What is a CDSS? A Clinical Decision Support System
Clinical decision support (CDS) is a process that “provides clinicians, staff, patients, or other individuals with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care” (Osheroff et al. 2007 ).
A CDS system (CDSS) is the information technology that assists CDS.
The key in the definition provided above is that such support provides “knowledge” or “information”. We refer this key concept to the DIKW model.
It is clear that information comes from the aggregation of data, and knowledge comes from the interpretation of information. A Computerized Physician Order Entry (CPOE) which mainly stores and displays the raw patient information is therefore not a CDSS unless it provides items more than data.
In fact, a CPOE is legally recognized as not a medical device by FDA regulation with FD&C Act Section (o)(1)(C).
The five right things a CDS system offers
A CDS system does not necessarily do the decision making. Rather, they enable the decision makers (physicians, pharmacists, patients, etc.) to make more informed choices.
An ideal CDS system provides five rights in the healthcare workflow — it provides ”the right information, to the right person, in the rights format, through the right channel, at the right point in workflow to improve health and healthcare decisions and outcomes.” (Osheroff et al. 2004).
Three basic varieties of CDSS
CDSS comes mainly in three forms.
- Infobuttons
Infobuttons retrive online evidence (documents, etc.) and provide the information to the user. - Recommendations for direct action
Patient-specific or situation-specific alerts/reminders are fired for the users to execute specific interventions. - Aggregated information support
A CDSS may organize and present information to faciliate problem solving. Related techniques include dashboards, documentation templates, and order sets.
So, is CDSS a medical product? It could be!
CDSS can be a product, and even a medical device. First of all, a CDSS is a software (as it is information technology); it is regulated under the category of “Software as a Medical Device (SaMD)” by FDA law. Intuitively, an SaMD is a software that provides functions including diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions. (as it is for medical devices in general)
FDA with the International Medical Device Regulators Forum (IMDRF) further define CDSS as Device CDS and Non-Device CDS (Note: FDA uses CDS to represent clinical decision support systems) with the following two questions:
- Is the Intended User an HCP (health care providers)?
It is important to recognize that only when users are HCP could a CDSS be a Non-Device CDS - Can the User Independently Review the Basis?
If the user is able to independently review the basis, then it will not be classified as a Device CDS for it violets the definition of an SaMD.
After a CDSS is determined as an SaMD, the assignment of its risk level is judged by the below table.
For detailed explanation about CDSS and SaMD regulations, please refer to this Draft Guideance: Clinical Decision Support Software. Draft Guidance for Industry and Food and Drug Administration Staff
A growing market of CDSS
Here is a list of recently FDA-approved A.I.-based algorithms provided by The Medical Futuris.
This article is inspired by Biomedical Informatics: Computer Applications in Health Care and Biomedicine (4th Edition).
