The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has initiated a public consultation on the risk classification of standalone medical mobile applications (SaMD) and qualification of clinical decision support software.
The appropriate draft guidance was published by the authority in July 2021. The regulatory approach described in the document is based on the Framework for Software as a Medical Device developed by the International Medical Device Regulators Forum, a voluntary association of national regulating authorities collaborating for further development of medical device regulations.
First, the guidance provides the definition of a standalone mobile application, which is a software and/or mobile application that is intended to function by itself and is not intended for use to control or affect the operation of other hardware medical devices. The authority also mentions that the term is interchangeable with the Software as Medical Device (SaMD).
Risk Classification: Regulatory Background
The HSA guidance further describes the main principles of the risk-based classification to be applied with regard to SaMDs. The factors to be considered when determining a class of the product should include the following:
- The significance of information provided by the standalone mobile application to healthcare decision (such information could be used for various purposes associated with different risks, so the purpose should be taken into consideration by the medical device manufacturer);
- The state of the patient’s healthcare situation or condition (it could be critical, serious, or non-serious);
- Existing GN-13 Guidance on Risk Classification of Medical Devices that describes the current regulatory approach to risk-based classification of medical devices applied in the country.
In order to assist medical device manufacturers in applying the appropriate classification rules, the authority further provides additional clarifications regarding the main concepts used in the context of risk-based classification for SaMD. For instance, the document describes in detail how the information provided by the software in question could be used. As mentioned, how it should be used and the impact it could potentially cause should be considered when determining the class of the software product. According to the guidance, the main concepts are:
Drive clinical/patient management – in such cases, the software would be used to diagnose and identify the disease, or in the course of treatment, for instance, to provide additional information necessary to ensure the safety and correct performance of medicines or medical devices, to predict the risk of disease, or to identify the signs of disease.
Inform clinical/patient management – the software could also be used to provide information about the treatment options available or to aggregate information deriving from various sources.
Critical situation or condition stands for the situation when timely intervention is necessary to prevent negative consequences, such as serious health deterioration. Usually, software intended to be used in such situations should be used by healthcare professionals having the necessary qualifications and knowledge.
For instance, this applies if the condition is:
- Life-threatening state of health, including incurable states,
- Requires major therapeutic interventions,
- Sometimes time-critical, depending on the progression of the disease or condition that could affect the user’s ability to reflect on the output information.
Serious situation or condition stands for the situation when information about the condition is necessary to avoid inappropriate treatment. The software intended to be used in such situations could be used not only by healthcare professionals but by laypersons as well. It could also be intended to be used for the general population and not groups that are especially fragile to the condition in question.
Such condition is usually:
- Moderate in progression, often curable,
- Does not require major therapeutic interventions,
- Intervention is normally not expected to be time-critical in order to avoid long-term disability or other serious deterioration of health, whereby providing the user an ability to detect erroneous recommendations.
Non-Serious situation or conditions is the one for which information plays an important role to ensure the safety of patient but is not critical in terms of patient’s health. The software intended to be used for such situations is usually applicable to a wide range of people and could be used by both healthcare professionals and laypersons.
Such a state is usually:
- May not be curable, can be managed effectively,
- Requires only minor therapeutic interventions, and
- Interventions are normally noninvasive in nature, providing the user the ability to detect erroneous recommendations.
The present HSA guidance also contains a table describing how the aforementioned classification rules should be applied to standalone mobile applications that are not in vitro diagnostic medical devices. The suggested classification is based on the evaluation of two main criteria:
- State of healthcare situation or condition (Critical, Serious, or Non-serious); and
- Significance of information provided by the software in the context of the decision-making process (Treat or diagnose, Drive clinical/patient management, or Inform clinical/patient management).
In the case of in vitro diagnostic standalone mobile applications, the manufacturer (developer) shall consider the recommendations provided in the aforementioned guidance GN-14.
The present HSA guidance also provides several examples of software products and describes how the classification principles described above should be applied in these situations.
For instance, if the software in question is intended to be used by healthcare professionals to detect early signals of a non-serious disease by continuously monitoring signals deriving from medical devices, the classification of such software should be based on the following points:
- Significance of information – the information is used to drive clinical management;
- State of healthcare situation or conditions – monitoring of a disease that could be cured effectively using the methods available.
According to the current risk-based classification, such software should be assigned to Class B. It is stated that SaMD will be classified as Class B if intended to image, measure or monitor a physiological process to drive in clinical/patient management.
If the software subject to review is intended to be used to analyze electrocardiograms in the context of diagnosing heart arrhythmias and should be used only by healthcare professionals having the necessary qualification and knowledge, such software should be assigned to Class B as well since due to the nature of the condition subject to monitoring a timely intervention is not required. As in the previous example, the software is used to drive clinical management.
In summary, the present HSA guidance describes the approach to be applied when determining the class of a standalone mobile application under the country’s risk-based classification. The document outlines the applicable classification criteria and highlights the most important aspects to be considered by the medical device manufacturer with regard to the intended use of the device, including conditions it should bed used in and its intended purpose.
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