National Alliance for Hispanic Health pushes for better data as mHealth goes mainstream

 

POSTED ON Jul 22, 2022

 

Over the past 20 years, less than half of all clinical trials (43%) in the U.S. reported race or ethnic data. According to the National Alliance for Hispanic Health, with the increasing acceptance of mobile health (mHealth) since the pandemic, there is an urgency to consider the multitude of mHealth software and the implications of a lack of adequate data by race, ethnicity, and gender.

The National Alliance for Hispanic Health is the foremost science-based source of information and trusted advocate for the health of Hispanics in the United States. mHealth is a term used for the practice of medicine and public health supported by mobile devices. The alliance’s mission is to achieve the best health for all.

In submitting comments for the U.S. Food and Drug Administration’s proposed 2022 report, the alliance commended FDA for using the World Health Organization (WHO) definition of health in mHealth.

The WHO defines health as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

In the submission, the alliance also urged the FDA to take that definition fully into account as they develop the 2022 Report.

“The COVID pandemic has changed the acceptance of mHealth throughout the nation,” said Jane L. Delgado, president and CEO of the National Alliance for Hispanic Health. “There is an urgency in FDA’s upcoming Congressionally mandated 2022 Report on the risks and health benefits of non-device software to consider the multitude of mHealth software in the new landscape of health and the implications of an ongoing lack of adequate data by race, ethnicity, and gender.”

The Hispanic health advocacy group also called for the 2022 FDA report to recognize patient safety risks, as a result of the lack of inclusion of known differences in drug response by race, ethnicity, and gender, and the risk of reliance on clinical decision systems that lack adequate race, ethnicity, and gender data from clinical trials.