Regulators Must Address Complexities to Stay Abreast of Medtech AI Advancements

Artificial intelligence (AI) is increasingly being integrated into medical devices, and the technology is benefitting patients. But regulatory bodies are struggling to keep up with the accelerated pace of adoption, claims GlobalData.

As many AI technologies have continuous learning capabilities, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and Health Canada should focus on creating a regulatory framework that would allow for ongoing changes, GlobalData suggests.
 
While technology is constantly changing in medicine, the COVID-19 pandemic has accelerated the process of digitalizing healthcare, including a need for “smarter” medical devices. Many medical devices are now 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 the market value for AI platforms for the healthcare industry will reach $4.3 billion that same year. 
 
“AI can be an extremely useful addition to the healthcare industry and will improve the quality of many medical devices,” said Alexandra Murdoch, a GlobalData medical analyst. “However, the rise of AI in medical has prompted questions surrounding regulation.”
 
Currently, many medical markets have not addressed the complexities of medical devices that incorporate AI capabilities. This could be problematic 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. 
 
“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,” Murdoch said. 
 
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. 
 
“Medical devices with AI capabilities are often more technologically advanced than other devices, and in some cases everchanging,” Murdoch noted. “Medical device regulations will have to address these complexities to effectively regulate such devices.”