Risk Assessments:Patient Safety and Innovation

20 May 2013

Agenda

• Objectives for call• Discussion of strawman framework for

patient-safety risk assessment (30 min)• Discussion of strawman framework for

innovation risk assessment (30 min)• Next steps• Public comment

Objectives for the Call

• Recall that objective for FDASIA WG is to provide input (not proposed regulations) to FDA, ONC, FCC for their report on risk-based regulatory framework that promotes innovation

• 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• Output of this call will be draft concepts to present to

FDASIA WG for their feedback• We will use their feedback as we continue to iterate on our

frameworks until we are satisfied with our deliverables

Problem Statement

“An appropriate balance must be reached between government oversight and market innovation.” – IOM Report

• Innovation and government oversight are in tension with one another

• “Balance” is the keyword

STRAWMAN PATIENT SAFETY RISK ASSESSMENT FRAMEWORK FOR

DISCUSSION(30 MIN)

STRAWMAN Dimensions of Patient-Safety Risks

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

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

• Complexity of development, implementation, use• Post-marketing changes

– Customizability of software– Integration with other system components

• Wireless connectivity

STRAWMAN Framework forAssessing Risk of Harm

STRAWMAN INNOVATION RISK ASSESSMENT FRAMEWORK FOR

DISCUSSION(30 MIN)

Innovation Risk Assessment Framework

• Regulatory options• Innovation risk profile– Measurement burden

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

• Update strawman frameworks based on group discussion

• Present strawman concepts for full WG feedback on May 30

• Schedule future subgroup calls for continued iteration

Public Comment