Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated

The consultation Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated was open from 12 March 2024 to 6 May 2024. This consultation aimed to gather feedback on the appropriateness of current CDSS regulation including exemption criteria, definitions of CDSS, and whether the regulatory requirements were clear. The proposals outlined in the consultation included:

• introducing a definition for CDSS software to provide clarity on the scope of products included and remove any ambiguity
• amendment of the conditional exemption for CDSS software (Schedule 4 Item 2.15 in the Therapeutic Goods (Medical Devices) Regulations 2002) to deliver certainty regarding the application of the exemption and improve transparency for practitioners and professionals by providing oversight of the datasets, information, or evidence underpinning the outputs of the system
• improving guidance for stakeholders with clear interpretations, definitions, and examples to help them understand legislative obligations before and after supply.

Thirty-five responses were received from various stakeholder groups including industry, health professionals, and consumers. Additional targeted discussions were held with representatives from commonwealth, state, and territory government departments.

All proposals received majority support across all stakeholder groups, with some suggested modifications. Feedback from respondents across all stakeholder cohorts confirmed there is confusion about when the exemptions should be applied and health professionals requested greater transparency of how the CDSS outputs can be verified during clinical use.

Key areas of feedback in response to the consultation include:

1. Definition for CDSS software:

The TGA proposed the introduction of a legislative definition for CDSS products to be included in the Regulations to provide clarity on the scope of products included and remove any ambiguity.

Most respondents (60%) across all stakeholder cohorts including members of industry, consumers, and health professionals broadly agreed to introducing a definition to clarify which software systems meet the definition of a CDSS software-based medical device. Respondents who disagreed (40%), including members of the medical device industry, preferred that the definition be included in guidance materials, where more details and case study examples could be provided.

Some respondents suggested minor amendments to the wording of the definition to improve clarity and mitigate concerns.

2. Amendment to the condition of CDSS software exemption in the Regulations:

The TGA proposed that the exemption criteria for certain low-risk CDSS products should be amended to provide clarity regarding the scope of excluded CDSS software functionality. In particular, the TGA wished to clarify the eligibility of software intended for in vitro diagnostic (IVD) and data compression or decompression purposes. Additionally, the TGA intended to clarify the importance of transparency in ensuring health care practitioner oversight of datasets, information, evidence, and review of outputs as key risk mitigation factors for exempt CDSS software. As such, the TGA proposed that exempt software display the details of clinical practice guidelines, calculations, or logic used by the CDSS software to the health professional to enable verification in a manner realistically performed in the intended clinical context.

The majority of all respondents (63%) voted in favour of the proposed amendments. Respondents from across all stakeholder cohorts expressed that certain terms in the exemption criteria need further clarification through guidance including ‘diagnosis’, ‘screening’, ‘triage’, ‘sole purpose’, ‘IVD’, ‘compress’, ‘decompress’, and ‘realistically’. Respondents also requested further clarification regarding the distinction between ‘providing’ and ‘supporting’ clinical decisions.

Respondents requested clarification around the level of technical detail required to be disclosed to the end user in order to meet the exemption criteria, regardless of whether they agreed or disagreed with the proposal.

Responses that indicated disagreement with the proposals stated:

• it would not be feasible to display the level of detail required for clinical validation
• displaying the level of detail required would be difficult to contain within the user interface and would therefore likely negatively impact the usability of CDSS products
• the information would be too technical to be of value to clinicians
• displaying the information could expose proprietary information resulting in the risk of plagiarism or misuse of data.

3. Improvement of guidance, resources, education, and communication:

Sponsors and manufacturers rely on the TGA’s general guidance on exempt CDSS software to provide detailed interpretations and definitions relating to their products. The consultation paper sought feedback on any opportunities to improve guidance materials.

The TGA received feedback that stakeholders believe a general review of the TGA website is required to improve accessibility to existing content and to identify where additional guidance is needed in relation to the exemption and software as a medical device more broadly. These respondents requested that the TGA:

• publish additional diverse examples and case studies
• use plain language, reduce jargon, and provide definitions
• develop and publish flow charts and decision trees
• streamline guidance materials into a central ‘software hub’
• frequently review and update guidance.

In addition, respondents requested specific guidance regarding:

• electronic medical records and clinical information systems
• AI and machine learning
• AI transcribing technology and AI-driven analyses for non-diagnostic purposes
• further guidance on the application of the conditions of exemption for certain low-risk CDSS products under Schedule 4 Item 2.15 of the Regulations.

The TGA will use feedback from this consultation to inform any future proposed amendments to CDSS regulation. Additionally, the TGA will improve and expand existing guidance materials to help stakeholders understand and comply with their regulatory obligations in this area.