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955			_dxm08 2022-02-04 _wxm08 2022-02-04 Telework
010			_a 2022000137
020			_a9781316514993 _q(hardback)
040			_aDNLM/DLC _beng _erda _cDLC
042			_apcc
050	0	0	_aR855.3
060	0	0	_aW 26.55.S6
082	0	0	_a610.285 _223/eng/202202046
084			_aTEC009000 _2bisacsh
100	1		_aPapademetris, Xenophon, _d1971- _eauthor.
245	1	0	_aIntroduction to medical software : _bfoundations for digital health, devices, and diagnostics / _cXenophon Papademetris, Ayesha N. Quraishi, Gregory P. Licholai.
263			_a2204
264		1	_aCambridge, United Kingdom ; _aNew York, NY : _bCambridge University Press, _c2022.
300			_apages cm
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
490	1		_aCambridge texts in biomedical engineering
504			_aIncludes bibliographical references and index.
505	0		_aIntroduction to Medical Software -- The FDA and Software -- Operating within a Healthcare System -- Quality Management Systems -- Risk Management -- Taking an Idea to Market : Understanding the Product Journey -- Medical Software Applications and Growth Drivers -- Mathematical Background -- Topics in Software Engineering -- The Overall Process -- Identifying User Needs -- The System Requirements Specification -- The Software Design Document -- Software Construction and Testing and Verification -- Software Validation -- Deployment, Maintenance, and Decommissioning -- Therac-25 : Software that Killed -- Mars Climate Orbiter: Lost without a Trace -- HealthCare.gov : The Failed Launch of a Critical Website -- The 2020 Iowa Caucus App : An Unreliable App that Caused National Embarrassment -- The Boeing 737 MAX Disasters : Using Software to Fix Hardware Problems -- The Averted Y2K Crisis : Successful Crisis and Risk Management.
520			_a"The goal of this book is to provide in one brief and accessible volume a survey of the critical material involved in the design, implementation, and management of medical software for both standalone software ("software as a medical device - SaMD") and software that is part of a physical medical device. One will find more detailed treatments of many of the topics covered in this book in specialized books that focus on some of the topics we cover (e.g. software engineering, systems engineering, probability theory, machine learning). Depth was not our goal; this book is explicitly designed to provide a broad survey. Our hope is to familiarize the reader with the span of topics he or she may need in entering this field and to provide pointers to more specialized publications as this becomes necessary. For example, most computer scientists have very limited exposure to statistical decision theory, and we think that even the cursory coverage in this book will at least enable them to understand "what they do not know" and seek help as opposed to being ignorant of this entire field and attempting to reinvent the wheel in an amateurish manner! An emerging challenge in medical software is the increasing use of big data and artificial intelligence/machine learning (AI/ML) techniques. This places an even greater stress on proper software design and management. Given that these are "black box" methods, in which the human understanding of what actually is going on is limited, a proper software quality process will be even more critical in creating reliable software tools. We introduce this topic in Section 1.3. In that section we also provide pointers to the other sections of the book in which we discuss issues related to the use of AI/ML methods. This is an introductory book. One can and should follow the material here with further study, using both original regulatory materials, industry standards,1 and more advanced books.2 Our goal can be summarized by the phrase "to convert unknown unknowns to known unknowns." Our goal is to make our reader aware of important material he or she is not as familiar with as one should be, and to pursue further study to acquire such knowledge. This is not a programming book. Our goal is to describe the enabling activities that support programmers in producing high-quality software in the context of medical applications. We are less concerned by questions such as 'How should we code?' Our focus, rather, is on answering higher-level questions such as 'How do we decide what we need to code?' and 'How should the process be organized?' There is a wealth of material available that describes the actual coding process, and, therefore, we chose not to duplicate this type of description here"-- _cProvided by publisher.
650	1	2	_aSoftware
650	1	2	_aMedical Informatics
650	2	2	_aArtificial Intelligence
650		7	_aTECHNOLOGY & ENGINEERING / Engineering (General) _2bisacsh
700	1		_aQuraishi, Ayesha N., _d1975- _eauthor.
700	1		_aLicholai, Gregory P., _d1964- _eauthor.
830		0	_aCambridge texts in biomedical engineering
985			_aDNLMCIP _d2022-01-05
999	f	f	_i50b83899-5ac7-5c6b-94a6-00b4ad4aec2b _s0b76b419-cd7b-4660-b79e-50c8d56fd4c1 _c607889 _d607889