David Higgins

Vince I. Madai, David C. Higgins

Artificial intelligence (AI) in healthcare is a potentially revolutionary tool to achieve improved healthcare outcomes while reducing overall health costs. While many exploratory results hit the headlines in recent years there are only few certified and even fewer clinically validated products available in the clinical setting. This is a clear indication of failing translation due to shortcomings of the current approach to AI in healthcare. In this work, we highlight the major areas, where we observe current challenges for translation in AI in healthcare, namely precision medicine, reproducible science, data issues and algorithms, causality, and product development. For each field, we outline possible solutions for these challenges. Our work will lead to improved translation of AI in healthcare products into the clinical setting

David Higgins, Vince I. Madai

Artificial Intelligence (AI) in healthcare holds great potential to expand access to high-quality medical care, whilst reducing overall systemic costs. Despite hitting the headlines regularly and many publications of proofs-of-concept, certified products are failing to breakthrough to the clinic. AI in healthcare is a multi-party process with deep knowledge required in multiple individual domains. The lack of understanding of the specific challenges in the domain is, therefore, the major contributor to the failure to deliver on the big promises. Thus, we present a decision perspective framework, for the development of AI-driven biomedical products, from conception to market launch. Our framework highlights the risks, objectives and key results which are typically required to proceed through a three-phase process to the market launch of a validated medical AI product. We focus on issues related to Clinical validation, Regulatory affairs, Data strategy and Algorithmic development. The development process we propose for AI in healthcare software strongly diverges from modern consumer software development processes. We highlight the key time points to guide founders, investors and key stakeholders throughout their relevant part of the process. Our framework should be seen as a template for innovation frameworks, which can be used to coordinate team communications and responsibilities towards a reasonable product development roadmap, thus unlocking the potential of AI in medicine.