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

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

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

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

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

Regulatory Approaches Medical Device regulation Certification regulation

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

Medical Device versus HIT Physical Device Physical Long development / enhancement cycles Fixed functionality Task oriented – Measured against the task Environment of operation relatively defined and static Contributing suppliers more controlled and measureable Software Virtual Constant change – Major releases, minor releases updates of currently running software – Network connectivity: security, privacy, upgradeability – Customization and configuration expectation – What does Pre-Marketing Approval mean when distributing monthly updates? Configurable by design Tools to extend the products function Can be process oriented vs single task – Measured against practice impact, not individual tasks Environment (hardware, other software on hardware) more open Contributing suppliers layered with many contributions not specifically designed for healthcare – e.g., PC or phone operating system

Medical Device Regulation Pros Process control, not outcomes – standard: – consistent manufacturing process that can be applied to software Confidence in resulting product Cons Clarity – Who is subject to regulation? – Implementation barriers – knowledge & overly prescriptive Geared to physical devices – Turnaround time – Configuration and extension – “Class Up” effect on software working with device Issue: – start small without regulation, but then applying regulation after the fact

Certification Regulation Motivation: defined product – Government is funding a capital improvement to healthcare practice (link to Meaningful Use) – Therefore, obligation to promote good products – Therefore, defined “Best Practice” Effect on Innovation: – Assumption of known Best Practice where not known – Specification of Best Practice and certifying specific test behaviors limits innovation – Working to the test – “Compliance Innovation”

Certification Regulation Role of Measurement Policy – Intent, vision, goal – Outcomes orientation Measurement – test cases – Specific imagined implementation “Not everything that can be counted counts, and not everything that counts can be counted.” – Einstein or Cameron “You can only manage what you measure.” ~Deming

Certification Regulation Other Impacts to Innovation Endorsement and empowerment of private certification regimens: SureScripts – Another certification involving “Best Practice” – Little option to avoid this certification even though not specifically mandated by regulation – “Best Practice” defined in less transparent, less responsive system; i.e., private entity Constant reporting of “changes” to software with unclear consequence of triggering re-certification – Uncertainty increase causes innovation decrease – every incentive NOT to change – Does not fit with constant updates of software

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

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

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

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

Sources of Innovation / Risk Full Spectrum of the SocioTechnical System Developed software – vendor and local 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 – software and hardware)

Questions What are the innovation requirements? – Stratified by level of innovation or opportunity for innovation Vended software Local creation of software Local configuration of software Local extension of software – using provided tools Local combination of technologies – Communication devices – Interoperability: HL7 interface, service calls, database sharing,

Vended Software Innovation requirements – Policy clarity In / out of regulatory focus Re-certification / re-authorization rules – Consistent international regulatory framework – Interoperability Standards – mixed effect Increased innovation opportunity for small-scale product to plug into existing market; “development ecosystem” Defined endpoint decreases innovation Limited governmental direction; facilitate market driven standards – Eliminate / minimize defined features / certification Process controls can enhance innovation – trust method – Goals – set problems-to-solve agenda for innovation – Provide pathway to become compliant with – Transparency between suppliers and with consumers – Accept relative risk Shift some process control to post-distribution Framework of non-punitive disclosure of issues Accountability model – Consistent national and international standards – Transparency of process, artifacts, and results

Locally Developed Software Innovation requirements – Policy clarity In / out of regulatory focus Re-certification / re-authorization rules – Interoperability Standards – mixed effect Increased innovation opportunity for small-scale product to plug into existing market; “development ecosystem” Defined endpoint decreases innovation Limited governmental direction; facilitate market driven standards – Eliminate / minimize defined features / certification Process controls can enhance innovation – trust method – Goals – set problems-to-solve agenda for innovation rather than feature agenda – Provide pathway to become compliant with existing software (i.e., software developed before regulatory focus) – Transparency into supplied software (locally developed software most often leverages pieces of software intended or not for medical use) – Accept relative risk Shift some process control to post-distribution Framework of non-punitive disclosure of issues – Local process controls – Turnaround time: lightweight process adaptable to different level of development effort and scope – Iterative development / implementation cycles Controlled pilots with real patient data and informed users Accountability model – National process controls – administered locally & available for audit – Local, continuous oversight – Surveillance: feedback loop of results – Local control, governance, and accountability for pilot use

Locally Configured Software Innovation requirements – Transparency into supplier process and results – Open communication of issues – Adequate training and documentation of supplied software – Local process controls: review, testing, implementation, and surveillance – None to little federal oversight: inheritance of supplier oversight Accountability model – Integration with local medical processes – Testing of configuration – Surveillance of results – Reporting of local results

Locally Extended Software Innovation requirements – Transparency into supplier process and results – Open communication of issues – Adequate training and documentation of supplied software – Local process controls: review, testing, implementation, and surveillance – Accept relative risk Framework of non-punitive disclosure of issues – Turnaround time: lightweight process adaptable to different level of development effort and scope – Iterative development / implementation cycles Controlled pilots with real patient data and informed users – Local process controls – None to little federal oversight: inheritance of supplier oversight Accountability model – Integration with local medical processes – Testing of extended software – Surveillance of results – Reporting of local results – Local control, governance, and accountability for pilot use

Local Combination of Technologies Innovation requirements – Local process controls Accountability model – Expectations of suppliers

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

Biggest picture (Regulatory Group) Looking at the three agencies together, is there a better way to regulate HIT?

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.

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.

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

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