Wearable Devices Raise Concerns about Data Privacy

As demand for wearable medical devices that track health measures continues to rise, manufacturers will have to navigate the very real concerns of data privacy as well as more closely define whether a device is clinical or consumer-facing, according to panelists at a Food and Drug Law Institute webinar last week.

Panel moderator Bethany Hills, partner in the law firm DLA Piper, asked about the differences between consumer-facing fitness tracker and clinical wearables, noting that it is possible that “even though [a fitness tracker] is putting data into a medical record, it isn’t really a [clinical] medical device.”

Patients may be tracking their blood sugar, exercise and meals through wearable apps that generate health data to be included in their medical records, said Jonelle Sauders, associate product counsel for Google Health, adding that “individuals need to understand how their data is being collected … and managed and how they can delete their data.”

To protect health data privacy there will need to be very close communication between industry and regulators, she said.