Software to predict risk of sepsis, stroke should be regulated as a medical device, says FDA
Dive Brief Some types of risk-scoring tools would be regulated as medical devices, according to […]
Dive Brief
- Some types of risk-scoring tools would be regulated as medical devices, according to a final guidance issued by the Food and Drug Administration on Sept. 28.
- Many of these software tools have been exempted from FDA regulation under the 21st Century Cures Act, as long as the healthcare provider can independently review the basis of the recommendations and doesn’t rely on it to make a diagnostic or treatment decision.
- Clarity on the rules was welcomed by some device makers, even as they cautioned that products may take longer to come to market. Some medical device companies supported the changes, saying they provided more clarity on the FDA’s thinking, while others saw the guidance as overstepping Congress’s intent.
Dive Insight
The guidance applies to clinical decision support software, a broad category of software tools that can help physicians and other healthcare providers detect illnesses and generate alerts when a patient’s condition changes. For example, software that uses electrocardiogram (ECG) data to detect arrhythmias, like that used by Apple’s and Fitbit’s smartwatches, is regulated as a medical device. The same goes for software that analyzes images to differentiate between ischemic and hemorrhagic stroke, or that is used by radiologists to “triage” patients and review potential cases of pulmonary embolism.
“The 21st Century Cures Act was very clear that anything that analyzes a medical image directly would be a medical device,” said Christina Silcox, research director for digital health at Duke-Margolis Center for Health Policy.
The biggest policy change, the FDA noted in the guidance, is that some types of predictive tools, which previously fell into a gray area, should now be regulated as medical devices. The agency gave an example of software that analyzes patient information to detect stroke or sepsis and generates an alarm to notify a healthcare provider.
Sepsis Detection
Several such risk-scoring tools are already in use: Electronic health record companies Epic Systems and Cerner have both made sepsis surveillance tools to detect the deadly condition before patients deteriorate. Neither are FDA-cleared, and a study last year by Michigan Medicine found that Epic’s tool performed worse than advertised.
“I think that there is a distinction in people’s minds around prediction and diagnosis. And you saw this with sepsis, where we’re not saying they have sepsis now, we’re predicting they’re going to have sepsis,” Silcox said. “In some ways, I think FDA said a risk score, the prediction, it’s still a device. That was a space where people weren’t quite sure.”
Bradley Merrill Thompson, an attorney with Epstein Becker Green in Washington, D.C., who advises clients on FDA regulations, wrote that part of the FDA’s argument is around automation bias, or the concern that healthcare providers might rely too much on an automated suggestion.
“FDA is desperately trying to draw a distinction between software that is too self-confident in its recommendations (Dr., the diagnosis is X), versus software that is more tentative in its recommendation, (Dr., the diagnosis is probably X, but might also be something else.) But that whole line of argument is a new addition from the draft guidance,” he wrote in an email. “Apparently, FDA has a very low view of healthcare professionals if the agency thinks that mere software can ‘direct’ doctors what to do, as if the doctor then has no choice.”
For patients, these tools are often used without their knowledge, and there’s nothing in the guidance that suggests they would have to be notified, Silcox said. But they could still benefit from the protection that someone has looked over the software tools to ensure they’re going to work, she said.
“There are always trade-offs, but in my view this guidance could provide a lot of benefit to patients,” Kellie Owens, an assistant professor of medical ethics at NYU’s Grossman School of Medicine, wrote in an email. “It could help protect patients from living under the jurisdiction of clinical decision support software that doesn’t work or that systematically prevents some groups from receiving the care they deserve.”
The guidance comes amid a broader discussion about how bias in medical devices can affect patient care. Multiple recent studies have pointed to evidence that pulse oximeters overestimate blood oxygen levels in patients with darker skin. Researchers at Sutter Health recently found the inaccuracy led to hours of delay in Black patients with COVID-19 receiving supplemental oxygen treatment.
Original Article: (https://www.medtechdive.com/news/fda-regulate-sepsis-software/633732/)