FDA isn't doing enough to prevent medical device hacking, HHS report says
&quot;Medical Device Hacking&quot; is a large part of how my wife and I slept at night for the last few years, based on the open source  Nightscout [1] project which interfaced my kids&#x27; Dexcom CGMs to our smartphones. Continuous Glucose Monitors allow T1Ds to track their blood sugar without finger sticks and are particularly useful at night for catching lows.<p>The Nightscout project was a strong motivator for Dexcom to push harder on developing and improving their remote monitoring solution. A solution which could easily have languished in R&amp;D and FDA approval hell for another 5-10 years got to market much more quickly once users were out there DIY&#x27;ing their own remote monitors.<p>Additionally there are a lot of &quot;mis-features&quot; that are coded into T1D products, presumably foisted on companies by the FDA to avoid liability, but which ultimately are a mild form of torture on end-users day in and day out. Having an option to turn to open source alternatives when the incessant alarms which can&#x27;t be disabled are driving you mad is better than throwing out the device altogether. For those who haven&#x27;t used or know anyone who has a pump, pod, or CGM -- the problem is that the devices are subject to dozens of variables which impact their performance, reliability, or accuracy, and alarms are often &quot;lacking context&quot; (to put it mildly) or outright wrong.<p>E.g. When you&#x27;ve treated a low and double checked with a finger stick that blood sugar is rising, a siren going off every 5 minutes from the CGM at 4am is enough to want to remove the CGM and smash it with a hammer.<p>Having open source alternatives is a large part of, I believe, forcing Dexcom and even the FDA &quot;to the table&quot; to reconsider hard-coded patient hostile &quot;features&quot;. It&#x27;s easier to appease the lawyers and go into CYA mode, when there&#x27;s isn&#x27;t a strong open source competitor with 28,000 Facebook followers and a Github repo with 21,000 forks [2].<p>[1] - <a href="http:&#x2F;&#x2F;www.nightscout.info&#x2F;" rel="nofollow">http:&#x2F;&#x2F;www.nightscout.info&#x2F;</a><p>[2] - <a href="https:&#x2F;&#x2F;github.com&#x2F;nightscout&#x2F;cgm-remote-monitor&#x2F;" rel="nofollow">https:&#x2F;&#x2F;github.com&#x2F;nightscout&#x2F;cgm-remote-monitor&#x2F;</a>