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

2. Assumptions Everyone is interest in patient safety. We need innovation to solve problems in healthcare. – IT tools have a central role in solving cost and quality issues. We need to encourage more, not less, participation in this innovation and this sector.

3. Sources of Innovation / Risk Full Spectrum of the SocioTechnical System Developed software Software setup / customization / extensions 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)

4. Regulatory Approach Standard approach – Risk – Regulation – Mitigate innovation harm Reverse – Promote innovation – Address patient risk – Address regulation

5. Regulatory Approach Legal framework – Prevention of then known risks – Prescriptive – Inhibits transparency – Effort to mitigate innovation risk Learning framework – Predicated on transparency – Acceptance of relative risk – Effort to prevent only the out of bounds errors E.g., lose track of the patient focus

6. IOM Report To encourage innovation and shared learning environments, the committee adopted the following general principles for government oversight: – Focus on shared learning, – Maximize transparency, – Be nonpunitive, – Identify appropriate levels of accountability, and – Minimize burden.

7. IOM Report Government’s Role – “The government in some cases is the only body able to provide policy guidance and direction to complement, bolster, and support private-sector efforts and to correct misaligned market forces.” – IOM Report

8. Work Product Approaches General Framework for analysis of proposed regulation / Appendix D – “Principles of preserving Innovation” Critique of current regulation / exemplars – “Don’t do this again!” and “This worked.” Regulation development process recommendations – “This is how innovation considerations should be resolved in the development of regulation.” Specific regulatory implementations – “This is the specific impact to innovation from specific regulatory interventions.” Innovation Requirements - ”These requirement must be met to foster innovation.”

9. Work Product Approaches General Framework for analysis of proposed regulation / Appendix D – “Principles of preserving Innovation” – Policy Uncertainty – Compliance Burden – Compliance and circumventive innovation – Incremental versus radical innovation – Flexibility, Stringency, and Information dimensions of regulation

10. Work Product Approaches Critique of current regulation / exemplars – “Don’t do this again!” and “This worked.” – Attempt to collect specific examples – Critique current regulation FDA development standards ARRA certification measures HIPAA SureScripts certification measures Incentive motivation programs Penalty motivation programs

11. Work Product Approaches Regulation development process recommendations – “This is how innovation considerations should be resolved in development of regulation.” – There is a process to create regulations already. These recommendations would be around how to improve that process. – For example, having a formal innovation impact report distributed with the proposed rule.

12. Work Product Approaches Specific regulatory implementations – “This is the specific impact to innovation from specific regulatory interventions.” – These recommendations would address known patient safety issues, recommending specific regulatory interventions to address the issue that preserves and promotes innovation. – Examples Capabilities Certification Process Certification Incentive programs Penalty for non-adoption programs Accountability models

13. Work Product Approaches Innovation Requirements - ”These requirement must be met to foster innovation.” – Solve problems – Turnaround time – – Iteration - experimentation – Involve the patients and physicians in the process and informed risk – Configurability / customization / extensibility – Standards – interoperability – plug in an incremental change – Transparency – shared, accumulated learning Capturing enhancement / ideas

14. Shared Learning / Market Forces “Transparency” – No barriers to sharing data – remove artificial barriers – Repository of data – Post marketing surveillance Breakdown legal barriers for transparency – Sharing of test cases and results