Publication Health and Care Machinery of government 30 October, 2019

Data-driven healthcare: regulation & regulators

Read the full report  

Last year, Matt Hancock, Secretary of State for Health and Social Care, set out his vision for the creation of a tech-driven NHS and for the UK to become a world leader in healthcare technologies. This field is indeed booming. In healthtech alone there are almost 4,000 companies operating in the UK, with a £24 billion industry turnover. Most importantly there is huge potential to improve the patient experience and care if these technologies are harnessed in the right way (see previous Reform research).

Central to making this vision a reality is smart regulation. Unfortunately, regulation is often viewed as a burden or barrier to innovation. In the area of data-driven innovation in healthcare, regulation can be particularly confusing to navigate as there are many rules and bodies involved in the process. There is also no single information repository compiling everything that a person would need to know to comply with regulatory requirements.

To remedy this, Reform has been working in collaboration with NHSX to produce several easily digestible sources of information which can be used by innovators, medical practitioners, statutory bodies, regulators and any other interested party to understand the full regulatory pipeline for data-driven technologies in healthcare. This work was developed with the invaluable input of regulators (i.e. CQC, ICO, HRA, MHRA) statutory bodies and other stakeholders working in this space. The innovation process was divided into three main stages in order to create short animated videos explaining what people need to do at each stage, as well as the different organisations they might need to contact.

The first video explains the idea generation and data access stage:


The second video explains the proof of concept stage for both non-CE and CE-marked devices:


The third video explains the CE-marking and post-market surveillance process:


A full-length video explaining the regulatory pipeline from idea generation through to post-market surveillance was also created:


Reform has also designed a high-level static map which gives an overview of the entire regulatory process:


Finally, a dynamic standalone presentation was created with full details and hyperlinks to guidance from regulators and statutory bodies. This presentation is optimised for wide screen viewing and should be used in presentation mode – various click through icons have been created so that you can move around the presentation in a dynamic way.

Click here to download the dynamic presentation (updated 03.03.20).

The research presented in these slides highlights the points of tension in the regulatory process. These have also been summarised in a short briefing document, which in addition contains details about the methodology used to produce all the videos.

Briefing document

Reform also contributed a chapter titled 'Mapping the regulation journey' to NHSX's report Artificial Intelligence: How to get it right, published on 30 October 2019.

Artificial Intelligence: How to get it right