Blog Tag: FitBit
Fitbit recently announced plans to build sleep apnea diagnostics into its wrist-worn activity tracking devices, stating that it expects do so within a year. If successful, Fitbit may be able to address a market that is expected to have $6.7 billion in revenue by 2021.
Sleep apnea is characterized by pauses in breathing and shallow breath and comes with an increased risk of heart failure, obesity, and strokes. While it affects about 18 million American adults today, one of the biggest concerns is that many affected people do not realize they are affected. Traditionally, sleep apnea diagnosis involved capturing electroencephalograms (EEG) using electrodes that track brain electrical activity. Such EEGs generally require cumbersome overnight visits to a sleep lab. Alternatively, although potentially not as definitive as EEGs, non-EEG based methods that combine cardiac, respiratory, and movement data may be used. However, alternative methods have not achieved broad use by the consuming public. According to its announcement, Fitbit aims to fill that gap in the market.
The fashion appeal of activity trackers and ease of use (i.e., simply wearing it) have fostered widespread adoption of activity tracking devices. Also, these devices have increased their functionalities over the years from merely counting steps to reporting heart rates and calories burnt, among others. It’s likely that these devices are here to stay and will get “smarter” and more capable. It may seem strange that “activity” trackers are seeking to carefully monitor inactivity, but they may prove up to the task — in fact, there is some evidence suggesting that the devices are better at measuring rest than activity.
In March, 2017, Fitbit released Sleep Stages, a feature that tracks whether the wearer is in a light, deep, or REM sleep. By combining heart rate analysis with more traditional movement tracking, a study found that it could determine sleep stages with a reasonable degree of accuracy. Fitbit has logged over 4 billion nights of sleep data, a data pool of over 23 million hours, from its users since 2010. However, reliable detection of sleep apnea may require a more advanced analysis than reliably categorizing sleep stages.
CNBC reports that Dr. Conor Heneghan, author of the study and Fitbit’s lead sleep research scientist, is researching additional data sources that Fitbit’s trackers may be able to exploit as potential indicators of sleep apnea. He explains:
We’re leveraging the fact that Fitbit has experience in optical electronics, and making them small and power efficient.
Fitbit’s activity/inactivity trackers will not cure or treat sleep apnea. Rather, CNBC reports that Fitbit seeks to provide reliable sleep apnea detection. Even if its forthcoming technically is sound, challenges may wait for Fitbit. The report notes that Fitbit isn’t yet certain how much it will need to work with the FDA and regulators in other countries. The device will most likely nudge a user to see a doctor rather than making a diagnosis. And, Roy Raymann, vice president of sleep science at SleepScore Labs, and the former sleep expert on Apple’s health team, opined that:
Doctors are often ultraconservative, so it remains to be seen whether they’ll accept data from a consumer wearable.
Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes of that associated data. In an interview with eWeek, chief intelligence officer Andrew Komarov noted that the hackers he investigated were able to compromise different health care institutions such as private clinics, vendors of medical equipment, and suppliers. Once inside the compromised systems, the hackers were able to take personally identifiable information and medical data, including imaging data (as shown to the right).
Komarov’s research should come as no surprise in view of a report issued by the Brookings Institute in May 2016 reporting that 23% of all data breaches occur in the healthcare industry. In fact, nearly 90% of healthcare organizations had some sort of data breach between 2013 and 2015, costing the healthcare industry nearly $6.2 billion.
According to a report done by Bloomberg BNA, while a number of legal mandates exist (e.g. the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology Certification Program, and the Food and Drug Administration’s (FDA) premarket review), the existing guidelines are limited. Furthermore, medical devices face certain unique cybersecurity pitfalls. For example, while HIPAA applies to protect health information regardless of where it’s stored, protected health information that exists on disposed of or nonfunctional medical devices can be overlooked.
Connected medical devices (i.e., medical devices that can transmit information through the internet or a networked system) also pose unexpected risks and challenges. For example, the ability for hackers to remotely access connected medical devices can hypothetically result in significant threats to patient health and safety. A 2012 episode of the television show Homeland featured a character hacking into and manipulating the pacemaker of the fictional vice president. While such situations seem far-fetched, in an interview on “60 Minutes,” it was revealed that Vice President Dick Cheney’s doctor had actually disabled the wireless functionality of his heart implant, fearing that it might be hacked in an assassination attempt.
While such fears may seem fueled by paranoia, recent studies have shown that such security threats may be a real concern. Bloomberg Businessweek reported in November 2015 that the Mayo Clinic engaged a number of high-profile “white hat” hackers to conduct a study of cybersecurity vulnerabilities in their medical devices. These “white hat” hackers worked on a number of different medical devices, including things such as cardiac monitors, infusion pumps, and hospital beds. In one alarming example, one hacker was able to gain control of an infusion pump – the Hospira Symbiq Infusion System – and was able to remotely cause it to deliver a potentially lethal dose of medication. Shortly thereafter, the FDA issued a safety notice recommending a recall and the stopped usage of the aforementioned pump.
With increasing concerns about cybersecurity, as discussed on this blog previously, the FDA is currently seeking comment on proposed guidelines that outline when software changes to medical devices would require manufacturers to submit a premarket notification.
Fitbit, Inc. reported its quarterly results which led to an 10% increase in its share price.
The company recently announced that Adam Pellegrini will join the company as Vice President of Digital Health on September 6th. According to the press release, Pellegrini has over 20 years of experience across multiple sectors in healthcare and was previously Walgreens Boots Alliance’s Vice President responsible for integrating digital health with the company’s wearables. According to the press release, Pellegrini is tasked to connect Fitbit’s products, information, data, and insights in new and innovative ways into clinical settings, and to develop new partnerships with healthcare, pharma, and medical device companies.
According to press releases, Fitbit products have been used frequently in clinical trials with scientists having already performed more than 200 studies based on 2 billion minutes of Fitbit data. One article professes that wearable devices can not only detect subtle shifts in biometrics, like heart rate and body temperature, but can also help women become pregnant with research indicating a spike from a resting heart rate before ovulation.
Although currently not a substitute for your annual checkup, wearable devices could potentially in the future suggest medical diagnoses, administer medication, and provide counseling.
Fitbit, Inc., a manufacturer of wearable health technology, is involved in a national class action lawsuit filed on January 5, 2016 in the Northern District of California over two of its wristbands, the Charge HR and the Surge, based on their “PurePulse” LED-based technology used for tracking heart rates. Generally, the lawsuit alleges that the heart-rate monitor used in those wristbands, advertised under the now amusing tag line “every beat counts,” does not monitor heart beats correctly. This allegedly especially occurs during times of intensive exercise.
In a statement to ArsTechnica responding to the lawsuit, a Fitbit spokesperson wrote, “We do not believe this case has merit. Fitbit stands behind our heart rate technology… [b]ut it’s also important to note that Fitbit trackers are designed to provide meaningful data to our users to help them reach their health and fitness goals, and are not intended to be scientific or medical devices.” Further, Fitbit released another statement after the lawsuit saying that “PurePulse provides better overall heart rate tracking than cardio machines at the gym.”