Risk Assessments: Patient Safety and Innovation

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

2. 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)

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

4. Thoughts from this morning • Re-consideration of existing regulation • can we “down scope” • Think outside of the box • Reduce risk to patient • So where is the justification of the best manufacturing practices by FDA meet that need? • Process regulation • Acceptable risks when measured by the benefit • Level of governance • Is it efficient to govern from the top • Turn around time – slows everything down • Safe but uninteresting • Practical level of regulation – regulatory discretion • “Encroachment on the practice of medicine” • Transparency and open communication • Non-communication • Non-monitoring • Belief system

5. Work Product(Discussion Strawman) • Defined risks to innovation • Mitigations of defined risks • Framework for evaluation • Content? • What’s important? What do we value in innovation? • How do we preserve what’s important? • Suggested behaviors or processes in regulatory development

6. Approaches • Reactive • Risk • Regulation • Innovation harm • Reverse • Promote innovation • Address risk • Address regulation

7. What is important to preserve in innovation? • Turnaround time – • Iteration - experimentation • Involve the patients and physicians in the process • Configurability • Standards – interoperability – plug in an incremental change • Transparency – shared, accumulated learning • Capturing enhancement / ideas

8. Promote Innovation • Economic models / levers

9. Approaches to risk • Transparency • Post marketing surveillance • Breakdown legal barriers for transparency • Sharing of test cases and results

10. 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

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