The document discusses standards and guidelines for software in the healthcare sector. It mentions that software on its own can be considered a medical device if intended for medical purposes. Validation of medical device software is an essential requirement. The IEC 62304 standard provides a framework for the software life cycle process for medical devices. Agile methodologies are discussed as an alternative to traditional waterfall models, emphasizing iteration, collaboration and quality. Techniques like unit testing, integration testing, versioning and bug tracking are recommended.

1. Standard internazionali e linee guida per
il software nel settore della salute
Federico Caboni - federico.caboni@crs4.it
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3. 1 progetto software su 6
sfora il budget del
200%
e i tempi del
70%
Flyvbjerg B., Why Your IT Project May Be Riskier Than You Think, Harvard Business Review, September 2011:3-4
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6. DIRECTIVE 2007/47/EC OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
of 5 September 2007
amending Council Directive 90/385/EEC on the
approximation of the laws of the Member States
relating to active implantable medical devices,
Council Directive 93/42/EEC concerning medical
devices and Directive 98/8/EC concerning the placing
of biocidal products on the market
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:
2007:247:0021:0055:en:PDF
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7. (6) It is necessary to clarify that software in its own
right, when specifically intended by the manufacturer to
be used for one or more of the medical purposes set
out in the definition of a medical device, is a medical
device. Software for general purposes when used in a
healthcare setting is not a medical device.
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8. (20) Taking account of the growing importance of
software in the field of medical devices, be it as stand
alone or as software incorporated in a device,
validation of software in accordance with the state
of the art should be an essential requirement.
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9. IEC 62304
Medical device software – Software life cycle processes
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12. Metodologia
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13. ricerca e sviluppo
creazione di nuovi prodotti, servizi, ecc.
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14. 1. agilità
2. collaborazione
3. qualità
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15. 1. agilità
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16. Waterfall
Design Implement Test
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17. Costo di soluzione di un difetto
costo
tempo
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18. Costo di soluzione di un difetto
costo
design implement test
tempo
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19. Iterativo
Design Implement
Test
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20. Iterativo
1a 2a 3a 4a
settimana settimana settimana settimana
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21. Iterativo
1a 2a 3a 4a
iterazione iterazione iterazione iterazione
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22. misurare
numero di bug, tempo medio di soluzione, ecc.;
usare le misurazioni subito per correggere la rotta.
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23. prototipi
pianifica di gettarne via (almeno) uno.
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24. 改善
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26. 2. collaborazione
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27. stakeholders
possono essere numerosi e eterogenei.
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28. scrivilo!
scrivere subito una bozza e migliorare;
usare strumenti con poco attrito (ad es. wiki).
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29. versioning
git, mercurial, svn... o perfino cvs;
chi ha fatto cosa? quando? come torno indietro?
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30. tener traccia dei difetti
come si riproduce;
cosa succede;
cosa dovrebbe succedere;
meglio un file excel condiviso che niente.
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31. 3. qualità
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32. unit test
provano una funzione/unità per volta;
si scrivono mentre si implementa (o prima! -TDD);
si usano anche come test di regressione.
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33. black box testing
provare il software dall'esterno;
integrare continuamente, e provare l'integrazione;
coinvolgere gli utenti il prima possibile.
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34. fuzz testing
il mondo reale non è deterministico;
nemmeno il testing dovrebbe esserlo;
vedi, ad esempio zzuf.
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35. automatizzare
deve essere possibile lanciare i test in un comando;
oltre ai test automatizzare tutto il resto.
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36. Brooks, Fred P. (1986). "No Silver Bullet — Essence and Accident in Software Engineering".
Proceedings of the IFIP Tenth World Computing Conference: 1069–1076.
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37. wiki
unit testing
fuzz testing
sviluppo iterativo
versioning
code review
integration testing bug tracking
automated building
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40. hf_jobs@crs4.it
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