AAMI HIT1000 3 2019
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AAMI HIT1000-3(PS):2019 – Safety and effectiveness of health IT software and systems-Part 3: Application of risk management
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 50 |
Specifies a process to identify the patient safety hazards associated with health IT software and systems, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI HIT1000-3 (PS):2019; Safety and effectiveness of health IT software and systems—Part 3: Application of risk management |
| 4 | Provisional AAMI/American National Standard Copyright information |
| 5 | Contents |
| 7 | Committee representation |
| 9 | Foreword |
| 10 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 19 | 4 Context and concepts |
| 20 | Table 1 – Health IT software lifecycle roles and activities involved in risk management |
| 25 | 5 Development stage risk management 5.1 General development stage risk management process 5.2 Development stage HIT Product risk analysis process |
| 26 | 5.3 Identification of the HIT Product |
| 27 | 5.4 Development stage identification of hazards to patients |
| 28 | 5.5 Development stage estimation of HIT Product risk |
| 29 | 5.6 Development stage HIT product risk evaluation 5.7 Development stage HIT product risk control options analysis |
| 30 | 5.8 Development stage HIT product risk benefit analysis 5.9 Development stage application of HIT product risk controls 5.10 Development stage completeness of HIT product risk control 5.11 Delivery |
| 31 | 6 Acquisition stage risk management 6.1 Procurement |
| 32 | 7 Integration stage risk management 7.1 General Integration stage risk management process 7.2 Integration stage HIT Product risk analysis process |
| 33 | 7.3 Defining the scope of the HIT system |
| 34 | 7.4 Identifying integration stage HIT hazards 7.5 Estimating integration stage HIT system risk |
| 35 | 7.6 Evaluating Integration stage HIT system risk 7.7 Integration stage risk control option analysis |
| 36 | 7.8 Integration stage HIT system risk-benefit analysis |
| 37 | 7.9 Integration stage application of HIT system risk control measures 7.10 Integration stage completeness of HIT system risk control |
| 38 | 8 Implementation stage risk management 8.1 General implementation stage risk management process |
| 39 | 8.2 Workflow assessment and optimization 8.3 Decision support |
| 40 | 8.4 Data Quality |
| 41 | 8.5 Patient Identification 8.6 Change management and Training |
| 42 | Figure 1 – New System Maturity Curve |
| 43 | 8.7 Deployment 8.8 Pilot or limited production roll-out |
| 44 | 8.9 Go-Live 9 Operational use in the clinical setting stage risk management 9.1 General operational use stage risk management process |
| 45 | 9.2 Post-deployment monitoring |
| 46 | 9.3 Post-deployment HIT product monitoring 9.4 HIT system modification and maintenance |
| 47 | 9.5 HIT product modification and maintenance 10 Decommission stage risk management 10.1 General decommission stage risk management process |
| 49 | Bibliography and cited references |
