Health apps are hailed for revolutionizing medicine. Just one single little problem: Many of them are wildly incorrect.
Can your smartphone save a visit to the doctor’s office or even to the ER? That’s the premise of the $4-billion mobile health industry, with over 165,000 health apps open to download on your phone to diagnose, manage, and treat medical problems. One of many biggest sellers: Instant Blood Pressure. A software that offered ways to measure your blood pressure using only your smartphone, and required neither a physician nor any special equipment, it cracked the most effective 50 sellers list on Apple’s App Store following its release in 2014 and stayed there for 156 days.
There clearly was just one single problem. The app became wildly inaccurate. In a recently available study, Dr. Timothy Plante and a group from Johns Hopkins University unearthed that, typically, the app was off by 10 to 15 points when it measured people’s blood pressure. Plante also unearthed that the app had a low sensitivity for catching high blood pressure. “It missed almost 80 percent of hypertension readings within our population,” he tells Maclean’s. That is clearly a critical flaw because treating high blood pressure early can prevent complications like vision loss, kidney failure, heart attacks, and stroke—and catching it’s presumably why a client would download the $3.99 app.
AuraLife, the organization behind the app, has responded by posting detailed criticisms of the research on the website. Based on Ryan Archdeacon, CEO, and founder of AuraLife, the mobile application development was just validated for systolic blood pressures between 102 and 158, as stated in the FAQ portion of their website. This means that the app won’t produce readings outside this range, and blood pressures above or below that threshold would either yield one message or wrong value. He also stresses that Instant Blood Pressure is not really a medical app and not designed to diagnose disease.
However, comments located on the App Store suggest that’s just what everyone was relying on it for. Numerous comments reveal that patients with hypertension, on dialysis, and with other medical problems were utilizing the app to monitor their blood pressure and adjust medications. Instant Blood Pressure had 148,000 downloads and spawned several copycat apps. Given its popularity, Plante worries about how precisely many individuals might be by using this technology inappropriately. “There is a big concern for public health complications from a wrong, popular app,” says Plante in an interview.
But Instant Blood Pressure isn’t the very first health app to flunk of its promises. In 2011, Pfizer sent a letter to doctors to give a warning that its Rheumatology Calculator app was making critical mistakes when it measures disease severity in arthritis patients. In 2012, Sanofi recalled its diabetes app for miscalculating insulin doses and putting users at an increased risk for severe blood sugar levels spikes and drops. And in February 2015, the Federal Trade Commission in the U.S. concluded a motion against two apps that claimed they may diagnose skin cancer by analyzing an image of a mole.
Nor is this a challenge for just very specialized apps. A 2015 systematic review discovered that while popular fitness trackers like Fitbit and Jawbone perform a good job as step counters, they often underestimate the total amount of energy you burn, and overestimate sleep time and sleep efficiency.
“Several of those apps are very impressive in idea and design, but what’s missing is of good research and data to guide them,” says Nathan Cortez, professor of law at Southern Methodist University. He says the area of the problem is that the FDA is not aggressive in forcing companies to substantiate their health claims. What enforcement that does happen is led by the FTC due to false or misleading consumer advertising. As an example, it had been the FTC that forced brain-training game maker Lumosity to drop claims that having its product may help prevent Alzheimer’s disease and dementia. Lumosity also had to cover a $2 million settlement to the U.S. government.
As you go along, medical apps also generally fall outside governmental regulation in regards to data security. A study published last month in the Journal of the American Medical Association discovered that over three-quarters of the 271 diabetes apps studied by researchers shared users’data with third-party websites and placed tracking cookies on users’ phones. Worse, over fifty percent didn’t disclose the fact these were sharing information. The authors of the analysis warn that while “patients might mistakenly think that health information entered into software is private . . . that generally isn’t the case.” Many apps, once downloaded, also outlive the businesses that built them. Of the diabetes apps that researchers looked over, 60 became unavailable within six months. Despite disappearing from the marketplace, they are able to stick to users’ phones unless actively deleted. The Instant Blood Pressure app was taken off the App Store in July 2015 for undisclosed reasons and it remains unclear just how many phones can always have working copies of the app installed on them. AuraLife CEO Archdeacon declined to comment for this informative article concerning the explanation for its removal.
Some in Congress expressed the worried that more regulation would stifle innovation. But Cortez sees it differently. He knows both patients and physicians begin to see the potential these apps provide with regards to convenience for patients. But he worries that without proper oversight and control, we won’t have the ability to trust the data medical apps are giving us. He chooses software outsourcing services to construct it and believes both the general public and the will be better off if the FDA required apps to substantiate their claims.
In Canada, the medical devices bureau of Health Canada has considered, regulates, and approves the sale of medical apps that impact positively on the industry. By email, Health Canada explained so it evaluates apps employing a risk-based strategy; those judged to be low-risk do not want a medical device license, so long as the owner is an authorized company. Additionally, it provides a website application development, mdall.ca, listing all licensed apps. Instant Blood Pressure isn’t on the list but was still open to Canadian consumers.
“I’d imagine that many of the apps Canadian consumers might have on the phones haven’t had their validity assessed by Health Canada,” says Matthew Herder, associate professor of law and medicine at Dalhousie University. He says the serious problem is that for too much time resources have already been rescinded from the folks in control of enforcement. “This really is not just a question of whether we’ve sufficient means in law to deal with the problem. It’s whether we have got the will to enforce the regulations we have.” Health Canada generally works on the “co-operative approach” in regards to enforcement. This usually involves sending offending companies a compliance letter asking them to voluntarily comply with the law. That will mean changing labeling or removing offending lines from their advertising. Much more serious actions like fines and court injunctions to prevent sales or advertising are rarely used options.
And yet, despite the countless problems, nearly everyone believes that mobile health apps have the ability to transform exactly how we practice medicine. “I love these specific things,” Cortez admits, “I have an Apple Watch and a telephone filled with apps. My interest is in trying to produce a framework so these specific things truly meet their potential down the road. I recently worry we’re likely to be flooded with products that don’t work.”