Risk Assessments:Patient Safety and Innovation

Paul Tang, MDKeith Larsen, RPh

18 June 2013WG Discussion

FDASIA Full Group Meeting

• Observations– Goal: regulatory framework for regulation of HIT

• Not specific or added response to individual patient risks– Regulatory Group

• Review of existing laws and regulation in regards to HIT– FDA

» Labeling regulation» Medical Device regulation

– ONC– FCC

• Request for innovation requirements

Questions

• Differences between Medical Devices and Software?

• What are the innovation requirements?– Stratified by level of innovation or opportunity for

innovation

Medical Device versus HIT

• What are the differences?– Turn around time• Major releases, minor releases updates of currently

running software– Customization and configuration expectation– Tools to extend the products function– Measured against practice impact, not absolutes

Questions

• Differences between Medical Devices and Software?

• What are the innovation requirements?– Stratified by level of innovation or opportunity for

innovation

Sources of Innovation / RiskFull Spectrum of the SocioTechnical System

• Developed software• 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)

Questions

• What are the innovation requirements?– Stratified by level of innovation or opportunity for

innovation• Vended software• Locally created software• Locally configured software• Locally extended software – using provided tools• Local combination of technologies

– Communication devices– Interoperability: HL7 interface, service calls, database sharing,

Vended Software• Innovation requirements– Policy clarity– Standards – increased opportunity for small scale

product

• Accountability model

Locally Developed Software• Innovation requirements– Policy clarity– Standards – increased opportunity for small scale

product– Local process controls

• Accountability model

Locally Configured Software• Innovation requirements– Local process controls

• Accountability model

Locally Extended Software• Innovation requirements– Local process controls

• Accountability model

Local Combination of Technologies• Innovation requirements– Local process controls

• Accountability model– Expectations of suppliers

Biggest picture

• 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.

Regulatory Approach

• Standard approach– Risk– Regulation– Mitigate innovation harm

• Reverse– Promote innovation– Address patient risk– Address regulation

Regulatory Approach

• Legal framework– Prevention of then known risks– Prescriptive– Inhibits transparency– Effort to mitigate innovation risk

• Learning framework– Predicated on transparency– Acceptance of relative risk– Effort to prevent only the out of bounds errors

• E.g., lose track of the patient focus

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.

IOM Report

• Government’s Role– “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.” – IOM Report

Work Product Approaches• General Framework for analysis of proposed regulation / Appendix D –

“Principles of preserving Innovation”

• Critique of current regulation / exemplars – “Don’t do this again!” and “This worked.”

• Regulation development process recommendations – “This is how innovation considerations should be resolved in the development of regulation.”

• Specific regulatory implementations –

“This is the specific impact to innovation from specific regulatory interventions.”

• Innovation Requirements - ”These requirement must be met to foster innovation.”

Work Product Approaches

• General Framework for analysis of proposed regulation / Appendix D –

“Principles of preserving Innovation”– Policy Uncertainty– Compliance Burden– Compliance and circumventive innovation– Incremental versus radical innovation– Flexibility, Stringency, and Information dimensions

of regulation

Work Product Approaches

• Critique of current regulation / exemplars – “Don’t do this again!” and “This worked.”

– Attempt to collect specific examples– Critique current regulation

• FDA development standards• ARRA certification measures• HIPAA• SureScripts certification measures• Incentive motivation programs• Penalty motivation programs

Work Product Approaches

• Regulation development process recommendations –

“This is how innovation considerations should be resolved in development of regulation.” – There is a process to create regulations already.

These recommendations would be around how to improve that process.

– For example, having a formal innovation impact report distributed with the proposed rule.

Work Product Approaches• Specific regulatory implementations –

“This is the specific impact to innovation from specific regulatory interventions.”

– These recommendations would address known patient safety issues, recommending specific regulatory interventions to address the issue that preserves and promotes innovation.

– Examples• Capabilities Certification• Process Certification• Incentive programs• Penalty for non-adoption programs• Accountability models

Work Product Approaches• Innovation Requirements -

”These requirement must be met to foster innovation.”– Solve problems - flexibility– Turnaround time – – Iteration – experimentation -growth– Involve the patients and physicians in the process and

informed risk– Configurability / customization / extensibility– Standards – interoperability – plug in an incremental change– Transparency – shared, accumulated learning

• Capturing enhancement / ideas

Shared Learning / Market Forces

• “Transparency”– No barriers to sharing data – remove artificial

barriers– Repository of data– Post marketing surveillance• Breakdown legal barriers for transparency

– Sharing of test cases and results