UK medicines watchdog vows to boost interoperability with AI

The UK’s medicines watchdog has vowed to improve interoperability and collaboration across the health system through “smart solutions” like artificial intelligence.

The Medicines and Healthcare products Regulatory Agency (MHRA) has committed to building on established technology platforms to “improve interoperability across the UK health system and internationally” as part of its Delivery Plan for 2021-23.

By the end of the 2021/22 financial year, the MHRA will finalise plans to “overhaul costly legacy systems” to deliver improved IT and digital services, as well as cost savings.

“We will deliver simple, smart solutions using automation, artificial intelligence and digital self-service,” the report states.

“It will also improve our ability to share data and collaborate across the UK health system and internationally; provide opportunities to reduce costs and ultimately enhance our ability to protect public health.”

Lord Bethell, minister for innovation, said: “MHRA’s new delivery plan sets out how the UK will apply the lessons learned from the pandemic and grasp the opportunity of innovation now we have left the EU to make sure NHS patients are able to benefit first from all medical innovations.”

The agency also aims to boost the UKs innovation, clinical trials and medical devices sector while ensuring it meets the needs of patients safely.

Part of this will involve a new legislative framework for medical devices with a focus on “levelling up” the UK.

The new framework will “support ongoing access to products” while supporting “safe innovation”.

A public consultation on the framework is expected by the second quarter of 2021/22. Key guidance is expected by the second half of 2022/23, with the aim of working with stakeholders to prepare them for the new framework over the course of the same financial year.

The MHRA will work with NHSX, NHS Digital and the National Institute for Health and Care Excellence to design the medical devices framework.

The Delivery Plan comes as the MHRA looks to learn from the Covid-19 pandemic with a renewed focus on innovative technologies and “putting patients first”.

At the core of the plan the agency will draw together its scientific and regulatory expertise to help facilitate the UK life sciences sector and health service.

The Delivery Plan replaces the MHRA’s current Corporate Plan 2018-23 to reflect the pace needed in “our aspiration to be a global leader”.

Better use of data

The plan also focuses on making the most of rich health data available both in the UK and internationally as the MHRA moves to bolster the UK with a “world-leading” clinical trials system.

Plans to overhaul the UKs clinical trial system include a commitment to deliver an NHSX funded “synthetic data research project” by the end of 2021/22 to drive uptake of innovative clinical trials.

The scaling up of data projects will also improve the detection, assessment and understanding of adverse medicine reactions, according to the regulator.

Further commitments to better use of data include the delivery of a data sharing strategy by the end of 2021/22.

The adoption of international standards, including “Identification of Medicinal Products”, will be achieved by the second quarter of 2022/23.

Stephen Lightfoot, chair MHRA, added: “Our Delivery Plan sets out our ambition plainly and prioritises the steps we are taking to achieve it: integrating our undeniable assets in science and regulation; building the UK and international partnerships we need to support our delivery; and taking the necessary decisions to improve our organisational resilience.

“These actions will enable us to dramatically improve patient involvement and outcomes from the faster introduction of safe and effective medical products to patients around the world.”