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Elderwise

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    Legal, Riesgo y Cumplimiento

    Información sobre nuestros estándares de cumplimiento, certificaciones, controles y prácticas de protección de datos

    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.

    Estándares de Atención Médica y Cumplimiento de Elderwise

    Última Actualización: 2025-09-27
    HIPAA
    Objetivo: Operational

    Salud Insurance Portability and Accountability Act (HIPAA)

    Ley de privacidad y seguridad de atención médica de EE.UU. que rige la PHI.

    Relevancia en Atención Médica:

    U.S. atención médica privacidad and seguridad requirements governing PHI handling by covered entities and negocio associates.

    Requisitos Clave:

    • Negocio Associate Agreements (BAAs)
    • Role-based access and MFA
    • Audit logging and monitoreo
    • Minimum necessary access
    • Encriptación in transit and at descanso
    • Breach notificación procedures
    • Periodic riesgo evaluaciones and workforce training

    Cómo Elderwise Cumple:

    BAAs in place with processors, enforced RBAC/MFA/SSO, centralized audit logs, least-privilege defaults, AES-256/TLS 1.3 encriptación, incident response runbooks, and recurring HIPAA training.

    GDPR
    Objetivo: Operational

    EU General Datos Protection Regulation (GDPR)

    Regulación de protección de datos de la UE que cubre procesamiento legal y derechos.

    Relevancia en Atención Médica:

    EU/EEA framework for datos protection, lawful processing, and datos subject rights.

    Requisitos Clave:

    • Lawful basis and consent management
    • Datos subject rights (access, erasure, portability)
    • Datos Processing Agreements
    • Datos Protection by Design and Default
    • Records of processing activities
    • International transfer safeguards

    Cómo Elderwise Cumple:

    Consent capture and audit trails, DPA addenda with vendors, privacidad by design reseñas, DSR workflows, and transfer impact evaluaciones where applicable.

    PDPA
    Objetivo: Operational

    Personal Datos Protection Act (PDPA, Singapore)

    Ley de protección de datos de Singapur que enfatiza consentimiento y limitación de propósito.

    Relevancia en Atención Médica:

    Singapore datos protection obligations for consent, purpose limitation, notificación, and access/correction.

    Requisitos Clave:

    • Consent and notificación
    • Purpose limitation
    • Access and correction rights
    • Protection and retention limits
    • Datos breach notificación

    Cómo Elderwise Cumple:

    Localized consent statements, retention schedules, access/correction channels, and breach notificación procedures aligned with PDPC guidance.

    ISO27001
    Objetivo: Q2 2026

    ISO/IEC 27001 Información Seguridad Management System

    Estándar SGSI internacional para gestionar riesgos de seguridad de información.

    Relevancia en Atención Médica:

    International standard for establishing, implementing, maintaining, and continuously improving an ISMS.

    Requisitos Clave:

    • Riesgo management program
    • ISMS governance and documentación
    • Seguridad controls per Annex A
    • Continuous improvement cycle

    Cómo Elderwise Cumple:

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

    SOC2
    Objetivo: Q2 2026

    SOC 2 Type II (Seguridad, Availability, Confidentiality)

    Attestation of seguridad controls effectiveness over a period (Type II).

    Relevancia en Atención Médica:

    Attestation of control effectiveness over a reseña period per AICPA Trust Services Criteria.

    Requisitos Clave:

    • Documented policies and procedures
    • Seguridad monitoreo and alerting
    • Change and incident management
    • Vendor riesgo management

    Cómo Elderwise Cumple:

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

    HITRUST
    Objetivo: 2026

    HITRUST CSF

    Marco de seguridad certificable centrado en atención médica que armoniza múltiples estándares.

    Relevancia en Atención Médica:

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

    Requisitos Clave:

    • Riesgo-based control selection
    • Policy/procedure implementation
    • Validation and scoring
    • External evaluación

    Cómo Elderwise Cumple:

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

    HSA
    Objetivo: Q2 2026

    Singapore HSA Guidance (Médico Technologies)

    Guía de HSA de Singapur para tecnologías médicas y software.

    Relevancia en Atención Médica:

    Regulatory guidance for médico device software and salud tech solutions in Singapore.

    Requisitos Clave:

    • Riesgo classification and documentación
    • Quality management alignment
    • Clínico and cybersecurity considerations

    Cómo Elderwise Cumple:

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

    HITECH
    Objetivo: Q1 2026

    HITECH Act (Breach Notificación)

    Mejoras de notificación de violaciones y aplicación de EE.UU. a HIPAA.

    Relevancia en Atención Médica:

    U.S. breach notificación and enforcement enhancements to HIPAA.

    Requisitos Clave:

    • Breach riesgo evaluación
    • Timely notificaciones
    • Media and HHS reporting thresholds

    Cómo Elderwise Cumple:

    Incident response runbooks, evidence preservation, decision trees for materiality and reporting timelines.

    FHIR
    Objetivo: Operational

    HL7 FHIR (Interoperability)

    Estándar moderno de interoperabilidad para intercambio estructurado de datos clínicos.

    Relevancia en Atención Médica:

    Modern atención médica interoperability standard for structured clínico datos exchange.

    Requisitos Clave:

    • FHIR recursos and profiles
    • RESTful APIs and conformance
    • Seguridad and authorization (SMART on FHIR)

    Cómo Elderwise Cumple:

    FHIR-first datos modeling for core entities, versioned profiles, and OAuth2/OpenID Conectar for seguro access.

    HL7
    Objetivo: Operational

    HL7 v2/v3 Messaging

    Estándares de mensajería de atención médica utilizados por HCE y laboratorios.

    Relevancia en Atención Médica:

    Legacy and current atención médica messaging standards widely used by EHRs and labs.

    Requisitos Clave:

    • Mensaje formats and segments
    • Ack/error handling
    • Transport and seguridad

    Cómo Elderwise Cumple:

    Adapters for HL7 v2.x integración where required, normalization to internal schemas, and seguro transport.

    ISO13485
    Objetivo: 2026

    ISO 13485 Médico Devices QMS

    Estándar de sistema de gestión de calidad para dispositivos médicos.

    Relevancia en Atención Médica:

    Quality management standard for organizations involved in médico device lifecycle.

    Requisitos Clave:

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

    Cómo Elderwise Cumple:

    Progressive QMS adoption for applicable software modules; align with regulatory pathways if device classification applies.

    ISO42001
    Objetivo: 2026

    ISO/IEC 42001 AI Management System

    Estándar de sistema de gestión de IA para gobernanza responsable de IA.

    Relevancia en Atención Médica:

    Framework for governing responsible AI systems across lifecycle.

    Requisitos Clave:

    • AI riesgo management and controls
    • Datos governance and transparency
    • Monitoreo and continuous improvement

    Cómo Elderwise Cumple:

    Map existing controls to AI riesgos, define KPIs and documentación 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.