Public Release Statement

This report is intended for healthcare institutions, professional societies, industry associations, research organizations, healthcare quality managers, specialty center developers, and international partners. It provides a research reference for the development, capability evaluation, regional collaboration, and international comparison of specialty disease and specialty medical centers.

The five-level framework, evaluation procedures, and indicator recommendations in this report are research and capacity-building proposals. They do not constitute a healthcare institution license to practice, scope of practice, government designation, medical insurance access, clinical guideline, medical advice, or statutory accreditation in any country or region. When applying this report, institutions shall comply with the laws and regulations of the applicable jurisdiction concerning medical practice, ethics, data protection, promotion, cross-border services, and medical devices.

Facts, comparative judgments, research recommendations, and items requiring further verification are identified or presented according to their respective nature. The accreditations, designations, service specifications, and professional consensuses cited in this report have different issuing bodies and legal effects and cannot substitute for one another.

Attribution and Publication Information

The following attribution and publication information is adopted for the official release of this report.

English title: Research Report on the Development and Evaluation of Asia-Pacific Specialty Disease and Specialty Medical Centers

Publishing organization: Asia-Pacific Health and Wellness Association

Research and drafting: Committee for the Development and Evaluation of Asia-Pacific Specialty Disease and Specialty Medical Centers, Asia-Pacific Health and Wellness Association

Lead author: Ning Hai, Executive Chair of the Asia-Pacific Health and Wellness Association. Major contributions include research design, framework development, research coordination, and substantive revision.

Release review: Executive Committee of the Asia-Pacific Health and Wellness Association

Compilation date: October 20, 2026; information updated through: October 31, 2026; public release version: v1.5 (October 31, 2026)

Publication platform: Official website of the Asia-Pacific Health and Wellness Association

Contact email: aphahk@163.com

Responsibility statement: The research and drafting body identified above is responsible for the content and evidentiary boundaries of this report. The publishing organization is responsible for release authorization, version confirmation, and maintenance of the official website information. This report does not represent an administrative license, accreditation, recognition, or endorsement of efficacy by any government department, international organization, accreditation body, or healthcare institution.

Conflict of interest statement: The author, research organization, and experts participating in this report declare that they have no conflict of interest that could affect the independence of this report.

Funding and support statement: This report was organized and researched by the Asia-Pacific Health and Wellness Association and did not receive commercial sponsorship that could affect its conclusions.

Copyright and citation: © 2026 Asia-Pacific Health and Wellness Association. Unless otherwise stated, non-commercial citation is permitted provided that the report title, version, publishing organization, and original link are retained in full. Suggested citation: Asia-Pacific Health and Wellness Association. Research Report on the Development and Evaluation of Asia-Pacific Specialty Disease and Specialty Medical Centers. Public Release Version v1.5, 2026. Official website of the Asia-Pacific Health and Wellness Association.

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Contents

Abstract

Executive Summary and Core Conclusions

I. Research Background, Research Questions, and the Need for Development

II. Current Status and Development of Specialty Disease and Specialty Medical Centers in China, the Asia-Pacific Region, and Worldwide

III. The Value of Developing Specialty Disease and Specialty Medical Centers

IV. The Concept, Scope, and Basic Functions of Medical Centers

V. Classification, Center Naming, and Language Standards

VI. The Tiered Development Framework for Asia-Pacific Specialty Disease and Specialty Medical Centers

VII. Development Components and the Evaluation System for Disease-Specific Centers

VIII. Developing the Evaluation Workforce and a Comprehensive Talent System

IX. Cross-Regional Collaboration and International Development

X. Laws and Regulations, Ethics, and Risk Control

XI. Association Services, Member Participation, and Sustainable Operations

XII. Implementation Pathways and Development Recommendations

Conclusion

Appendix I. Proposed Evaluation Indicators

Appendix II. Public Sources and References

Appendix III. Statement of Evidentiary Boundaries

Abstract

This report examines the development and evaluation of Asia-Pacific specialty disease and specialty medical centers, focusing on comparisons of disease-specific centers, centers of excellence, regional collaborative networks, and international accreditation practices in China, the Asia-Pacific region, and worldwide. Building on the original research framework, the report defines the Hospital Disease-Specific Center Development Support and Pre-Evaluation Unit as a preparatory development tier preceding the five-level framework. The five formal levels are standardized as follows: Incubation Institutions of the Asia-Pacific Specialty Disease and Specialty Medical Centers Consortium; Institutions of the Asia-Pacific Specialty Disease and Specialty Medical Centers Consortium; Asia-Pacific Specialty Disease and Specialty Medical Centers with a Single Function or Multiple Functions; Asia-Pacific Specialty Disease and Specialty Medical Centers with Full Functions; and Certification Bodies. The report further incorporates research on compliance boundaries in mainland China, international personnel and services, inbound medical care, the international expansion of medical technologies, and the international expansion of medical equipment. It proposes a development and evaluation pathway centered on practical technology implementation, organizational capabilities, patient safety, quality outcomes, regional collaboration, and continuous improvement.

Keywords: specialty disease and specialty medical centers; development and evaluation; quality and safety; regional collaboration; international development; transition to accreditation

Executive Summary and Core Conclusions

· WHO data indicate that noncommunicable diseases account for approximately 74% of deaths worldwide. Chronic respiratory diseases, cancers, cardiovascular and cerebrovascular diseases, and diabetes impose a long-term healthcare burden.[1]

· WHO's Western Pacific Region notes that important gaps remain in the size, distribution, quality, and working conditions of the health workforce. Population aging and noncommunicable diseases further increase the need for capacity building.[7]

· China's national medical centers and national regional medical centers form part of a government planning and administrative management system. The Association's framework should draw on their approaches to regional outreach and coordination of healthcare, education, and research, without replicating administrative titles or statutory powers.[9][10][11]

· Established international practices share a foundation of quality and safety, evidence-based evaluation, workforce development, research translation, data governance, and continuous improvement, rather than the plaques themselves.[2][13][14][15]

· The Asia-Pacific framework should initially focus on voluntary capability development and collaborative networks. Certification bodies should be considered subsequently, once conditions concerning legality, independence, procedures, public disclosure, and appeals are sufficiently developed.

I. Research Background, Research Questions, and the Need for Development

1.1 Changes in Global Disease Patterns and Demand for Disease-Specific Care

WHO identifies cardiovascular diseases, cancers, diabetes, and chronic respiratory diseases as major noncommunicable diseases. Their management involves long-term care, repeat visits and follow-up, and multidisciplinary collaboration.[1]

1.2 Practical Context for the Development of Disease-Specific and Specialty Services

Increasing disease complexity, rapid technological updates, and patients seeking care across regions make it difficult for a single hospital to provide every capability. Disease-specific networks can reduce duplication through consultations, referrals, training, and shared data.

1.3 Differences in Healthcare Resources and Collaboration Needs across the Asia-Pacific Region

Materials from the Western Pacific and South-East Asia regions show a substantial burden of noncommunicable diseases and uneven distribution of diagnostic services, medicines, and specialist personnel.[6][7][8]

1.4 The Need to Develop Specialty Disease and Specialty Medical Centers

Development is needed to improve the quality of care for complex diseases, extend resources to lower-level services, train personnel across professional disciplines, and generate comparable improvement data.

1.5–1.7 Research Objectives, Sources, and Boundaries

Research methods and evidence classification: The search used four categories of public sources: government departments, international organizations, professional bodies, and institutional websites. Laws, regulations, and formal government documents were prioritized, followed by documents from international organizations such as WHO and the European Commission, and then professional standards such as those of NCI and JCI. News and unverified promotional materials were used only as leads. The report distinguishes verified facts, comparative judgments, Association recommendations, and matters requiring verification.

This is a study of institutional arrangements and frameworks, not a study of clinical outcomes in patients. Internal Association proposals are treated separately from public facts, and the conclusions do not replace national laws, guidelines, or administrative approvals.

The 2025 Expert Consensus on Pathways for Developing Operational Disease-Specific Centers in General Hospitals, published by West China Hospital, provides an important foundation for development within Chinese hospitals. Its “1+5+7” framework can be adapted to this project as follows: one core condition confirms explicit hospital authorization, a defined disease-specific focus, and an accountable entity; five necessary conditions verify organizational governance, professional teams, clinical services and pathways, quality and safety, and operational management; and seven supporting or enabling conditions evaluate education and training, research translation, data governance, patient education, regional collaboration, digital technologies, and continuous improvement. This framework is used for development diagnostics and task specifications at the hospital preparatory tier. It does not directly replace status evaluation at the Association's first four levels.

The 2026 consensus on governance pathways for operational disease-specific centers remains a registered protocol and cannot be treated as a final standard. However, its evidence classification, Delphi expert scoring, importance and feasibility assessment, and lifecycle approach covering development, operation, improvement, and exit can inform subsequent pilot calibration. This report therefore treats the West China consensus as a domestic development framework, international standards as comparative evidence, and the Association's five-level framework as a project governance arrangement. These three are not treated as standards of the same nature.

To ensure that comparisons can be reviewed, this study divides its sources into four categories: first, laws, designations, and service licensing documents issued by governments or statutory bodies; second, standards and application and reassessment rules issued by national or professional accreditation bodies; third, development and quality documents from professional societies, hospital networks, and disease-specific centers; and fourth, public statistics, annual reports, and industry data. The first three explain how centers are developed and evaluated. The fourth informs judgments about the scale and measurability of international services, technology exports, and equipment collaboration. Materials of different types are not merged into a single category of “accreditation standards.”

The research materials used in this report include reference standards from the United States, Japan, Singapore, Germany, Hong Kong, and Europe, together with materials on breast care, pediatric chronic lung disease and cystic fibrosis, cancer, stroke, imaging and ultrasound, UK NHS networks, and mainland Chinese regional projects. Conclusions are used only where the issuing body, intended subjects, version, and legal nature can be confirmed. Controlled materials or materials for which the full text has not been obtained serve only as entry points to projects and leads for comparison.

II. Current Status and Development of Specialty Disease and Specialty Medical Centers in China, the Asia-Pacific Region, and Worldwide

2.1 Current Development in China

China has established systems including national medical centers, national regional medical centers, key clinical specialties, specialty alliances, and medical consortia. Public information from the National Health Commission indicates that, by 2023, national medical centers had been established in 13 professional categories and 76 national regional medical center development projects had been approved.[9][10]

2.2 Current Development in the Asia-Pacific Region

Development across the Asia-Pacific region is uneven. Chronic respiratory diseases, cancers, and other noncommunicable diseases place pressure on primary-care diagnosis, access to medicines, and specialist personnel.[6][7][8]

2.3 Current Development Worldwide

The EU's European Reference Networks promote collaboration on complex diseases through cross-border networks of expert centers and continuous monitoring. The US NCI classifies cancer centers into basic, clinical, and comprehensive categories. Comprehensive centers emphasize breadth of research, interdisciplinary integration, training, and service to their regions.[13][14]

Materials from global hospital and quality evaluation organizations must also be used according to their respective subjects. JCI, DNV, ACHS, Accreditation Canada, NABH, HCAC, CBAHI, GAHAR, and Thailand's HAI primarily provide accreditation, assessment, or quality improvement frameworks for hospitals or healthcare service organizations. WHO and ISQua/IEEA focus on external evaluation of health systems and the credibility of accreditation bodies. ISO 7101, ISO 15189, ISO 27799, ISO 17021-1, and ISO/IEC 17065 respectively address healthcare quality management, medical laboratories, health information security, and requirements for conformity assessment bodies. Together, these can support gap analysis for the fourth level's transition to accreditation, but they must not be collectively described as a single set of “international accreditation standards.”

At the level of original disease-specific programs, international practice does not constitute a single uniform “disease-specific center accreditation.” The US Joint Commission's Disease-Specific Care program and JCI centers of excellence emphasize standardized pathways, teamwork, and outcome indicators. ACS/NAPBC in the United States and EUSOMA/ECO in Europe specify multidisciplinary teams, case volumes, continuity of care, and quality improvement for breast centers. ECFS links teams, facilities, registries, and continuous improvement in cystic fibrosis centers. Germany's OnkoZert establishes separate requirements catalogs and data sheets for breast, lung cancer, comprehensive cancer, and other centers.

Japan more often combines government designation with professional society recognition. Singapore places initial emphasis on healthcare service licensing, infection prevention, and risk control. The Hong Kong Hospital Authority advances hospital quality through service frameworks, quality and safety, and locally adapted accreditation. UK NHS sarcoma and pediatric cancer systems center on disease-specific networks, service specifications, and commissioning eligibility. Materials on stroke centers in South Korea and Thailand further show how professional organizations can establish a complete quality cycle through preliminary review, on-site assessment, accreditation committees, and periodic reassessment.

Together, these materials show that the transferable elements of center development lie not in names but in an evidence chain: lawful entity, disease-specific team, technologies and processes, case or service volumes, collaborative network, data quality, outcome improvement, and periodic reassessment. Designation, accreditation, service qualifications, and internal hospital evaluation in different countries must be identified separately.

2.4 Comparison of Development Levels

China has a strong foundation in administrative planning and regional projects. Europe and North America have more established experience in network governance, transparent evaluation, and continuous monitoring. The Asia-Pacific region needs more adaptable entry points for collaboration.

Moving from jurisdictional comparison to project design, the most prudent approach is a four-part structure comprising a common quality foundation, disease-specific modules, regional compliance adaptation, and transition to independent accreditation. The common foundation covers governance, personnel, patient safety, data, ethics, and continuous improvement. Disease-specific modules follow the different technical pathways for conditions such as pediatric chronic lung disease, breast tumors, and thyroid diseases. Regional adaptation addresses practice, data, advertising, and cross-border responsibilities in mainland China and other Asia-Pacific jurisdictions. Independent accreditation separately requires impartiality, competence, appeals, and oversight arrangements for certification bodies.

2.5 Assessment of Development Stages

Overall comparative conclusion: China has a strong institutional foundation in government planning, national medical centers, regional medical centers, and medical consortia. The Asia-Pacific region shows substantial differences in healthcare resources, the health workforce, data infrastructure, and cross-border collaboration. Established European and North American practices are relatively mature in member admission, continuous monitoring, peer evaluation, research translation, and public directories. For this project, the implication is that the Association should develop network organization, training, and voluntary capability evaluation without replacing government approvals. Evaluation should center on functions and evidence. Data and AI applications must meet requirements for interoperability, privacy, validation, and human oversight simultaneously.

Four stages are recommended: single-institution services, regional collaboration, comprehensive medical centers, and international coordination and standards development.

III. The Value of Developing Specialty Disease and Specialty Medical Centers

3.1–3.3 Clinical and Referral Value

Centers organize care across the full disease course, quality and safety, and two-way referrals, promoting tiered healthcare and the extension of resources to lower-level services.[2][12]

3.4–3.6 Value in Workforce Development, Education, Research, and AI

Capabilities are strengthened through courses, case discussions, multicenter research, translation of research findings, and governed medical AI applications.[4][5][7]

3.7–3.9 Value in International Collaboration and Networks

Consistent terminology, indicators, and evidence packages facilitate cross-regional exchange and the formation of regional disease-specific service networks.

IV. The Concept, Scope, and Basic Functions of Medical Centers

4.1–4.3 Definition and Boundaries

A specialty disease and specialty medical center is a capability platform organized around a particular disease or group of diseases. Appropriately qualified institutions or institutional networks undertake clinical and related collaborative functions, supported by education, research, quality, data, and continuous improvement.

4.4–4.7 Core Healthcare, Education, and Research Functions

These include disease-specific clinical care, consultations and referrals, teaching and continuing education, research, and translation of research findings.

4.8–4.11 Standards, AI, Data, and International Collaboration Functions

These include international standards development, medical AI applications, data governance and patient follow-up, international exchange, and resource integration. Each function requires evidence of policies, personnel, processes, records, and outcomes.

Accordingly, an English name, international conferences, or the number of foreign experts do not provide sufficient proof of a medical center's international development. Instead, four progressively higher levels should be used: knowledge that can be exchanged, practices that can be compared, projects that can be undertaken collaboratively, and outcomes that can be traced. Cross-border patient services, consultations, training, research, technology licensing, and equipment services should all record participating countries or regions, diseases, projects, accountable entities, data authorizations, quality outcomes, and revenue definitions.

V. Classification, Center Naming, and Language Standards

5.1–5.4 Classification and Tier Naming

Names should reflect regional or organizational affiliation, disease scope, and the nature of the center. Tiers should be stated in evaluation documents. Plaques should use stable, concise names that do not create a mistaken impression of administrative accreditation.

5.5–5.7 Multilingual Names, Plaques, and Authorization

Chinese, English, and local official-language versions should correspond one to one. Validity periods, annual review requirements, and conditions for suspension and withdrawal should be established.

VI. The Tiered Development Framework for Asia-Pacific Specialty Disease and Specialty Medical Centers

6.1–6.8 The Updated Five-Level Framework and Preparatory Development Tier

This report adopts a structure comprising a preparatory development tier and five formal levels. The Hospital Disease-Specific Center Development Support and Pre-Evaluation Unit evaluates the development process of a specific disease-specific center within an individual hospital; it is not a formal status within the five-level framework. The formal framework begins with consortium incubation institutions and progresses to consortium institutions, centers with a single function or multiple functions, centers with full functions, and finally a transition to independent certification bodies.

Hospital Disease-Specific Center Development Support and Pre-Evaluation Unit → Incubation Institution of the Asia-Pacific Specialty Disease and Specialty Medical Centers Consortium → Institution of the Asia-Pacific Specialty Disease and Specialty Medical Centers Consortium → Asia-Pacific Specialty Disease and Specialty Medical Center (Single Function or Multiple Functions) → Asia-Pacific Specialty Disease and Specialty Medical Center (Full Functions) → Independent certification by a certification body. The first four levels fall within the Association's development and capability evaluation remit. The fifth level is implemented separately through a dedicated independent certification program.

This pathway corresponds to the progression of capabilities commonly found in international materials. The hospital preparatory tier addresses organizational authorization, implementation of disease-specific technologies, and coordination with administrative departments. Consortium incubation institutions address authenticity, willingness to cooperate, and basic capabilities. Consortium institutions must undertake actual consultations, training, research, or continuing education tasks. Centers with a single function or multiple functions must have at least one sustainable and verifiable disease-specific service function. Centers with full functions must connect clinical care, consultations and referrals, education and training, research translation, quality and safety, data governance, and international collaboration into a complete operational cycle.

Outputs from the hospital preparatory tier should not consist solely of a recommendation to apply. They should comprise four evidence packages: entity and authorization; disease-specific development gaps; technology implementation and operations; and pre-evaluation for advancement. During development, trial operation, and advancement, records should identify tasks, responsible departments, operating cycles, indicator denominators, original evidence, rectification deadlines, and review findings. Mandatory gates should address major issues in medical safety, privacy, data authenticity, responsibilities exceeded, and misleading publicity. Outcomes may include correction, deferral, suspension, reinstatement, or exit.

6.9–6.11 Tier Advancement, Annual Reassessment, and Transition to Independent Accreditation

Advancement must be based on evidence of actual operation. An application for the first level may be made only after the preparatory tier has completed hospital authorization, development diagnostics, technology implementation, and at least one operating cycle. The first level advances to the second after incubation and annual reassessment. The second advances to the third after establishing stable collaborative functions. The third advances to the fourth after achieving a complete cycle of multifunctional coordination, quality improvement, workforce development, and data governance. The fourth is transferred to the fifth after meeting the requirements of the independent certification pathway. No tier constitutes government permission, a healthcare institution's qualification to practice, statutory certification, or successful international accreditation.

VII. Development Components and the Evaluation System for Disease-Specific Centers

7.1–7.4 Foundations, Clinical Care, Consultations, and Referrals

Verify the entity and qualifications before evaluating functions. Consultation and referral evaluation should focus on responsiveness, transfer of responsibility, and completed feedback cycles.

7.5–7.9 Education, Research, Standards, AI, and Data

Evaluate course quality, ethical compliance, research design, standards mapping, AI validation, human review, and data governance.[5][15]

7.10–7.12 Workforce, Quality, and Procedures

The recommended evaluation structure comprises prerequisite compliance, capability modules, outcome evidence, and continuous improvement. Entity status and compliance are mandatory requirements and should not be offset by high scores elsewhere. Other weights are research recommendations requiring calibration after piloting.

Sources of evaluation indicators should remain traceable. Breast centers should primarily reference NAPBC, EUSOMA/ECO, Germany's OnkoZert, and European breast service quality schemes. Pediatric chronic lung disease and cystic fibrosis should reference ATS, ACGME pediatric pulmonology program requirements, and ECFS standards of care. Comprehensive cancer centers should reference NCI, Japan's designated cancer care institutions, UK NHS disease-specific networks, and Hong Kong's cancer service framework. Imaging and ultrasound modules should reference ACR and related quality-control requirements. Stroke modules should reference Joint Commission/AHA, South Korean and Thai stroke center programs, and Chinese chest pain center standards. These sources inform candidate indicators and evidence checklists; they do not directly become mainland Chinese administrative licenses or Association certification decisions.

Evaluation forms should therefore record more than whether a policy exists. They should distinguish thresholds, operational targets, and exemplary values. Thresholds address safety and legality; operational targets address technology implementation and service stability; exemplary values address outcome improvement, regional collaboration, and replicability. Each item should specify the responsible department, data source, statistical period, sampling method, rectification deadline, and review conclusion.

Evaluate workforce succession, quality and safety, risk management, expert recusal, the validity period of results, appeals, and continuous improvement.

Evaluation governance should separate responsibilities among the Rules and Standards Group, Secretariat, Professional Evaluation Group, Medical and Risk Review Group, and Recognition and Appeals Decision Group. The Secretariat handles applications, document completeness, evidence numbering, schedules, and records. The Professional Evaluation Group conducts on-site or remote interviews, verifies functions, and recommends improvements. The Medical and Risk Review Group independently addresses patient safety, privacy, data authenticity, conflicts of interest, and responsibilities exceeded. The Recognition and Appeals Decision Group does not directly advise applicants on development and makes decisions on confirmation, correction, deferral, suspension, reinstatement, or withdrawal on the basis of complete evidence. Evaluation, training, consultancy, conference hosting, and commercial services must not be combined by the same person acting in the same capacity.

Result documentation for the first four levels should include, at a minimum, application and authorization documents, an evidence directory, an evaluation plan, expert recusal and confidentiality declarations, evaluation records, nonconformities and corrective action plans, corrective action review reports, recognition or confirmation documents, annual reassessment records, status change records, and appeals records. These documents establish only evaluation or collaborative status within the Association's project. They do not change a healthcare institution's qualification to practice or constitute government designation or international accreditation.

VIII. Developing the Evaluation Workforce and a Comprehensive Talent System

8.1–8.7 Categories of Personnel

At a minimum, coverage should include disease-specific clinical practice, quality and safety, research, education and evidence-based practice, data, digital healthcare and AI, international standards, management and operations, and project coordination.

8.8–8.10 Appointment and Exit

The evaluation workforce should cover disease-specific clinical practice, quality and safety, research, education and evidence-based practice, data, digital healthcare and medical AI, international standards, management and operations, and project coordination. Basic requirements include verifiable identity and qualifications, evaluation training, and signed confidentiality and recusal undertakings. Appointment involves initial training, supervised practice, independent evaluation, annual refresher training, and periodic review. Conflicts of interest or a mismatch in professional competence require suspension or exit.

Identity and qualifications must be verifiable. Personnel must receive training, sign confidentiality and recusal undertakings, and undergo supervised practice, independent evaluation, annual refresher training, and periodic review.

The evaluation workforce system should be developed separately from hospital workforce systems. The Association's evaluator database should contain at least five professional pools: disease-specific clinical practice; continuing care, nursing, and rehabilitation; healthcare quality and patient safety; data privacy and AI; and international evaluation and cross-cultural communication. Levels should include observers, independent evaluators, review and decision experts, and mentors. Named competence profiles, training calibration, conflict-of-interest recusal, assignment rotation, annual review, and exit mechanisms should apply. Evaluators may understand hospital development but must not make clinical decisions on behalf of hospitals or market training, consultancy, equipment, consumables, or certification services to evaluated institutions.

IX. Cross-Regional Collaboration and International Development

9.1–9.5 Collaborative Networks

Drawing on the ERN network approach, establish mechanisms for membership, consultations and referrals, workforce development, research and teaching, and feedback on outcomes, while complying with the laws of participating countries.[13]

9.6–9.8 International Standards and Project Management

Establish terminology, indicator, and guideline mappings. Specify lead institutions, schedules, funding, responsibilities, data boundaries, and acceptance criteria.

International development should be evaluated using verifiable project evidence. Inbound medical care should record the number of overseas patients or visits, countries of origin, diseases, referral sources, payment methods, medical revenue, and repeat visits. International expansion of medical technologies should record cross-border consultations, training, joint research, technology licensing, overseas joint centers, the number of countries, and project revenue. International expansion of medical equipment should record product categories, destination countries, registration or market access, overseas installations, after-sales services, and overseas revenue. Medical tourism visits are not equivalent to the number of foreign patients; medical device export value is not equivalent to a company's overseas sales revenue; and potential total license-out deal value is not equivalent to revenue recognized in the current period. Statistical definitions must be identified separately in annual reassessments.

Available public information can serve as methodological examples: Shanghai public hospitals recorded approximately 73,200 foreign-patient visits in 2025; Boao Lecheng recorded approximately 865,300 medical tourism visits in 2025, including nearly 10,000 overseas medical tourism visits; and Sanya traditional Chinese medicine institutions reported medical revenue of RMB 2.8455 million in 2024. These figures cannot be added together and should be used separately to illustrate statistical definitions and service readiness. Separate data tables should also be established for medical device exports, international patient services, and technology licensing.

X. Laws and Regulations, Ethics, and Risk Control

10.1–10.4 Responsibilities, Cross-Border Activities, and Data

Diagnosis and treatment, prescriptions, nursing, and patient management are the responsibility of legally authorized providers. Cross-border consultations, patient referrals, data transfers, and research must comply with the legal and ethical requirements of the places where they occur.

10.5–10.8 Evaluation, Publicity, and Dispute Resolution

The Association should use terms such as collaborative directories, capability evaluation, training certificates, and annual reassessment, and establish mechanisms for conflicts of interest, appeals, suspension, withdrawal, and public corrections.

For this project, the international certification pathway should maintain three separations: first, hospitals or disease-specific centers undergo service and capability evaluation; second, certification bodies themselves undergo evaluation of impartiality, competence, auditing, decisions, complaints, and supervision; third, accreditation bodies or external evaluation systems evaluate certification bodies, standards, and surveyor systems. Status evaluation at the Association's first four levels draws only on their evidence structures and continuous improvement methods. It must not prematurely use expressions such as certification certificates, international mutual recognition, or government recognition.

When implemented in mainland China, “center” must be interpreted as a collaborative or capability-evaluation status within an Association project. It does not replace a healthcare institution's license to practice, approved clinical departments, special permits, internal hospital authorization, or government establishment. External use of expressions such as “international,” “Asia-Pacific,” “regional,” “demonstration,” or “certification” must also disclose the evaluating body, evaluation scope, validity period, evidentiary boundaries, and legal effects that do not arise. Cross-border consultations, patient referrals, data transfers, research, advertising, technology exports, and medical device sales must each be reviewed by the respective responsible entities.

Mainland Chinese compliance review should also address operational details. Applications for evaluation must be voluntary, and membership, training, consultancy, procurement, sponsorship, or designated services must not be prerequisites for passing. Association evaluation cannot replace a healthcare institution's license to practice, approved clinical departments, or internal hospital authorization. Contracts, charges, evaluation, and interests among the Association, hospitals, commercial advisory organizations, and experts should be separated. Publicity must not present Association names, expert positions, patient cases, or evaluation results as guarantees of efficacy, government endorsement, patients' preferred choices, or medical advertising. Cases, images, follow-up records, genetic information, AI training, cross-border meetings, and research registration should follow de-identification and minimum-necessary principles and undergo separate reviews of authorization, ethics, data security, and responsibilities.

XI. Association Services, Member Participation, and Sustainable Operations

11.1–11.4 Membership and Services

Members may participate as collaborating institutions, trainers, evaluators, researchers, and data governance personnel. Training, evaluation, research, and healthcare services should have separate contracts and responsibilities.

Disease-specific projects also aim to translate needs into service cycles that can be delivered and reviewed. Patients and families, clinicians, department heads, nurses and head nurses, hospital managers, Association experts, and international partners each provide channels for identifying needs. A needs register, consultations and referrals, training and conferences, research collaboration, and feedback on outcomes connect membership development with center evaluation. Conference-hosting capability can serve as evidence of collaboration for consortium institutions, but cannot independently demonstrate clinical capability. It must be evaluated alongside coordination with administrative departments, technology implementation, patient safety, and operational outcomes.

XII. Implementation Pathways and Development Recommendations

12.1–12.3 From Entry to Center Development

First establish an alliance directory, then develop joint consortium projects, and subsequently evaluate centers with a single function or multiple functions.

12.4–12.7 Comprehensive Development and Long-Term Objectives

Develop centers with comprehensive functions through multifunctional coordination, data governance, quality improvement, workforce succession, and annual reassessment. Certification bodies should be studied separately at a later stage.

The Hainan pilot on chronic lung disease in infants and young children should validate methods rather than be treated as an established certification outcome. The first pilot round may operate through four channels: clinical care and research; continuing care; education and international collaboration; and medical technologies and data. All tasks should use materials without patient identifiers. Work must stop immediately if actual patient records are introduced, unauthorized patient communication occurs, undisclosed conflicts of interest arise, or pilot results are used for certification publicity. Hospital teams should cover, at a minimum, clinical care, nursing and continuing care, rehabilitation or respiratory therapy, nutrition and child healthcare, quality data, bilingual liaison, and junior workforce succession. One operating cycle should be completed before discussing consortium incubation status or higher levels.

For implementation, the Hospital Disease-Specific Center Development Support and Pre-Evaluation Unit is recommended as the entry point, with initial disease-specific modules for pediatric chronic lung disease, breast tumors, and thyroid diseases. The Hainan pilot on chronic lung disease in infants and young children can validate progression from the preparatory tier to a consortium incubation institution, focusing on whether hospital authorization, technology implementation, coordination with administrative departments, expert systems, training, consultations and referrals, data recording, and annual reassessment can actually operate. Breast and thyroid modules can test the transferability of oncology, imaging, interventional, and whole-course disease-management indicators.

The research repository, original standards library, and evaluation forms should form a single evidence chain: every indicator has a source; every source has an applicable scope; every evaluation conclusion has supporting evidence; and every corrective action has a review record. This converts external research into project tools while preventing foreign standards, Association recommendations, and mainland Chinese statutory requirements from being conflated.

Conclusion

Overall statement of boundaries: This report may serve as a reference for public research, professional discussion, institutional development, and subsequent evaluation design. It cannot replace actual institutional data, statutory approvals, formal legal opinions, or independent third-party certification.

· The value of disease-specific center development lies in organizing services across the full disease course and capabilities across institutions, rather than adding titles.

· Center capabilities must be demonstrated through evidence concerning clinical care, quality, workforce, research, data, and continuous improvement.

· The Association can integrate resources in membership, conferences, training, research, AI, and international collaboration, but these must be separated from clinical responsibilities.

· Collaborative alliances provide a prudent entry point, consortia provide a transition to actual collaboration, and the third and fourth levels advance according to functions and evidence. Certification bodies should be considered when conditions are sufficiently developed.

· The evaluation system should first establish terminology, evidence packages, procedures, and annual improvement before expanding plaque awards or directories.

Appendix I. Proposed Evaluation Indicators

Appendix II. Public Sources and References

[1] WHO, Noncommunicable diseases. https://www.who.int/health-topics/noncommunicable-diseases

[2] WHO, Integrated people-centred health services. https://www.who.int/teams/integrated-health-services/integrated-people-centred-health-services

[3] WHO, A Global Health Strategy for 2025-2028. https://www.who.int/publications/i/item/9789240101012

[4] WHO, Digital health strategy extension to 2027. https://www.who.int/news/item/23-05-2025-world-health-assembly-endorses-extension-of-the-global-digital-health-strategy-to-2027

[5] WHO, Ethics and governance of AI for health. https://www.who.int/publications/i/item/9789240029200

[6] WHO Western Pacific, Noncommunicable diseases. https://www.who.int/westernpacific/health-topics/noncommunicable-diseases

[7] WHO Western Pacific, Health workforce. https://www.who.int/westernpacific/health-topics/health-workforce

[8] WHO South-East Asia, Chronic respiratory diseases 2025. https://www.who.int/southeastasia/publications/i/item/9789290221494

[9] National Health Commission of China, Administrative Measures for National Medical Centers and National Regional Medical Centers. https://www.nhc.gov.cn/yzygj/c100067/202212/611ae4e134cb46a2b947ffdcc157d27b.shtml

[10] National Development and Reform Commission and other departments, Work Plan for the Orderly Expansion of National Regional Medical Center Development. https://www.ndrc.gov.cn/xwdt/tzgg/202204/t20220427_1323261.html

[11] National Health Commission of China, Procedures for the Establishment and Management of National Medical Centers and National Regional Medical Centers. https://www.nhc.gov.cn/ewebeditor/uploadfile/2019/01/20190125165755286.pdf

[12] National Health Commission of China, Guiding Opinions on Promoting the Development of Medical Consortia. https://www.nhc.gov.cn/bgt/gwywj2/201704/112fc3fd390e448ab52eb6aff14a74c6.shtml

[13] European Commission, European Reference Networks. https://health.ec.europa.eu/rare-diseases-and-european-reference-networks/european-reference-networks_en

[14] US NCI, NCI-Designated Cancer Centers. https://cancercenters.cancer.gov/

[15] JCI, Hospital and Academic Medical Center Standards. https://www.jointcommissioninternational.org/-/media/jci/jci-documents/accreditation/hospital-and-amc/jcih24_standards-only.pdf

[16] WHO, National health workforce accounts 2026. https://www.who.int/publications/i/item/9789240122925

[17] American College of Surgeons, National Accreditation Program for Breast Centers Standards and Resources. https://www.facs.org/quality-programs/cancer-programs/national-accreditation-program-for-breast-centers/standards-and-resources/

[18] EUSOMA and European Cancer Organisation, The Requirements of a Specialist Breast Centre. https://europeancancer.org/resources/publications/essential-requirements/the-requirements-of-a-specialist-breast-centre.html

[19] European Cystic Fibrosis Society, Standards of Care Publications. https://www.ecfs.eu/ecfs-standards-care/publications

[20] NHS England, Service Specifications. https://www.england.nhs.uk/specialised-commissioning-document-library/service-specifications/

[21] Japan Ministry of Health Labour and Welfare, Cancer Collaboration Hospitals and Pediatric Cancer Hubs. https://www.mhlw.go.jp/

[22] German Cancer Society and OnkoZert, Certification Systems and Centre Requirements. https://www.onkozert.de/en/certification-systems/

[23] Singapore Ministry of Health, Singapore's Approach to Cancer. https://www.moh.gov.sg/

[24] Hong Kong Hospital Authority, Cancer Services and Quality Safety materials. https://www.ha.org.hk/

[25] Joint Commission, Disease-Specific Care Certification. https://www.jointcommission.org/en/certification/disease-specific-care

[26] Chinese Chest Pain Center Accreditation Standards, Sixth Edition, and Standards for the Establishment of National Cancer Medical Centers. https://sxwjw.shaanxi.gov.cn/

[27] Shanghai Municipal People’s Government, Data on Foreign-Patient Services in Shanghai Public Hospitals in 2025. https://www.shanghai.gov.cn/

[28] Hainan Provincial People’s Government and Boao Lecheng International Medical Tourism Pilot Zone, Public Medical Tourism Data. https://en.hainan.gov.cn/

[29] China Chamber of Commerce for Import and Export of Medicines and Health Products, Briefing on China’s Imports and Exports of Medicines and Health Products in 2024. https://www.cccmhpie.org.cn/

[30] Seoul Metropolitan Government, International Medical Tourists and Medical Spending in 2024. https://english.seoul.go.kr/

[31] Malaysia Ministry of Health, Annual Report 2024 and Malaysia Healthcare Travel Council. https://www.moh.gov.my/

[32] Government of India Press Information Bureau, Medical Tourism Statistics. https://www.pib.gov.in/

[33] West China Hospital, Announcement of the 2025 Expert Consensus on Pathways for Developing Operational Disease-Specific Centers in General Hospitals. https://www.wchscu.cn/comprehensive/88902.html

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[36] National Health Commission of China, Measures for the Assessment of Healthcare Institutions. https://www.nhc.gov.cn/fzs/c100048/201808/3611d232e5c14b279e2e7fdcd52c4aa9.shtml

[37] State Administration for Market Regulation, Requirements Concerning the Management of Certification Supervision Experts. https://www.samr.gov.cn/rzjgs/tzgg/

[38] State Administration for Market Regulation, Measures for the Administration of Medical Advertising and Measures for the Administration of Internet Advertising. https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/ggjgs/

[39] Mainland Chinese Legal Documents on Personal Information Protection, Data Security, and Cybersecurity. https://www.cac.gov.cn/

[40] Beijing Municipal Health Commission, Cases of PCCM Demonstration Units for Five Major Diseases. https://wjw.beijing.gov.cn/xwzx_20031/jcdt/202506/t20250624_4122335.html

[41] Shanxi Provincial Health Commission, Documents on the Development and Management of Disease-Specific Diagnosis and Treatment Centers. https://wjw.shanxi.gov.cn/tzgg/zcwj/202509/t20250929_9969457.shtml

Appendix III. Statement of Evidentiary Boundaries

The statistics and institutional facts in this report derive from the listed public sources. The Asia-Pacific Association's tiered framework, functional combinations, evaluation evidence packages, working-group arrangements, and implementation pathways are research recommendations informed by public practice. They do not represent recognition, authorization, or endorsement of the Asia-Pacific Health and Wellness Association by WHO, China's National Health Commission, the European Commission, NCI, JCI, or any other organization. This report also uses global accreditation benchmarks, original documents on disease-specific and specialty centers, comparative materials from the United States, Japan, Singapore, Germany, and Hong Kong, the Hainan chronic lung disease pilot, and public research on inbound medical care and the international expansion of medical technologies and equipment. These materials inform comparative judgments and Association research recommendations; they do not change the legal nature of the original documents or replace formal legal opinions, clinical guidelines, or independent certification decisions. A consistent rule applies to the use of research materials: public webpages support initial screening, while original institutional documents, authorization documents, operational records, and traceable data support formal evaluation. Partner confirmations, conference materials, and applicant statements serve only as supplementary evidence. Each item of evidence should identify its source, version, applicable scope, responsible person, time period, and verification status. Inclusion in the research repository does not automatically establish that a hospital or center has attained the corresponding level. The report integrates sources as follows: framework documents provide project structure; the West China consensus provides the logic for operational development within Chinese hospitals; original international standards provide comparisons and indicator sources; mainland Chinese regulations define responsibilities; Hainan chronic lung disease documents provide pilot operating methods; membership and audience-development documents provide mechanisms for responding to needs and conference collaboration; inbound medical care and international expansion documents provide statistical definitions for international development; and papers and conference materials provide research dissemination context. Facts, user-confirmed matters, research inferences, and matters requiring verification from different documents continue to be identified separately.

Guidance for public use: This report is suitable for research exchange, project appraisal, capacity building, and international cooperation discussions. Conversion into internal hospital standards, Association evaluation rules, or a certification scheme requires separate jurisdictional review, expert review, pilot validation, and version confirmation.