Monday 24th July 2023

(9 months, 2 weeks ago)

Lords Chamber
Read Full debate Read Hansard Text Watch Debate Read Debate Ministerial Extracts
Lord Kakkar Portrait Lord Kakkar (CB)
- View Speech - Hansard - -

My Lords, it is a distinct pleasure to follow the noble Lord, Lord Browne of Ladyton, and to join other noble Lords in congratulating my noble friend Lord Ravensdale on the very thoughtful way in which he introduced this important debate. I declare my interests as chairman of King’s Health Partners, chairman of the King’s Fund and chairman of the Office for Strategic Coordination of Health Research.

There are few areas in national life, the conduct of government and the delivery of public services that will become as dependent on artificial intelligence as that of healthcare. It is that particular area to which I will confine my remarks. We all recognise that there are increasing demands on the delivery of healthcare services through a changing population demographic, a subsequent increased demand on clinical services and a substantial workforce shortage. Of course, with all that increasing demand, there will be the need either for the economy to grow at a substantial rate to be able to provide funding for those services or for us to adopt innovation to deliver those services. One of the important innovations is of course the application of artificial intelligence. We have seen that already in healthcare in the areas of diagnostics, imaging and pathology. It is helping us to deliver high-throughput analysis of scans of pathological samples, and, through the application of algorithms, it is helping us to determine better the risk of poor outcomes in patients, to improve diagnosis and therefore to improve the efficiency of our service.

However, there are also substantial challenges. The development of artificial intelligence modalities requires access to high-quality data, and in healthcare we know that data are fragmented across the system through the use of different methods for the collection and creation of them. As a result, unless we have a single approach to the collection of data, we run a substantial risk that the data used to develop and to train AI systems will be inaccurate, and, as a consequence, inaccuracy will be translated into the provision of clinical services. That will potentially drive discrimination in those services, whereby the data on underrepresented populations are not sufficiently incorporated into the development of such technologies and tools.

Successive Governments have had great difficulty in establishing the social licence that will allow for the broad collection and use of those data to drive research, technology and innovation opportunities in healthcare. The whole data area will be one of the most important regulatory challenges in the safe and effective development of AI technologies in healthcare. Does the Minister believe that His Majesty’s Government are at a place now where they can secure access to those data to drive these important opportunities? If not, how will they drive the data revolution in such a way that the public, more generally, are confident that those data will be used broadly for this purpose and other research and development purposes?

The MHRA in 2020 defined the regulatory pathway for the adoption of AI technologies as one very much mirroring those for medical devices. Clearly, some years have passed since that important approach to the regulation of AI was first established. The rigour with which the development of devices, or the regulatory supervision of the development of devices, is applied is slightly different to that for other therapeutic innovations. Is the Minister content that, in pursuing a pathway of regulatory development that is based on the device pathway—which is predominantly risk-based; that is reasonable—and looks at the safety and performance of these applications, there will be sufficient regulatory rigour to provide public confidence?

Regulatory elements of that pathway must not only include an understanding of the source of the data used to develop these technologies but provide a requirement for transparency in terms of an appropriate understanding of what forms the basis of the AI application. That is so that there can be a proper clinical understanding of the appropriateness of that application and of how it can be applied in the broader context of what must be understood about patients and their broader circumstances to reach an appropriate clinical decision.

Beyond that, there are also substantial concerns about ethical considerations in terms of both data privacy and the questions asked to train a clinical application being properly grounded in the modern ethics of healthcare delivery. Is the Minister content that the current regulatory pathway is sufficient and what steps are proposed by His Majesty’s Government to continue to develop these regulatory pathways so that they keep pace with the important advances and therefore benefits that will be derived from AI in healthcare?