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Risk Assessments: Patient Safety and Innovation

Risk Assessments: Patient Safety and Innovation. Paul Tang, MD Keith Larsen, RPh. Background. This subgroup is addressing how to assess 1) risk of software to patient safety, and 2) risk of regulatory approaches to innovation First of several iterations of our frameworks

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Risk Assessments: Patient Safety and Innovation

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  1. Risk Assessments:Patient Safety and Innovation Paul Tang, MD Keith Larsen, RPh

  2. Background • This subgroup is addressing how to assess 1) risk of software to patient safety, and 2) risk of regulatory approaches to innovation • First of several iterations of our frameworks • We will use FDASIA WG feedback to continue to iterate on our frameworks until we are satisfied with our deliverables

  3. STRAWMAN Dimensions of Patient-Safety Risks • Purpose-user • Intended purpose of software • Intended user • Characterizing patient-harm risk • Magnitude of risk • Population exposed • Likelihood of risk situation arising • Ability to mitigate risk • Complexity of software • Development • Implementation • Training and use • Integration with other system components • Network connectivity

  4. STRAWMAN Framework forAssessing Risk of Harm

  5. Innovation Impact Framework • Not writing regulation • Not responding to specific regulatory interventions • Framework for evaluation of innovation impact

  6. Sources of InnovationFull Spectrum of the SocioTechnical System • Developed software • Software setup / customization • Integration with medical processes – sociotechnical system • Communication devices • Combining technologies • Predictable (e.g., HL7 interfaces) • Non-predictable (e.g., end user combination of available technologies)

  7. “Regulatory Response Appropriate to Patient Risk”

  8. Medical Intervention Paradigm Maintain / Restore Wellness Best Practice Do No Harm

  9. “Good Idea…Gone Bad”Role of Measurement • Policy • Intent, vision, goal • Outcomes orientation • Measurement • Specific imagined implementation “Not everything that can be counted counts, and not everything that counts can be counted.” – Einstein or Cameron “You can only manage what you measure.” ~Deming

  10. “Status Quo is not always the safest state.” • Risk of the innovation • Risk of the status quo • Neither is risk free • Balance of risk

  11. Risks to Innovation • Uncertainty – policy and / or compliance • Competitive advantage / disadvantage • Regulatory solution itself does direct harm • Homogenization of solutions / prevention of better solutions • Re-direction of resources to lesser value activities – compliance innovation • Barrier to new entries to space • Stagnates or kills industry

  12. Promotion of Innovation • Moon shots – goals, future state definitions • Outcome measures – variety of paths to accomplish • Fuel efficiency standards

  13. Distillation to an Innovation Risk Assessment Framework • Regulatory interventions • Implementation / Measurement • Innovation impact

  14. Innovation Risk Assessment Framework (examples)

  15. Next Steps • Feedback from FDASIA work group • Continue iteration of framework

  16. Additional Slides for Breakout Session

  17. Review: Ways of thinking about innovation risk • Stratification of regulation targets: • Prevention of harm versus promotion of “best practices” • Impact of each on innovation • Measurement as a dimension of innovation risk • Status quo not always the safest state

  18. Activities / Evaluations • Use Case Evaluation • Blood Bank • http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/UCM051540.pdf • ARRA Certification and Meaningful Use • Hong Kong SARS outbreak and HIT response • Starter Questions • What has worked and what has not? • Profile against risk parameters in IOM Appendix D • What have you experienced as an impact to your innovation?

  19. Additional Questions • Are the risks to innovation adequately enumerated? • How can regulatory interventions promote valuable innovation as opposed to compliance innovation? • What are specific behaviors that we would recommend for the FDA/ONC/FCC in balancing regulation and innovation? • How much or how should “best practice” be incorporated or a driver for regulation? • How role and impact do standards have on innovation?

  20. Work Product(Discussion Strawman) • Defined risks to innovation • Mitigations of defined risks • Framework for evaluation • Content? • Suggested behaviors or processes in regulatory development

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