Primum non nocere: Software engineering for medicine

Description

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.

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Bibliographic information

Book title

Primum non nocere: Software engineering for medicine

Book subtitle

From the clinical problem to the regulated product

Authors

Annier Jesús Fajardo Quesada, Eduardo Antonio Hernández González, René Herrero Pacheco, Rolando Javier Álvarez Pérez

DOI

https://doi.org/10.62486/978-9915-9876-8-2

Publisher

South American Publishing

Imprint

South American Publishing

ISBN

978-9915-9876-8-2 (eBook, English)
978-9915-9876-9-9 (Softcover, English)

Published

2026-09-29

Language

English

Edition number

1

Publication type

monograph

Subject area

Health Sciences

BISAC

MED117000 (Primary)
COM051230
TEC059000
MED003040

THEMA

MBPM

License

Creative Commons Attribution 4.0 International

Copyright

© 2026 The Authors