SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is regulated under the existing medical device framework, however a reform is required to keep up with the latest technological advances. Since the emergence of mobile medical applications and patients being able to manage their own health data through these applications on their smartphones, there is a requirement for stricter control on how this data is used to make clinical decisions and how these apps are downloaded and used by the patient. Appropriate classification of this software is required to ensure the highest level of safety for patients.
Under the current framework, software is regulated as a medical device if it meets the definition in section 41BD of the Therapeutic Goods Act 1989, which states that a medical device is:
“Any instruments, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
- investigation, replacement or modification of the anatomy or a physiological process,
- control of conception,
and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means.”
Examples of software that meet this definition and are therefore regulated as medical devices include:
- Smart phone applications that calculate insulin doses based on a patient’s blood glucose level
- X-ray image-processing software
- Software that includes an algorithm to make a clinical diagnosis
Software that monitors lifestyle such as a step counter or appointment schedules are not considered to be a medical device because the data generated is not used for clinical benefits.
The majority of SaMD are developed by software developers who are new to the regulated medical device industry. Developers should consider the intended use of the software and what is stated on labelling claims. If the software is used to “Monitor”, “Detect”, “Calculate”, “Diagnose”, “Alarm”, “Analyse”, “Interpret”, “Prevent”, “Control” – then the software will be considered a medical device as it will be acting on the data generated to provide a clinical benefit.
The current medical device regulations as they stand may be inhibiting major advances in innovation when it comes to software. The regulations need to be updated to encourage innovative medical devices reaching the market.
SaMD: What are the proposed regulatory changes?
Under the current regulations, the majority of SaMD are considered a Class I device and do not consider standalone software. SaMD which includes an algorithm that can monitor, detect, diagnose and make clinical decisions should be considered a higher risk to patients. New classification rules should classify SaMD products according to the potential harm they could cause to patients.
Examples of the different classification of software with an appropriate level of detail should be provided as guidance for SaMD developers.
The new regulations could have significant impact for SaMD already on the market especially if re-classification is required.
The current requirements that medical devices must comply with to demonstrate safety and performance do not explicitly mention software. This has created uncertainty as to which requirements apply to SaMD. The Essential Principles need to be updated to clarify those which apply to SaMD in order to encourage these innovative medical device solutions reaching the market.
The new regulation would require increased cyber security controls, features, capabilities and risks of the computing platform, software designed using best practice software engineering principles, appropriate alarm features, information of updates to the use.
Australian Register of Therapeutic Goods (ARTG)
Under the current regulations, SaMD products can be imported into Australia without being included in the ARTG by an Australian sponsor or can be imported using the Personal Importation provision exemption. This is a big gap in the current regulations as there is no TGA oversight, ongoing monitoring of the safety, quality and performance of the software or any post-market surveillance regarding recalls. The new regulation would require SaMD to be included in the ARTG with the requirement of having an Australian sponsor and removing SaMD from the Personal Importation provision.
The new regulation would require overseas developers to have an Australian sponsor so there can be TGA oversight of the product(s) being used in Australia.
TGA to align to International Best Practices
The TGA will align the new medical device reform with current industry best practices as set out by the International Medical Device Regulators Forum (IMDRF) and the new EU Medical Device Regulation.
The IMDRF guidelines for risk categorisation of SaMD consider the following:
- The significance of the information provided by the SaMD to the healthcare decision.
- The context in which the information will be used.
- The state of the healthcare situation or condition.
The new EU Medical Device Regulations 2017/745 has included a new rule for Software (Rule 11):
Software that provides information to be used in making decisions for diagnosis or treatment is:
- Class III if the decisions have an impact that may cause death or an irreversible deterioration of a person’s state of health
- Class IIb if the decisions have an impact that may cause a serious deterioration of a person’s state of health or a surgical intervention
- Class IIa in any other case
All other software is considered Class I.
If you have any questions regarding SaMD, please contact PharmOut for more guidance.