Publication Health and Care 24 September, 2020

Realising Smart Regulation in Healthcare

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This event write up brings together the ideas generated at Reform and Imperial College London's policy hackathon 'Realising Smart Regulation in Healthcare'. 

In late 2018, Matt Hancock, Secretary of State for Health and Social Care, announced that “the tech revolution is coming to the NHS” and set out his vision for the creation of a tech-driven healthcare system. Matthew Gould, CEO of NHSX, highlighted that regulation is key to making this vision a reality as it is necessary to protect patients from unsafe uses of technology and “smart regulation could really help make the UK the best place in the world” to develop innovations in healthcare.

However, more work is needed to achieve this vision of smart regulation which promotes patient safety, upholds high evidence standards, and fosters innovation. As shown by the award-winning project Reform produced in collaboration with NHSX in October 2019, Data-driven healthcare: regulation and regulators, the regulatory landscape for data-driven technologies in healthcare is complex and can be confusing due to the number of rules and bodies involved in the process.

On July 22nd 2020, Reform, in partnership with Imperial College London’s The Forum, held a virtual Policy Hackathon on the topic of "Realising Smart Regulation in Healthcare". The event convened a leading group of experts including healthcare regulators, statutory bodies, NHS leaders, academics and senior policymakers, to propose solutions to specific challenges identified in the regulatory pathway for data-driven healthcare innovations found in Data-driven healthcare: regulation and regulators. This event-write up presents a summary of the main solutions discussed by attendees.

Hackathon participants were asked to work through specific policy challenges organised across four domains:

  • Data access
  • Proof of concept & evidence building
  • CE marking & post-market surveillance
  • The overall regulatory process

Reform and The Forum would like to extend its thanks to participants of the Policy Hackathon for their work and ideas to make this document possible.

The NHSX AI Lab has “regulation as one of its core streams of activity” and has provided funding to regulators to work through the bottle necks in the regulatory process. This event-write up offers a great contribution to the ongoing work in this space.