1. Risk Assessments: Patient Safety and Innovation Innovation Discussion 02 July 2013

2. FDASIA Group Charter – The Food and Drug Administration Safety and Innovation Act (FDASIA) directed the HHS Secretary, acting through the Commissioner of the U.S. Food and Drug Administration (FDA), and in consultation with ONC and the Chairman of the FCC, to develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. – The FDA, FCC, and the HHS Office of the National Coordinator for Health IT (ONC) will review and consider the recommendations provided by the Health IT Policy Committee, based on input from the workgroup, as the three agencies write the report. Goal: recommended regulatory framework for regulation of HIT

3. Work Product Approaches Exam Results from Current Regulation – Experiences with current regulation – Impact on innovation Innovation Requirements – General requirements – Specific requirements - stratified by source of innovation Thoughts on new framework for innovation

4. IOM Report Government’s Role (IOM Report) – “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.” Shepherding Role versus Defining or Leadership Role

5. Question What has been the impact of current regulatory approaches on innovation?

6. Regulatory Approaches Medical Device regulation Certification regulation

7. Nature of Innovation Risk General Attributes / Requirements IOM Report, Appendix D Stringency Innovation FlexibilityInnovation – Defined as the number of implementation paths to meet compliance.. InformationInnovation – Defined as if a regulation promotes more or less complete information in the market. Measurement Innovation Goal Attainment Specificity

8. Comparison of Approaches Medical Device Regulation Process control Pre-marketing approval – in some cases Impact – Can be positive when combining software from different sources – increased trust – Lack of clarity (flipside of Regulatory Discretion) yields policy uncertainty – Entry impedance Clarity on requirements & process – purpose of AAMI report Late entry into process with existing product – Continued overhead: heavy process versus agile development – If fully applied to HIT and local implementation, devastating to market – Blood Bank example – Regulatory avoidance: dis-qualify for regulatory inclusion – taxonomy discussion Certification Regulation Product definition “Best Practice” feature definitions Pre-use approval Impact – Reduced flexibility (defined features), reduced innovation – Empowered added private regulation – Non-productive work to test – “Compliance Innovation” – Less market neutral – favors existing software with defined features – Regulatory avoidance: control each features and test script

9. Lessons Learned Certification regimens should be avoided – They narrow creativity and innovation by either design or measurement to a specific or narrowed list of solutions – They channel energy into working to the test – compliance innovation – They channel the discussion to definitional terms rather than meeting the market needs Transparency of results to replace certification – Instead of a certification process to differentiate the market, use transparency – Transparency in the marketplace is more efficient and richer in content Certification just reveals that the system passed the certification test and all vendors will – at that point, there is no differentiation – Having a transparent, “learning system” would provide a continuous spectrum of solutions and their results; i.e., rather than knowing that all the vendors have med reconciliation (the end result of a certification system), it could be discovered which vendor does it better. National goals should be encouraged – JCAHO, Meaningful Use – They meet the “flexibility” test (Appendix D – IOM Report) – Set problem agenda, not product agenda – They do change and, if well set, correct the market and create markets – Where the market goes, vendors will follow

10. Questions What are the specific innovation requirements? Stratified by level of innovation or opportunity for innovation

11. Nature of Innovation Risk General Attributes / Requirements IOM Report, Appendix D Stringency Innovation FlexibilityInnovation – Defined as the number of implementation paths to meet compliance.. InformationInnovation – Defined as if a regulation promotes more or less complete information in the market. Measurement Innovation Goal Attainment Specificity

12. Summary Define process not product National and international standards for quality process – measureable and transparent National interoperability standards lower the entry cost Encourage configuration and extension to support process and solve problems Transparency of product and results Ability to experiment Local control, local accountability

13. Biggest picture (Regulatory Group) 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. 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.

16. Learning Environment Requirements Increase Information in the Marketplace – Pre- and Post marketing information – Common reporting format – Providers and vendor contribution – Open access Environment – Non-punative

17. Comparison Current Regulation Defined solution Slow response to innovation and problems Opaque results Discourages participation Learning Environment Multiple solutions Continuous innovation Continuous measurement of results Encourages participation