South American Publishing books@southam.pub 20261001T013828Z eng

9789915987682-en-1 03 01 15 9789915987682 06 10.62486/978-9915-9876-8-2 00 ED E107 00 01 01 Primum non nocere: Software engineering for medicine From the clinical problem to the regulated product 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 1 01 eng 10 MED117000 MEDICAL / Informatics 10 COM051230 COMPUTERS / Software Development & Engineering / General 10 TEC059000 TECHNOLOGY & ENGINEERING / Biomedical 10 MED003040 MEDICAL / Allied Health Services / Medical Technology 93 MBPM 20 Medical software; Software as a Medical Device; Digital health; Clinical artificial intelligence; Medical device regulation; Patient safety 30 00 Software has become part of the clinical environment, where technical defects, ambiguous data, poor usability, or unvalidated models can translate into direct consequences for patients and professionals. This volume examines medical software as a multidisciplinary product whose development requires the integration of software engineering, clinical reasoning, quality management, regulation, data standards, cybersecurity, and evidence generation. It begins by defining the digital health ecosystem and the boundary between general-purpose software and Software as a Medical Device. It then addresses regulated development through ISO 13485, IEC 62304, ISO 14971, and IEC 62366, linking lifecycle processes with traceability, risk control, verification, and human factors. Subsequent chapters examine clinical terminologies, FHIR, HL7, DICOM, healthcare architectures, and security requirements that support interoperable systems. The treatment of artificial intelligence covers clinical dataset construction, internal and external validation, dataset shift, MLOps, large language models, hallucinations, explainability, and communication of algorithmic risk. The final section considers prospective and retrospective study design, real-world evidence, economic evaluation, bias, informed consent, liability, reimbursement, technology transfer, and regulatory pathways in the United States, Europe, Latin America, and Spain. Throughout the book, technical choices are interpreted in relation to clinical context and patient safety rather than as isolated engineering decisions. The accompanying appendices provide terminology, a readiness checklist, and templates for risk management and verification. The result is a lifecycle-oriented framework for clinicians, engineers, researchers, and multidisciplinary teams working on software intended for healthcare use. 04 00 Chapter 1: Chapter 1. The Digital Health Ecosystem; Chapter 2: Chapter 2. Introduction to Regulated Environments; Chapter 3: Chapter 3. IEC 62304: Medical software lifecycle; Chapter 4: Chapter 4. ISO 14971: Risk Management; Chapter 5: Chapter 5. IEC 62366: Human Factors and Usability; Chapter 6: Chapter 6. Clinical Terminologies and Languages; Chapter 7: Chapter 7. Interoperability Standards; Chapter 8: Chapter 8. Architecture in the Healthcare Environment; Chapter 9: Chapter 9. Clinical Cybersecurity; Chapter 10: Chapter 10. Construction and Validation of Clinical Datasets; Chapter 11: Chapter 11. Model Development and Validation; Chapter 12: Chapter 12. Generative AI and Large Language Models; Chapter 13: Chapter 13. Explainability and Trust (XAI); Chapter 14: Chapter 14. Study Design for Medical Software; Chapter 15: Chapter 15. Real-World Evidence and Economic Evaluation; Chapter 16: Chapter 16. Ethics and Algorithmic Bias; Chapter 17: Chapter 17. Business Models in Digital Health; Chapter 18: Chapter 18. Comparative Regulatory Landscape 01 00 03 02 https://southam.pub/book-catalog/2026/978-9915-9876-8-2/978-9915-9876-8-2_Portada.png 1 03 06 10.62486/978-9915-9876-8-2.Ch01 01 04 1 Chapter 1. The Digital Health Ecosystem 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 2 03 06 10.62486/978-9915-9876-8-2.Ch02 01 04 2 Chapter 2. Introduction to Regulated Environments 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 3 03 06 10.62486/978-9915-9876-8-2.Ch03 01 04 3 Chapter 3. IEC 62304: Medical software lifecycle 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 4 03 06 10.62486/978-9915-9876-8-2.Ch04 01 04 4 Chapter 4. ISO 14971: Risk Management 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 5 03 06 10.62486/978-9915-9876-8-2.Ch05 01 04 5 Chapter 5. IEC 62366: Human Factors and Usability 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 6 03 06 10.62486/978-9915-9876-8-2.Ch06 01 04 6 Chapter 6. Clinical Terminologies and Languages 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 7 03 06 10.62486/978-9915-9876-8-2.Ch07 01 04 7 Chapter 7. Interoperability Standards 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 8 03 06 10.62486/978-9915-9876-8-2.Ch08 01 04 8 Chapter 8. Architecture in the Healthcare Environment 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 9 03 06 10.62486/978-9915-9876-8-2.Ch09 01 04 9 Chapter 9. Clinical Cybersecurity 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 10 03 06 10.62486/978-9915-9876-8-2.Ch10 01 04 10 Chapter 10. Construction and Validation of Clinical Datasets 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 11 03 06 10.62486/978-9915-9876-8-2.Ch11 01 04 11 Chapter 11. Model Development and Validation 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 12 03 06 10.62486/978-9915-9876-8-2.Ch12 01 04 12 Chapter 12. Generative AI and Large Language Models 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 13 03 06 10.62486/978-9915-9876-8-2.Ch13 01 04 13 Chapter 13. Explainability and Trust (XAI) 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 14 03 06 10.62486/978-9915-9876-8-2.Ch14 01 04 14 Chapter 14. Study Design for Medical Software 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 15 03 06 10.62486/978-9915-9876-8-2.Ch15 01 04 15 Chapter 15. Real-World Evidence and Economic Evaluation 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 16 03 06 10.62486/978-9915-9876-8-2.Ch16 01 04 16 Chapter 16. Ethics and Algorithmic Bias 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 17 03 06 10.62486/978-9915-9876-8-2.Ch17 01 04 17 Chapter 17. Business Models in Digital Health 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 18 03 06 10.62486/978-9915-9876-8-2.Ch18 01 04 18 Chapter 18. Comparative Regulatory Landscape 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng South American Publishing 01 South American Publishing 02 https://southam.pub/book-catalog/isbn/978-9915-9876-8-2.php Montevideo UY 04 01 20260929 01 WORLD 06 15 9789915987699 9789915987699-en-2 03 01 15 9789915987699 06 10.62486/978-9915-9876-8-2 00 BC 01 01 Primum non nocere: Software engineering for medicine From the clinical problem to the regulated product 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 1 01 eng 10 MED117000 MEDICAL / Informatics 10 COM051230 COMPUTERS / Software Development & Engineering / General 10 TEC059000 TECHNOLOGY & ENGINEERING / Biomedical 10 MED003040 MEDICAL / Allied Health Services / Medical Technology 93 MBPM 20 Medical software; Software as a Medical Device; Digital health; Clinical artificial intelligence; Medical device regulation; Patient safety 30 00 Software has become part of the clinical environment, where technical defects, ambiguous data, poor usability, or unvalidated models can translate into direct consequences for patients and professionals. This volume examines medical software as a multidisciplinary product whose development requires the integration of software engineering, clinical reasoning, quality management, regulation, data standards, cybersecurity, and evidence generation. It begins by defining the digital health ecosystem and the boundary between general-purpose software and Software as a Medical Device. It then addresses regulated development through ISO 13485, IEC 62304, ISO 14971, and IEC 62366, linking lifecycle processes with traceability, risk control, verification, and human factors. Subsequent chapters examine clinical terminologies, FHIR, HL7, DICOM, healthcare architectures, and security requirements that support interoperable systems. The treatment of artificial intelligence covers clinical dataset construction, internal and external validation, dataset shift, MLOps, large language models, hallucinations, explainability, and communication of algorithmic risk. The final section considers prospective and retrospective study design, real-world evidence, economic evaluation, bias, informed consent, liability, reimbursement, technology transfer, and regulatory pathways in the United States, Europe, Latin America, and Spain. Throughout the book, technical choices are interpreted in relation to clinical context and patient safety rather than as isolated engineering decisions. The accompanying appendices provide terminology, a readiness checklist, and templates for risk management and verification. The result is a lifecycle-oriented framework for clinicians, engineers, researchers, and multidisciplinary teams working on software intended for healthcare use. 04 00 Chapter 1: Chapter 1. The Digital Health Ecosystem; Chapter 2: Chapter 2. Introduction to Regulated Environments; Chapter 3: Chapter 3. IEC 62304: Medical software lifecycle; Chapter 4: Chapter 4. ISO 14971: Risk Management; Chapter 5: Chapter 5. IEC 62366: Human Factors and Usability; Chapter 6: Chapter 6. Clinical Terminologies and Languages; Chapter 7: Chapter 7. Interoperability Standards; Chapter 8: Chapter 8. Architecture in the Healthcare Environment; Chapter 9: Chapter 9. Clinical Cybersecurity; Chapter 10: Chapter 10. Construction and Validation of Clinical Datasets; Chapter 11: Chapter 11. Model Development and Validation; Chapter 12: Chapter 12. Generative AI and Large Language Models; Chapter 13: Chapter 13. Explainability and Trust (XAI); Chapter 14: Chapter 14. Study Design for Medical Software; Chapter 15: Chapter 15. Real-World Evidence and Economic Evaluation; Chapter 16: Chapter 16. Ethics and Algorithmic Bias; Chapter 17: Chapter 17. Business Models in Digital Health; Chapter 18: Chapter 18. Comparative Regulatory Landscape 01 00 03 02 https://southam.pub/book-catalog/2026/978-9915-9876-8-2/978-9915-9876-8-2_Portada.png 1 03 06 10.62486/978-9915-9876-8-2.Ch01 01 04 1 Chapter 1. The Digital Health Ecosystem 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 2 03 06 10.62486/978-9915-9876-8-2.Ch02 01 04 2 Chapter 2. Introduction to Regulated Environments 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 3 03 06 10.62486/978-9915-9876-8-2.Ch03 01 04 3 Chapter 3. IEC 62304: Medical software lifecycle 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 4 03 06 10.62486/978-9915-9876-8-2.Ch04 01 04 4 Chapter 4. ISO 14971: Risk Management 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 5 03 06 10.62486/978-9915-9876-8-2.Ch05 01 04 5 Chapter 5. IEC 62366: Human Factors and Usability 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 6 03 06 10.62486/978-9915-9876-8-2.Ch06 01 04 6 Chapter 6. Clinical Terminologies and Languages 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 7 03 06 10.62486/978-9915-9876-8-2.Ch07 01 04 7 Chapter 7. Interoperability Standards 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 8 03 06 10.62486/978-9915-9876-8-2.Ch08 01 04 8 Chapter 8. Architecture in the Healthcare Environment 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 9 03 06 10.62486/978-9915-9876-8-2.Ch09 01 04 9 Chapter 9. Clinical Cybersecurity 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 10 03 06 10.62486/978-9915-9876-8-2.Ch10 01 04 10 Chapter 10. Construction and Validation of Clinical Datasets 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 11 03 06 10.62486/978-9915-9876-8-2.Ch11 01 04 11 Chapter 11. Model Development and Validation 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 12 03 06 10.62486/978-9915-9876-8-2.Ch12 01 04 12 Chapter 12. Generative AI and Large Language Models 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 13 03 06 10.62486/978-9915-9876-8-2.Ch13 01 04 13 Chapter 13. Explainability and Trust (XAI) 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 14 03 06 10.62486/978-9915-9876-8-2.Ch14 01 04 14 Chapter 14. Study Design for Medical Software 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 15 03 06 10.62486/978-9915-9876-8-2.Ch15 01 04 15 Chapter 15. Real-World Evidence and Economic Evaluation 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 16 03 06 10.62486/978-9915-9876-8-2.Ch16 01 04 16 Chapter 16. Ethics and Algorithmic Bias 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 17 03 06 10.62486/978-9915-9876-8-2.Ch17 01 04 17 Chapter 17. Business Models in Digital Health 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng 18 03 06 10.62486/978-9915-9876-8-2.Ch18 01 04 18 Chapter 18. Comparative Regulatory Landscape 1 A01 21 0000-0002-2071-3716 Annier Jesús Fajardo Quesada Annier Jesús Fajardo Quesada 2 A01 21 0000-0001-7325-6099 Eduardo Antonio Hernández González Eduardo Antonio Hernández González 3 A01 21 0000-0002-9450-1572 René Herrero Pacheco René Herrero Pacheco 4 A01 21 0000-0003-0606-2993 Rolando Javier Álvarez Pérez Rolando Javier Álvarez Pérez 01 eng South American Publishing 01 South American Publishing 02 https://southam.pub/book-catalog/isbn/978-9915-9876-8-2.php Montevideo UY 04 01 20260929 01 WORLD 06 15 9789915987682