The Health Sciences Authority, Singapore’s agency in the sphere of medical devices, announced public consultations on the risk classification of Standalone Medical Mobile Applications (SaMD) and qualification of Clinical Decision Support Software (CDSS). The present article is dedicated to the part of the guidance describing the existing regulatory framework for CDSS, which in certain cases is subject to regulation as medical devices.
The authority additionally emphasizes that the guidance is intended to provide additional clarifications regarding the current regulatory requirements and does not introduce new rules or obligations for the parties involved.
According to the guidance, Clinical Decision Support Software stands for standalone software (including mobile applications, cloud-based and web-based software) that can perform a wide range of functions for health professionals, patients and caregivers to support clinical practice, clinical and patient management. As mentioned, some examples of CDSS should not be treated as medical devices, so the present guidance provides additional clarifications on the approach to be applied in order to make such determination, as well as on the applicable risk-based classification such products are subject to.
The aforementioned determination of the regulatory status of CDSS should be based on the intended use of the product specified by its manufacturer (developer) and also on the way the product is marketed. Should the intended use fall within the scope of the definition of a medical device provided in the First Schedule of Health Products Act (HPA), such a product should be regulated as a medical device. For instance, CDSS intended for medical purposes such as investigation, detection, diagnosis, prevention, monitoring, treatment, or management of any medical condition, disease, anatomy or physiological process are subject to regulation as medical devices. At the same time, the product should not be considered a medical device if its intended use falls outside the scope of the definition of a medical device or such product is intended solely to display various medical information (except real-time patient data).
The document further describes how CDSS should be classified under the current risk-based classification for medical devices.
According to the guidance, a clinical decision support software should be assigned to Class A if it meets any and all criteria listed below:
- It is intended to analyze medical information;
- It is not intended to process data collected from another medical device;
- Its intended use is limited to providing support in making clinical decisions;
- It is not intended to substitute the respective decisions taken by a qualified healthcare professional but rather to allow the latter to review the basis for recommendations provided by the software.
In order to assist medical device manufacturers (software developers) in applying the rules described above the HSA also provides the following flowchart.
As stated, if the only purpose of the software is to display medical information or to print it, or the software in question falls outside the scope of the definition of a medical device as prescribed by the current legislation, such software should not be regulated as a medical device. The reason is that such software is not intended to analyze patient-specific information and provide recommendations for particular cases.
Examples of such software include:
- Patient appointment and surgery schedule management software;
- Software intended for patient billing purposes;
- Calculator software for clinicians to perform simple medical calculations;
- Laboratory Information Management System (LIMS) or Laboratory Information System (LIS) to support a laboratory work flow and data tracking;
- Software incorporating a digitized clinical decision flow with no analysis performed on patient information.
Hence, software excluded from regulation under the medical devices’ framework is not intended to provide patient-specific recommendations with regard to clinical decisions to be taken. Software of this type is usually intended for general administrative purposes and provides ancillary functions supporting the operations of healthcare facilities even if it processes (but not analyses) the data and information deriving from patients.
At the same time, software qualified as a Class A medical device is usually intended to analyze patient-related data and information. However, it neither analyzes images nor intervenes directly in the operations of medical devices, while healthcare professionals still have a possibility to independently verify the recommendation through available clinical guidelines.
Examples of Class A CDSS include the following:
- Software intended for healthcare professionals to analyze a patient’s symptoms and test results against accepted clinical guidelines to recommend specific diagnostic tests or therapy;
- Software intended for healthcare professionals to analyze a patient’s test results to recommend the most appropriate surgical action and describes a surgical workflow based on accepted clinical guidelines.
Hence, according to the examples provided, clinical decision support software subject to regulation under the medical devices’ framework is intended to process data and information deriving from patients and contribute to the clinical decision-making process by providing recommendations to healthcare professionals. At the same time, the authority additionally emphasizes that the latter should be able to access the underlying information such recommendations are based on in order to be able to verify the accuracy and relevance of recommendations provided by the software.
Additional Classification Rules
Should the software fail to meet the classification criteria for Class A CDSS described above, such software should be subject to classification under additional classification rules, which are also described in the present HSA guidance. Software that is subject to special classification rules includes those intended to analyze images deriving from medical devices or impact the operations of devices. This category also includes software products providing healthcare professionals with the final result (recommendation) without a possibility to access the underlying data in order to verify the recommendation made by the software. Such products usually include software utilizing pre-defined algorithms or Artificial Intelligence (AI).
The examples of clinical decision support software to be assigned to Class B include:
- Software intended for healthcare professionals to analyze a patient’s images to annotate anatomical features for therapy or surgical removal;
- Software intended for healthcare professionals to analyze genotyping data to provide personalized drug combinations and dosage recommendations for the management of transplant patients.
In summary, the present draft guidance published by the HSA addresses the most important aspects related to clinical decision support software and how it should be regulated under the existing framework. The document describes the approach to be applied by software developers for determining the regulatory status of their products and also provides clarifications on the current risk-based classification to be applied for the products that are considered medical devices due to their intended use and functions.
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