Risk Assessments: Patient Safety and Innovation

1. Risk Assessments:Patient Safety and Innovation Paul Tang, MD Keith Larsen, RPh 18 June 2013 WG Discussion

2. FDASIA Full Group Meeting • Observations • Goal: regulatory framework for regulation of HIT • Not specific or added response to individual patient risks • Regulatory Group • Review of existing laws and regulation in regards to HIT • FDA • Labeling regulation • Medical Device regulation • ONC • FCC • Request for innovation requirements

3. Questions • Differences between Medical Devices and Software? • What are the innovation requirements? • Stratified by level of innovation or opportunity for innovation

4. Medical Device versus HIT • What are the differences? • Turn around time • Major releases, minor releases updates of currently running software • Customization and configuration expectation • Tools to extend the products function • Measured against practice impact, not absolutes

5. Questions • Differences between Medical Devices and Software? • What are the innovation requirements? • Stratified by level of innovation or opportunity for innovation

6. Sources of Innovation / RiskFull 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)

7. Questions • What are the innovation requirements? • Stratified by level of innovation or opportunity for innovation • Vended software • Locally created software • Locally configured software • Locally extended software – using provided tools • Local combination of technologies • Communication devices • Interoperability: HL7 interface, service calls, database sharing,

8. Vended Software • Innovation requirements • Policy clarity • Standards – increased opportunity for small scale product • Accountability model

9. Locally Developed Software • Innovation requirements • Policy clarity • Standards – increased opportunity for small scale product • Local process controls • Accountability model

10. Locally Configured Software • Innovation requirements • Local process controls • Accountability model

11. Locally Extended Software • Innovation requirements • Local process controls • Accountability model

12. Local Combination of Technologies • Innovation requirements • Local process controls • Accountability model • Expectations of suppliers

13. Biggest picture • Looking at the three agencies together, is there a better way to regulate HIT?

14. 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.

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

16. 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

17. 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.

18. 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

19. 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.”

20. 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

21. 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

22. 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.

23. 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

24. Work Product Approaches • Innovation Requirements -   ”These requirement must be met to foster innovation.” • Solve problems - flexibility • Turnaround time – • Iteration – experimentation -growth • 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

25. 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