Source: Forbes
There is no central clearinghouse for regulating algorithms used in healthcare. Certain commercial applications, such as the heart rate monitor in the Apple Watch, are authorized by the Food and Drug Administration. However, algorithms developed by electronic health records companies, like Epic or Oracle Cerner, fall under the Office of the National Coordinator for Health IT, or ONC. “We are not regulating the AI-enabled tools themselves,” ONC director Micky Tripathi told Forbes about the new rules his agency recently finalized that go into effect on March 11, 2024. Rather, he compares the approach to a “nutrition label” found on food packaging – electronic health records companies will be required to document 33 different data elements that give their hospital and doctor customers information about what data the model is trained on and how it works. In technical parlance, these labels are often called model cards. “We’re not getting deep into ‘is this a good product, is this a bad product,” said Tripathi. “We’re just saying information should be provided to the customer, so that they themselves can make the decision. But it applies to a much broader array of products than FDA regulations do.”