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Chapter 1: Digital Health; 1.1 The Book; 1.2 Who Should Read This Book; 1.3 Historical Developments; 1.4 Socioeconomic Aspects of℗ Health and℗ Care; 1.5 The Emergence of℗ New Models for℗ Health and℗ Care; 1.6 The Evolution of℗ Digital Health; 1.7 Social Technological Alignment; 1.8 Challenges for℗ Requirements Engineers in℗ the℗ Healthcare Domain; 1.9 Lessons Learned; References; Chapter 2: Requirements Engineering: Best Practice; 2.1 Introduction; 2.2 Requirements Engineering State of℗ the℗ Art; 2.2.1 Requirements Engineering Techniques; 2.2.2 Requirements Engineering Success
2.3 Industry Survey2.4 Requirements Engineering Practice and℗ Success; 2.4.1 Responding Projects; 2.4.2 Common Practice; 2.4.3 Requirements Engineering Success; 2.4.4 Success-Correlating Practice; 2.5 Discussion; 2.5.1 Contribution; 2.5.2 Threats to℗ Validity; 2.5.3 Need for℗ Research; 2.6 Summary and℗ Conclusions; References; Chapter 3: Laws and℗ Regulations for℗ Digital Health; 3.1 Introduction; 3.2 Methodology for℗ Mapping Laws and℗ Regulations; 3.3 Mapping Relevant Laws and℗ Regulations; 3.3.1 Users' Rights; 3.3.1.1 EU Data Protection Framework and℗ Requirements; Fair and℗ Lawful Processing
Legitimate GroundPurpose Limitation and℗ Secondary Use; Data Protection Rights; Data Security; Other Provisions; 3.3.1.2 Patients' Rights Specific to℗ Health Care; Clinical Investigations; Patients' Rights in℗ Cross-Border Health Care; 3.3.2 Safety and℗ Performance Requirements to℗ Medical Devices; 3.3.2.1 Defining a℗ Medical Device; 3.3.2.2 Requirements; 3.4 Compliance by Design; 3.4.1 Privacy Impact Assessment ("PIA"); 3.4.1.1 Importance and℗ Implementation So℗ Far; 3.4.1.2 PIA Methodology for℗ eHealth; 3.4.1.3 Future Data Protection Impact Assessment; 3.4.2 Data Protection by Design ("DPbD")
3.5 Discussion: Contribution to℗ the℗ State of℗ Art Scholarship and℗ Challenges for℗ Legal Requirements Engineering3.5.1 Contribution to℗ Legal Requirements Engineering; 3.5.2 Recommendations to℗ eHealth Stakeholders; 3.5.3 Challenges; 3.5.3.1 Mapping and℗ Assessing Rules; 3.5.3.2 Interfacing Laws and℗ Regulations with℗ eHealth Technology; 3.6 Summary and℗ Conclusions; References; Chapter 4: Ethical Issues in℗ Digital Health; 4.1 Introduction; 4.2 Overview of℗ Digital Health; 4.3 Ethical Implications of℗ Digital Health Technologies; 4.3.1 Privacy, Confidentiality and℗ Security of℗ Personal Healthcare Data
4.3.2 Equality of℗ Access to℗ Healthcare Services4.3.3 Accountability; 4.3.4 Effectiveness of℗ Patient Empowerment; 4.3.5 Quality of℗ Healthcare Information; 4.4 Ethical Frameworks and℗ Guidelines in℗ Digital Health; 4.4.1 The Four Principles of℗ Biomedical Ethics [26]; 4.4.2 Code of℗ Informatics Ethics [27]; 4.4.3 Ethics for℗ eHealth [18]; 4.4.4 eHealth Standardisation and℗ Internet Domain Names [24]; 4.4.5 WMA Declaration on℗ Ethical Considerations Regarding Health Databases [28]
2.3 Industry Survey2.4 Requirements Engineering Practice and℗ Success; 2.4.1 Responding Projects; 2.4.2 Common Practice; 2.4.3 Requirements Engineering Success; 2.4.4 Success-Correlating Practice; 2.5 Discussion; 2.5.1 Contribution; 2.5.2 Threats to℗ Validity; 2.5.3 Need for℗ Research; 2.6 Summary and℗ Conclusions; References; Chapter 3: Laws and℗ Regulations for℗ Digital Health; 3.1 Introduction; 3.2 Methodology for℗ Mapping Laws and℗ Regulations; 3.3 Mapping Relevant Laws and℗ Regulations; 3.3.1 Users' Rights; 3.3.1.1 EU Data Protection Framework and℗ Requirements; Fair and℗ Lawful Processing
Legitimate GroundPurpose Limitation and℗ Secondary Use; Data Protection Rights; Data Security; Other Provisions; 3.3.1.2 Patients' Rights Specific to℗ Health Care; Clinical Investigations; Patients' Rights in℗ Cross-Border Health Care; 3.3.2 Safety and℗ Performance Requirements to℗ Medical Devices; 3.3.2.1 Defining a℗ Medical Device; 3.3.2.2 Requirements; 3.4 Compliance by Design; 3.4.1 Privacy Impact Assessment ("PIA"); 3.4.1.1 Importance and℗ Implementation So℗ Far; 3.4.1.2 PIA Methodology for℗ eHealth; 3.4.1.3 Future Data Protection Impact Assessment; 3.4.2 Data Protection by Design ("DPbD")
3.5 Discussion: Contribution to℗ the℗ State of℗ Art Scholarship and℗ Challenges for℗ Legal Requirements Engineering3.5.1 Contribution to℗ Legal Requirements Engineering; 3.5.2 Recommendations to℗ eHealth Stakeholders; 3.5.3 Challenges; 3.5.3.1 Mapping and℗ Assessing Rules; 3.5.3.2 Interfacing Laws and℗ Regulations with℗ eHealth Technology; 3.6 Summary and℗ Conclusions; References; Chapter 4: Ethical Issues in℗ Digital Health; 4.1 Introduction; 4.2 Overview of℗ Digital Health; 4.3 Ethical Implications of℗ Digital Health Technologies; 4.3.1 Privacy, Confidentiality and℗ Security of℗ Personal Healthcare Data
4.3.2 Equality of℗ Access to℗ Healthcare Services4.3.3 Accountability; 4.3.4 Effectiveness of℗ Patient Empowerment; 4.3.5 Quality of℗ Healthcare Information; 4.4 Ethical Frameworks and℗ Guidelines in℗ Digital Health; 4.4.1 The Four Principles of℗ Biomedical Ethics [26]; 4.4.2 Code of℗ Informatics Ethics [27]; 4.4.3 Ethics for℗ eHealth [18]; 4.4.4 eHealth Standardisation and℗ Internet Domain Names [24]; 4.4.5 WMA Declaration on℗ Ethical Considerations Regarding Health Databases [28]