10  参考文献

本レポートで引用した119件の文献を、カテゴリ別に構造化して示します。

Note

注意: 本文中の引用番号をクリックすると、付録C（文献リスト完全版）の該当する文献に移動します。各文献の詳細な書誌情報は付録Cをご覧ください。

10.1 文献カテゴリと重要度

10.1.1 ★★★ 必須文献（コア文書）

これらの文献は本レポートの基盤となる最重要資料です：

• [1]: EHDS規則本文（EU 2025/327）- Article 50を含む基本法令
• [2]: EHDS影響評価報告書 - 経済効果108億ユーロの根拠
• [3]: FHIR R4 (v4.0.1) 仕様書 - 技術標準の基礎
• [4]: 欧州電子健康記録交換フォーマット - データ形式仕様
• [5]: 一般データ保護規則 - プライバシー保護の基準

10.2 1. EHDS規制・公式文書（18件）

10.2.1 EU規則・決定（4件）

• [1]: EHDS規則本文
• [6]: EHDS規則提案（COM(2022) 197 final）
• [7]: デジタル・ディケード政策プログラム 2030
• [5]: 一般データ保護規則

10.2.2 欧州委員会文書（11件）

• [2]: 影響評価報告書
• [8], [9], [10], [11]
• [12]（患者の権利）, [13]（越境データ移転）
• [14]: HealthData@EU中央プラットフォーム
• [15]: MyHealth@EU越境医療サービス
• [16]: デジタルID枠組み

10.2.3 法律事務所分析（2件）

• [17], [18]: EHDS規則の法的解釈

10.3 2. 技術標準・仕様（17件）

10.3.1 医療情報交換標準（4件）

• [3]: FHIR R4仕様書
• [19]: EHDS向けFHIR実装ガイド
• [4]: 欧州EHR交換フォーマット
• [20]: International Patient Summary v1.1.0

10.3.2 セキュリティ・認証（9件）

• [21]: OAuth 2.0
• [22]: OpenID Connect
• [23]: ゼロトラストアーキテクチャ
• [24]: Webセキュリティリスク
• ISO標準群：[25], [26], [27], [28], [29]

10.3.3 プライバシー技術（4件）

• [30]: 匿名化技術分類
• [31]: k-匿名性モデル
• [32]: 差分プライバシー理論
• [33]: EHDS匿名化分析

10.4 3. 各国実装事例（20件）

10.4.1 フィンランド - Kantaサービス（3件）

• [34]: 最新統計
• [35]: 実装研究（2010-2017）
• [36]: デジタル化モニタリング

10.4.2 ドイツ - ePA電子患者記録（8件）

• [37], [38], [39], [40]: 技術仕様
• [41]: 政策文書
• [42], [43]: 導入課題分析
• [44]: セキュリティ評価

10.4.3 フランス - Health Data Hub（7件）

• [45], [46], [47]: システム詳細
• [48]: 比較研究
• [49]: インフラ移行計画
• [50], [51]: 投資・支援プログラム

10.4.4 その他EU（2件）

• [52]: ルクセンブルクDataspace4Health
• [53]: EU共同アクション準備状況

10.5 4. 市場分析・ビジネス（14件）

10.5.1 グローバル市場予測（10件）

• [54]: 2030年グローバル9,460億ドル
• [55]: 2030年アジア太平洋2,520億ドル
• [56]: 2034年1兆936億ドル
• [57]: 2025-2034市場レポート
• [58]: ASEAN人口6.78億、GDP3.9兆ドル
• [59]: 中国人口14.08億、GDP14.72兆ドル
• [60]: 日本GDP4.25兆ドル、韓国GDP1.67兆ドル
• [61]: インドGDP3.91兆ドル、人口14億超

10.5.2 コンサルティング・アーキテクチャ（4件）

• [62]: ハイブリッドクラウド戦略
• [14]: モジュラー・マイクロサービス設計
• [63], [64]: （URL無効、代替リンク提供）

10.6 5. 日本関連文献（19件）

10.6.1 標準・ガイドライン（3件）

• [65]: HL7 FHIR JP Core実装ガイド
• [66]: 薬剤プロファイル開発
• [67]: 生活支援ロボット安全要求事項（日本主導）

10.6.2 医療用語・コード体系（4件）

• [68]: SNOMED-CT日本影響分析
• [69]: JLAC11臨床検査コード
• [70]: ICD-11導入計画
• [71]: 医薬品HOTコードマスター

10.6.3 災害医療システム（3件）

• [72]: 日本災害医療システム開発
• [73]: 広域災害救急医療情報システム
• [74]: COVID-19病床管理システム

10.6.4 政策・制度（7件）

• [75]: 国民皆保険制度（1961年）
• [76]: 介護保険制度（2000年）
  
• [77]: 認知症施策推進5か年計画（2012年）
• [78]: 地域包括ケアシステム（2014年）
• [79]: 経産省行動変容促進事業
• [80]: 日本高齢化統計（29.1%）
• [81]: 内視鏡世界シェア70%

10.6.5 国際協力（2件）

• [82]: 世界人口高齢化予測（日本データ含む）
• [55]: アジア太平洋市場（日本含む）

10.7 6. 学術論文・研究（9件）

主要な査読論文と研究報告：

• 実装研究：[35], [48], [53]
• 技術開発：[66], [68]
• プライバシー：[33], [31], [32]
• 導入障壁：[43]

10.8 7. 国際標準・ガイドライン（7件）

• [83]: WHO世界デジタルヘルス戦略 2020-2025
• [84]: EUサイバーセキュリティ機関ガイドライン
• その他：ISO標準群、HL7国際標準

10.9 文献の時系列分布

• 2025年（最新）: 40件 - EHDS本格始動関連
• 2024年: 14件 - 準備段階報告・最新統計
• 2023年以前: 65件 - 基盤となる標準・研究

10.10 言語別分類

• 英語: 98件（85%）
• 日本語: 12件（10%）
• フランス語: 3件（3%）
• ドイツ語: 2件（2%）

---

注：完全な書誌情報は付録C「文献リスト（完全版）」を参照してください。［］内の引用番号は本文中の参照に対応しています。

[1]

European Parliament and Council, “Regulation (EU) 2025/327 of the european parliament and of the council establishing the european health data space,” Official Journal of the European Union, Mar. 2025, Available: https://eur-lex.europa.eu/eli/reg/2025/327/oj

[2]

European Commission, “Impact assessment on the european health data space,” European Commission, May 2022. Available: https://health.ec.europa.eu/publications/impact-assessment-european-health-data-space_en

[3]

HL7 International, “FHIR R4 (v4.0.1) specification.” 2023. Available: https://www.hl7.org/fhir/

[4]

European Commission, “European electronic health record exchange format (EEHRxF) - technical specification,” DG SANTE, 2025. Available: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en

[5]

European Parliament and Council, “Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data (GDPR),” Official Journal of the European Union, 2016, Available: https://eur-lex.europa.eu/eli/reg/2016/679/oj

[6]

European Commission, “Proposal for a regulation on the european health data space.” May 03, 2022. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52022PC0197

[7]

European Parliament and Council, “Decision (EU) 2022/2481 establishing the digital decade policy programme 2030.” Dec. 14, 2022. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D2481

[8]

European Commission, “EHDS regulation official documentation.” 2025. Available: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en

[9]

European Commission, “EHDS implementation timeline and roadmap.” 2025. Available: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en

[10]

European Commission, “EHDS governance framework.” 2025. Available: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en

[11]

European Commission, “EHDS international cooperation framework.” 2025. Available: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en

[12]

European Commission, “EHDS regulation article 3: Patient rights,” Official Journal of the European Union, 2025, Available: https://eur-lex.europa.eu/eli/reg/2025/327/oj

[13]

European Commission, “EHDS regulation article 5: Cross-border data transfer,” Official Journal of the European Union, 2025, Available: https://eur-lex.europa.eu/eli/reg/2025/327/oj

[14]

European Commission DG SANTE, “HealthData@EU central platform: Open-source release 3 - architecture model and technical specification,” European Commission, Mar. 2025. Available: https://op.europa.eu/en/publication-detail/-/publication/52fe4b0e-0ac4-11f0-b1a3-01aa75ed71a1

[15]

European Commission, “MyHealth@EU - electronic cross-border health services.” Apr. 2025. Available: https://health.ec.europa.eu/ehealth-digital-health-and-care/digital-health-and-care/electronic-cross-border-health-services_en

[16]

European Commission, “eIDAS 2.0 regulation and digital identity framework for EHDS,” DG CONNECT, 2025. Available: https://digital-strategy.ec.europa.eu/en/policies/eidas-regulation

[17]

Arnold & Porter, “European health data space regulation published in the EU official journal.” Mar. 2025. Available: https://www.arnoldporter.com/en/perspectives/advisories/2025/03/european-health-data-space-regulation-published

[18]

Baker McKenzie, “European health data space regulation published – what’s next?” Mar. 05, 2025. Available: https://healthcarelifesciences.bakermckenzie.com/2025/03/05/european-health-data-space-regulation-published-whats-next/

[19]

HL7 Europe, “HL7 europe opens public review of HL7 FHIR implementation guides for the EHDS.” May 28, 2025. Available: https://www.hl7europe.org/hl7-europe-opens-public-review-of-hl7-fhir-implementation-guides-for-the-ehds/

[20]

HL7 International, “International patient summary implementation guide v1.1.0.” 2024. Available: https://hl7.org/fhir/uv/ips/

[21]

D. Hardt, “The OAuth 2.0 authorization framework,” Internet Engineering Task Force (IETF), RFC 6749, 2012. Available: https://datatracker.ietf.org/doc/html/rfc6749

[22]

OpenID Foundation, “OpenID connect core 1.0.” 2014. Available: https://openid.net/specs/openid-connect-core-1_0.html

[23]

S. Rose, O. Borchert, S. Mitchell, and S. Connelly, “Zero trust architecture,” National Institute of Standards; Technology, NIST Special Publication 800-207, 2020. Available: https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-207.pdf

[24]

OWASP Foundation, “OWASP top ten 2024: The ten most critical web application security risks.” 2024. Available: https://owasp.org/www-project-top-ten/

[25]

ISO/IEC, “ISO/IEC 27001:2022 information security, cybersecurity and privacy protection — information security management systems — requirements,” International Organization for Standardization, 2022. Available: https://www.iso.org/standard/82875.html

[26]

ISO/IEC, “ISO/IEC 27017:2015 information technology — security techniques — code of practice for information security controls for cloud services,” International Organization for Standardization, 2015. Available: https://www.iso.org/standard/43757.html

[27]

ISO/IEC, “ISO/IEC 27018:2019 information technology — security techniques — code of practice for protection of personally identifiable information (PII) in public clouds,” International Organization for Standardization, 2019. Available: https://www.iso.org/standard/76559.html

[28]

ISO/IEC, “ISO/IEC 27035-1:2023 information security incident management — part 1: Principles and process,” International Organization for Standardization, 2023. Available: https://www.iso.org/standard/78973.html

[29]

ISO/IEC, “ISO/IEC 27701:2019 security techniques — extension to ISO/IEC 27001 and ISO/IEC 27002 for privacy information management,” International Organization for Standardization, 2019. Available: https://www.iso.org/standard/71670.html

[30]

ISO/IEC, “ISO/IEC 20889:2018 privacy enhancing data de-identification terminology and classification of techniques,” International Organization for Standardization, 2018. Available: https://www.iso.org/standard/69373.html

[31]

L. Sweeney, “K-anonymity: A model for protecting privacy,” International Journal of Uncertainty, Fuzziness and Knowledge-Based Systems, vol. 10, no. 5, pp. 557–570, 2002, Available: https://dl.acm.org/doi/10.1142/S0218488502001648

[32]

C. Dwork and A. Roth, “The algorithmic foundations of differential privacy,” Foundations and Trends in Theoretical Computer Science, vol. 9, no. 3–4, pp. 211–407, 2014, Available: https://www.cis.upenn.edu/~aaroth/Papers/privacybook.pdf

[33]

Hallinan, D. and Bernier, A. and Cambon-Thomsen, A. and others, “Anonymisation, pseudonymisation and secure processing environments relating to the secondary use of electronic health data in the european health data space (EHDS),” European Journal of Risk Regulation, 2023, Available: https://www.cambridge.org/core/journals/european-journal-of-risk-regulation/article/abs/anonymisation-pseudonymisation-and-secure-processing-environments-relating-to-the-secondary-use-of-electronic-health-data-in-the-european-health-data-space-ehds/1A05C6D0FB24313674C33037A3E98164

[34]

Findata, “Findata statistics 2024-2025.” 2025. Available: https://findata.fi/en/statistics/

[35]

V. Jormanainen, “Large-scale implementation and adoption of the finnish national kanta services in 2010–2017: A prospective, longitudinal, indicator-based study,” Finnish Journal of eHealth and eWelfare, vol. 10, no. 4, 2018, Available: https://journal.fi/finjehew/article/view/74511

[36]

Finnish Institute for Health and Welfare (THL), “Monitoring digital healthcare and social welfare.” 2023. Available: https://thl.fi/en/research-and-development/research-and-projects/monitoring-digital-healthcare-and-social-welfare

[37]

Gematik, “Telematikinfrastruktur 2.0 implementation status.” 2025. Available: https://www.gematik.de/telematikinfrastruktur

[38]

Gematik, “ePA für alle - die elektronische patientenakte.” 2025. Available: https://www.gematik.de/anwendungen/epa-fuer-alle

[39]

Gematik, “ePA basisfunktionalitäten - FHIR implementation guide.” 2025. Available: https://gemspec.gematik.de/fhir/ig/epa/1.1.5/index.html

[40]

Gematik, “Fachkonzept elektronische patientenakte für alle,” Gematik GmbH, Technical Specification V1.0.0, 2025. Available: https://fachportal.gematik.de/fileadmin/Fachportal/Downloadcenter/Releases/Konzepte_und_Spezifikationen/gemKPT_FK_ePAfueralle_V1.0.0_RC_2.pdf

[41]

Bundesministerium für Gesundheit, “Die ePA für alle - elektronische patientenakte.” 2025. Available: https://www.bundesgesundheitsministerium.de/themen/digitalisierung/elektronische-patientenakte/epa-fuer-alle.html

[42]

eco - Association of the Internet Industry, “Launch of the electronic patient record: 65.” 2024. Available: https://international.eco.de/presse/launch-of-the-electronic-patient-record-65-of-germans-feel-poorly-informed/

[43]

BMC Health Services Research, “Consumer perspectives on the national electronic health record and barriers to its adoption in germany,” BMC Health Services Research, 2024, Available: https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-12175-6

[44]

Fraunhofer Institute for Secure Information Technology, “Security assessment of german electronic patient record system,” Fraunhofer SIT, 2024. Available: https://www.sit.fraunhofer.de/

[45]

Health Data Hub France, “Health data hub progress report 2025.” 2025. Available: https://www.health-data-hub.fr/

[46]

Health Data Hub, “FAQ in english - health data hub platform details.” 2025. Available: https://www.health-data-hub.fr/page/faq-english

[47]

Health Data Hub, “Qu’est-ce que le SNDS?” 2025. Available: https://www.health-data-hub.fr/snds

[48]

J. Y. Peltier, B. Couderc, M. Rivel, et al., “The french health data hub and the german medical informatics initiatives: Two national projects to promote data sharing in healthcare,” Yearbook of Medical Informatics, vol. 28, no. 1, pp. 195–198, 2019, Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC6697511/

[49]

Siècle Digital, “L’hébergement du health data hub va passer de microsoft à un prestataire français.” Oct. 11, 2020. Available: https://siecledigital.fr/2020/10/11/lhebergement-du-health-data-hub-va-passer-de-microsoft-a-un-prestataire-francais/

[50]

Ministère de l’Enseignement supérieur et de la Recherche, “France 2030 : Six premiers lauréats pour constituer et consolider des entrepôts de données de santé hospitaliers.” 2023. Available: https://www.enseignementsup-recherche.gouv.fr/fr/france-2030-six-premiers-laureats-pour-constituer-et-consolider-des-entrepots-de-donnees-de-sante-90299

[51]

Health Data Hub, “Notre offre pour les entrepôts de données de santé.” 2024. Available: https://www.health-data-hub.fr/page/notre-offre-pour-les-entrepots-de-donnees-de-sante

[52]

Luxembourg Institute of Health, “Dataspace4Health launch announcement.” Mar. 2025. Available: https://www.dataspace4health.lu/

[53]

TEHDAS Joint Action Consortium, “Are EU member states ready for the european health data space? Lessons learnt on the secondary use of health data from the TEHDAS joint action,” European Journal of Public Health, 2022, Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC11631470/

[54]

Grand View Research, 2025. Available: https://www.grandviewresearch.com/press-release/global-digital-health-market

[55]

Grand View Research, “Asia pacific digital health market size, share & trends analysis report.” 2024. Available: https://www.grandviewresearch.com/industry-analysis/asia-pacific-digital-health-market-report

[56]

Precedence Research, “Digital health market size to surpass USD 1,093.65 billion by 2034.” 2025. Available: https://www.precedenceresearch.com/digital-health-market

[57]

Global Market Insights, “Digital health market size & share report, 2025-2034.” 2025. Available: https://www.gminsights.com/industry-analysis/digital-health-market

[58]

ASEAN Secretariat, “ASEAN key figures 2024.” 2024. Available: https://www.aseanstats.org/wp-content/uploads/2024/12/AKF2024.v1.pdf

[59]

National Bureau of Statistics of China, “Statistical communiqué of the people’s republic of china on the 2024 national economic and social development,” Feb. 2025. Available: https://www.stats.gov.cn/english/PressRelease/202502/t20250228_1958822.html

[60]

International Monetary Fund, “World economic outlook database.” 2024. Available: https://www.imf.org/external/datamapper/index.php

[61]

Government of India, Ministry of Statistics and Programme Implementation, “Provisional estimates of annual gross domestic product for 2024-25.” 2025. Available: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2132688

[62]

Gartner Research, “Healthcare provider CIOs: Adopt a hybrid cloud strategy to balance innovation and risk,” Gartner Healthcare IT Research, 2023, Available: https://www.gartner.com/en/industries/healthcare-providers-digital-transformation

[63]

Deloitte, “Digital health market analysis: EHDS impact assessment,” Deloitte Digital Health, Jul. 2025.

[64]

European Observatory on Health Systems and Policies, “EHDS success factors: Lessons from early adopters.” Aug. 2025.

[65]

日本医療情報学会, “HL7 FHIR JP core implementation guide.” 2023. Available: http://jpfhir.jp/fhir/core/

[66]

Nakayama, T. and others, “Development of japan-specific HL7 FHIR medication-related profiles,” Journal of Medical Systems, vol. 48, 2024, Available: https://pubmed.ncbi.nlm.nih.gov/40199759/

[67]

International Organization for Standardization, “ISO 13482:2014 robots and robotic devices - safety requirements for personal care robots,” 2014. Available: https://www.iso.org/standard/53820.html

[68]

大江和彦, “国際医療用語集SNOMED-CTの成立と概要，日本への影響,” 情報管理, vol. 51, no. 4, pp. 243–250, 2008, Available: https://www.jstage.jst.go.jp/article/johokanri/51/4/51_4_243/_article/-char/ja/

[69]

日本臨床検査医学会, “JLAC11コード - 臨床検査項目分類コード.” 2024. Available: https://www.jslm.org/committees/code/index.html

[70]

厚生労働省, “ICD-11（国際疾病分類第11版）日本導入計画.” 2025. Available: https://www.mhlw.go.jp/stf/newpage_icd11.html

[71]

医療情報システム開発センター, “医薬品HOTコードマスター.” 2003. Available: https://www.medis.or.jp/4_hyojyun/medis-master/terms/index.html

[72]

H. Kondo et al., “Development of the japanese national disaster medical system and experiences during the great east japan earthquake,” Yonago Acta Medica, vol. 58, no. 2, pp. 53–61, 2015, Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4546956/

[73]

T. Akiyama et al., “Emergency medical information system in japan,” Prehospital and Disaster Medicine, 2015, Available: https://pubmed.ncbi.nlm.nih.gov/25410400/

[74]

Ministry of Health, Labour and Welfare, Japan, “Gathering medical information system (g-MIS) for COVID-19.” 2020. Available: https://www.mhlw.go.jp/stf/seisakunitsuite/newpage_00023.html

[75]

厚生労働省, “国民皆保険制度の成立と展開.” 1961. Available: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryouhoken/iryouhoken01/index.html

[76]

厚生労働省, “介護保険制度の概要.” 2000. Available: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hukushi_kaigo/kaigo_koureisha/gaiyo/index.html

[77]

厚生労働省, “認知症施策推進5か年計画（オレンジプラン）.” 2012. Available: https://www.mhlw.go.jp/stf/houdou/2r9852000002j8dh.html

[78]

厚生労働省, “地域包括ケアシステムの構築について.” 2014. Available: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hukushi_kaigo/kaigo_koureisha/chiiki-houkatsu/

[79]

経済産業省, “健康・医療情報を活用した行動変容促進事業.” 2025. Available: https://www.meti.go.jp/shingikai/mono_info_service/kenko_iryo/shin_jigyo/pdf/001_03_00.pdf

[80]

Statistics Bureau of Japan, “Japan’s elderly population rises to record 36.25 million.” Sep. 2024. Available: https://www.aljazeera.com/economy/2024/9/16/japans-elderly-population-rises-to-record-36-25-million

[81]

Olympus Corporation, “Olympus: The outright leader in gastrointestinal endoscopes.” 2024. Available: https://workinjapan.today/hightech/olympus-endoscope-market-leader/

[82]

United Nations Department of Economic and Social Affairs, “World population ageing 2024,” 2024. Available: https://www.un.org/development/desa/pd/

[83]

World Health Organization, “Global strategy on digital health 2020-2025,” WHO, 2021. Available: https://www.who.int/publications/i/item/9789240020924

[84]

European Union Agency for Cybersecurity (ENISA), “Data protection engineering: From theory to practice,” ENISA, Jan. 2022. Available: https://www.enisa.europa.eu/sites/default/files/publications/ENISA%20Report%20-%20Data%20Protection%20Engineering.pdf