Becker's Hospital Review

51 CIO / HEALTH IT Cardiologists warn against Apple's health push, FDA watch software approval By Mackenzie Garrity W ith the release of its latest Apple Watch, Apple touted features that detect if wearers have atrial fibril- lation, but some cardiologists are questioning the feature's effectiveness and potential for harm, according to Politico. When the watch detects an irregular heart rhythm, it warns users, possibly prompting them to seek medical help. is is what cardi- ologists are concerned about, as many of the warnings could be false positives leading to unnecessary medical tests. Apple Watch users are typically younger, wealthier and healthier, not the average profile for someone who needs to worry about atrial fibrillation. Cardiologists suggest that the watch may detect atrial fibrillation in people who are not seriously sick or at danger of a cardiac event. "It might turn out to be the case that if you put a monitor on a hundred people who'll never turn out to have a stroke, some of them might have tiny amounts of afib throughout their life," Ann Arbor-based University of Michigan nuclear cardiologist Venk Murthy, MD, told Politico. Cardiologists also don't know the percent- age of healthy people who might have atri- al fibrillation with no medical significance. It becomes concerning to think people are getting unnecessary treatment because atrial fibrillation treatment can involve a lifetime taking blood thinners. e FDA seemed overly eager to approve the Apple Watch's atrial fibrillation feature, according to some people quoted in the Po- litico article. While the agency granted clear- ance of the new watch feature last fall, the company has published little performance data. In data that was published in Decem- ber, Apple revealed the watch had sensitivity and specificity rates greater than 98 percent. Cardiologists describe the sensitivity rate as a "moderately good" result, but Dr. Murphy told Politico: "Take a moderately good test and apply it to a population with a very low risk of atrial fibrillation, and you will have a lot of false positives." And while FDA Commissioner Scott Gottli- eb hailed his agency's approval of the watch's atrial fibrillation soware as a "significant step forward in FDA policy because we de- coupled review of the app from review of the watch itself," some critics have complained about his enthusiasm for Apple. "e FDA is responsible for regulating the industry, not fostering its growth," Jason Brooke, a medical device expert, wrote to Politico. "eir mission is to promote and protect the public health." n Change Healthcare files for $100M IPO By Emily Rappleye C hange Healthcare submitted an S-1 filing March 15 to the Securities and Exchange Commission for a proposed $100 million initial public offering, Seeking Alpha reported. The Nashville, Tenn.-based data analytics firm provides health systems, physicians and pay- ers with information to improve clinical de- cision-making, streamline the revenue cycle process and enhance patient experience. Last year, it launched an enterprise-level blockchain solution for claims management, its Intelligent Healthcare Network. Change Healthcare has not yet determined the number of shares it will offer, nor the price range of the offering, according to a company statement emailed to Becker's. It applied to list its common stock on the NASDAQ Global Select Market under the symbol "CHNG." Change Healthcare reported nearly $3.3 billion in total revenue and $192.4 million in net income for the fiscal year ended March 31, 2018. n Former Theranos employees report being blacklisted by other tech firms By Emily Rappleye W ith a black mark on their resumes, some former Thera- nos employees report having trouble finding new work, according to a CNN Business report based on interviews with recruiters and seven former employees. The company, valued at $9 billion in 2014, went from famous to infamous after the first damning report was published in The Wall Street Journal in 2015. The company officially shut down last fall, and now founder and former CEO Elizabeth Holmes faces federal fraud charges. However, in 2016, roughly 700 to 900 people still worked at the company. While some former employees have moved on to roles at tech firms like Facebook and Amazon, other former employees — particularly those with longer tenures or more senior roles — have spent months or years searching for a new job, according to CNN Business. Former employees told the publication recruiters pointed to Theranos as the reason they were rejected from jobs. One em- ployee said they took a job at a startup, only to be told their past at Theranos would be a red flag to investors. Multiple companies told CNN Business they do not have policies against hiring Theranos employees. However, tech recruiter Sam Wholley told CNN Business skepticism still exists. Companies think, "My board would kill me," he said. n

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