“For CDS [clinical decision support] software that FDA [United States of America Food & Drug Administration] does not regulate, industry is best served by self-regulating through adopting basic software design guidelines. To that end, these guidelines are intended to foster the design of software in such a manner that healthcare professional users will be able to independently review the basis for the recommendations the CDS software produces, such that the professionals will not need to rely primarily on the recommendations. The purpose of these guidelines is to provide a unified approach that CDS software developers can employ to ensure they are providing at least a basic level of transparency and the opportunity to review the basis of the recommendations made.
At their core, these guidelines are intended to give software developers a framework for
discerning whether additional validation – beyond that which they would ordinarily do – is required as a consequence of the software taking over decision-making from healthcare professionals. These guidelines reflect the view that taking over, in any substantial way, the healthcare decision-making carries with it heightened responsibility for validation. The new subparagraph 520(o)(1)(E) [of the December 2016 U.S. “21st Century Cures Act”] on CDS software addresses that same topic. As a statute, it establishes the minimum design elements necessary to avoid FDA regulation. These industry guidelines are not an attempt to simply apply that legislation, but rather establish voluntary industry guidelines for accomplishing those same objectives and more. In the development of these guidelines, the statute was relevant in the sense that the Coalition wanted to establish guidelines that, if met, would assure that the software is not regulated by FDA. At the same time, the Coalition wanted to go beyond merely repeating the statute. Instead, the Coalition sought to identify guidelines that would more broadly assure some consistency in approach by software developers with regard to design features intended to assure the central role of healthcare professionals in clinical decision-making. The Coalition believes that leaving the healthcare professional in control helps to ensure the appropriateness of the clinical decision-making. Software that does not meet these guidelines can be quite safe and effective, but may require additional validation because of the risk that such software will supplant the judgement of healthcare professionals.
As already noted, FDA will regulate high risk CDS software where, among other things, (1) the user does not have a reasonable opportunity to review the basis of a recommendation and (2) the software performs important functions where, should the software not work as intended, someone could get seriously hurt. Further, in our judgment, low risk CDS software where the risk of injury is low regardless of whether there is reasonable opportunity to review the basis for the recommendation need not be burdened by these guidelines. Instead, these guidelines focus on what we call “medium risk clinical decision support” software or ‘MR-CDS.’ MR-CDS is software that:
- Uses patient-specific information and organized clinical knowledge;
- Performs some analysis using that information and knowledge (rather than simply
displaying or transmitting the information);
- Produces a particular actionable recommendation (with or without additional
recommendations) for the diagnosis, treatment or management of a disease or condition for a particular patient; and
- Is not an accessory to a medical device.
That last point is important in distinguishing MR-CDS software from software that is used in conjunction with a specific medical device to analyze the output of that device. MR-CDS software may well be incorporated into an electronic health record, for example, but so long as it is not an accessory to a medical device, it would fall within the scope of these guidelines.”
The preceding excerpts from the August 30, 2017, Clinical Decision Support Coalition’s white paper entitled “Voluntary Industry Guidelines for the Design of Medium Risk Clinical Decision Support Software to Assure the Central Role of Healthcare Professionals in Clinical Decision-Making” (http://bit.ly/2wed3lF) are an apt characterization of any information technology (IT) solution compliant with the Cloud Healthcare Appliance Real-Time Solution as a Service reference architecture (CHARTSaaS RA). Such an IT solution would enable healthcare provider subject matter experts (SMEs) to create IT applications a.k.a. “apps” with minimal operating expense (no capital costs required) and IT complexity (little/no provider IT system or staff impact); and it would meet the following three Coalition criteria for healthcare professional user independent review of the basis for a medium risk clinical decision support software recommendation:
- Transparency: Does the software provide enough information for the user to understand and be able to evaluate the clinical basis for the software recommendation?
- Competent Human Intervention: Is the intended user competent — through training, experience or otherwise — to make the clinical decision in question without the MR-CDS software?
- Sufficient Time to Reflect: Based on the intended use, is the user expected to have enough time to reflect on the software output before making a decision?
CHARTSaaS-built apps would operate as systems of engagement with professional providers and their patients to leverage the on-premise legacy systems of record referred to as electronic health record (EHR) or hospital information systems (HIS) using secure intelligent interoperability. Furthermore, they would meet the MR-CDS criteria to the extent that the prospective healthcare provider SME users design them to do so. And all of these capabilities would be facilitated by the fact that a CHARTSaaS RA compliant IT solution is a cloud-based solution as a service, designed for use in a hybrid cloud environment.
Please validate these CHARTSaaS RA-related propositions to your own satisfaction by reading the white paper at http://bit.ly/2vmK1Rx, viewing the tutorials posted on YouTube (http://bit.ly/2sVajvS and https://www.youtube.com/watch?v=f5OtbCCDNLs) and also by reviewing the details of CHARTSaaS™ and the CHARTSaaS RA™ in these presentations:
Healthcare providers will benefit significantly from appreciating and then applying a CHARTSaaS RA-compliant IT solution. To do so will mitigate medical mistakes (currently the third leading cause of patient deaths. per Makaray and Daniel (http://bit.ly/1rtW6Sa); thereby minimizing patient adverse events and optimizing clinical case outcomes while maximizing the cost-effectiveness of care and treatment, and also accelerating the accrual and facilitating the application of medical knowledge.