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Medtronic, which has a database of information on 400,000 patients who have implanted defibrillators, says patients aren’t likely to be able to make use of the data. “We understand patients want to see their data, but we want to make sure it’s data that is valuable to them,” says Wendy Dougherty, a spokesperson for Medtronic. “We’re working with patients to understand what kind of information would be beneficial for them.”

To Campos, the idea that patients need to be protected from this information is infuriating. “Who owns the data collected in my body?” he says. “Should it benefit the company, so they can use it for post-market surveillance? Or me, so that I can make better decisions about my health?” He has declined to use a bedside monitor that collects information from his defibrillator. (The device can still deliver life-saving electrical shocks, if needed.)

The industry’s stance may at last be changing. In September, Campos talked with the director of the FDA’s Center for Devices and Radiological Health, which told him it has no official jurisdiction over the raw data collected from implanted devices. But a representative did bring up the issue at a meeting of ADVAMED, the trade industry for medical-device makers, where some of the major manufacturers reportedly said they are open to the idea.

In addition to working with device makers and the FDA, Campos is considering a less conventional tactic: hacking into his device. He has collected an array of implantable defibrillators and external monitors, both from eBay and from other patients, so that he can figure out how to listen in on the flow of information. He has yet to do so, however.

For now, Campos laments the strange position he is in. “The device is part of me; parts of it can never be removed,” he says. “It’s like I am just the host of it. It creates a weird divorce of the self.”

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Credit: Hugo Campos

Tagged: Biomedicine, data, medical implants, hardware hacks, open access

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