Regulatory bodies in the healthcare industry are failing to keep up with the accelerating adoption of artificial intelligence (AI) in medical devices. As many AI technologies have continuous learning capabilities, regulatory bodies such as the FDA and Health Canada should focus on creating a regulatory framework that would allow for ongoing changes, says GlobalData, a leading data and analytics company.

While technology is everchanging in medicine, the COVID-19 pandemic has accelerated the process of digitalizing healthcare, including a need for ‘smarter’ medical devices. We are now seeing many medical devices incorporating AI capabilities including enhanced imaging systems, smart robots and wearable technology. As a result of these advancements, GlobalData forecasts that AI platform revenue will reach $52 billion in 2024 and that the market value for AI platforms for the healthcare industry will reach $4.3 billion in 2024.

Alexandra Murdoch, Medical Analyst at GlobalData, comments: “AI can be an extremely useful addition to the healthcare industry and will improve the quality of many medical devices. However, the rise of AI in medical has prompted questions surrounding regulation.”

At present, many medical markets have not addressed the complexities of medical devices that incorporate AI capabilities. This is a potential cause of concern, because, while AI can improve medical devices, it can also pose some safety concerns. Many AI technologies use large datasets and complex algorithms, and as a result, assessing AI functionality can be difficult without specific guidelines to follow.

Murdoch continues: “While many AI-based medical devices are not regulated in such a specific way that caters to their AI functionalities, the FDA has recently released a final guidance on ‘Clinical Decision Support Software’. This final guidance aims to clarify the scope of the FDA’s oversight of clinical decision support software, and it excludes certain medical software functions (including some decision support software) from the definition of device.”

While the FDA’s guidance on Clinical Decision Support Software is a start in regulating AI-based devices, there should also be a priority to re-evaluate how other AI-based devices are regulated.

Murdoch adds: “Medical devices with AI capabilities are often more technologically advanced than other devices, and in some cases everchanging. Medical device regulations will have to address these complexities to effectively regulate such devices.”