The FDA is paying more attention to how digital health technologies can collect patient data outside of a clinical setting as they become more widespread. A limited number of wearables have previously received approval to track Parkinson’s disease symptoms.

In 2021, according to Apple’s Motor Fluctuations Monitor—a device that tracks variations in dyskinesia and tremor at rest using sensors—for Parkinson’s disease, it was made public. Similarly, H2O Therapeutics was granted 510(k) approval for their Parky app, which provides a patient’s doctor with Apple Watch data. H2O was recently given permission to develop another app that gives haptic feedback to users who exhibit indications of freezing or movement.

The StrivePD programme from Rune Labs and an app created by the digital health startup NeuroRPM are two other approved apps that use data from Apple Watches. The FDA estimates that there are around one million Parkinson’s disease sufferers in the United States.

“With the fast-paced innovation and proliferation of DHT capabilities, including the use of Artificial Intelligence, the healthcare and technology ecosystems have a responsibility to ensure and support the safety, effectiveness and privacy of digitally-derived endpoints,” agency officials said.

The organisation will initially request AI models from researchers, developers and inventors by August. It allows them to bring their own data or use open data sources. The FDA will then select the best models from that group and compare them to its own gait data that has been frozen. Its objective is to ascertain optimal procedures for using AI models to create and verify metrics from smartphones and wearables.