New guidance to support innovators fighting COVID-19

Imperial researchers have set out key regulations innovators must comply with when designing and building technologies safely to tackle COVID-19.

The paper, entitled ‘Mobilising the COVID-19 response in the United Kingdom’, serves as a guide for those wishing to act quickly in manufacturing devices and equipment, conducting services or clinical studies or wishing to use data and algorithms, but are unsure of the regulatory pathways to fast-tracking their work for the COVID-19 response.

Imperial researchers Dr Aldo Faisal and Ignacio Albert Smet from the UKRI Centre in AI for Healthcare prepared the paper, with the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the UK Government’s Department of Health and Social Care, the Health Research Authority (HRA) and the Care Quality Commission (CQC).

Separated into three sections, the paper outlines how you can help in the fight against COVID-19 as an individual or as a business, and the regulation and coordination for new services, devices and technologies.

This paper sets out how innovators can contribute in a way that is helpful, compliant, and promotes high quality care at pace in a safety critical industry. Care Quality Commission

Based on a report by the Imperial academics, the MHRA, the HRA and the CQC, the paper emphasises the need for products, equipment and technologies to be safe and legal, explaining how innovators can work within our legal and regulatory framework.

It outlines the four regulatory authorities innovators must consult, depending on their area of work: the MHRA for medicines and medical devices, the CQC for health and social care services, the NHS Health Research Authority (HRA) for ethics approval for medical research, and the Information Commissioner’s Office (ICO), which upholds information rights in the public interest.

Promoting innovation

Dr Aldo Faisal, Director of the UKRI Centre in AI for Healthcare at Imperial, said "The number of initiatives rising to the call of developing innovation to tackle COVID-19 has been amazing, but their efforts are hampered by the perceived restrictions of regulations.

"We address this challenge, as there are many exemptions and processes that innovators and regulatory experts are currently unaware of that can drastically accelerate the process."

The Care Quality Commission added: "People delivering health and care services need the support of innovators from universities and beyond to overcome this crisis.

"At the same time, the challenging environment means that innovators in the sector need to work differently to support them best. This paper sets out how innovators can contribute in a way that is helpful, compliant, and promotes high quality care at pace in a safety critical industry."

Imperial has been at the forefront of the COVID-19 response, including modelling the disease and racing to develop a vaccine. You can also support the Imperial College COVID-19 Response Fund.

The Forum is Imperial’s policy engagement programme, connecting Imperial researchers with policy makers to discover new thinking on global challenges.