I’ve always had a keen interest in all things digital. It probably started from when I bought my first computer in 1981 (albeit a 1K ZX81) whilst still at primary school. My coding as child on that first machine did not get much better than
10 PRINT “Mark is Cool”
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but, it gave me a lifelong interest in technology.
It’s been just over a year since I moved from heading the Inspectorate to taking a role in the Devices Division at MHRA, and in that time I have been responsible for leading two groups. One focussed on the safety and surveillance of medical devices and the other team focussed on software and apps, which has allowed me to continue my interest in this rapidly evolving area within healthcare.
This post is a look at some of the exciting pieces of work that I have been involved within the digital space over the last year and then a look at how the Inspectorate is evolving to support the growth of digital within the pharmaceutical industry, including developments associated with the 4th industrial revolution and what has been labelled "Pharma 4.0".
MHRA work on digital health
This work can be largely broken down in to three key areas
- Cross Government work on Artificial Intelligence (AI)
- Cross healthcare landscape work on digital and AI, including MHRA using this technology to support its regulatory role across medicines and medical devices, and regulate this technology where it is a medical device.
- Internal MHRA work - here focussing upon work undertaken by the Inspectorate
Cross Government work on Artificial Intelligence
Over the last year I have been afforded the opportunity to be involved with numerous cross Government working groups on Innovation and Artificial Intelligence. The attendance at these meetings is broad and diverse, with representation including: ICO - Information Commissioners Office, The Office for AI, CDEI - Centre for Data Ethics and Innovation, BEIS - Department for Business, Energy & Industrial Strategy; and then a wide spectrum of other Government departments including those covering education, gambling, the environment, banking, and healthcare to name a few. This has given me and the MHRA a far wider view of the issues associated with using AI - whether that be to regulate its use or to support regulatory frameworks. One really useful piece of work that has been discussed at length is the ICO work on Project explAIn which I thoroughly recommend a read of.
Cross healthcare landscape work on digital and AI
Across the healthcare system MHRA has been very much plugged in to the exciting changes that are developing with the creating of NHSX and what technology can do for primary care, in particular with the recent announcement of an investment of £250m associated with the creation of an AI lab.
Many of the current developments in this space are medical devices so MHRA participation in further developing the system is key. MHRA guidance from the Devices Software and Apps Group exists to help software developers understand if they are working within this regulated area.
Additionally, numerous discussions are ongoing with HRA, NICE and CQC around closer joined up working in this space.
Another key piece of work that the MHRA, in particular the Devices Division and CPRD, have been involved in is related to the Regulators Pioneer Fund (RPF). It felt somewhat strange to have the announcement bundled up with robolawyers and flying cars, but, this work to develop synthetic data sets to validate software that is a medical device is ground breaking as a regulatory resource.
Finally, there is much work ongoing within MHRA to develop further use of AI to support regulation and in particular for vigilance of medicines and medical devices through accessing big data sets to support earlier interventions.
MHRA Inspectorate work
Within the Inspectorate work has focussed on how support can be given to digitise the GXP arena, whilst ensuring patient safety.
- The newly formed AI Focus Group, led by Dominic Nguyen-Van-Tam, is aiming to develop a coordinated Inspectorate approach to data integrity (DI) and computer system validation (CSV) issues associated with the development of AI technologies. This is a sub group to the main data integrity group and sits alongside other focus groups such as the rapid data capture systems, blockchain and Internet of Things (IoT) groups
- The Pharmacovigilance Inspectorate has been engaging with stakeholders on developments in AI, including Natural Language Processing, and its application in pharmacovigilance, such as automated case processing and earlier detection of potential drug-related side effects
- Our recent blog post on electronic health records (EHR) and GCP highlights the Inspectorate has a desire to engage and drive forward thinking in this space
- The opportunities afforded by the use of blockchain to provide even more security to the pharmaceutical supply chain is another area where MHRA has been widely engaging with stakeholders
- Training Inspectors in the practical use of these technologies to support inspection techniques and capabilities, including augmented reality (AR) and virtual reality (VR), along with AI
- Responding to Innovation Office requests that have focused on work in this area
- Producing a Lunch & Learn session for the GMP Symposium on AI and its use in GMP (developed by Kevin Bailey, Ewan Norton and me). So if you are attending I hope you enjoy it.
I’m not alone in having a passion for technology and the Inspectorate is full of like-minded individuals ready to engage with you as these developments in this rapidly growing area start to come to fruition in your organisations. One of the challenges the Inspectorate faces is understanding how you will be applying AI technologies and we welcome your feed back on any potential regulatory challenges you foresee in the use of AI within in your organisation.
Perhaps going back to my primary school coding, remember
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