資訊 關於 our compliance standards, certifications, controls, and 資料 protection practices
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.
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.
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
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.
We provide interim compliance documentation to customers, including security questionnaire responses, SOC 2 readiness assessments, and draft BAAs/DPAs while formal certification is underway.
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.
規範 PHI 隱私與安全的美國醫療法規。
規範醫療機構與其業務夥伴對受保護健康資訊 (PHI) 的隱私與安全處理。
與處理方簽訂 BAA、落實 RBAC/MFA/SSO、集中式稽覈日誌、最小權限、AES‑256/TLS 1.3 加密、事件回應手冊與定期 HIPAA 訓練。
規範合法處理與資料當事人權利的歐盟資料保護法規。
EU/EEA 的資料保護框架，涵蓋合法處理與資料當事人權利。
蒐集並追蹤同意、與供應商簽署 DPA、隱私內建審查、DSR 流程，以及跨境傳輸影響評估。
強調同意與目的限制的新加坡資料保護法。
關於同意、目的限制、通知、存取/更正等義務的在地法規。
在地化同意聲明、保存政策、存取/更正管道，並依 PDPC 指引執行外洩通報。
用於資訊安全風險管理的國際 ISMS 標準。
建立、實施、維護與持續改進 ISMS 的國際標準。
界定 ISMS 範圍、建立風險登錄與政策/控制對映、內部稽覈進行中與認證稽覈進行中。
針對安全控制在一定期間之有效性進行鑑證。
依 AICPA 信任服務準則，對控制成效進行期間性鑑證。
對齊 TSC 控制、證據自動蒐集、持續監控、按季測試控制並準備外部稽覈。
整合多項標準的醫療領域資安框架。
以醫療為核心、整合 HIPAA、ISO、NIST 等要求的可鑑證框架。
界定 PHI 系統範圍、適用時繼承控制，分階段朝驗證性評估前進。
新加坡 HSA 針對醫療科技/軟體之監管指引。
醫療軟體與健康科技解決方案之監管指引。
遵循 HSA 建議，文件化預期用途與風險控制；參考 ISO 14971/IEC 62304。
強化 HIPAA 的外洩通報與執法要件。
強化 HIPAA 的外洩通報與執法。
事件回應手冊、證據保存，以及重大性/通報時機的決策樹。
現代化的結構化臨牀資料交換標準。
現代化的臨牀資料交換標準。
核心實體採 FHIR 優先建模、版本化設定檔、OAuth2/OIDC 授權。
醫院與檢驗機構廣泛採用的醫療訊息標準。
於醫院與檢驗機構廣泛使用的醫療訊息標準。
視需要提供 HL7 v2.x 轉接、內部模型正規化與安全傳輸。
醫療器材品質管理系統 (QMS) 國際標準。
針對醫療器材全生命週期的品質管理標準。
於相關軟體模組逐步導入 QMS；如適用，配合器材分級與法規路徑。
面向負責任 AI 治理的 AI 管理系統標準。
面向負責任 AI 治理的全流程框架。
將既有控制對映至 AI 風險，建立透明度文件與指標，完善模型治理流程。
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.
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
Elderwise's phased certification timeline:
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.