Christy Lynn was tired all the time, and, after months of trying to diagnose the problem, one of her doctors thought they’d figured out why.“I didn’t fit any of the descriptions for sleep apnea,” she told me on a phone call. “I’m a woman, I wasn’t overweight. No one would have thought to test me, except I was seeing a doctor who had a similar medical history.”
Some CPAP machines allow patients to see rudimentary data on the screens of the machines themselves, but very few machines actually give patients access to all the data that’s being collected. One popular CPAP manufacturer, ResMed, makes data analysis software called ResScan, which, because of federal law, is only available to medical professionals or “on the order of a physician.”
"I became increasingly disgusted at how the CPAP industry is using and abusing people"
Campos “was tracking his Pacemaker data on a Google Spreadsheet—not an ideal patient care situation,” Andrew Sellars, who at the time was a lawyer at Harvard’s Berkman Center for Internet and Society and represented Campos, told me on the phone. “The pacemaker transmits data to a base station. His idea was to intercept that signal as it’s taken off the pacemaker in order to find out what his heart was doing.”Medical device companies vehemently fought Campos and Sellars’s petition: “The medical device manufacturers took the position that the data is formatted in such a way that it’s protected, copyrighted information that’s protected by the DMCA,” Sellars, who is now director of the Boston University/MIT Technology & Cyberlaw Clinic, added.AdvaMed, a trade organization that lobbies on behalf of the medical device industry, told the copyright office in a petition to block Campos’s request that “patients directly accessing the data on their devices may not understand the format of the data or may misinterpret the data. Such data access rights can be exercised (and already are provided) through health care providers having the appropriate tools and training to collect and protect patient data without compromising the safety and longevity of his or her device.”
The medical industry argued that "patients directly accessing the data on their devices may not understand the format of the data or may misinterpret the data. Such data access rights can be exercised (and already are provided) through health care providers"
The FDA, meanwhile, told the Copyright Office at the time that any device that was user-modified could not be marketed or resold without FDA approval, and that if any modified machine hurt a patient, the agency could have trouble determining whether it was the device manufacturer’s fault or the software modifier’s fault. But ultimately, the FDA did not try to stop the exemption from going through: “FDA recommends that the final rule explain that nothing in the rule will affect the regulation of products that fall within the jurisdiction of other federal agencies.”In a major win for consumers, the Librarian of Congress granted the exemption, which legalized not only Campos’s attempts to gain access to his pacemaker data, but also the type of hacking that Watkins is doing with SleepyHead. Earlier this year, the exemption was renewed, and no medical device manufacturers (nor anyone else) attempted to stop it. AdvaMed declined to comment for this article. Medical Alley did not respond to a request for comment in time for publication; none of the CPAP manufacturers I contacted responded to a request for comment.
"Apnea Board freely distributes CPAP Clinician Manuals and publicizes the ‘secrets’ of these CPAP machines to our members so they can educate themselves and take control of their own sleep apnea therapy if they so choose"
Apnea Board has become a bastion of information and self-taught sleep apnea experts; the forum features a private section in which users can download user manuals and, in some cases, leaked manuals that are intended for doctors. These manuals teach users how to get into the “clinician menu” where they’re able to modify their CPAP’s settings to tailor their treatment in coordination with what SleepyHead is telling them about their treatment.“Apnea Board freely distributes CPAP Clinician Manuals and publicizes the ‘secrets’ of these CPAP machines to our members so they can educate themselves and take control of their own sleep apnea therapy if they so choose,” SuperSleeper told me. “Once one knows these ‘secrets,’ it's relatively easy to get into and program the ‘Clinician Menu’ of most CPAP machines, although increasingly, manufacturers are making it more difficult for patients to do that, and a bit of ‘hacking’ might become necessary with some machines.”Both Levine and Lynn say that the combination of SleepyHead and the forums has completely changed their lives and their treatments.“When you’re first diagnosed, you feel alone,” Levine said. “On the forum, people say ‘hey, this is what happened to me last night, and this is what I did. What do you recommend?’”Lynn said that, when her doctors analyzed her numbers, they were looking at an average of her last six months, and not individual nights that may have been harder than others: “They’re not drilling down to where your problems are happening.”“I can see the numbers every day on SleepyHead and I can tweak my settings,” she said. “I’ve been upping my exhale pressure to get my numbers down. I feel a lot better than I did when I was first diagnosed. I have more energy, I sleep better.”Several people with sleep apnea I spoke to said that any concern that altering their treatment is dangerous is misplaced; many said they believe it’s fear-mongering by doctors and device manufacturers, and all of them stressed that they would never make modifications without fully understanding how the machines work and what the data is telling them.Lynn said that treating herself is the only option that’s ever worked, and it’s the only option she has.“I’m 62 years old and I don’t have health insurance because I can’t afford it and I’m self employed,” she said. “I would be devastated if I lost the software. If it quit working, I don’t know what I would do.”
"I would be devastated if I lost the software. If it quit working, I don’t know what I would do.”