- The Clinical Decision Support (CDS) Coalition recently requested public comment on its voluntary guidelines for software developers designing clinical decision support (CDS) systems.
The CDS Coalition — including software developers, hospitals, and medical device developers — crafted the guidelines to focus on ensuring CDS is user-centric and puts clinicians in charge of decision-making as much as possible.
Additionally, the guidelines were designed to prevent FDA regulation over CDS software in accordance with the 21st Century Cures Act of 2016.
“These guidelines are intended not to dip below the requirements of the new law, but may well at times exceed those requirements,” the coalition states. “Software that does not meet these guidelines necessarily relies more on the proper functioning of the software over the judgment of the healthcare professional, and therefore may require a higher level of validation and potentially FDA oversight.”
The guidelines pose two overarching questions CDS software developers should consider when designing clinical decision support systems:
- Are healthcare professional users able to independently review the basis of the recommendations the software makes?
- Under the intended circumstances of use, will healthcare professional users not need to rely primarily on the software?
While CDS software is useful in promoting well-informed decisions at the point of care, the technology is by no means intended to take the reins away from clinicians.
According to the guidelines, allowing clinicians to independently review clinical decision support recommendations first requires transparency.
Healthcare providers must be able to use provided information to trace back the clinical basis for CDS recommendations. CDS software developers should ensure clinicians have an idea of what information the software is responsible for providing and what clinicians themselves must decide on their own.
“It is important in this regard that the labeling for the software communicate to the user the limits of the software’s functionalities,” coalition members write.
Additionally, the guidelines advise software developers to provide clinicians with information about the source of CDS recommendations, providing insight into how specific patient information is analyzed.
If a decision guided by a software recommendation could lead to patient harm, software developers should also provide clinicians with an indication of the reliability of the recommendation as well as the clinical rationale and explanation for the recommendations themselves.
In addition to transparency, the guidelines emphasize the importance of competent human intervention.
“The education and experience required to be competent depends on the nature of the decision,” write members. “A nurse, a primary care physician, and a specialist are each competent to make different types of decisions, as are pharmacists, home health aides and other health professionals and care-givers.”
According to the guidelines, clinical decision support should not serve to amplify the competency of an unqualified individual in administering care. Instead, CDS should assist nurses and clinicians in applying existing knowledge for delivering the best possible patient care for a given situation.
“It is important to note that it may be prudent for decision-makers to also consider data outside of what the CDS has collected,” notes the document. “Competent decision-makers will recognize that need and incorporate such information into their decision making process.”
Finally, the guidelines advise CDS software give clinicians a sufficient amount of time to reflect on software output before making a decision when delivering care.
“The amount of time available to reflect will depend on the acuity of the condition, and how much time can lapse before the patient receives medical care without risk,” the document states. “The amount of time needed to reflect may also depend on the complexity of the decision.”
Without sufficient time to reflect on proposed recommendations, clinicians may not be able to independently review the source and rationale of the information presented.
After ensuring clinicians and nurses have the opportunity and means to independently review CDS recommendations, software developers should take into account the likelihood the user has other sources of clinical information at their disposal to aid in diagnostic and treatment decisions.
With these guidelines in mind, the CDS Coalition intends to allow software developers to avoid additional regulations imposed by the FDA by putting the power of clinical decision making primarily in the hands of providers.
The coalition intends to revise the guidelines after closing the period for public comment on July 1, 2017 and submit the revised version to the FDA for feedback.