iii
Contents
Author Acknowledgements .....................................................................................................................................vii
Preface ......................................................................................................................................................................ix
Chapter 1: Introduction .............................................................................................................................................1
By Koen Cobbaert, MSc and Gert Bos, MSc, PhD, FRAPS
Chapter 2: Software as a Medical Device ..................................................................................................................5
By Koen Cobbaert, MSc and Pat Baird, MSc, MBA
Chapter 3: Software as an IVD Medical Device. .....................................................................................................21
By Christie Hughes, MPH, MT (ASCP) and Henk-Willem Mutsaers, MSc
Chapter 4: Classification of Medical Device Software. ............................................................................................43
By Koen Cobbaert, MSc
Chapter 5: Clinical Evaluation of Software..............................................................................................................63
By Zuzanna Kwade, MSc, PhD
Chapter 6: Safety Risk Management of Software. ...................................................................................................75
By Mikael Dahlke, MSc and Robert Ginsberg, MSc
Chapter 7: Security Risk Management. ...................................................................................................................93
By Ben Kokx
Chapter 8: Software Development. ........................................................................................................................103
By Jaap Noordmans, BSc
Chapter 9: Open Source and Third-Party Software Components..........................................................................123
By Siegfried Schmitt, PhD
Chapter 10: Software Usability Engineering..........................................................................................................131
By Marc Coomans, MSc and Koen Cobbaert, MSc
Chapter 11: Artificial Intelligence..........................................................................................................................159
By Koen Cobbaert, MSc
Chapter 12: Quality and Reliability of Health Apps..............................................................................................183
By Petra Hoogendoorn and Charlie McCay
Chapter 13: Regulatory Implications of Digital Distribution Models for Medical Device Software.....................187
By Tobias Schreiegg
Chapter 14: Market Access and Reimbursement for Digital Health Technologies................................................197
By Tifanny Istamto, MBA, MSc
Chapter 15: Software Liability. ..............................................................................................................................221
By Julie Hantson
Acronyms Used in This Book. ................................................................................................................................228
Index .....................................................................................................................................................................231
Contents
Author Acknowledgements .....................................................................................................................................vii
Preface ......................................................................................................................................................................ix
Chapter 1: Introduction .............................................................................................................................................1
By Koen Cobbaert, MSc and Gert Bos, MSc, PhD, FRAPS
Chapter 2: Software as a Medical Device ..................................................................................................................5
By Koen Cobbaert, MSc and Pat Baird, MSc, MBA
Chapter 3: Software as an IVD Medical Device. .....................................................................................................21
By Christie Hughes, MPH, MT (ASCP) and Henk-Willem Mutsaers, MSc
Chapter 4: Classification of Medical Device Software. ............................................................................................43
By Koen Cobbaert, MSc
Chapter 5: Clinical Evaluation of Software..............................................................................................................63
By Zuzanna Kwade, MSc, PhD
Chapter 6: Safety Risk Management of Software. ...................................................................................................75
By Mikael Dahlke, MSc and Robert Ginsberg, MSc
Chapter 7: Security Risk Management. ...................................................................................................................93
By Ben Kokx
Chapter 8: Software Development. ........................................................................................................................103
By Jaap Noordmans, BSc
Chapter 9: Open Source and Third-Party Software Components..........................................................................123
By Siegfried Schmitt, PhD
Chapter 10: Software Usability Engineering..........................................................................................................131
By Marc Coomans, MSc and Koen Cobbaert, MSc
Chapter 11: Artificial Intelligence..........................................................................................................................159
By Koen Cobbaert, MSc
Chapter 12: Quality and Reliability of Health Apps..............................................................................................183
By Petra Hoogendoorn and Charlie McCay
Chapter 13: Regulatory Implications of Digital Distribution Models for Medical Device Software.....................187
By Tobias Schreiegg
Chapter 14: Market Access and Reimbursement for Digital Health Technologies................................................197
By Tifanny Istamto, MBA, MSc
Chapter 15: Software Liability. ..............................................................................................................................221
By Julie Hantson
Acronyms Used in This Book. ................................................................................................................................228
Index .....................................................................................................................................................................231