Equitable Use of Sex in Clinical Algorithms

On January 16, 2025, a significant discussion emerged around the equitable use of clinical algorithms that incorporate biological sex as a factor in healthcare decision-making. This new exploration calls for a framework aimed at minimizing bias and ensuring legal compliance, as articulated by a collaborative effort from experts at the University of Maryland School of Medicine and the University of Maryland Francis King Carey School of Law. The importance of this topic lies in the potential implications for patient care and resource allocation, particularly in contexts like organ transplants.

The Need for a New Framework

As physicians increasingly rely on algorithms for assessing risks related to various health conditions, concerns have arisen regarding the differential treatment of patients based on their sex. While these algorithms aim to personalize healthcare, the lack of standardized criteria for determining when the inclusion of sex is appropriate raises legal and ethical issues. Notably, the anticipated federal regulations aimed at promoting anti-discrimination may create further complexities, leaving healthcare organizations in a precarious position regarding algorithm implementation.

Key Questions in the Framework

The proposed framework, detailed in their article published in the New England Journal of Medicine, presents several critical questions that healthcare providers must consider:

• Is the inclusion of sex "prognostically necessary"? Does the algorithm significantly lose accuracy without considering sex?
• What are the underlying reasons for differences in risk and outcomes between sexes? Are these differences attributable to biological variances or influenced by societal stereotypes?
• Does the algorithm risk penalizing a disadvantaged sex? Is there potential for bias to skew results against one gender over the other?

Implications of the Framework

This framework aims not just to comply with legal requirements but to foster a more equitable approach in healthcare settings. Understanding the context of sex differences in risk can guide healthcare systems in the design and use of algorithms, ultimately leading to improved health outcomes. The authors express that an approach based on informed decisions related to biological factors can enhance both fairness and clinical effectiveness.

“This framework will help health care systems improve outcomes and should save more lives and reduce morbidity by ensuring that when sex is considered in clinical algorithms, it's being used appropriately and not based on biases or stereotypes.” – Diane Hoffmann, JD, MSc

Future Considerations

With new guidelines from the Department of Health and Human Services set to take effect soon, healthcare practitioners are under increased pressure to refine their metrics for incorporating sex into clinical algorithms. Moving forward, a few considerations must be prioritized:

Concluding Remarks

The significance of bridging the gap between algorithms and equitable healthcare cannot be overstated. With disparities in health outcomes linked to sex, the strategic application of this new framework stands to benefit not only individual patients but the healthcare system as a whole. Ongoing research and adherence to evolving regulations will guide future algorithmic practices in a manner that prioritizes patient welfare.

For more details, refer to the study by Katherine E. Goodman et al. titled FAIRS — A Framework for Evaluating the Inclusion of Sex in Clinical Algorithms published in the New England Journal of Medicine.

References

• Katherine E. Goodman et al. FAIRS — A Framework for Evaluating the Inclusion of Sex in Clinical Algorithms, _New England Journal of Medicine_ (2025).
• Lifespan.io