1. Risk Assessments: Patient Safety and Innovation 20 May 2013

2. Agenda Objectives for call Discussion of strawman framework for patient-safety risk assessment (30 min) Discussion of strawman framework for innovation risk assessment (30 min) Next steps Public comment

3. Objectives for the Call Recall that objective for FDASIA WG is to provide input (not proposed regulations) to FDA, ONC, FCC for their report on risk-based regulatory framework that promotes innovation 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 Output of this call will be draft concepts to present to FDASIA WG for their feedback We will use their feedback as we continue to iterate on our frameworks until we are satisfied with our deliverables

4. Problem Statement “An appropriate balance must be reached between government oversight and market innovation.” – IOM Report Innovation and government oversight are in tension with one another “Balance” is the keyword

5. STRAWMAN PATIENT SAFETY RISK ASSESSMENT FRAMEWORK FOR DISCUSSION(30 MIN)

6. STRAWMAN Dimensions of Patient-Safety Risks Purpose-user – Intended purpose of software – Intended user Characterizing patient-harm risk – Magnitude of risk – Likelihood of risk situation arising – Ability to mitigate risk Complexity of development, implementation, use Post-marketing changes – Customizability of software – Integration with other system components Wireless connectivity

7. STRAWMAN Framework for Assessing Risk of Harm

8. STRAWMAN INNOVATION RISK ASSESSMENT FRAMEWORK FOR DISCUSSION(30 MIN)

9. Innovation Risk Assessment Framework Regulatory options Innovation risk profile – Measurement burden

10. Innovation Risk Assessment Framework (examples)

11. Next Steps Update strawman frameworks based on group discussion Present strawman concepts for full WG feedback on May 30 Schedule future subgroup calls for continued iteration

12. Public Comment