App-based diagnosis moves closer, but control is vital
Adrian Tombling, partner and patent attorney at Withers & Rogers, highlights the steps innovators can take to protect their ideas en route to market.
Artificial intelligence is already widely used to inform the diagnosis and treatment of a variety of health conditions and with app-based tools increasingly being used, concern is growing that they need to be closely controlled to ensure their safety and efficacy.
Among the latest examples of an app-based diagnostic tool is Google’s ‘dermatology assist tool’, which is designed for use by members of the public to identify conditions that might warrant clinical investigation. Large volumes of data have been processed, analysed and visualised in order to develop algorithms, which are capable of diagnosing a specific group of skin conditions. While such AI-based tools are not new in themselves, the development of diagnostic tools for patients is a key area of interest for medtech innovators.
As an assurance of its safety and efficacy, Google’s app has secured a CE marking. The requirements for obtaining a CE mark depend on a number of factors, including flagging a concerning condition, or providing a diagnosis. In this case, the app is being used to flag concerning conditions, which should then be explored by a clinician who will make a formal diagnosis. AI systems that are used to provide evidence-based clinical diagnosis would require a higher level of approval.
Many other AI-enabled diagnostic tools are used in a clinical setting, by patients at home, or both.
However, concerns have been raised recently by the MHRA, about whether the chatbot has been subjected to sufficient clinical testing. Recognising the important role that AI-enabled diagnostic tools can play in preventative medicine and facilitating personalised patient care, more products are coming to market all the time. However, the proliferation of tools entering the market is making it more difficult for regulators and consumers to evaluate their relative efficacy and safety.
To address this, the Government launched a new two-year delivery plan for the MHRA on 4th July 2021, with the aim of giving the health service ‘safe and speedy access to the most transformative products’. The plan includes evolving and strengthening the regulatory framework to ensure that AI-based medical technologies are underpinned by robust evidence, and to provide a more responsive safety surveillance and risk management system.
Having exited the EU, there is an opportunity for the UK to establish a world-leading regulatory approval system to expedite the market entry of new diagnostic technologies, while ensuring they meet the required standards of efficacy, quality and safety. Greater focus on control and risk management will be required to ensure these tools are fit for purpose and achieve the right balance between erroneously raising patient concerns (false positives) and optimising detection rates. In the future, an additional indication may be required to reassure consumers of the best available diagnostic tools to meet their needs.
For medtech innovators, there is still an opportunity to get ahead of the innovation curve by developing AI-based diagnostic solutions that are easy to use and support patient care. To commercialise their investment in bringing such tools to market, they should explore the possibility of securing patent protection for any algorithms developed, as well as the diagnostic methods employed. As most patent offices around the world regard medical applications as ‘technical’, software-based innovations are more likely to be eligible for patent protection as long as they deliver a diagnostic solution rather than simply fulfilling an administrative function, such as booking appointments.
The 20-year period of market exclusivity that accompanies patent protection is intended to reward innovators in the sector for their investment in developing innovative technologies that provide a benefit. However, in some instances, depending on the nature of the innovation, IP professionals may advise that the technology is kept as a ‘trade secret’ rather than pursuing a published patent application. While this approach brings more risk and should therefore be weighed up carefully, it could extend the period of commercial reward. Other forms of IP protection, such as copyright, trademark and design registrations should also be considered.
With more app-based diagnostic tools entering the market, it is clear that greater focus on control and risk management is needed. The Government’s focus on strengthening the regulator’s role is a welcome step forward, and innovators must provide robust evidence of the efficacy of their technology. Investing in this way deserves commercial reward and innovators should seek holistic IP advice en route to market.