What: The governance of Radiology AI involves the policies, procedures, and oversight mechanisms that manage the entire lifecycle of an AI system. From initial procurement and deployment, to post market surveillance and decommissioning. It encompasses ethical considerations, data privacy, regulatory compliance, and clinical accountability.

Why: With systems as complex as AI that could potentially be autonomous, there is a critical need for oversight and accountability. Without a formal governance strategy, organizations face significant clinical and operational risks such as, algorithmic bias, performance drift, and legal liability in the event of diagnostic errors. Effective governance provides the necessary assurance to stakeholders that AI tools are delivering a measurable return on investment without compromising patient safety.

How: Unfortunately, there is no shared set of international standards governing the development and use of AI. So every country is different, and every healthcare organization has their own interpretation of their own national rules. Furthermore, the regulatory landscape is changing in response to the rapid pace of change in these technologies, so those responsible for regulating the use of AI tools have the unenviable task of keeping up with the technology and understanding the regulations.

Connect with your Governance Team: Firstly it is important to discover and connect with the governance teams within your organization. You may work in a low regulatory environment where you can deploy AI without consulting anyone, or a high regulatory environment with many hurdles to overcome. Whichever way, make sure you speak to your IT Department, PACS Team, Medical physicists( if you have them), Information Governance and your Procurement/Commissioning Team. Ideally your organization should have a well worn regulatory path that is managed by clearly defined individuals.

Connect with the AI Suppliers: The best people to speak to when trying to understand your local governance environment are the system suppliers. If they have already deployed systems in your country, state or municipality, they will have a good idea of what is required. Also, one of the advantages of deploying an AI Portal is that the supplier will manage the governance of your tools as part of the contract.

Follow the Guidance from your National Authorities: Most countries provide high-level information through government or federal agencies such as the U.S. Food and Drug Administration (FDA), or the European Medicines Agency (EMA). All agencies attempt to provide comprehensive information in relation to the appropriate use and monitoring of AI tools in healthcare. Hardrian Health provide a useful world map of National Agencies, see link in the Bibliography.