The Therapeutic Goods Administration (TGA) has announced that it is cracking down on regulatory compliance issues in relation to digital scribes which are deemed to be 'medical devices'.
What are digital scribes?
Digital scribes use artificial intelligence to collect conversations. They are increasingly used in all workplaces including clinical settings and in interactions between healthcare practitioners and patients.
Any instrument or software will be deemed to be a 'medical device' under the Therapeutic Goods Act 1989 (Cth) (the Act) if it is used for a therapeutic purpose, even if that is not its primary purpose.
Specifically digital scribes will be considered medical devices if they:
- provide a diagnosis or recommend a treatment for a disease, injury or disability not explicitly suggested by the health practitioner,
- investigate the anatomy or a physiological process,
- control or support conception, or
- examine specimens derived from the human body for a medical purpose.
If any of these criteria are met digital scribes must be included in the Australian Register of Therapeutic Goods (ARTG) and satisfy other regulatory requirements.
Digital scribes limited to transcribing or translating clinical conversations as opposed to analysing or interpreting patient information are unlikely to be considered medical devices for the purposes of the Act. However, with rapidly evolving technology there is potential for lines to be blurred.
How will digital scribes affect product manufacturers and suppliers?
Product suppliers need to be aware that a digital scribe, even if not necessarily developed for clinical use, may by virtue of its use be a medical device. Substantial penalties apply for supply of a medical device which is not listed on the ARTG and the TGA has flagged a clear intention to take enforcement action in the event of breaches. Suppliers of products not traditionally considered to be in the healthcare area will need to carefully consider whether their products are or have evolved to be medical devices.
How does this affect health practitioners?
Prior to implementing a digital scribe in the clinical setting, healthcare practitioners should consider whether the device is being used for a therapeutic purpose and, if so, whether it has been listed on the ARTG. Either way healthcare practitioners should assess whether appropriate privacy safeguards have been implemented to protect patient data recorded. Importantly, it remains the healthcare practitioner’s responsibility to ensure the accuracy of patient records. Healthcare practitioners should also obtain informed consent from patients prior to using any digital scribe.
