The FDA Should Better Regulate Medical Algorithms

Thu, 07 Oct 2021 05:00:00 GMT
Scientific American - Technology

Most do not require the agency’s approval, and those that do often don’t require clinical trials

Medical algorithms are used across the health care spectrum to diagnose disease, offer prognosis, monitor patients' health and assist with administrative tasks such as scheduling patients.

From sexual trauma victims being unfairly labeled as "High-risk" by substance-abuse-scoring algorithms to diagnostic algorithms failing to detect sepsis cases in more than 100 health systems nationwide to clinical decision support software systematically discriminating against millions of Black patients by discouraging necessary referrals to complex care-this problem abounds.

The kicker: most of these algorithms did not require FDA approval, and the ones that did often were not required to conduct clinical trials.

Under current law, medical algorithms are classified as medical devices and can be approved with the 510(k)-approval process.

The primary difference is that medical algorithms are less transparent, far more complex, more likely to reflect preexisting human bias and more apt to evolve over time, compared with medical devices of the past.

Some medical algorithms, such as CDS, can evade FDA oversight all together.

Given the threats of unregulated medical algorithms for patients and communities, we believe the U.S. must improve regulations and oversight on these new-age devices.

The second action is to dismantle systems that foster overreliance on medical algorithms by health care workers.

In general, unless doctors' decisions lead to patient harm, they should not face significant penalties for using their own clinical judgement instead of following recommendations from medical algorithms.

For medical algorithms that function in health care settings, the FTC could require more frequent assessments to monitor for any changes over time.