It is often said that it only takes one person to initiate change. Hugo Campos, a tech-savvy patient outfitted with an implantable cardioverter-defibrillator (ICD), is trying to be that catalyst for change in the medical device industry through his crusade for access rights to the data collected by his implant. And while Campos's campaign for patients' rights is just beginning to gain momentum, it signifies a larger paradigm shift in healthcare that will likely force medical device manufacturers to adapt their business models as patients become more active in managing their health and more vocal with their demands.
Thanks to a video of his presentation at TEDxCambridge (below), Campos has garnered increased attention from patients and media outlets alike in his quest for knowledge about his own health in the form of the raw, real-time data that the ICD collects. "Doctors have full, 24-7, unrestricted access to this information. Even some of the manufacturers of these medical devices offer the ability for doctors to access this information through mobile devices," Campos said during the presentation. "Compare this to the patient's experience. Patients have no access to this information; the best we can do is to get a print-out, hard-copy of an interrogation report when you go into the doctor's office for a 6- or 12-month visit. Also, these reports are designed for doctors, not patients, so a lot of patients are discouraged from even getting this information because it's hard to read. The irony is that patients are the ones living with heart disease—not doctors —and yet patients are the ones left in the dark."
Reasons cited by ICD manufacturers for leaving patients in the dark, according to Campos's blog, include the Health Insurance Portability and Accountability Act (HIPAA), the complexity of the raw data output, the desire to put the information into a meaningful context first, potential alarmism on the part of patients, and the fact that providing patient data does not fit into ICD makers' business models.
To be fair, they have some valid arguments. Access to seemingly infinite amounts of information on any disease or ailment has indisputably empowered patients and management of their health. On the flip side, this unlimited access to information has cultivated a tendency for information-seeking patients to be alarmist or self-diagnose, to some extent. Furthermore, complex technical data that are not presented in a user-friendly manner may do more harm than good for patients if misinterpreted or they could prove too difficult to bother. So, I don't think all of these defenses are mere excuses.
"The problem with this type of data is that it is very technical," David Lee Scher, MD, posted in the comments section of an NPR interview with Campos. "I make an argument for the device company to provide patients with portals which contain summaries that are easily understandable with explanations of pertinent data. The entirety of the data is sometimes too technical for even some physicians to understand and not relevant to patients. But there is definitely data which patients should have. I think a panel of patients with physicians of professional organizations (heart rhythm society) should work together on this."
And while ICD manufacturers certainly don't seem to be clamoring to accommodate this request for raw data, they don't seem to be ruling the possibility out, according to statements provided to MPMN. “Boston Scientific has been studying the option of releasing remote-monitoring data to patients for some time. We are still evaluating guidelines and other implications," company spokesperson Dave Knutson comments. "In addition, device data is much more complex than standard laboratory data and patients may require physician input to put the data in context. This context can be obtained during a regularly scheduled follow-up.”
Medtronic issued a similar response: "Medtronic CareLink data is provided to physicians to enable them to provide better care for patients. Medtronic is looking into ways to provide patients with meaningful and actionable information with regard to their implantable devices," says company spokesperson Kathleen Janasz. "We welcome the opportunity to hear from patients about what their needs are; we will take all of this feedback into consideration as we move forward in assessing the most-appropriate solution."
Both companies will likely get increasing feedback in coming months and years whether they welcome it or not, however. Because this issue isn't going away. "One thing is for sure: In this world of low-cost connectivity in which we live today, we all here should find it unacceptable for data to bypass the patient," Campos notes near the end of his TEDxCambridge presentation.
Whether you agree with Campos's stance or not about patient access to data aside, this last comment really resonates. Thanks to affordable smartphones, tablets, and ubiquitous Internet access, the age of the informed patient is here. Telehealth/telemedicine and remote monitoring have already begun shifting healthcare from the hospital to the home while the proliferation of apps and smartphone-enabled gadgets are empowering consumers to take control of their various conditions. So, it's only a matter of time before patients want access to all of their data and the means to monitor all conditions at their fingertips. Thus, providing patients with real-time data from their implants may not be part of medical device manufacturers' business models now, but it seems unavoidable that it will have to be in the not-too-distant future if they want to remain on top. Don't forget: If a company chooses not to accommodate this demand, eventually a competitor will.
It looks as though this debate about who owns the data being produced by a patient's body is just getting started. Luckily, it's an interesting one. Who do you side with: medical device manufacturers, Campos and patient advocacy groups, or both? Let us know in the comments section below. Plus, check out Campos's presentation in the video below. --Shana Leonard