SNQ Quality Mark

SNQ is built on evidence-based standards, setting trusted quality and safety benchmarks for healthcare, biomedical, health, and animal care services and products.

  • 9F, No. 508, Sec. 7, Zhongxiao E. Rd., Nangang Dist., Taipei City, Taiwan
  • +886 2 2655 7888
  • snq@snq.com.tw

About the National Quality Mark

  • Vision & Mission
  • Review Committee
  • Certification Schedule

Certification Methods

  • Medical Service
  • Biomedical Product
  • Health Product
  • Animal Care & Products

SNQ Certified

  • Certified Services & Products
  • Certified Organizations
  • Quality Award Winners

International Certification

  • ICHOM PROMs
  • NSF Certification

Quality Focus

  • Apply for Certification →
Organized by|Research Center for Biotechnology and Medicine PolicyOperated by|Kuanglu International Quality Standards Co., Ltd.© 2026 Kuanglu International Quality Standards Co., Ltd. All rights reserved.Privacy Policy
SNQ Quality Mark
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Target Population

  • Users of CMU medical system 25-hospital data

  • Researchers using 5.37M medical records

  • Researchers using medical imaging (X-ray/CT/MRI)

  • Biomedical signal/gene/physiology data analysts

  • AI/smart medicine researchers

  • Patients benefiting from privacy protection


Description

China Medical University Hospital, led by Vice Superintendent Chun-Liang Chen and Manager Han-Mi Chen, integrates the IT Office (data source), Big Data Center (clinical data de-identification), and AI Medical Diagnosis Center (medical imaging de-identification) into the "Hidden but Not Obscured" smart medical data management mechanism. The CMU medical system encompasses 25 hospitals with 5.37 million accumulated records covering text records, medical imaging (X-ray/CT/MRI), biomedical signals (ECG/EEG), bioinformatics (genes), and personal physiological/environmental data, spanning medical centers, regional, district hospitals, and clinics. Clinical data de-identification uses pseudonymization (ID hash as primary key), merger transformation (ordered encryption of visit/form numbers), fuzzification (dates to ages, addresses to towns), text report processing, and consistency transformation (offset by same value to preserve research value). Medical imaging de-identification handles DICOM tags by classification and masks/restores personal info in image margins. Implemented in 2020 conforming to ISO/IEC 29100, ISO/IEC 29191, CNS 29100-2—Taiwan-first and only medical institution to pass CNS 29100-2 accreditation. Established a one-way hashing mechanism for de-identified yet linkable data; published 40+ papers, obtained 12 patents (4 pending review), 1 US FDA approval (K212624), 4 FDA/TFDA medical software licenses.


Key Highlights

  • Hidden yet not obscured: de-id and linkable

  • Only TW medical institution with CNS 29100-2 certification

  • 25 hospitals, 5.37M records

  • One-way hashing preserves linking

  • Covers clinical data + medical imaging

  • Fuzzification/consistency/merger transformations

Service Data

  • 25 hospitals in medical system

  • 5.37M medical records

  • 40+ journal papers

  • 12 patents obtained, 4 under review

  • 1 US FDA, 4 FDA/TFDA software licenses

  • HIS/PACS/genetics/pathology/cancer database integration


Featured Outcomes

  • ISO/IEC 29100/29191/CNS 29100-2 certifications

  • Taiwan-first & only CNS 29100-2 medical institution

  • US FDA software certification K212624

  • SOPs SOP-A80-B0501/SOP-JZ0-A0001

  • Medical data application review procedure

  • Patient-signed consent for special-purpose use


Safety Outcomes

  • Hash function protection measures

  • Text content with PII processed by case

  • DICOM tag classification

  • Image margin PII masking

  • Strict strong/weak/no-PII classification

  • Adheres to ISO/IEC international PII standards


Satisfaction

  • User-friendly medical data

  • Online application/dashboard convenience

  • Patient PII protection recognized

  • Trust enhanced by ISO certification

  • 25 hospitals collaborate

  • Transparent personal consent forms


International Achievements

  • 40+ journal papers

  • 12 patents (4 under review)

  • 1 US FDA approval (K212624)

  • 4 FDA/TFDA software licenses

  • ISO/IEC 29100, 29191 intl certifications

  • Taiwan-first & only medical institution with CNS 29100-2


Benefits and Impacts

  • Balances personal privacy and medical research

  • Leads future smart medicine development

  • Builds linkable medical Digital Twin

  • Integrates 25-hospital data

  • Benchmark for domestic institutions

  • Enhances medical data reuse value

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Healthcare Administration

Mechanism for effective de-identification of medical data

Organization
China Medical University Hospital
Specialties/Units
IT Office (cross Big Data Center, AI Medical Diagnosis Center)
Certification Year
2022、2023、2024、2025
Mechanism for effective de-identification of medical data

Related Insights

From Data to Care Outcomes: How Does Technology Advance Healthcare Quality?
A leaders' dialogue at the second Asia-Pacific Healthcare Quality Forum: ICHOM, the European Union of Private Hospitals, Stanford University and three Taiwanese hospitals on measurement, clinical use, and the obstacles that remain.
China Medical University Hospital

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