Digital Health Legal
Back to Contents

Volume: 4 Issue: 9
(September 2017)

Keywords:
uk life sciences industrial strategy highlights potential digitisation ai government commissioned ‘life sciences industrial strategy report government life

Jurisdictions:
UK Europe EU

Options:
Share This Page



UK Life Sciences Industrial Strategy highlights potential of digitisation and AI

The Government commissioned ‘Life Sciences Industrial Strategy: A report to the Government from the life sciences sector’ published on the 30 August 2017 outlines multiple recommendations pertaining to digital health development in the UK. Amongst the findings of the Strategy, led by Sir John Bell, a Professor of Medicine at the University of Oxford, developed in consultation with the Life Sciences Industrial Strategy Board, is the potential for digitisation and artificial intelligence (‘AI’) to transform pathology and imaging. According to the Strategy it should be the ambition of the UK to develop and test integrated AI systems that provide real time data, as especially within the context of the UK’s National Health Service (‘NHS’) ‘no other system has the scale to provide such important data that, when captured, could produce a globally dominant commercial offering in this diagnostic space.’

The Strategy states that its recommendations ‘will emerge as a dynamic set of actions that will ensure the most desirable outcomes for the economy, industry and the NHS.’ Among the recommendations put forward in the Strategy are proposals for ePrescription services to be made available across all UK hospitals, the development of several new Digital Innovation Hubs, and the formation of a working group to develop a new regulatory Health Technology Assessment and commercial framework ‘to capture for the UK the value in algorithms generated using NHS data.’ Hilary Jones, Of Counsel at Bristows, comments that creating a working group for this purpose “could be a way to encourage the development and uptake of new digital tools, and it would be beneficial to include all relevant stakeholders in the working group including industry, academia, and patient representatives in addition to the NHS and the competent authorities.”

The Strategy’s recommendation for two to five new Digital Innovation Hubs seeks to address the ‘significant regional variation in digital maturity and the readiness of systems for real-world evidence studies,’ which would retain comprehensive and secure data in primary, secondary and tertiary care as well as social care and community data for populations of between three to five million people per Hub. “Setting up Digital Innovation Hubs across the UK is a good idea,” said Carina Healy, Partner at CMS Cameron McKenna Nabarro Olswang LLP, “but whether they will succeed in spreading uptake evenly is a different issue. Uptake depends on the approach of the local NHS bodies and an element of national direction or coordination may be required to ensure even access. However, the Hubs should be able to share and promote best practice, hopefully helping to embed the best innovations into clinical practice.”

The introduction to the Strategy begins by acknowledging that the UK is currently planning its future outside of the European Union, and as such identifying and supporting specific sectors of the economy is a clear priority. Given the importance of life sciences to the innovation economy in the UK there are few, if any, sectors more important to support, states the Strategy, and the UK is ‘powerfully positioned’ to lead in the discovery of innovative new digital approaches to healthcare. “With Brexit on the horizon and given the developments in medicine that have been made since the last Strategy was published in December 2011, it is certainly an important time to be considering measures to help the UK become a leader in this area,” adds Jones. Despite the immediate context relating to the ongoing Brexit negotiations, the Strategy emphasises that its recommendations have been drafted with long-term goals in mind, stating that ‘it is the view of the industry that this Strategy needs to be seen over at least a five year period, not as a moment in time when a sector deal is agreed. To retain the UK’s competitive edge in this sector, there is a requirement for sustained effort over a longer period of time.’

In addition to this, the future of regulation in the life sciences will need to be considered in light of the UK leaving the EU, stresses the Strategy, and any future arrangement should ideally take into account the MHRA’s innovative leadership in the field. ‘There has been much discussion about the opportunity of the UK to develop an innovative regulatory approach to emerging technologies outside of the EU,’ explains the Strategy. However, it will be important for any future regulatory system to regulate emergent and convergent technologies, as well as digital medicines, and whilst this innovative strand in the MHRA approach might be theoretically desirable from a UK life sciences ecosystem point of view, the Strategy warns that ‘it would only be additive if it did not jeopardise the UK’s participation in the EU systems and processes. Relatively speaking, the UK market is too small even with the fastest and most innovative regulatory system in the world, to stand alone from a larger decision-making bloc.’

The Strategy also acknowledges the importance of the General Data Protection Regulation for data sharing and suggests that ‘Outside the EU we should attempt to maintain the current balanced approach to data sharing regulations if we are to enjoy the benefits for healthcare […] This will add to the attractiveness of an integrated digital environment in the UK because of the predictability and consistency of data sharing regulations.’

The UK Government has yet to respond to the recommendations outlined in the Strategy.

Search Publication Archives



Our publication archives contain all of our articles.
Can’t find what you are looking for?
Try an Advanced Search

Log in to digital health legal
Subscribe to digital health legal
Register for a Free Trial to digital health legal
Sign up for e-mail alerts
digital health legal Pricing

Social Media

Follow digital health legal on TwitterView digital health legal LinkedIn Profiledigital health legal RSS Feed