Risk Assessments:Patient Safety and Innovation

Paul Tang, MDKeith Larsen, RPh

Background

• This subgroup is addressing how to assess 1) risk of software to patient safety, and 2) risk of regulatory approaches to innovation

• First of several iterations of our frameworks• We will use FDASIA WG feedback to continue to iterate on

our frameworks until we are satisfied with our deliverables

STRAWMAN Dimensions of Patient-Safety Risks

• Purpose-user– Intended purpose of software– Intended user

• Characterizing patient-harm risk– Magnitude of risk– Population exposed– Likelihood of risk situation arising– Ability to mitigate risk

• Complexity of software– Development– Implementation– Training and use

• Integration with other system components• Network connectivity

STRAWMAN Framework forAssessing Risk of Harm

Innovation Impact Framework

• Not writing regulation• Not responding to specific regulatory

interventions• Framework for evaluation of innovation

impact

Sources of InnovationFull Spectrum of the SocioTechnical System

• Developed software• Software setup / customization• 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)

“Regulatory Response Appropriate to Patient Risk”

Medical Intervention Paradigm

Maintain / Restore Wellness

Do No Harm

Best Practice

“Good Idea…Gone Bad”Role of Measurement

• Policy– Intent, vision, goal– Outcomes orientation

• Measurement– 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

“Status Quo is not always the safest state.”

• Risk of the innovation• Risk of the status quo• Neither is risk free• Balance of risk

Risks to Innovation

• Uncertainty – policy and / or compliance• Competitive advantage / disadvantage• Regulatory solution itself does direct harm• Homogenization of solutions / prevention of

better solutions• Re-direction of resources to lesser value activities

– compliance innovation• Barrier to new entries to space• Stagnates or kills industry

Promotion of Innovation

• Moon shots – goals, future state definitions• Outcome measures – variety of paths to

accomplish– Fuel efficiency standards

Distillation to an Innovation Risk Assessment Framework

• Regulatory interventions• Implementation / Measurement• Innovation impact

Innovation Risk Assessment Framework (examples)

Regulatory Method Low Risk Medium Risk High Risk

Accountability modelMore transparent pre and post marketing data collection

Process Model

Software development process

Entity documents their process and measures their compliance to their defined process. An internal party defined to review and approve the clinical use of software.

Regulation defines the process and the measurements of the process that are published. Internal party set up to review and approve the clinical use of software.

Regulation defines the process, the measures, and inserts a third-party approval process before the software can be put into production.

Implementation process

Entity documents their process and measures their compliance to their defined process. An internal party defined to review and approve the clinical use of software.

Regulation defines the process and the measurements of the process that are published. Internal party set up to review and approve the clinical use of software.

Regulation defines the process, the measures, and inserts a third-party approval process before the software can be put into production.

Certification ModelRegulatory definition of principles with flexibility of innovation.

Test cases with precise user interface presentations and/or precise process behavior.

Innovation Impact

Next Steps

• Feedback from FDASIA work group• Continue iteration of framework

Additional Slides for Breakout Session

Review: Ways of thinking about innovation risk

• Stratification of regulation targets: – Prevention of harm versus promotion of “best

practices”– Impact of each on innovation

• Measurement as a dimension of innovation risk

• Status quo not always the safest state

Activities / Evaluations

• Use Case Evaluation– Blood Bank

• http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/UCM051540.pdf

– ARRA Certification and Meaningful Use– Hong Kong SARS outbreak and HIT response

• Starter Questions– What has worked and what has not?– Profile against risk parameters in IOM Appendix D– What have you experienced as an impact to your

innovation?

Additional Questions

• Are the risks to innovation adequately enumerated?• How can regulatory interventions promote valuable

innovation as opposed to compliance innovation?• What are specific behaviors that we would

recommend for the FDA/ONC/FCC in balancing regulation and innovation?

• How much or how should “best practice” be incorporated or a driver for regulation?

• How role and impact do standards have on innovation?

Work Product(Discussion Strawman)

• Defined risks to innovation• Mitigations of defined risks• Framework for evaluation– Content?

• Suggested behaviors or processes in regulatory development