous improvement

    Comment Elderwise se conforme:

    Map existing controls to AI risques, define KPIs and documentation for transparency, and institute model governance workflows.

    Data Protection & Compliance

    Elderwise maintains data protection controls designed for healthcare regulatory compliance, with an ongoing certification program. Target dates are subject to change.

    Legal Documents & Compliance Materials

    • Request Business Associate Agreement (BAA)
    • Request Data Processing Agreement (DPA)
    • Request Security & Privacy Documentation
    • Request Compliance Attestation
    • Request Penetration Test Executive Summary

    Data Protection & Security Contacts

    Data Protection Officer:dpo@elderwise.ai

    EU Representative (Art. 27 GDPR):eu-rep@elderwise.ai

    APAC Representative:apac-rep@elderwise.ai

    Security Team:security@elderwise.ai

    Vulnerability Reporting:security-alerts@elderwise.ai

    Certification Roadmap

    Elderwise is pursuing industry certifications on a phased timeline. Target dates are subject to change.

    • FHIR & HL7 interoperability: validation in progress
    • GDPR compliance: assessment underway
    • ISO 27001: audit in progress (target 2026)
    • ISO 42001 (AI Management System): planned
    • HIPAA & HITECH: designed for compliance — formal certification in progress (target Q2 2026)
    • SOC 2 Type II & HITRUST CSF: planned

    Healthcare-Specific Security Features

    • for all sensitive health information
    • for healthcare provider access
    • aligned with clinical workflows
    • for all actions on protected health information
    • Secure API design for healthcare system integrations
    • Context-aware access controls for different care settings
    • Session timeout controls for clinical environments
    • Secure offline caching for emergency care scenarios

    Healthcare Infrastructure Security

    • Hosting in data centers with industry-standard security controls
    • Region-specific data residency options for regulatory compliance
    • Regular vulnerability scanning and penetration testing
    • Disaster recovery with high-availability architecture
    • Infrastructure as Code (IaC) for secure, consistent deployments
    • Network segmentation for data isolation
    • Infrastructure monitoring with automated alerting
    • Continuous security control validation using automated tools

    Continuous Compliance Program

    • Automated compliance monitoring tools
    • Regular internal audits specific to healthcare requirements
    • Vendor security assessment program for all third parties
    • Compliance training for all staff, with healthcare-specific modules
    • Quarterly security steering committee with clinical stakeholders
    • Real-time compliance monitoring dashboard for leadership visibility
    • Automated evidence collection to streamline certification maintenance

    Healthcare Data Governance Framework

    Data Collection in Healthcare Context
    • Explicit consent mechanisms for patient data with healthcare-specific language
    • Transparent data collection purposes aligned with clinical needs
    • Minimized data collection following principles of medical necessity
    • Special handling procedures for sensitive medical categories
    • Patient-centric approach to data ownership and control
    Healthcare Data Retention
    • Retention policies aligned with medical record requirements by jurisdiction
    • Secure, compliant data archiving for long-term medical records
    • Automated data deletion when retention periods expire
    • Special provisions for pediatric and geriatric record retention
    • Data lifecycle management specific to clinical documentation standards
    Clinical Data Processing
    • Processing limited to intended healthcare purposes
    • Secure analytics for population health insights
    • De-identified data use for research and development
    • Quality checks on AI-generated summaries before they reach clinicians
    • Secure federated learning techniques for model improvements
    Patient Data Rights
    • Patient access to personal health information
    • Correction mechanisms for inaccurate health data
    • Data portability between healthcare providers
    • Special handling for vulnerable populations and proxy access
    • Transparent record of all third-party data sharing

    Elderwise Healthcare Compliance Commitment:

    Our compliance strategy follows industry-standard "security by design" principles, embedding healthcare compliance requirements into our development process from inception to deployment. We recognize that healthcare data security directly impacts patient outcomes and provider efficiency, so our approach integrates technical safeguards with clinical workflow considerations to create a secure environment that enhances rather than impedes care delivery. Our compliance program emphasizes both regulatory adherence and the ethical responsibility we have to protect sensitive health information.