We’re used to vulnerabilities in data systems leading to massive personal data breaches (cool visualization of those here.) But there’s an even darker side to hacking that can put peoples’ lives directly at risk. We’re talking medical device hacks. Two “white-hat” (good) hackers identified vulnerabilities in pacemakers and insulin pumps which “black-hat” (bad) hackers could use to injure patients. One scenario put forth is a pacemaker being manipulated to deliver too many or too few electric shocks, which obviously could lead to negative patient outcomes. The researchers shared their findings with the device manufacturer and relevant regulatory bodies, but they say these authorities are playing down the risks. They apparently considered bringing in a pig they could kill with an app to make their point, so we should probably take them seriously.
Tell us about your fitness device use…
Last week, researchers found that exercise can counteract the cognitive decline some patients experience post-breast cancer treatment. It’s the 457th publication since 2012 to use a Fitbit device in research. Or to put it a different way, this study found that 83 percent of clinical trials used a Fitbit as opposed to another brand. Researchers apparently just really prefer it. That’s good news for the company, since it now has a slew of clinical data under its belt, and it’s thinking about a run at a medical device designation a few years in the future. According to their GM of Health Solutions, “as we start going deeper down the health road with more and more advanced sensors, I’d say, just stay tuned.” Oooooh, mysterious.
When a medical device malfunctions, it is up to the doctor to alert the hospital, the hospital to alert the device maker, and the device maker to alert the FDA 30 days later. Not exactly a fast process. Well the US House of Representatives just approved a renegotiated agreement between the FDA and device industry that would push this 30 days back to three months. While device makers are happy because this agreement also includes lowering the proposed annual user fees, it has some watchdog groups and critics up in arms and bringing up all the bad memories the device industry wishes they could forget. Who knows, maybe malfunctioning trends will become more apparent with this extension, but it certainly doesn’t scream “patient safety.”
Millions of people depend on inhalation drug delivery devices to aid in relieving the symptoms of chronic respiratory diseases and acute respiratory attacks. Machines can often be bulky or inefficient in delivering the right doses of necessary drugs to the human system. But change is coming. Companies like SmartInhaler and Propeller are working to provide more data and reminders to patients online and through apps about the efficiency of their inhalation. These data can also be transmitted digitally to doctors or caregivers, presumably in support of monitoring medication compliance. It’s about time your inhaler joined the Internet of Things community, right? What’ll we connect next, an egg tray? That’s so 2016. Here are some other goofy things we’ve felt the need to webify.
Between emails, private information and (ahem) elections, what else could we possibly worry about getting hacked? How about medical devices? Yep, our pacemakers and insulin pumps are sitting there pretty much defenseless. To bring in some reinforcements, the US FDA has just released its final guidance on the post-market management of medical device cybersecurity. Devices nowadays are connected to hospital networks and even patients’ Wi-Fi so the FDA is suggesting that manufacturers consider cybersecurity throughout a device’s development and even once on the market (i.e., inside patients). This guidance includes detecting vulnerabilities, assessing the risk and deploying mitigations to address any issues. Thanks, technology. By the way, this is what we think all hackers look like. (Warning, you will not get smarter if you click that link).
In accordance with a new policy released last Wednesday, the FDA has increased patient accessibility to hearing aids. The guidance, which takes effect immediately, removes the requirement of medical evaluation or waiver-signing before buying a hearing device. The agency also said they’ll consider creating a category for OTC hearing aids. So go ahead and prepare yourself now for some campy, elderly-consumer-focused commercials. The move was done in part to encourage industry innovation/competition to create cheaper hearing devices, which would also serve to increase access for the 30 million Americans who live with hearing loss. That’s something we can all get behind, right? Hear, hear!
We’ve all had cuts and scrapes and most of them have healed pretty quickly. Well, the chronic wounds (i.e. diabetic ulcers) that affect 6 million US patients per year require a little more attention than antiseptic and a band aid. So much in fact that the US health care system spends an estimated $20B annually on treating these wounds. Cue the brilliant minds at Drexel University who have created a small, battery-powered, wearable device that uses low-frequency ultrasound to heal wounds. This caught the attention of the NIH who has awarded Drexel $3M to test the therapy over the next five years. Batteries make terrible band aids, but 6M patients a year means they’ll be in a lot of medicine cabinets.