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Abstract Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and creators of artificial intelligence/machine learning (AI/ML)-enabled medical devices. Lack of equitable access to diagnosis and treatment may be improved through new digital health technologies, especially AI/ML, but these may also exacerbate disparities, depending on how bias is addressed. We propose an expanded Total Product Lifecycle (TPLC) framework for healthcare AI/ML, describing the sources and impacts of undesirable bias in AI/ML systems in each phase, how these can be analyzed using appropriate metrics, and how they can be potentially mitigated. The goal of these “Considerations” is to educate stakeholders on how potential AI/ML bias may impact healthcare outcomes and how to identify and mitigate inequities; to initiate a discussion between stakeholders on these issues, in order to ensure health equity along the expanded AI/ML TPLC framework, and ultimately, better health outcomes for all.

Responsible adoption of healthcare artificial intelligence (AI) requires that AI systems which benefit patients and populations, including autonomous AI systems, are incentivized financially at a consistent and sustainable level. We present a framework for analytically determining value and cost of each unique AI service. The framework’s processes involve affected stakeholders, including patients, providers, legislators, payors, and AI creators, in order to find an optimum balance among ethics, workflow, cost, and value as identified by each of these stakeholders. We use a real world, completed, an example of a specific autonomous AI service, to show how multiple “guardrails” for the AI system implementation enforce ethical principles. It can guide the development of sustainable reimbursement for future AI services, ensuring the quality of care, healthcare equity, and mitigation of potential bias, and thereby contribute to realize the potential of AI to improve clinical outcomes for patients and populations, improve access, remove disparities, and reduce cost.