ie no one has seen or approved this Draft 070113 Coordination This is the point at which we need to truly start integrating the work products of the subgroups We need to look at the safety issues and assess whether they are addressed ID: 737203
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Slide1
Regulatory weaknesses
A report of the typist for the Regulation Subgroup(i.e. no one has seen or approved this)Draft 07/01/13Slide2
Coordination
This is the point at which we need to truly start integrating the work products of the subgroups.We need to look at the safety issues and assess whether they are addressed
We need to consider the elements of innovation that need to be protected and describe regulatory features that protect them
This is also the point at which we need to make sure we do not duplicate each other’s work.Slide3
Process over the next week
Discussion of the Regulations Subgroup over the next week:Are the three regulatory systems – ONC, FCC and FDA – deficient in any way with regard to how HIT is regulated?
(July 1, except reporting which will be on July 3)
Are
there ambiguities in the three regulatory systems that need to be clarified so that HIT vendors and others can proceed more easily to innovate?
(July 3)
Do
any of the three regulatory systems duplicate one another, or any other legal, regulatory or industry requirement? (July 3)Is there a better way to assure that innovation is permitted to bloom, while safety is assured? (July 8)Slide4
Started by
Examining the work of the Safety & Innovations SubgroupSafety gridInnovation featuresHeld 5 sessions on—
FDA regulation
ONC regulation
FCC regulation
Other federal and state regulation and private effortsSlide5
Questions considered on July 1
For FDA, FCC and ONC, identify regulatory requirements that:
Are
broader or more onerous than need to be to assure the safety of HIT
Fail to be risk-based, for example by either failing to utilizing available mitigation or failing to identify appropriate risk aggravating circumstances.
Are
insufficient in some specific way to assure the safety of HIT
Unnecessarily interfere with some specific needed feature of innovationMiss or omit a sensible opportunity to promote innovationSlide6
FDA issues where attention needed
Item
Issue:
A or B
Description of challenge
Wellness/disease borderline
A & B
FDA needs to explain
how to discern disease related claims from wellness, and needs to deregulate low risk disease related claims
Accessory issues
A & B
FDA needs to explain its position on which basic IT elements are regulated when connected to a medical device, and deregulate or down-regulate those that are low risk
CDS software
A
FDA needs to explain which forms of clinical
decision support software it regulates
Software modularizationAFDA needs to specify its rules for deciding the regulatory status of software modules either incorporated into a medical device, or accessed by a medical device
A = Ambiguous and B = Broken at the written law levelSlide7
FDA issues where attention needed
Item
Issue:
A or B
Description of challenge
Labeling issues
A
FDA needs to explain how the concept of intended use will
be applied to standalone software where the use might evolve over time, perhaps using risk management and
postmarket
surveillance to manage the risks associated with the evolution in the intended use
QS application to standalone software
A
FDA needs
to explain how the quality system requirements and facility registration apply to manufacturing of standalone software
Premarket
requirements for interoperable devicesAFDA needs to adopt a paradigm for reviewing software that is intended to be part of a larger, but unspecifiedPostmarket requirements for networksA & B
Responsibilities for reporting adverse events and conducting corrective actions can be clarified, but also likely need a new approach that reflects shared responsibility across users, producers, and across regulatory agencies
A = Ambiguous and B = Broken at the written law levelSlide8
FDA Program Administration
Apart from those regulatory issues, the subgroup has also identified an issue with how the agency administers the law. There is presently a weakness in the agency coordination of policymaking with regard to HIT software, and especially including mobile medical apps. This weakness
includes:
inconsistencies
in information shared with individual companies, and
unclear
guidance more
generally, including the lack of a final guidance on mobile medical apps.Slide9
ONC issues where attention needed
Item
Issue:
A or B
Description of challenge
Mandatory
elements
BONC program does not include capability in law enforcement, nor its programs framed with mandates where necessary
Assurance
of Safe Configuration
A
Safety
depends on appropriate post-installation configuration. No means to educate or require compliance with documented and evolving best practices
Coverage of interoperability
issues*
*could be inter-agency ONC/FDA/FCC
BUnclear and incomplete responsibility. Assumption that ONC does regulate HIT/medical device interface and FDA regulates med device/med device interface. But same med device (e.g. infusion pump) could be installed in either configuration. Which agency would receive report of “pump-server-HIT equipment-wireless infrastructure-EHR” related adverse event? Who is responsible for resolving?A = Ambiguous and B = Broken at the written law levelSlide10
FCC issues where attention needed
Item
Issue:
A or B
Description of challenge
Linkage to FDA reporting
B
FCC and FDA have not merged their reporting processes in a way that allows for
transparent
analysis (also see gaps slide below)
Linkage to FDA review
B
FCC and FDA do not
coordinate their review processes (equipment authorization program and premarket review) to ensure they are consistent
Linkage to FDA: Conformity Assessment
AIncomplete/missing clinically focused wireless conformity assessment tools that would facilitate safety and co-existence analysisPost-installation Surveillance ASpectrum management and identification, diagnosing, and resolving wireless co-existence/EMC problems that affect HIT and medical device performance (in healthcare facilities and mHealth environments)A = Ambiguous and B = Broken at the written law levelSlide11
Bigger Picture
Whether collectively the regulatory scheme in totality:Fails to address some particular safety risk
Is
too costly in relation to the risks it is designed to reduce
Is
demonstrably
too burdensome on innovation, apart from imposing costs
We agreed not to get into politics or philosophy but instead stick to evidence driven policy.Slide12
Gaps where attention needed
Item
Description of challenge
Reporting of safety
issues
The need to aggregate data across all three agencies to understand what the data are really telling us
A = Ambiguous and B = Broken at the written law levelSlide13
Next step
Wednesday call will be a deep dive into reporting and the prioritization of the ambiguities that need clarification