IET’s response to the regulation of AI in healthcare consultation

The IET responded to a consultation on the regulation of AI in healthcare by the MHRA.

With the publication of the 10 Year Plan and Life Sciences Strategy outlining digital transformation of the NHS, there is a significant opportunity to reshape healthcare delivery through innovation, however implementation is going to be key to success. It is, therefore, important to ensure that when considering regulation of AI in healthcare we start with the service transformation requirements and then consider the technological solution. AI should support existing patient pathways, build resilience and improve data flow within healthcare. Regulatory expectations should explicitly reference cognitive load reduction, support for shared decision making, and safeguards against automation bias. To do this a systems thinking approach is required.

Key recommendations:

• The Responsible Handover of AI should be included as part of ethical guidance. 
• Systems thinking must be used to ensure that there are patient pathways and adequate workforce capacity in place to direct patients to once they have been diagnosed.
• We advise continued development of technical standards, transparent documentation expectations, and harmonisation with international frameworks.
• There needs to be transparency on what data has been used to develop the AI tools that are being used.
• An oversight body, potentially the MHRA, should be used to assess the technology on its usefulness, usability, and value to the system. 
• IET recommends an infrastructure plan for power stability and connectivity, alongside targeted funding to ensure resilience and safe development of robotic technology in healthcare.
• We recommend adoption of a structured and robust cybersecurity assurance model and the routine use of continuous monitoring tools for detecting drift, anomalies, or unsafe behaviour across the lifecycle of artificial intelligence‑driven systems.