Many healthcare providers are now utilizing algorithms that take into account a patient’s biological sex when making clinical decisions. These algorithms, such as those used for assessing heart disease risk, can potentially lead to differences in care and access to healthcare resources between men and women. For example, individuals may be prioritized differently on organ transplant lists based on their sex.
Despite the widespread use of these algorithms, there has been a lack of clear guidelines on when it is appropriate to consider sex in medical decision-making. With new federal healthcare regulations set to come into effect later this year to address discrimination in clinical algorithms, there is a growing need for clarity on the legal and ethical implications of including biological sex in these algorithms.
To help fill this void, experts from the University of Maryland School of Medicine and the University of Maryland Francis King Carey School of Law have developed a new framework for evaluating the inclusion of sex in clinical algorithms. Their research, published in the New England Journal of Medicine, aims to provide guidance to healthcare organizations on the appropriate and lawful use of sex-inclusive algorithms.
Lead author Katherine E. Goodman, Ph.D., JD, emphasized the importance of understanding the reasons behind differences in risk between men and women when considering the inclusion of sex in algorithms. The framework proposed by Goodman and her colleagues includes questions to assess the prognostic necessity of considering sex in a particular algorithm, as well as whether the inclusion of sex may perpetuate biases or stereotypes.
According to Diane Hoffmann, JD, MSc, the new framework is intended to help healthcare systems improve outcomes and reduce bias in clinical decision-making. With the implementation of new guidelines by the Department of Health and Human Services this year, healthcare providers will benefit from clear guidance on when and how to incorporate sex into their algorithms.
By promoting a more thoughtful and evidence-based approach to the use of sex in clinical algorithms, the framework developed by the University of Maryland experts aims to enhance patient care and mitigate the potential for bias and discrimination in healthcare settings. This research underscores the importance of ensuring that the inclusion of sex in algorithms is based on medical necessity and scientific evidence, rather than on outdated stereotypes or biases.
