Introduction to medical software: foundations for digital health, devices, and diagnostics
Gespeichert in:
| Hauptverfasser: | , , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Cambridge
Cambridge University Press
2022
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| Schriftenreihe: | Cambridge texts in biomedical engineering
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| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis Klappentext |
| Beschreibung: | xvi, 322 Seiten Illustrationen, Diagramme |
| ISBN: | 9781316514993 1316514994 |
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| adam_text | Contents Preface Acknowledgments Part I page xi xvii Regulatory, Business, and Management Background 1 Introduction to Medical Software Introduction 1.1 Medical Software and the Regulatory Process 1.2 The Medical Domain and Software 1.3 Emerging Challenges from the use of ML/AI 1.4 Conclusions 1.5 Summary Recommended Reading and Resources 2 The FDA and Software Introduction 2.1 The FDA and Medical Devices 2.2 A Review of Relevant FDA Documents 2.3 The FDA Regulatory Process 2.4 Regulatory Documents from Outside the United States 2.5 Implications of Regulatory Requirements for Software Design 2.6 The Future: Digital Health, AI, Self-Driving Cars? 2.7 Conclusions 2.8 Summary Recommended Reading and Resources 3 Operating within a Healthcare System Introduction 3.1 Software as Part of an Ecosystem 3.2 The Users: Patients, Doctors, and Everybody Else 3.3 Clinical Information Technology 3.4 Data Privacy 3.5 Cybersecurity 3.6 Conclusions 3.7 Summary Recommended Reading and Resources 3 3 3 8 12 13 13 14 15 15 15 20 32 34 35 37 39 40 40 44 44 44 46 49 52 56 60 60 60
Contents 4 Quality Management Systems Introduction 4.1 Introduction: The Organization Matters 4.2 Standards: ISO 9001, 90003, and 13485 4.3 The IMDRF QMS Document 4.4 Implications for Research and Scientific Software 4.5 General Remarks 4.6 Conclusions 4.7 Summary Recommended Reading and Resources 5 Risk Management Introduction 5.1 An Overview of Risk Management 5.2 Risk Analysis 5.3 Risk Evaluation 5.4 Risk Control 5.5 Risk Management and the Software Life Cycle 5.6 Conclusions 5.7 Summary Recommended Reading and Resources 6 Taking an Idea to Market: Understanding the Product Journey Introduction 6.1 Entrepreneurship: Should I Start a Company? 6.2 User-Centered Design: Consumer-Facing Medical Software Requires Finesse 6.3 Value Proposition: What Do You Bring to the Healthcare Conversation? 6.4 Intellectual Property 6.5 When to Raise Capital: Debt or Equity and What Does It All Mean? 6.6 Conclusions 6.7 Summary Recommended Reading and Resources 7 Medical Software Applications and Growth Drivers Introduction 7.1 Background and Definitions 7.2 The Technological Transformation of Healthcare 7.3 Healthcare Challenges 7.4 Promises of Healthcare Technology 7.5 Technology Growth Drivers 7.6 Healthcare Data 7.7 Technology in Clinical Trials 7.8 Regulatory Drivers 64 64 64 66 68 73 74 74 75 75 77 77 77 81 84 85 86 87 87 88 90 90 90 92 93 94 95 96 97 97 98 98 98 101 103 106 107 110 112 113
vii Contents 7.9 Industry Organizations 7.10 Remote Monitoring 7.11 Recommendations 7.12 Conclusions 7.13 Summary Recommended Reading and Resources Part II Scientific and Technical Background 8 Mathematical Background Introduction 8.1 Data-Based Decision-Making 8.2 A Brief Introduction to Probability Theory 8.3 An Introduction to Statistics 8.4 Machine Learning and Its Complications 8.5 Are These Results Statistically Significant? 8.6 Importance of Randomization in Clinical Trials 8.7 Conclusions 8.8 Summary Recommended Reading and Resources 9 Topics in Software Engineering Introduction 9.1 Software Engineering Overview 9.2 Software Life Cycles 9.3 Software Engineering with AI/ML Modules 9.4 Modern Computing Environments 9.5 Software Testing 9.6 Source-Code Management 9.7 Conclusions 9.8 Summary Recommended Reading and Resources Part III 114 116 117 117 118 118 123 123 123 125 131 137 139 141 143 143 144 147 147 147 148 152 157 160 163 167 167 168 An Example Medical Software Life Cycle Process 10 The Overall Process Introduction 10.1 Overview of the Software Life Cycle Process 10.2 The IEC 62304 Standard 10.3 The Life Cycle Process 10.4 Software Safety Classifications 10.5 Other Issues 10.6 Conclusions 10.7 Summary Recommended Reading and Resources 175 175 175 176 178 182 183 186 186 187
viii Contents 11 Identifying User Needs 189 Introduction 11.1 Exploring the User’s Needs 11.2 Creating a Use Specification Document 11.3 Example: The Image-Guided Neuro-navigation Project 11.4 Conclusions 11.5 Summary Recommended Reading and Resources 189 190 195 196 197 198 198 12 201 The System Requirements Specification Introduction 12.1 A Bridge from User Needs to Software Design 12.2 Regulatory Background 12.3 An Example System Requirements Template 12.4 Writing a Requirement 12.5 Risk Management and Requirements 12.6 Reviewing System Requirements 12.7 Example: The Image-Guided Neuro-navigation Project 12.8 An Annotated Outline 12.9 Conclusions 12.10 Summary Recommended Reading and Resources 13 The Software Design Document Introduction 13.1 A Bridge from Requirements to Code 13.2 Regulatory Background 13.3 Writing the Software Design Document 13.4 Risk Management 13.5 User Interface Evaluation 13.6 Example: The Image-Guided Neuro-navigation Project 13.7 Conclusions 13.8 Summary Recommended Reading and Resources 201 201 202 203 207 208 209 210 213 216 216 216 218 218 218 218 220 225 227 228 230 230 231 Software Construction, Testing, and Verification 232 Introduction 14.1 Two Concrete Steps of the Software Life Cycle 14.2 Software Construction 14.3 Software Testing and Verification 14.4 Creating a Testing and Verification Plan 14.5 Conclusions 14.6 Summary Recommended Reading and Resources 232 232 232 235 237 238 239 239 14
¡X Contents 15 Software Validation Introduction 15.1 Regulatory Background 15.2 Human Subject Studies and Clinical Trials 15.3 Designing a Validation Strategy 15.4 Conclusions 15.5 Summary Recommended Reading and Resources 16 Deployment, Maintenance, and Decommissioning Introduction 16.1 Deployment 16.2 Maintenance 16.3 Decommissioning 16.4 Conclusions 16.5 Summary Recommended Reading and Resources Part IV 241 241 242 247 249 252 252 253 256 256 256 257 258 259 259 259 Case Studies 17 Therac-25: Software that Killed 263 Introduction 17.1 Radiation Therapy 17.2 The Therac Accidents 17.3 Regulatory Reforms and Future Considerations 263 263 264 266 Mars Climate Orbiter:Lost without a Trace 268 18 Introduction 18.1 Outer Space Exploration 18.2 The Mars Orbiter Mission 18.3 Fault Investigation 18.4 Lessons Learned 19 HealthCare.gov: The Failed Launch of a Critical Website Introduction 19.1 Background 19.2 The Launch of the Website 19.3 The Post-Failure Investigation 20 The 2020 Iowa Caucus App: An Unreliable App that Caused National Embarrassment Introduction 20.1 The US Presidential Election Primary Process 20.2 The 2020 Iowa Caucus 268 268 269 270 273 274 274 274 276 277 280 280 280 281
x Contents 20.3 The Software Engineering Aspects 20.4 Conclusions 21 The Boeing 737 MAX Disasters: Using Software to Fix Hardware Problems Introduction 21.1 Background 21.2 Disaster Strikes 21.3 Disaster Aftermath 22 The Averted Y2K Crisis: Successful Crisis and Risk Management 283 284 286 286 286 289 290 293 Introduction 22.1 The Y2K Problem 22.2 Preparations 22.3 The Aftermath 293 293 294 296 References Index 299 316
A real-world view of medical software development that explains what needs to be done to put a medical product on the market, and the mistakes that have led to the establishment of industry-standard development processes. Ron Kikinis, Harvard Medical School Ί wish I had this book 25 years ago when my start-up company was bringing a product to market. Covering a spectrum of practical and critically important topics, people considering careers in medical software would be wise to study this book. Steve Pieper, Founder and CEO oflsomics, Inc. A must-read for anyone, especially the entrepreneur. An accessible and practical overview of the regulatory, business, and technical considerations critical for success in this exciting area. Sean Khozin, former FDA officer, CEO ofCancerLinQ A significant milestone in the understanding of how technology will constitute an emerging and solidifying asset class in healthcare, medicine, and precision medicine... groundbreaking and absolutely commendable. Mark Esposito, Harvard University and University of Cambridge Providing a concise and accessible overview of the design, implementation, and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical
software lifecycle process; an accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering, and healthcare, bringing readers up to speed; six cautionary real-world case studies which illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.
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| adam_txt |
Contents Preface Acknowledgments Part I page xi xvii Regulatory, Business, and Management Background 1 Introduction to Medical Software Introduction 1.1 Medical Software and the Regulatory Process 1.2 The Medical Domain and Software 1.3 Emerging Challenges from the use of ML/AI 1.4 Conclusions 1.5 Summary Recommended Reading and Resources 2 The FDA and Software Introduction 2.1 The FDA and Medical Devices 2.2 A Review of Relevant FDA Documents 2.3 The FDA Regulatory Process 2.4 Regulatory Documents from Outside the United States 2.5 Implications of Regulatory Requirements for Software Design 2.6 The Future: Digital Health, AI, Self-Driving Cars? 2.7 Conclusions 2.8 Summary Recommended Reading and Resources 3 Operating within a Healthcare System Introduction 3.1 Software as Part of an Ecosystem 3.2 The Users: Patients, Doctors, and Everybody Else 3.3 Clinical Information Technology 3.4 Data Privacy 3.5 Cybersecurity 3.6 Conclusions 3.7 Summary Recommended Reading and Resources 3 3 3 8 12 13 13 14 15 15 15 20 32 34 35 37 39 40 40 44 44 44 46 49 52 56 60 60 60
Contents 4 Quality Management Systems Introduction 4.1 Introduction: The Organization Matters 4.2 Standards: ISO 9001, 90003, and 13485 4.3 The IMDRF QMS Document 4.4 Implications for Research and Scientific Software 4.5 General Remarks 4.6 Conclusions 4.7 Summary Recommended Reading and Resources 5 Risk Management Introduction 5.1 An Overview of Risk Management 5.2 Risk Analysis 5.3 Risk Evaluation 5.4 Risk Control 5.5 Risk Management and the Software Life Cycle 5.6 Conclusions 5.7 Summary Recommended Reading and Resources 6 Taking an Idea to Market: Understanding the Product Journey Introduction 6.1 Entrepreneurship: Should I Start a Company? 6.2 User-Centered Design: Consumer-Facing Medical Software Requires Finesse 6.3 Value Proposition: What Do You Bring to the Healthcare Conversation? 6.4 Intellectual Property 6.5 When to Raise Capital: Debt or Equity and What Does It All Mean? 6.6 Conclusions 6.7 Summary Recommended Reading and Resources 7 Medical Software Applications and Growth Drivers Introduction 7.1 Background and Definitions 7.2 The Technological Transformation of Healthcare 7.3 Healthcare Challenges 7.4 Promises of Healthcare Technology 7.5 Technology Growth Drivers 7.6 Healthcare Data 7.7 Technology in Clinical Trials 7.8 Regulatory Drivers 64 64 64 66 68 73 74 74 75 75 77 77 77 81 84 85 86 87 87 88 90 90 90 92 93 94 95 96 97 97 98 98 98 101 103 106 107 110 112 113
vii Contents 7.9 Industry Organizations 7.10 Remote Monitoring 7.11 Recommendations 7.12 Conclusions 7.13 Summary Recommended Reading and Resources Part II Scientific and Technical Background 8 Mathematical Background Introduction 8.1 Data-Based Decision-Making 8.2 A Brief Introduction to Probability Theory 8.3 An Introduction to Statistics 8.4 Machine Learning and Its Complications 8.5 Are These Results Statistically Significant? 8.6 Importance of Randomization in Clinical Trials 8.7 Conclusions 8.8 Summary Recommended Reading and Resources 9 Topics in Software Engineering Introduction 9.1 Software Engineering Overview 9.2 Software Life Cycles 9.3 Software Engineering with AI/ML Modules 9.4 Modern Computing Environments 9.5 Software Testing 9.6 Source-Code Management 9.7 Conclusions 9.8 Summary Recommended Reading and Resources Part III 114 116 117 117 118 118 123 123 123 125 131 137 139 141 143 143 144 147 147 147 148 152 157 160 163 167 167 168 An Example Medical Software Life Cycle Process 10 The Overall Process Introduction 10.1 Overview of the Software Life Cycle Process 10.2 The IEC 62304 Standard 10.3 The Life Cycle Process 10.4 Software Safety Classifications 10.5 Other Issues 10.6 Conclusions 10.7 Summary Recommended Reading and Resources 175 175 175 176 178 182 183 186 186 187
viii Contents 11 Identifying User Needs 189 Introduction 11.1 Exploring the User’s Needs 11.2 Creating a Use Specification Document 11.3 Example: The Image-Guided Neuro-navigation Project 11.4 Conclusions 11.5 Summary Recommended Reading and Resources 189 190 195 196 197 198 198 12 201 The System Requirements Specification Introduction 12.1 A Bridge from User Needs to Software Design 12.2 Regulatory Background 12.3 An Example System Requirements Template 12.4 Writing a Requirement 12.5 Risk Management and Requirements 12.6 Reviewing System Requirements 12.7 Example: The Image-Guided Neuro-navigation Project 12.8 An Annotated Outline 12.9 Conclusions 12.10 Summary Recommended Reading and Resources 13 The Software Design Document Introduction 13.1 A Bridge from Requirements to Code 13.2 Regulatory Background 13.3 Writing the Software Design Document 13.4 Risk Management 13.5 User Interface Evaluation 13.6 Example: The Image-Guided Neuro-navigation Project 13.7 Conclusions 13.8 Summary Recommended Reading and Resources 201 201 202 203 207 208 209 210 213 216 216 216 218 218 218 218 220 225 227 228 230 230 231 Software Construction, Testing, and Verification 232 Introduction 14.1 Two Concrete Steps of the Software Life Cycle 14.2 Software Construction 14.3 Software Testing and Verification 14.4 Creating a Testing and Verification Plan 14.5 Conclusions 14.6 Summary Recommended Reading and Resources 232 232 232 235 237 238 239 239 14
¡X Contents 15 Software Validation Introduction 15.1 Regulatory Background 15.2 Human Subject Studies and Clinical Trials 15.3 Designing a Validation Strategy 15.4 Conclusions 15.5 Summary Recommended Reading and Resources 16 Deployment, Maintenance, and Decommissioning Introduction 16.1 Deployment 16.2 Maintenance 16.3 Decommissioning 16.4 Conclusions 16.5 Summary Recommended Reading and Resources Part IV 241 241 242 247 249 252 252 253 256 256 256 257 258 259 259 259 Case Studies 17 Therac-25: Software that Killed 263 Introduction 17.1 Radiation Therapy 17.2 The Therac Accidents 17.3 Regulatory Reforms and Future Considerations 263 263 264 266 Mars Climate Orbiter:Lost without a Trace 268 18 Introduction 18.1 Outer Space Exploration 18.2 The Mars Orbiter Mission 18.3 Fault Investigation 18.4 Lessons Learned 19 HealthCare.gov: The Failed Launch of a Critical Website Introduction 19.1 Background 19.2 The Launch of the Website 19.3 The Post-Failure Investigation 20 The 2020 Iowa Caucus App: An Unreliable App that Caused National Embarrassment Introduction 20.1 The US Presidential Election Primary Process 20.2 The 2020 Iowa Caucus 268 268 269 270 273 274 274 274 276 277 280 280 280 281
x Contents 20.3 The Software Engineering Aspects 20.4 Conclusions 21 The Boeing 737 MAX Disasters: Using Software to Fix Hardware Problems Introduction 21.1 Background 21.2 Disaster Strikes 21.3 Disaster Aftermath 22 The Averted Y2K Crisis: Successful Crisis and Risk Management 283 284 286 286 286 289 290 293 Introduction 22.1 The Y2K Problem 22.2 Preparations 22.3 The Aftermath 293 293 294 296 References Index 299 316
'A real-world view of medical software development that explains what needs to be done to put a medical product on the market, and the mistakes that have led to the establishment of industry-standard development processes." Ron Kikinis, Harvard Medical School Ί wish I had this book 25 years ago when my start-up company was bringing a product to market. Covering a spectrum of practical and critically important topics, people considering careers in medical software would be wise to study this book." Steve Pieper, Founder and CEO oflsomics, Inc. A must-read for anyone, especially the entrepreneur. An accessible and practical overview of the regulatory, business, and technical considerations critical for success in this exciting area." Sean Khozin, former FDA officer, CEO ofCancerLinQ A significant milestone in the understanding of how technology will constitute an emerging and solidifying asset class in healthcare, medicine, and precision medicine. groundbreaking and absolutely commendable." Mark Esposito, Harvard University and University of Cambridge Providing a concise and accessible overview of the design, implementation, and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical
software lifecycle process; an accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering, and healthcare, bringing readers up to speed; six cautionary real-world case studies which illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs. |
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| id | DE-604.BV048381221 |
| illustrated | Illustrated |
| index_date | 2024-07-03T20:18:50Z |
| indexdate | 2024-08-01T11:33:51Z |
| institution | BVB |
| isbn | 9781316514993 1316514994 |
| language | English |
| lccn | 2022000137 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-033760069 |
| oclc_num | 1339082043 |
| open_access_boolean | |
| owner | DE-1050 DE-860 DE-898 DE-BY-UBR DE-384 DE-862 DE-BY-FWS |
| owner_facet | DE-1050 DE-860 DE-898 DE-BY-UBR DE-384 DE-862 DE-BY-FWS |
| physical | xvi, 322 Seiten Illustrationen, Diagramme |
| publishDate | 2022 |
| publishDateSearch | 2022 |
| publishDateSort | 2022 |
| publisher | Cambridge University Press |
| record_format | marc |
| series2 | Cambridge texts in biomedical engineering |
| spellingShingle | Papademetris, Xenophon 1971- Quraishi, Ayesha N. 1975- Licholai, Gregory P. 1964- Introduction to medical software foundations for digital health, devices, and diagnostics Software Medical Informatics Artificial Intelligence TECHNOLOGY & ENGINEERING / Engineering (General) BISAC Anwendungssoftware (DE-588)4120906-0 gnd Medizin (DE-588)4038243-6 gnd |
| subject_GND | (DE-588)4120906-0 (DE-588)4038243-6 |
| title | Introduction to medical software foundations for digital health, devices, and diagnostics |
| title_auth | Introduction to medical software foundations for digital health, devices, and diagnostics |
| title_exact_search | Introduction to medical software foundations for digital health, devices, and diagnostics |
| title_exact_search_txtP | Introduction to medical software foundations for digital health, devices, and diagnostics |
| title_full | Introduction to medical software foundations for digital health, devices, and diagnostics Xenophon Papademetris, Yale University, Connecticut, Ayesha N. Quraishi, Harvard Medical School and Yale University, Connecticut, Gregory P. Licholai, Yale University, Connecticut |
| title_fullStr | Introduction to medical software foundations for digital health, devices, and diagnostics Xenophon Papademetris, Yale University, Connecticut, Ayesha N. Quraishi, Harvard Medical School and Yale University, Connecticut, Gregory P. Licholai, Yale University, Connecticut |
| title_full_unstemmed | Introduction to medical software foundations for digital health, devices, and diagnostics Xenophon Papademetris, Yale University, Connecticut, Ayesha N. Quraishi, Harvard Medical School and Yale University, Connecticut, Gregory P. Licholai, Yale University, Connecticut |
| title_short | Introduction to medical software |
| title_sort | introduction to medical software foundations for digital health devices and diagnostics |
| title_sub | foundations for digital health, devices, and diagnostics |
| topic | Software Medical Informatics Artificial Intelligence TECHNOLOGY & ENGINEERING / Engineering (General) BISAC Anwendungssoftware (DE-588)4120906-0 gnd Medizin (DE-588)4038243-6 gnd |
| topic_facet | Software Medical Informatics Artificial Intelligence TECHNOLOGY & ENGINEERING / Engineering (General) Anwendungssoftware Medizin |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033760069&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033760069&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
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Inhaltsverzeichnis
THWS Schweinfurt Zentralbibliothek Lesesaal
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2000 ST 640 P213 |
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| Exemplar 1 | ausleihbar Checked out – Rückgabe bis: 31.12.2099 Vormerken |