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