Regulations & exemptions during the COVID-19 pandemic for new medical technology, health services & data
File(s)A guide to supporting the COVID-19 outbreak.pdf (227.51 KB)
Supporting information
Author(s)
Albert-Smet, Ignacio
McPherson, Duncan
Navaie, Will
Stocker, Tom
Faisal, Aldo A
Type
Report
Abstract
The rapid evolution of the COVID-19 pandemic has sparked a large unmet need for new or additional medical technology and healthcare services to be made available urgently. Healthcare, Academic, Government and Industry organizations and individuals have risen to this challenge by designing, developing, manufacturing or implementing innovation. However, both they and healthcare stakeholders are hampered as it is unclear how to introduce and deploy the products of this innovation quickly and legally within the healthcare system. Our paper outlines the key regulations and processes innovators need to comply with, and how these change during a public health emergency via dedicated exemptions. Our work includes references to the formal documents regarding UK healthcare regulation and governance, and is meant to serve as a guide for those who wish to act quickly but are uncertain of the legal and regulatory pathways that allow new a device or service to be fast-tracked.
Date Issued
2020-04-28
Citation
2020, pp.1-16
Start Page
1
End Page
16
Subjects
COVID-19
regulation
exemption
medical devices
health services
pandemic
data
Publication Status
Published