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Elderwise

สงวนลิขสิทธิ์ทุกประการ

    Legal, Risk & Compliance

    Information about our compliance standards, certifications, controls, and data protection practices

    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.

    Healthcare Standards & Elderwise Compliance

    Last Updated: 2025-09-27
    HIPAA
    เป้าหมาย: เสร็จสมบูรณ์แล้ว

    พระราชบัญญัติการพกพาและความรับผิดชอบด้านการประกันสุขภาพ

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

    Healthcare Relevance:

    ความปลอดภัยของข้อมูลสุขภาพของสหรัฐอเมริกา

    Key Requirements:

      How Elderwise Complies:

      การเข้ารหัส AES-256, การควบคุมการเข้าถึงตามบทบาท, เส้นทางการตรวจสอบที่ครอบคลุม

      GDPR
      เป้าหมาย: ไตรมาส 2 ปี 2026

      กฎระเบียบทั่วไปว่าด้วยการคุ้มครองข้อมูล

      EU data protection regulation covering lawful processing and rights.

      Healthcare Relevance:

      การคุ้มครองข้อมูลสำหรับพลเมือง EU

      Key Requirements:

        How Elderwise Complies:

        สถาปัตยกรรมความเป็นส่วนตัวตั้งแต่การออกแบบ พร้อมเครื่องมือจัดการความยินยอม

        PDPA
        เป้าหมาย: เสร็จสมบูรณ์แล้ว

        พระราชบัญญัติคุ้มครองข้อมูลส่วนบุคคล

        Singapore data protection law emphasizing consent and purpose limitation.

        Healthcare Relevance:

        การคุ้มครองข้อมูลสำหรับสิงคโปร์

        Key Requirements:

          How Elderwise Complies:

          การปฏิบัติตามกรอบ PDPA อย่างสมบูรณ์

          ISO27001
          เป้าหมาย: Q2 2026

          ISO/IEC 27001 Information Security Management System

          International ISMS standard for managing information security risks.

          Healthcare Relevance:

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

          Key Requirements:

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

          How Elderwise Complies:

          Formal ISMS scope definition, risk register, policies and control mapping, internal audits in progress, and certification audit underway.

          SOC2
          เป้าหมาย: อยู่ระหว่างดำเนินการ

          การควบคุมองค์กรบริการ 2

          การรับรองความปลอดภัยและความพร้อมใช้งานขององค์กร

          Healthcare Relevance:

          มาตรฐานความปลอดภัยและความพร้อมใช้งาน

          Key Requirements:

            How Elderwise Complies:

            การตรวจสอบและการรับรองอย่างต่อเนื่อง

            HITRUST
            เป้าหมาย: 2026

            HITRUST CSF

            Healthcare-centric certifiable security framework harmonizing multiple standards.

            Healthcare Relevance:

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

            Key Requirements:

            • Risk-based control selection
            • Policy/procedure implementation
            • Validation and scoring
            • External assessment

            How Elderwise Complies:

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

            HSA
            เป้าหมาย: Q2 2026

            Singapore HSA Guidance (Medical Technologies)

            Singapore HSA guidance for medical technologies and software.

            Healthcare Relevance:

            Regulatory guidance for medical device software and health tech solutions in Singapore.

            Key Requirements:

            • Risk classification and documentation
            • Quality management alignment
            • Clinical and cybersecurity considerations

            How Elderwise Complies:

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

            HITECH
            เป้าหมาย: ไตรมาส 1 ปี 2026

            พระราชบัญญัติ HITECH (การแจ้งเตือนการละเมิด)

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

            Healthcare Relevance:

            การปรับปรุงการแจ้งเตือนการละเมิดและการบังคับใช้ของสหรัฐอเมริกาต่อ HIPAA

            Key Requirements:

            • การประเมินความเสี่ยงจากการละเมิด
            • การแจ้งเตือนตามเวลา
            • เกณฑ์การรายงานต่อสื่อและ HHS

            How Elderwise Complies:

            คู่มือการตอบสนองเหตุการณ์ การรักษาหลักฐาน แผนภูมิการตัดสินใจ

            FHIR
            เป้าหมาย: ไตรมาส 3 ปี 2026

            Fast Healthcare Interoperability Resources

            Modern interoperability standard for structured clinical data exchange.

            Healthcare Relevance:

            มาตรฐานการแลกเปลี่ยนข้อมูลสุขภาพ

            Key Requirements:

              How Elderwise Complies:

              การออกแบบ API ที่สอดคล้องกับ FHIR R4

              HL7
              เป้าหมาย: Operational

              HL7 v2/v3 Messaging

              Healthcare messaging standards used by EHRs and labs.

              Healthcare Relevance:

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

              Key Requirements:

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

              How Elderwise Complies:

              Adapters for HL7 v2.x integration where required, normalization to internal schemas, and secure transport.

              ISO13485
              เป้าหมาย: 2026

              ISO 13485 Medical Devices QMS

              Quality management system standard for medical devices.

              Healthcare Relevance:

              Quality management standard for organizations involved in medical device lifecycle.

              Key Requirements:

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

              How Elderwise Complies:

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

              ISO42001
              เป้าหมาย: 2026

              ISO/IEC 42001 AI Management System

              AI management system standard for responsible AI governance.

              Healthcare Relevance:

              Framework for governing responsible AI systems across lifecycle.

              Key Requirements:

              • AI risk management and controls
              • Data governance and transparency
              • Monitoring and continuous improvement

              How Elderwise Complies:

              Map existing controls to AI risks, 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.