Patient advocates Hugo Campos and Amy Tenderich
In the era of Big Data, medical devices and hospitals will collect and analyze vast amounts of information in an effort to improve patient outcomes and reduce healthcare costs. But this impending influx of information is creating a data dilemma that medtech needs to resolve as the growing number of empowered patients fight for the right to access their medical device data.
“[With] implantable cardiac devices, medical device companies don’t look at patients as their customers; the patient is only the recipient of the therapy,” e-patient advocate Hugo Campos said during a patient perspectives panel at MD&M West in February. “As such, I’m expected to just consent, comply, and hope everything is all right. There’s not much room for collaboration; there are no incentives.”
Campos is hoping to change that. In 2012, he made headlines upon launching a campaign to access the data collected by his Medtronic implantable cardioverter-defibrillator (ICD). Since then, Campos has emerged as a champion of the e-patient movement and ardent supporter of providing patients with the same level of access to device data as their physicians.
|Learn more about the innovative wireless and mHealth applications collecting data for the empowered patient at BIOMEDevice Boston March 26-27.|
“People with diabetes need access to their glucose levels in order to manage their lifestyle, and the perception is that cardiac rhythm is not quite like this,” Campos said. “Medical device companies aren’t in the business of providing data to patients; they’re in the business of designing life-saving therapy, which is a fair point. But it’s important not just what the device knows in terms of the data it collects from my body… but also data in the [larger] context of other patient-generated health data.”
But do the majority of patients really need—or even want—access to their medical device data?
For e-patient advocate Amy Tenderich, founder and editor of the blog DiabetesMine, the question is much more fundamental than that. “Is the patient respected? Is the patient considered a partner in their own care? Is there some level of acceptance that the patient might be able to do something with that data and might want to have the right to see the data collected about their own body?” she asked during the MD&M West panel. “There is the quantified-self group who want to look up everything, and they should have the freedom to do that. Other patients may not want to have the mountain of data, and they may not know what to do with it.”
The issue of granting patients access to medical device data is certainly a slippery slope. On one hand, informed patients may be more compliant and attentive, helping them to better manage their condition and, in turn, cutting costs out of the system. But unfettered access to device data could introduce a host of new issues, headaches, and possibly hazards.
Take, for example, the patient who wants data and then misinterprets or misuses it. Such a situation could pose a serious threat to patient safety—or at the very least prompt panicked calls to physicians. Lee Ehrlichman of LifeWatch Services noted during a presentation at MD&M West that FDA even questioned the depiction of an ECG waveform on the screen of the company’s Android-based medical smartphone. “They’re concerned that we’re going to scare people; they’re not going to understand what their ECG is, what is that waveform telling you? [FDA] wants it out,” he said.
Despite the complexity, it’s an issue that needs to be addressed. “This [issue is] not going to go away; I think it’s only going to become more ubiquitous as younger patients start getting these devices,” Campos said. “As the younger folks who are growing up with technology start getting these devices, I don’t think they’re going to settle for no access.”
He has a point. The next generation of tech-savvy, data-driven patients likely won’t sit idly by while they’re denied access to the data their own bodies are producing. Especially in the looming age of Apple’s rumored iWatch and other biosensing devices.
Part of the solution will likely come from an increasing emphasis on actionable data that will simultaneously sate patients’ appetite for data while aiming to improve outcomes. “The people who are designing the products can help us by making the data useful,” Tenderich said. “But at the same time, the core issue of this patient movement is that medical device design is about us. It’s about the lives of the people who are wearing these things all the time and the impact that these devices have on our lives.” That logic is tough to argue.