AAMI HIT1000 4 PS 2020
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AAMI HIT1000-4 (PS):2020 Safety and effectiveness of health IT software and systems-Part 4: Application of human factors engineering
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 |
Provisional standard
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI HIT1000-4 (PS):2020; Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering |
| 3 | Title page |
| 4 | Provisional AAMI/American National Standard Copyright language |
| 5 | Contents |
| 6 | Committee representation |
| 8 | Foreword |
| 9 | Introduction |
| 11 | 1 Scope 2 Normative References 3 Terms and definitions |
| 13 | 4 Context and concepts |
| 15 | Table 1 – Lifecycle roles and responsibilities |
| 16 | Figure 1 – Health IT software lifecycle stages within a HIT system (with integration and recursion possible on all paths) |
| 17 | Table 2 – Health IT software lifecycle stages, roles, and activities involved in HFE |
| 23 | 5 Development stage human factors engineering 5.1 General Development stage human factors engineering process |
| 24 | Figure 2 – An illustration of a sample implementation of a user-centered design process |
| 25 | 5.2 Development stage optimizing the user experience through user-centered design and evaluation methods |
| 26 | Table 3 – Examples of User interface characteristics that can promote or degrade usability |
| 27 | 5.3 Development stage conducting user research |
| 35 | Table 4 – Measurable usability goals |
| 36 | Table 5 – Sample objective and subjective usability goals 5.4 Development stage managing use-related risk |
| 37 | Table 6 – Sample use errors and hazardous situations leading to possible harm |
| 40 | Figure 3 – FDA Design Control Guidance for Medical Device Manufacturers |
| 41 | Table 7 – Examples of use-safety benefit |
| 42 | 5.5 Development stage designing the user interface |
| 43 | 5.6 Development stage evaluating the user interface |
| 49 | 6 Acquisition stage human factors engineering 6.1 Procurement |
| 50 | 6.2 Guidance and good practice for procurement |
| 51 | 7 Integration stage human factors engineering 7.1 General Integration stage human factors engineering 7.2 Integration stage of human factors engineering process |
| 52 | 7.3 Guidance and good practice for integration stage of human factors engineering process |
| 53 | 8 Implementation stage human factors engineering 8.1 General Implementation stage – human factors engineering 8.2 Implementation stage – human factors engineering process |
| 54 | 8.3 Guidance and good practice for implementation stage – human factors engineering process |
| 55 | 9 Operational use in the clinical setting stage – human factors engineering 9.1 General operational use in the clinical setting stage – human factors engineering 9.2 Operational use in the clinical setting stage – human factors engineering process |
| 56 | 9.3 Guidance and good practice for Operational stage – human factors engineering process |
| 57 | 10 Decommissioning stage – human factors engineering 10.1 General decommissioning stage – human factors engineering |
| 58 | 10.2 Decommissioning stage – human factors engineering process 10.3 Guidance and good practice for Decommissioning stage – human factors engineering process |
| 59 | Annex A Summary of Requirements Table 8 – Summary of Requirements |
| 64 | Annex B Considerations for conducting validation usability tests B.1 Overview of validation usability tests |
| 65 | Figure 4 – An illustration of the risk analysis and mitigation process (Johnathan Kendler, Curiolis) B.2 Recommendations for conducting successful validation usability tests (See IEC 62366-1 and IEC 62366-2) |
| 68 | B.3 Additional considerations for usability testing B.3.1 Selecting usability test participants |
| 69 | B.3.2 Specifying usability test tasks B.3.3 Conducting root cause analysis |
| 70 | B.3.4 Documenting user interaction problems |
| 72 | Annex C Sample expert review findings C.1 Sample Finding (Opportunity for Improvement): Placement of referral function Figure 5 – Referral function located under Demographics C.2 Sample Finding (Opportunity for improvement): Use of ellipses |
| 73 | Figure 6 – Indication of allergies is subtle Figure 7 – Clicking on “…” leads to list of allergies or none C.3 Sample Finding (Strength): Allergy Alerts Figure 8 – Clinical Reminders |
| 74 | Bibliography and cited references |
