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Should Patients Have Access to Data from Their Implanted Medical Devices?

Posted Dec 14 2012 12:00am

Here's an interesting topic that I had never considered before: should patients have unfettered access to the data captured by their implanted medical devices (see: Should You Have Unfettered Access to Your Implanted Medical Device Data?IMPLANT DEVICES COLLECT PATIENT DATA, BUT PATIENTS DENIED ACCESS ). Below is an excerpt from the first article that introduces the topic:

There was a very interesting story in the Wall Street Journal [see: Heart Gadgets Test Privacy-Law Limits ] that looked at the inability of patients who have implanted medical devices such as defibrillator implants to gain access to the raw information the devices are sending out. According to the story, the device manufacturers say that rules by the U.S. Food and Drug Administration (FDA) require that the information be only sent to the patients’ hospitals or doctors, who are in fact the device manufacturers’ end-item customers. If a patient want’s to get access to the raw device data, they are told that they have to get it from their healthcare provider...The device manufacturers argue that the data from a medical device like a defibrillator isn’t in a “useful format” that patients could understand anyway, and that if they were to try make it so, it would (a) require FDA approval and (b) cost the manufactures a lot of money, which they don’t want to spend. They also argue that they haven't seen any customer demand for such information.The FDA...generally “supports patient access” to medical device information, but only if it is in a format that is presented in a way that provides “proper interpretation and explanation,” like that delivered by a doctor. In other words, don’t count on the FDA to approve broad patient access to medical device information in “useful format” or not.

Many doctors support the FDA’s position, arguing that getting access to device information – especially raw information - might cause “cause anxiety or even harm if a patient misunderstood the signals.” However, there are other incentives also at work keeping patients from accessing raw or even interpreted medical device information.......If a patient wants their implanted device information, the patient is likely going to have get an appointment and pay whatever fee the doctor or hospital charges....Furthermore, a doctor or hospital usually doesn’t get the devices' raw data themselves anyway: device manufacturers only send output summaries to them....Device manufacturers typically make doctors and hospitals sign contracts that restrict use of the devices’ raw data. The manufacturers can do that because raw data from an implanted device is not considered to be medical record information under the 1996 Health Insurance Portability and Accountability Act (HIPAA) which gives a patient the right to access their medical information held by their healthcare provider.

It also turns out that the device manufacturers are exploring business opportunities to sell “the data to health systems or insurers that could use it to predict diseases and possibly lower their costs.”....The WSJ says that Medtronic , for example, “is developing a matchstick-size monitor, implantable without surgery, that could track measures such as heart rate and arrhythmia that can predict heart disease.” With such a device, Medtronic “envision(s) a future where employers might require insured workers with a family history of heart disease to have the device implanted or face higher insurance premiums.” Of course, if that "vision" became the norm, I wouldn’t doubt that the next step would be for employers to start insisting that all of their insured employees have non-surgically implantable devices to check on a whole host of health factors, such as drug and alcohol use...., the amount of sleep they are getting.

It becames rapidly apparent that this discussion has very little to do with access to the raw data being captured by defibrillator implants. Neither patients nor even cardiologists would be able to make sense of such data. However, fast-forward to the idea that patients at risk for acute cardiac problems in the near future may have implanted devices that would monitor their cardiac status in real-time and predict imminent problems. I could envision a scenario, as described in the excerpt above, in which employers or health insurance companies would be eager to tap into such data streams. In this way, they could avoid the high costs of acute care episodes by requiring early medical intervention. I Googled the search term "health monitoring device" and got 695,000 hits  so there is lots of interest in this topic. I predict that this will be one of the hottest topics in healthcare in the next year or two, particularly in relationship to smart phones supplemented by additional hardware and software that will be more common than implanted devices (see: "Check Engine Light" for Health Surveillance on Our Smart Phones ). 

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