The new article provides additional clarifications regarding the regulatory approach to be followed with respect to the tools intended to be used for the digitalization of paper-based records used in the healthcare sphere.
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The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the interpretation of software exclusion criteria. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Overview of Exclusion 14L
According to the guidance, Exclusion 14L pertains to software designed as calculators that utilize authoritative clinical sources or display calculation logic to allow user validation. This type of software is excluded from being classified as a medical device under the existing TGA regulations, provided it is not intended to control the administration of calculated dosages.
The exclusion specifically addresses software that makes calculations based on established clinical standards or allows users to verify the calculations, ensuring transparency and accuracy in the software’s function.
Understanding the Role of Calculation Software
As explained by the TGA, calculation software in a healthcare context refers to digital tools that perform numerical calculations related to patient care, often replacing manual or paper-based methods. These calculators are essential in various clinical scenarios, such as determining medication dosages based on patient-specific factors like age or weight.
The key factor in whether such software is excluded from TGA regulation depends on its reliance on published clinical standards, its ability to display calculation steps, and its role in administering dosages.
Key Questions for Classification of Calculation Software
In order to determine if calculation software qualifies for Exclusion 14L, the following questions must be considered:
- Is the software a calculator? The software must function as a digital numerical calculator, performing calculations that would typically be done manually or using traditional tools.
- Does the software use relevant published clinical standards or authoritative sources to make calculations? The software must base its calculations on recognized clinical standards or authoritative sources, ensuring that the methodology is consistent with established medical practices.
- Does the software display calculations and outputs in a manner that can be validated by the user? For the software to be excluded, it must allow users to see the logic behind the calculations, providing transparency that enables users to validate the results.
- Does the software control the administration of a calculated dosage? If the software controls how a calculated dosage is administered, whether automatically or manually, it is considered a medical device and does not qualify for exclusion.
Terms and Definitions
In order to assist the parties involved with interpreting the relevant provisions of the applicable legislation and following the rules and requirements set forth therein, the document also provides definitions of the key terms and concepts used in this respect including, inter alia, the term “calculator”. In the context of Exclusion 14L, a calculator refers to software that performs digital numerical calculations.
Examples include digitized versions of dose calculators or smartphone apps linked to health-related systems. The exclusion applies only to software with purely numerical functions; if the software includes other functionalities, such as decision trees or rules-based logic, these must be evaluated separately to determine if they fall under medical device regulations.
Relevant Published Clinical Standards or Authoritative Sources
For software to be excluded, its calculations must be based on formulas or guidelines recognized in the medical community. These could include widely used formulas like the Parkland formula or dosage calculations based on information published in a medicine’s product information (PI).
The use of these authoritative sources ensures that the software’s calculations align with standard clinical practices.
Displaying Calculations for User Validation
According to the guidance, a crucial aspect of Exclusion 14L is the transparency of the calculation process. If the software allows users to see or step through the logic of a calculation (e.g., “patient weight x 100mg”), it qualifies for exclusion.
This transparency allows users to verify the accuracy of the results. However, if the calculations are too complex to be displayed in an understandable manner, or if the logic is not based on a published clinical standard, the software does not qualify for exclusion.
Controlling the Administration of a Calculated Dosage
The exclusion does not apply if the software does more than just calculate and display information. If it also controls the administration of the calculated dosage, such as by determining the schedule, volume, or frequency of medication delivery, the software is classified as a medical device.
This control can be automatic, as in the case of software managing a medication pump, or manual, where the software provides instructions to the user.
Excluded and Non-Excluded Examples
The document also provides a few examples demonstrating the applicable regulatory approach.
Non-Excluded Example: Intravenous Device Software
Software integrated into an intravenous device administering chemotherapy medication, which calculates the volume and frequency of each dose, does not qualify for exclusion. This software directly controls the administration of the calculated dosage, making it a medical device subject to TGA regulation.
Excluded Example: Smartphone App for Pediatric Medication Dosage
A smartphone app that calculates the dosage of children’s pain medication based on age and weight, using a formula provided on the medication’s labeling, is excluded from TGA regulation. The app uses authoritative information from the medicine’s approved labeling and displays both the formula and calculation results, allowing the user to verify the accuracy. As the software does not control the administration of the dosage, it qualifies for the exclusion under 14L.
Conclusion
In summary, Exclusion 14L under TGA regulations provides specific criteria for determining whether calculation software can be classified as a medical device. To qualify for the exclusion, the software must function as a digital calculator, utilize published clinical standards or authoritative sources for its calculations, and display the calculation process in a way that allows user validation. However, if the software goes beyond providing information and also controls the administration of a calculated dosage, it is considered a medical device and does not qualify for exclusion. This framework ensures that only software with a limited, well-defined role in healthcare calculations is excluded from the more stringent regulations applied to medical devices.
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