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
Creation of policies, procedures, and controls documentation
Assessment of current practices against certification requirements
Deploying necessary controls and remediation activities
Verification of control effectiveness before external assessment
Official certification audit by accredited third parties
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
Health Insurance Portability and Accountability Act
Health Insurance Portability and Accountability Act - U.S. regulations for protecting sensitive patient data
Healthcare Relevance:
As a healthcare solution handling protected health information (PHI), Elderwise is committed to maintaining HIPAA compliance to ensure secure handling of patient data throughout the geriatric care process.
Key Requirements:
- Comprehensive security measures for protected health information (PHI)
- Data encryption during transmission and storage
- Patient rights to access their own health information
How Elderwise Complies:
Elderwise employs end-to-end encryption, role-based access controls, and detailed audit logging to maintain HIPAA compliance. Our infrastructure is designed with healthcare privacy as a foundational principle.
General Data Protection Regulation
General Data Protection Regulation - EU's comprehensive data privacy and security law
Healthcare Relevance:
For our European patients and healthcare providers, GDPR compliance ensures transparency in data collection, processing, and the right to access or delete personal data while maintaining healthcare records appropriately.
Key Requirements:
- Legal basis for processing personal health data
- Enhanced user rights including access, deletion, and portability
- Data protection impact assessments for sensitive health information
How Elderwise Complies:
Our platform includes consent management systems specifically designed for healthcare contexts, data portability mechanisms, and regional data storage options to support GDPR compliance in clinical settings.
Personal Data Protection Act (Singapore)
Personal Data Protection Act - Singapore's framework for data collection, use, and disclosure
Healthcare Relevance:
Singapore's PDPA compliance is crucial for our expansion in Southeast Asia, ensuring that patient consent processes meet local regulatory requirements for healthcare data.
Key Requirements:
- Specific consent requirements for health information
- Data breach notification procedures
- Cross-border data transfer restrictions for patient records
How Elderwise Complies:
Elderwise implements healthcare-specific consent frameworks that align with PDPA requirements while ensuring clinicians can access necessary information for patient care.
ISO/IEC 27001 Information Security Management
International standard for information security management systems (ISMS)
Healthcare Relevance:
Our information security management system (ISMS) follows ISO27001 standards to protect sensitive geriatric assessment data and maintain the integrity of clinical decision support systems.
Key Requirements:
- Risk-based approach to information security management
- Comprehensive security controls framework
- Continuous monitoring and improvement processes
How Elderwise Complies:
We've implemented a comprehensive ISMS that addresses the unique challenges of managing healthcare data, including specialized risk assessments for clinical data flows and decision support algorithms.
SOC 2 (System and Organization Controls)
Service Organization Control reporting focused on security, availability, processing integrity, confidentiality, and privacy
Healthcare Relevance:
SOC2 compliance demonstrates our commitment to securing patient data while ensuring it's available to authorized healthcare providers when needed for continuity of care.
Key Requirements:
- Trust service criteria: Security, Availability, Processing Integrity, Confidentiality, and Privacy
- Evidence of effective control implementation
- Regular independent attestation
How Elderwise Complies:
Our SOC 2 compliance program emphasizes the availability and integrity aspects critical for healthcare systems while maintaining strong security controls for sensitive patient information.
HITRUST CSF (Common Security Framework)
Health Information Trust Alliance - comprehensive framework to manage security, privacy and regulatory compliance risks
Healthcare Relevance:
HITRUST certification integrates requirements from multiple regulations, making it easier for healthcare institutions to trust Elderwise with their patients' data and clinical workflows.
Key Requirements:
- Comprehensive security controls tailored to healthcare
- Integration of multiple regulatory frameworks (HIPAA, GDPR, etc.)
- Risk-based implementation approach
How Elderwise Complies:
Elderwise is implementing HITRUST's prescriptive set of controls specifically designed for healthcare technology, simplifying compliance verification for our healthcare institution partners.
Health Sciences Authority (Singapore)
Health Standards Authority guidelines for health information protection
Healthcare Relevance:
Health Sciences Authority compliance ensures our platform meets Singapore's specific requirements for healthcare software that influences clinical decision-making and patient care.
Key Requirements:
- Quality management system for medical software
- Clinical evaluation and validation requirements
- Post-market surveillance processes
How Elderwise Complies:
Our platform undergoes rigorous clinical validation specific to geriatric assessment workflows, and maintains traceability between clinical requirements and software functionality.
Health Information Technology for Economic and Clinical Health Act
Health Information Technology for Economic and Clinical Health Act - strengthens HIPAA enforcement and breach notification requirements
Healthcare Relevance:
HITECH Act compliance ensures that Elderwise incorporates the latest security requirements for electronic health records, particularly important for our integration with existing healthcare systems.
Key Requirements:
- Enhanced penalties for HIPAA violations
- Breach notification requirements
- Security technology requirements for EHRs
How Elderwise Complies:
We implement breach detection, notification systems, and encryption technologies that exceed HITECH requirements while ensuring seamless integration with clinical workflows.
Fast Healthcare Interoperability Resources
Fast Healthcare Interoperability Resources - standard for healthcare data exchange
Healthcare Relevance:
By supporting FHIR standards, Elderwise ensures interoperability with other healthcare systems, enabling seamless sharing of geriatric assessment data across the care continuum.
Key Requirements:
- Standardized data models for healthcare information
- Secure API implementations for data exchange
- Patient-centric data access mechanisms
How Elderwise Complies:
Our platform is built with FHIR compatibility at its core, with specialized resources for geriatric assessments that maintain semantic integrity across healthcare systems.
Health Level 7
Health Level Seven International - standards for exchange of clinical and administrative data
Healthcare Relevance:
HL7 compatibility ensures that Elderwise can integrate with legacy healthcare systems, maintaining continuity for institutions transitioning to modern digital health solutions.
Key Requirements:
- Standardized message formats for clinical data
- Integration capabilities with legacy systems
- Support for clinical workflows and processes
How Elderwise Complies:
Elderwise maintains compatibility with both modern FHIR implementations and legacy HL7 v2 systems, ensuring our platform can integrate with any healthcare IT ecosystem regardless of maturity.
ISO 13485 Medical Devices Quality Management System
Medical Devices Quality Management System - international standard for quality management systems specific to medical devices
Healthcare Relevance:
ISO 13485 certification demonstrates our commitment to quality management systems specifically designed for medical device software, ensuring our platform meets international standards for safety and effectiveness.
Key Requirements:
- Risk management throughout the product lifecycle
- Design controls for medical software development
- Validation and verification processes
- Post-market surveillance and continuous improvement
How Elderwise Complies:
Elderwise implements rigorous quality management systems that address the specialized requirements for medical software, with comprehensive documentation, testing, and validation protocols designed to meet international standards.
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
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
- Q1 2026: ISO 27001 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
- End-to-end encryption for all sensitive health information
- Multi-factor authentication for healthcare provider access
- Role-based access control aligned with clinical workflows
- Audit logging 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 decision support
- 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.