Hugo Campos is a man on a mission. He wants access to the data being collected inside his body by an implanted cardiac defibrillator. He believes that having this information could help him take control of his health—for example, by helping him figure out what triggers his frequent attacks of abnormal heart rhythms. While not life-threatening, they cause dizziness, fainting, and chest pain. But he says device makers are reluctant to make that information available, mostly for commercial reasons.
“I have this complex little computer implanted in my body, but I have no access to it,” says Campos. “The best that patients can do is get a printout of the report given to the doctor, and that’s designed for doctors, not patients. Patients are left in the dark.”
Campos’s goal is a new twist on the concept of open access, one that has emerged as implanted medical devices become more common and patients increasingly use wireless devices and smart-phone tools to track their health and take control of their care.
Campos was diagnosed with hypertrophic cardiac myopathy, a muscle thickening that makes it harder for the heart to pump blood, after passing out on a train platform several years ago. In November 2007, doctors implanted the defibrillator, a battery-powered device that monitors heart rhythm and delivers an electric shock to regulate it if needed.
These devices continually collect data on such metrics as heart rhythm, variations in impedance in the chest—an indicator of fluid build-up in the heart—battery life, and the time it takes to deliver a shock.
Cardiologist Eric Topol, director of the Scripps Translational Science Institute, says giving defibrillator patients access to their data is an excellent idea. “It could be an option for those individuals who want to learn about what triggers their arrhythmias,” he says. “The data would be helpful in resolving whether their symptoms, such as light-headedness or dizziness, were correlated in any way with an abnormal heart rhythm.”
By tracking episodes of light-headedness with a smart-phone app, Campos has discovered that scotch and caffeine appear to trigger his own abnormal rhythms. But detailed data on his heart activity might make that analysis much more accurate.
Campos, who talked about his efforts at a TEDx conference in Cambridge on Saturday, has approached both device makers and the U.S. Food and Drug Administration to try to get access to the data. But manufacturers have told him that the device is implanted to deliver therapy, not to provide information to the patient. And doing so is not part of their business model. He believes that because device makers see their primary market as physicians rather than patients, they are less motivated to make this information available to the people who actually live with the devices in their bodies. Another obstacle to open access, he adds, is that the information is incredibly valuable.
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.”