Will AI Be Legally Mandated for Medical Diagnoses in the Future?

By Campion Quinn, MD

 Introduction

The integration of Artificial Intelligence (AI) into healthcare has revolutionized various aspects of medical practice, particularly in diagnostics. AI's ability to process vast amounts of data and identify patterns has led to significant advancements in early disease detection and personalized treatment plans. As these technologies become more prevalent, a critical question arises: Will the use of AI in medical diagnoses become a legal requirement in the future?

Consider a fictional case: Dr. Vale, an internist, bypasses an AI dermoscopy tool available in the clinic for evaluating a patient with a suspicious lesion on his shoulder. Although no policy mandates its use, she documents no rationale for omitting it. The patient is diagnosed a year later with advanced melanoma. A review committee questions whether the omission of the AI tool constituted a lapse in care. While this is a constructed example, it is rooted in real-world debates. In specialties like radiology, legal scholars and malpractice insurers have already begun to examine whether failure to consult validated algorithmic tools could amount to negligence. As AI becomes more embedded in clinical workflows, physicians may find themselves obligated not only to consider AI outputs but also to justify their decision to override them. The Promise of AI in Diagnostics

AI has demonstrated remarkable proficiency in analyzing complex medical data, often surpassing human capabilities in specific tasks. For example, AI algorithms have been developed to detect diabetic retinopathy with high accuracy, leading to the FDA's approval of autonomous diagnostic systems like IDx-DR [1]. Such tools enhance diagnostic precision and alleviate the workload on healthcare professionals, allowing them to focus on patient care.

Moreover, AI's potential to standardize diagnostic procedures can reduce variability and improve healthcare outcomes. By providing consistent analyses, AI systems can help minimize diagnostic errors and ensure patients receive timely and appropriate treatments.

Legal and Ethical Considerations

Despite the advantages, the mandatory implementation of AI in medical diagnostics raises several legal and ethical concerns. One primary issue is liability. If an AI system provides an incorrect diagnosis, determining responsibility becomes complex. Traditionally, physicians are held accountable for their clinical decisions. However, with AI involvement, questions arise about whether liability should shift to the software developers or the institutions deploying these technologies [2].

Additionally, the standard of care in medicine is evolving. As AI tools become more integrated into clinical practice, there may be legal expectations for physicians to utilize these technologies. Failure to do so could be interpreted as negligence, especially if AI systems are proven to enhance diagnostic accuracy [2].

Ethical considerations also play a crucial role. Issues such as patient consent, data privacy, and algorithmic bias must be addressed to ensure that AI integration does not compromise patient rights or exacerbate health disparities.

Regulatory Landscape

Currently, there is no legal mandate requiring the use of AI in medical diagnostics. Regulatory bodies like the FDA have established frameworks for approving AI-based medical devices, focusing on safety and efficacy. However, these approvals do not equate to mandates for clinical use.

In some jurisdictions, discussions are underway regarding the regulation of AI in healthcare. For instance, the European Union's proposed AI Act aims to establish comprehensive guidelines for AI applications, including those in the medical field. While these regulations may set standards for AI deployment, they stop short of mandating its use.

In the United States, the American Medical Association (AMA) has issued policy recommendations urging the profession to develop standards for augmented intelligence. The AMA highlights the need for transparency, physician oversight, and support for clinicians who choose to override algorithmic output when justified [3].

Future Outlook

The prospect of legally mandating AI in medical diagnostics depends on several factors:

1. Demonstrated Efficacy: Widespread clinical evidence supporting AI's superiority in diagnostics could prompt policymakers to consider mandates.

2. Regulatory Evolution: As legal frameworks adapt to technological advancements, there may be increased pressure to integrate AI into standard medical practices.

3. Professional Acceptance: The medical community's willingness to embrace AI will influence its integration. Training and education will be essential to facilitate this transition.

4. Public Trust: Ensuring transparency and addressing ethical concerns will be vital in gaining public support for AI in healthcare.

Conclusion

While AI holds significant promise in enhancing medical diagnostics, its mandatory implementation faces legal, ethical, and practical challenges. The future may see a gradual integration of AI into standard care, driven by demonstrated benefits and evolving regulations. However, a legal mandate for its use will require careful consideration of liability, ethical implications, and the readiness of both the medical community and the public to embrace such a shift.

References

1. Abràmoff, M. D., Lavin, P. T., Birch, M., Shah, N., & Folk, J. C. (2018). Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices. NPJ Digital Medicine, 1(1), 39. https://doi.org/10.1038/s41746-018-0040-6

2. Price, W. N. II, Gerke, S., & Cohen, I. G. (2019). Potential liability for physicians using artificial intelligence. JAMA, 322(18), 1765–1766. https://doi.org/10.1001/jama.2019.15064

3. American Medical Association. (2022). Augmented intelligence in health care: AMA policy recommendations. https://www.ama-assn.org/delivering-care/public-health/augmented-intelligence-health-care