The new article clarifies the exclusion requirements for the software products intended to be used for communication purposes, as well as for administration of healthcare facilities.
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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.The authority acknowledges that the advancement of telehealth technologies has facilitated the delivery of healthcare services through digital means.
This has been achieved by leveraging software that enables communication between patients and healthcare professionals. The effectiveness and categorization of such software are governed by specific exclusions that determine whether the software falls under regulatory oversight based on its intended use.
Communications Exclusion (14F)
According to the guidance, exclusion 14F pertains to software designed to facilitate communication for supporting the delivery of health services.
Specifically, this exclusion applies if the software:
- Is intended to enable communication, including the transmission of patient information, to support health services.
- Is not intended to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or recommend or decide on the treatment of any disease, condition, ailment, or defect.
Understanding whether software qualifies for Exclusion 14F involves addressing two primary questions:
- Is the software intended to enable communications, including transmitting patient information, to support health services?
- Does the software make any claims related to a disease, condition, ailment, or defect?
The key terms and definitions used in this respect include:
- Enable Communications: The software provides an electronic communication medium for transmitting patient information, which can range from SMS and emails to audio and video calls. This term specifically refers to human-to-human communication rather than device-to-device communication.
- Transmission of Patient Information: The software is designed to send and receive patient-related health information. This could include transmitting patient records between healthcare professionals or from patients to providers.
The primary role of the software under Exclusion 14F is to assist in delivering health services by transmitting patient information. This can include various telehealth services, such as sharing test results, providing diagnostic advice, or guiding emergency procedures.
However, the software itself must not engage in activities like diagnosing or making treatment decisions to qualify for the exclusion.
In order to illustrate the approach outlined hereabove, the guidance also provides certain examples of both excluded and not excluded products, such as:
- Excluded Example: A software tool purely for communication, such as sending an SMS with patient results or sharing a PDF file of health information, is excluded. The software is used solely for communication, even if a health professional uses it to diagnose or treat during the communication.
- Not Excluded Example: A telehealth feature that includes functionality beyond communication, such as measuring a patient’s limb movement for monitoring recovery, is not excluded. This software makes claims about a patient’s condition and involves monitoring or prognosis.
Administration and Management Exclusion (14G)
Exclusion 14G applies to software intended for administrative or management purposes within healthcare facilities. This includes various non-clinical functions essential for the efficient operation of health services.
In particular, exclusion 14G covers software that:
- Is intended to be used for the administration or management of health processes or facilities, including handling financial records, claims, billing, scheduling, operating theatre management, hospital bed management, and other similar functions.
- Is not intended to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or recommend or decide on the treatment of any disease, condition, ailment, or defect.
To determine if software falls under Exclusion 14G, the parties involved should consider the following questions:
- Is the software intended for the administration or management of health processes or facilities?
- Does the software make any claims related to a disease, condition, ailment, or defect?
The most important concept used in this respect is “Administration or Management of Health Processes or Facilities”: The software is used for tasks such as ordering medications, scheduling appointments, planning, and recording the administrative aspects of health processes or facilities. This exclusion specifically does not cover software intended for clinical patient use but includes vital non-clinical operations that support patient care.
The guidance also provides several examples, such as:
- Excluded Example: Software that manages Medicare claims for a GP practice. This software handles administrative tasks without engaging in clinical activities like diagnosis or treatment.
- Not Excluded Example: A software module that manages hospital admissions and screens patients for conditions. This software is intended for clinical use in screening and thus does not qualify for the exclusion.
Conclusion
In summary, exclusions 14F and 14G delineate the boundaries for software intended to support healthcare delivery and administrative functions without direct involvement in clinical decision-making or treatment. The present TGA guidance provides additional clarifications on categorizing and regulating software based on their intended use, ensuring that communication and administrative tools can efficiently support healthcare services while maintaining clarity on regulatory oversight for clinical functionalities.
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