The U.S. Foodstuff and Drug Administration merely released its guidance on a category of software called “medical decision support,” which is designed to help doctors produce extra data-driven decisions about patient care.
It sounds wonky, but companies for a long time have been begging for clarity on whether this kind of software is regulated — or it isn’t.
Experts say that insufficient clarity is holding rear start-ups and big firms alike in their attempt to bring new technology to health. Which includes Apple’s plans to make use of its smartwatch to find irregularities with the heart’s rhythm and notify users if they desire a medical consultation.
“I know builders who sat in my own office and explained they didn’t create a life-saving feature because they didn’t know if it would be regulated or not,” explained Morgan Reed, president of an application developers’ interest group called ACT.
Three documents from the FDA take away some doubts by describing various types of medical software and what sorts of claims would be regulated.
Reed said it’s now very clear that if a health care provider makes the decision and analysis, and uses software to make more informed decisions about treatment, that software would not be regulated.
It would be regulated, however, if the program makes a analysis. For example, if it notifies a consumer they have a certain medical condition.
Reed said this category of software is indeed important as it takes a number of the guesswork out of medicine.
Previously, doctors made decisions predicated on patients they’ve seen with an identical condition and background. “If you are lucky, that’s 500 persons who appear to be you,” explained Reed. But with innovative technology from “a large number of doctors on an incredible number of people,” he said, treatments could be more evidence-based.
Apple, Google, Fitbit and others are working with FDA as it figures out how to fast-track the approval procedure for digital health firms.
Some people in the market think the guidance will not go far enough.
Some clinical decision support software is extra “risky” to a patient than others. For example, some app manufacturers will recommend chemotherapy to a cancer patient predicated on information in their data source. Others will merely make use of data to predict a risk rating for populations of individuals who are more likely to develop migraines.
Bradley Merrill Thompson, an FDA expert and lawyer with the organization Epstein, Becker & Green, would have liked to find FDA distinguish between these various use-cases predicated on risk.
“We didn’t get that,” he wrote in an email. “Worse, it appears based on the direction that the FDA is not interested in drawing that line.”