v
Figure 10-4. Example of a Process Representing Activities Related to Usability Engineering. .............................137
Figure 10-5. Relationship Between User Needs, Usability Sensitive User Needs, Use Scenarios, and Usability Goals. ..138
Figure 10-6. Examples of User Interface Requirements.........................................................................................141
Figure 10-7. Example Table of Contents for a Template to Document User Observations. ..................................142
Figure 10-8. Example of a Walkthrough Evaluation..............................................................................................143
Figure 10-9. Walkthrough Example Involving a Scenario With Different Tasks...................................................144
Figure 10-10. Example of Usability Severity Scale.................................................................................................146
Figure 10-11. Single Ease Question (SEQ). ..........................................................................................................149
Figure 10-12. Intuitive SUS Score Graph..............................................................................................................151
Figure 10-13. SUS Scale Interpretation. ................................................................................................................152
Figure 11-1. A Simplified Diagram of Different AI Techniques...........................................................................160
Figure 11-2. Global and Local Model Change. .....................................................................................................161
Figure 11-3. Visualization of Federated Learning..................................................................................................162
Figure 11-4. Three Scenarios for Change of Machine Learning Devices in Relation to Their Placement on the
Market....................................................................................................................................................................163
Figure 11-5. Visualization of Postmarket Significant Change...............................................................................165
Figure 11-6. Illustration of AI Change Types. .......................................................................................................167
Figure 11-7. Types of Controllability. ....................................................................................................................168
Figure 11-8. Transparency and Interpretability of AI.............................................................................................170
Figure 11-9. Bias Entry Points in the AI Development Chain. .............................................................................173
Figure 11-10. Geographic Distribution of Issuers of Ethical AI Guidelines by Number of Documents Released.........174
Figure 11-11. Overview of NMPA Regulation and Standardization Applicable to AI-Enabled Medical Devices .......175
Figure 12-1. Health App Evaluation Criteria. .......................................................................................................184
Figure 12-2. Health App Quality Assessment. ......................................................................................................185
Figure 13-1. Economic Operators Under EU MDR and EU IVDR Encountered for Devices Produced in a Third
Country. .................................................................................................................................................................188
Figure 14-1. The Fourth Hurdle.............................................................................................................................199
Figure 14-2. mHealth Belgium Validation Pyramid...............................................................................................201
Figure 14-3. DHTs Classified by Function and Stratified Into Evidence Tiers. ....................................................203
Figure 14-4. Evidence Tiers Requirement..............................................................................................................204
Figure 14-5. Economic Analysis of DHT..............................................................................................................204
Figure 14-6. Assessment Process in France. ...........................................................................................................206
Figure 14-7. Act Assessment and Reimbursement Process....................................................................................207
Figure 14-8. DiGA Process....................................................................................................................................209
Figure 14-9. Applications Submitted to BfArM as of 14 January 2021.................................................................210
Figure 14-10. Overview of DiGA Criteria and Assessment Process......................................................................210
Figure 14-11. Availability of Digital Health Solutions in Spain. ...........................................................................213
Figure 14-12. MAST Framework. .........................................................................................................................216
Figure 10-4. Example of a Process Representing Activities Related to Usability Engineering. .............................137
Figure 10-5. Relationship Between User Needs, Usability Sensitive User Needs, Use Scenarios, and Usability Goals. ..138
Figure 10-6. Examples of User Interface Requirements.........................................................................................141
Figure 10-7. Example Table of Contents for a Template to Document User Observations. ..................................142
Figure 10-8. Example of a Walkthrough Evaluation..............................................................................................143
Figure 10-9. Walkthrough Example Involving a Scenario With Different Tasks...................................................144
Figure 10-10. Example of Usability Severity Scale.................................................................................................146
Figure 10-11. Single Ease Question (SEQ). ..........................................................................................................149
Figure 10-12. Intuitive SUS Score Graph..............................................................................................................151
Figure 10-13. SUS Scale Interpretation. ................................................................................................................152
Figure 11-1. A Simplified Diagram of Different AI Techniques...........................................................................160
Figure 11-2. Global and Local Model Change. .....................................................................................................161
Figure 11-3. Visualization of Federated Learning..................................................................................................162
Figure 11-4. Three Scenarios for Change of Machine Learning Devices in Relation to Their Placement on the
Market....................................................................................................................................................................163
Figure 11-5. Visualization of Postmarket Significant Change...............................................................................165
Figure 11-6. Illustration of AI Change Types. .......................................................................................................167
Figure 11-7. Types of Controllability. ....................................................................................................................168
Figure 11-8. Transparency and Interpretability of AI.............................................................................................170
Figure 11-9. Bias Entry Points in the AI Development Chain. .............................................................................173
Figure 11-10. Geographic Distribution of Issuers of Ethical AI Guidelines by Number of Documents Released.........174
Figure 11-11. Overview of NMPA Regulation and Standardization Applicable to AI-Enabled Medical Devices .......175
Figure 12-1. Health App Evaluation Criteria. .......................................................................................................184
Figure 12-2. Health App Quality Assessment. ......................................................................................................185
Figure 13-1. Economic Operators Under EU MDR and EU IVDR Encountered for Devices Produced in a Third
Country. .................................................................................................................................................................188
Figure 14-1. The Fourth Hurdle.............................................................................................................................199
Figure 14-2. mHealth Belgium Validation Pyramid...............................................................................................201
Figure 14-3. DHTs Classified by Function and Stratified Into Evidence Tiers. ....................................................203
Figure 14-4. Evidence Tiers Requirement..............................................................................................................204
Figure 14-5. Economic Analysis of DHT..............................................................................................................204
Figure 14-6. Assessment Process in France. ...........................................................................................................206
Figure 14-7. Act Assessment and Reimbursement Process....................................................................................207
Figure 14-8. DiGA Process....................................................................................................................................209
Figure 14-9. Applications Submitted to BfArM as of 14 January 2021.................................................................210
Figure 14-10. Overview of DiGA Criteria and Assessment Process......................................................................210
Figure 14-11. Availability of Digital Health Solutions in Spain. ...........................................................................213
Figure 14-12. MAST Framework. .........................................................................................................................216