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Risk Assessments: Patient Safety and Innovation. Innovation Discussion 02 July 2013. FDASIA Group . Charter

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Risk assessments patient safety and innovation

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
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
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


        Defining or Leadership Role


What has been the impact of

current regulatory approaches

on innovation?

Regulatory approaches
Regulatory Approaches

  • Medical Device regulation

  • Certification regulation

Nature of innovation risk general attributes requirements
Nature of Innovation RiskGeneral Attributes / Requirements

IOM Report, Appendix D



  • Defined as the number of implementation paths to meet compliance.



  • Defined as if a regulation promotes more or less complete information in the market.

    Measurement Innovation Goal Attainment


Comparison of approaches
Comparison of Approaches

Medical Device Regulation

Certification Regulation

Product definition

“Best Practice” feature definitions

Pre-use approval


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

  • 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

Lessons learned
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


What are the specific

innovation requirements?

Stratified by level of innovation or

opportunity for innovation

Nature of innovation risk general attributes requirements1
Nature of Innovation RiskGeneral Attributes / Requirements

IOM Report, Appendix D



  • Defined as the number of implementation paths to meet compliance.



  • Defined as if a regulation promotes more or less complete information in the market.

    Measurement Innovation Goal Attainment



  • 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
Biggest picture(Regulatory Group)

Looking at the three agencies together, is there a better way to regulate HIT?


  • 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 report1
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
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


Current Regulation

Learning Environment

Multiple solutions

Continuous innovation

Continuous measurement of results

Encourages participation

  • Defined solution

  • Slow response to innovation and problems

  • Opaque results

  • Discourages participation