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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 compliance certifications with timelines tailored to each standard's complexity. We prioritize certifications based on market requirements and technical complexity, with our most comprehensive certifications (HITRUST) targeted for Q3 2026, while more focused certifications like ISO 27001 are targeted for completion by Q1 2026.

    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: 2025-09-27
    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:

    • Business Associate Agreements (BAAs)
    • Role-based access and MFA
    • Audit logging and surveillance
    • Minimum necessary access
    • Encryption in transit and at repos
    • Breach notification procedures
    • 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
    • Data subject rights (access, erasure, portability)
    • Data Processing Agreements
    • Data Protection by Design and Default
    • Records of processing activities
    • International transfer safeguards

    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:

    • Consent and notification
    • Purpose limitation
    • Access and correction rights
    • Protection and retention limits
    • Data breach notification

    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

    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
    • ISMS governance and documentation
    • Security controls per Annex A
    • Continuous improvement cycle

    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
    • Security surveillance and alerting
    • Change and incident management
    • 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

    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
    • Validation and scoring
    • External évaluation

    Comment Elderwise se conforme:

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

    HSA
    Objectif: Q2 2026

    Singapore HSA Guidance (Médical Technologies)

    Singapore HSA guidance for médical technologies and software.

    Santé Relevance:

    Regulatory guidance for médical device software and santé tech solutions in Singapore.

    Exigences clés:

    • Risque classification and documentation
    • Quality management alignment
    • Clinique and cybersecurity considerations

    Comment Elderwise se conforme:

    Alignment with HSA advisories, documentation of intended use and risque controls; leverage ISO 14971/IEC 62304 where applicable.

    HITECH
    Objectif: Q1 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
    • Timely notifications
    • Media and HHS reporting thresholds

    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:

    • FHIR resources and profiles
    • RESTful APIs and conformance
    • Security and authorization (SMART on 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:

    • Message formats and segments
    • Ack/error handling
    • Transport and security

    Comment Elderwise se conforme:

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

    ISO13485
    Objectif: 2026

    ISO 13485 Médical Devices QMS

    Quality management system standard for médical devices.

    Santé Relevance:

    Quality management standard for organizations involved in médical device lifecycle.

    Exigences clés:

    • Documented QMS
    • Design and development controls
    • Risque management and traceability
    • Post-market surveillance

    Comment Elderwise se conforme:

    Adoption progressive du SMQ pour les modules logiciels applicables ; alignement sur les voies réglementaires si la classification de dispositif s'applique.

    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
    • Data governance and transparency
    • 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 is committed to maintaining the highest standards of data protection and regulatory compliance in healthcare technology, with a progressive certification roadmap for completion between Q3 2025 and Q4 2026.

    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's phased certification timeline:

    • Q3 2025: FHIR & HL7 interoperability certifications
    • Q4 2025: GDPR compliance validation
    • Q2 2026: ISO 27001 certification (audit in progress)
    • February 2026: ISO 42001 (AI Management System) certification
    • Q2 2026: HIPAA, HITECH & HSA certifications
    • Q3 2026: SOC 2 Type II & HITRUST CSF certifications
    • Q4 2026: ISO 13485 certification & continuous compliance monitoring

    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 ISO 27001 certified data centers
    • Region-specific data residency options for regulatory compliance
    • Regular vulnerability scanning and penetration testing
    • Disaster recovery with 99.9% uptime commitment
    • Infrastructure as Code (IaC) for secure, consistent deployments
    • Network segmentation for clinical vs. administrative data
    • 24/7 infrastructure monitoring with healthcare-specific alerts
    • 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
    • Validation processes for algorithm-assisted clinical reference tools
    • 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 Vanta's recommended "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.