What is the HRA doing to improve AI regulation? A blog by Elizabeth Bohm, Head of Data and AI Policy

Last updated on 28 Jan 2021

Data driven technologies and AI could produce significant patient benefits. Organisations throughout the NHS are looking at how these benefits can be realised. Part of this is to have the right regulatory environment. We are working to improve the regulation of these technologies, by making sure that they are safe and effective and that patient data is protected during their development.

We have established a new data and AI policy team to focus on the issues these technologies raise. We will be streamlining our processes for the review of AI- and data-driven medical devices and our approval for the use of patient data without consent for research. This work is funded by NHSx as part of the regulating the AI ecosystem programme. To achieve this, we are working with the other healthcare regulators, the Care Quality Commission (CQC), Medicines and Healthcare products Regulatory Authority (MHRA) and the National Institute for health and Care Excellence (NICE).

The developments that we are working on are:

  • a multi-agency advice service developed with the CQC, MHRA and NICE. This will provide a one stop shop for support, information and guidance on regulation and evaluation. This will also give a clear overview of the regulatory pathway for AI technologies.
  • a project to streamline the process for technological review. This will ensure that developers can easily access research approvals and start their research as soon as possible. We will be conducting our own research to understand the hurdles that developers face. We will use the insights from this to ensure our new platforms create a smoother pathway.
Elizabeth Bohm, Head of Data and AI

These projects aim to ensure that the regulation of data-driven and AI technologies is efficient and appropriate. They will also increase the transparency so that people can easily understand our role. We will work together with the other regulators to protect patients and their data in the development and use of these technologies.

I am excited to be leading this work. There will be opportunities to get involved and we will be putting into action what we hear about how to streamline our services.

Elizabeth Bohm
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