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死于千次点击:电子病历问题在哪

美国政府曾经声称,病历电子化后,医疗系统将更完善、更安全,费用也会更亲民。十年之间花费了360亿美元,系统却还是一团糟,根源在于数字革命出了问题。就此,《财富》杂志和《凯撒健康新闻》展开了联?#31995;?#26597;。

47岁的安妮特·莫纳切利曾经在佛?#21830;?#24030;当律师,后来转行当旅店老板。最近她头顶阵阵发疼,调整姿势后疼痛反而加剧,感觉不像平常的偏头痛。2012年11月底,她两次前往斯托家庭诊所求医,但疼痛并未好转。

两个月后,莫纳切利死于脑动脉瘤。尽管出现了种种症状,也及时看了医生,但一直没有做检查和诊断,一直到她去世前几天被送往急诊才确诊。

莫纳切利的丈夫起诉了医生的工作单位斯托家庭诊所,该诊所拥有联邦资格?#29616;ぁ?#20315;?#21830;?#24030;新聘的检察官助理欧文·福斯特获指定为政府辩护。尽管看起来是一起典型的医疗事故案例,但福斯特即将有大发现。他的老板,美国律师?#27515;?#26031;蒂娜·诺兰称之为“医疗欺诈的新领域?#20445;?#24182;提出同类案件第一起诉讼,也获得了佛?#21830;?#24030;有史以来最高额的经济赔偿。

福斯特从莫纳切利的病历开始研究,发现一个难题。政府在法庭文件中声称,她的医生考虑过动脉瘤的可能性,为了排除,医生已经要求通过诊所的软件系统进行头?#21487;?#25551;。理论上,该项检测会发现莫纳切利大脑出血。但医生的指令并未进入检测室,压根就没有发出去。

医院的软件是由eClinicalWorks (eCW)开发的电子病历系统,简称EHR。eCW是美国病历软件主要销售商之一,目前在美国有85万专业用户。?#36824;?#22810;久福斯特便收集到一份令人不安的报告,?#19978;?#36153;者维权机构商业改进会提交的投诉,主要关于eCW用户面板出现的问题,还整理了全国各地提交的法律诉讼,?#24471;?#20844;司的技术并没有声称的先进。

在此之前,福斯特和大多数美国人一样,对电子病历几乎一无所知,但他很快就收集到了eCW 软件存在重大问题的线索,其中一些问题可导致安妮特·莫纳切利之类患者面临危险。

确凿的证据来自于2011年对该公司提出的指控。布兰登·德莱尼原先是英国警察,转行为成为电子病历专家,2010年纽约市聘用他负责赖克斯岛的eCW系?#31216;?#21160;工作。赖克斯岛是个监狱,当时关有10多万名囚犯。德莱尼入?#23433;?#20037;便发现系统出?#20013;?#22810;令人不安的问题,也成了他控告的基础。指控称,系统里病人的服药清单不可靠,处方药开不出来,已经停用的药物会显示为近期正在服用。有时电子病历列出一位患者的服药情况,备注却是医生给另外一名患者写?#21738;?#23481;,如此一来很容易误诊或开错药。2010年?#21152;?0000种处方缺少准确的开始和停药日期,可能引起用药不足或用药过量问题。德莱尼总结说,eCW的系统并未准确跟踪检测结果,据他统计有1884次检测没给结果。

2015年,佛?#21830;?#24030;正式启动了联邦调查。

The pain radiated from the top of Annette Monachelli’s head, and it got worse when she changed positions. It didn’t feel like her usual migraine. The 47-year-old Vermont attorney turned innkeeper visited her local doctor at the Stowe Family Practice twice about the problem in late November 2012, but got little relief.

Two months later, Monachelli was dead of a brain aneurysm, a condition that, despite the symptoms and the appointments, had never been tested for or diagnosed until she turned up in the emergency room days before her death.

Monachelli’s husband sued Stowe, the federally qualified health center the physician worked for. Owen Foster, a newly hired assistant U.S. attorney with the District of Vermont, was assigned to defend the government. Though it looked to be a standard medical malpractice case, Foster was on the cusp of discovering something much bigger—what his boss, U.S. Attorney Christina Nolan, calls the “frontier of health care fraud”—and prosecuting a first-of-its-kind case that landed the largest-ever financial recovery in Vermont’s history.

Foster began with Monachelli’s medical records, which offered a puzzle. Her doctor had considered the possibility of an aneurysm and, to rule it out, had ordered a head scan through the clinic’s software system, the government alleged in court filings. The test, in theory, would have caught the bleeding in Monachelli’s brain. But the order never made it to the lab; it had never been transmitted.

The software in question was an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble a dossier of troubling reports—Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country—suggesting the company’s technology didn’t work quite like it said it did.

Until this point, Foster, like most Americans, knew next to nothing about electronic medical records, but he was quickly amassing clues that eCW’s software had major problems—some of which put patients, like Annette Monachelli, at risk.

Damning evidence came from a whistleblower claim filed in 2011 against the company. Brendan Delaney, a British cop turned EHR expert, was hired in 2010 by New York City to work on the eCW implementation at Rikers Island, a jail complex that then had more than 100,000 inmates. But soon after he was hired, Delaney noticed scores of troubling problems with the system, which became the basis for his lawsuit. The patient medication lists weren’t reliable; prescribed drugs would not show up, while discontinued drugs would appear as current, according to the complaint. The EHR would sometimes display one patient’s medication profile accompanied by the physician’s note for a different patient, making it easy to misdiagnose or prescribe a drug to the wrong individual. Prescriptions, some 30,000 of them in 2010, lacked proper start and stop dates, introducing the opportunity for under- or overmedication. The eCW system did not reliably track lab results, concluded Delaney, who tallied 1,884 tests for which they had never gotten outcomes.

The District of Vermont launched an official federal investigation in 2015.

?#35745;?#26469;源:Photograph by The Voorhes for Fortune

政府发现,eCW系统当中面条一般混乱的代码错漏百出,修复一个故障就会冒出另外一个。举个例子,用户界面提供了要求检测或调出诊断图像的方法,但用起来经常失灵。软件可以检测并警告用户某些药物相互作用存在风险,但医生并不知情,只要药品订单是个性化定制的,警报就会停止。“就好比我在开车,收音机开着,雨刷也在工作,我一打转向灯,刹车突然失灵了。”福斯特说。

政府称,eCW系统没有采用标?#23478;?#29289;代码,有时连实验室和诊断代码也没有采用。

此案未提交陪审团审理。2017年5月,eCW 因涉?#21360;?#34394;假陈述”和向推广其产品的客户提供回扣支?#35835;?.55亿美元与政府和解,其中一名医生从中赚了数万美元。尽管和解金额创下纪录,但公司否认行为不当。多次要求eCW置评均未获回?#30784;?/p>

如果说,故事结局出人意料,那就是:美国政府提供资金帮助软件应用,而且资金一直没断。或者应该说:其?#30340;?#19968;直在?#25163;?#35813;软件。

说到这里,是个奇怪、悲伤,而且令人恼火的故事。焦点并不是一场诉讼,也不是一项草率的技术。确切地说,这是个容易出现问题的行业,而且以非常私人的方式与每个人生活相连。故事的核心是价值3.7万亿美元却徘徊在十字路口的医疗系统。最后是一系列无意中产生的后果,一项看起来引领时代潮流的大创意导致的意外死亡。

eCW’s spaghetti code was so buggy that when one glitch got fixed, another would develop, the government found. The user interface offered a few ways to order a lab test or diagnostic image, for example, but not all of them seemed to function. The software would detect and warn users of dangerous drug interactions, but unbeknownst to physicians, the alerts stopped if the drug order was customized. “It would be like if I was driving with the radio on and the windshield wipers going and when I hit the turn signal, the brakes suddenly didn’t work,” says Foster.

The eCW system also failed to use the standard drug codes, and in some instances, lab and diagnosis codes as well, the government alleged.

The case never got to a jury. In May 2017, eCW paid a $155 million settlement to the government over alleged “false claims” and kickbacks—one physician made tens of thousands of dollars—to clients who promoted its product. Despite the record settlement, the company denied wrongdoing; eCW did not respond to numerous requests for comment.

If there is a kicker to this tale, it is this: The U.S. government bankrolled the adoption of this software—and continues to pay for it. Or we should say: You do.

Which brings us to the strange, sad, and aggravating story that unfolds below. It is not about one lawsuit or a piece of sloppy technology. Rather, it’s about a trouble-prone industry that intersects, in the most personal way, with every one of our lives. It’s about a $3.7-trillion-dollar health care system idling at the crossroads of progress. And it’s about a slew of unintended consequences—the surprising casualties of a big idea whose time had seemingly come.

****

虚拟魔术子弹

电子病历本应发挥巨大作用,让药物更安全,提供更优质的护理,给患者更多权利,甚至还能省钱。支持者宣称,将来研究人员可以利用系统内的大数据来找出最?#34892;?#30340;治病方法,同时大幅减少医疗差错。相应地,患者也可?#26434;?#26377;真正便携的病历,瞬息之间就能向全国任何地方的医生和医院发送病史,急诊室抢救面临生死抉择时,病历堪称至关重要。

但是,距前美国总统奥巴马与联邦政府签署加速病历数字化的法律已经十年,联邦政府也已经大笔投入360亿美元,却拿不出什么像样的成果。《凯撒健康新闻》和《财富》杂志联合采访了超过100位医生、患者、IT专家和管理人员、医疗政策负责人、律师、政府高级官员以及好几家电子病历供应商的代表,其中还包括两家公司的首席执行官。采访揭?#35835;?#19968;次不幸错失的良机?#21512;?#22312;美国成千上万的电子病历并未形成电子信息生态,仍然处在杂乱无章?#20063;?#36830;贯的状态。此外,推广电子病历还将医疗机构与几乎难以忍受的技术强行捆绑,将电子病历行?#30340;?#38144;售额推上了130亿美元。

The Virtual Magic Bullet

Electronic health records were supposed to do a lot: make medicine safer, bring higher-quality care, empower patients, and yes, even save money. Boosters heralded an age when researchers could harness the big data within to reveal the most effective treatments for disease and sharply reduce medical errors. Patients, in turn, would have truly portable health records, being able to share their medical histories in a flash with doctors and hospitals anywhere in the country—essential when life-and-death decisions are being made in the ER.

But 10 years after President Barack Obama signed a law to accelerate the digitization of medical records—with the federal government, so far, sinking $36 billion into the effort—America has little to show for its investment. Kaiser Health News (KHN) and Fortune spoke with more than 100 physicians, patients, IT experts and administrators, health policy leaders, attorneys, top government officials, and representatives at more than a half-dozen EHR vendors, including the CEOs of two of the companies. The interviews reveal a tragic missed opportunity: Rather than an electronic ecosystem of information, the nation’s thousands of EHRs largely remain a sprawling, disconnected patchwork. Moreover, the effort has handcuffed health providers to technology they mostly can’t stand and has enriched and empowered the $13-billion-a-year industry that sells it.

2009年2月,乔·拜?#24378;?#30528;贝拉克·奥巴马签署《美国?#27492;?#21644;再投资法?#32602;?#20854;中包括推广电子病历。?#35745;?#26469;源:Charles Ommanney—Getty Images

从一方面来看,努力已经实现目标,现在96%的医院采用了电子病历,2008年只有9%。但在大多数其他方面,新技术远未达到目标。医生抱怨系统笨拙不直观,还有花费在点击、打字和应付麻烦的大量时间,比花在病人身上的时间还长。与全球联网的ATM不一样,电子病历系统有700多家供应商,相互之间并不通气,也就是说医生传输医疗数据还是得用传真和CD-ROM。同时,患者想查看病历仍然不方便,就?#20146;?#19981;?#20581;?/p>

许多人说,电子病历的初衷是改善收费,而不是加强病患护理,所以并未降?#32479;?#26412;,“费用?#31995;鰲?#26356;容易,也就是账单支出上升(?#36824;行?#20154;说系统侦测欺诈行为也更容易)。

更?#29616;?#30340;是,《凯撒健康新闻》和《财富》杂志长达数月的联?#31995;?#26597;发现,政府提倡的电子病历并没有简化医疗流程,而是导致了大量未知的安全风险。调查发现上千份与软件故障、用户失误或其他缺陷有关,涉及病人死亡、重伤和侥幸脱险的惊人报告。多数资料淹没在政府?#25163;?#21644;私人资料堆里,鲜为人知。

导致问题更复杂的是根深蒂固的保密政策,因为一直保密,所以公众很难得知软件故障问题。电子病历供应商经常强制执行合同的“限制条款?#20445;?#38459;止采购方就安全问题和糟糕的软件安装情况发声,?#36824;行?#23458;户已经向法院起诉表达不满。此外,原告称医院经常拼命扣留受影响患者或家人的病历。两位坦?#29616;?#20986;电子病历问题的医生事后要求报道中不要泄露姓名,补充说他们工作的医疗机构禁止告诉外界。检察官助理福斯特说,“一?#33713;?#40664;之?#20581;?保护着电子病历供应商。

虽然软件减少了?#20013;?#26102;代一些常见的临床差错,但华盛顿特区梅德斯塔健康中心的研究员拉吉·拉特瓦尼记录了一些与电子病历有关的错误新方式,他认为新出现的问题很危险而?#31227;?#23454;可以预防。“我们不能在全国公布并要求立即解决问题,其他地方的患者可能受到同样问题的影响,不应该发生。”他表?#23613;?

大卫·布鲁门撒尔曾经在奥巴马政府担任全国医疗信息技术协调人,也是电子病历计划的设计者之一。他向《凯撒健康新闻》和《财富》杂志承认,电子病历“没有发挥潜力。也基本没有人会说发挥了潜力”。

By one measure, certainly, the effort has achieved what it set out to do: Today, 96% of hospitals have adopted EHRs, up from just 9% in 2008. But on most other counts, the newly installed technology has fallen well short. Physicians complain about clumsy, unintuitive systems and the number of hours spent clicking, typing, and trying to navigate them—which is more than the hours they spend with patients. Unlike, say, with the global network of ATMs, the proprietary EHR systems made by more than 700 vendors routinely don’t talk to one another, meaning that doctors still resort to transferring medical data via fax and CD-ROM. Patients, meanwhile, still struggle to access their own records—and, sometimes, just plain can’t.

Instead of reducing costs, many say EHRs, which were originally optimized for billing rather than for patient care, have instead made it easier to engage in “upcoding” or bill inflation2 (though some say the systems also make such fraud easier to catch).

More gravely still, a months-long joint investigation by KHN and Fortune has found that instead of streamlining medicine, the government’s EHR initiative has created a host of largely unacknowledged patient safety risks. Our investigation found that alarming reports of patient deaths, serious injuries, and near misses—thousands of them—tied to software glitches, user errors, or other flaws have piled up, largely unseen, in various government-funded and private repositories.

Compounding the problem are entrenched secrecy policies that continue to keep software failures out of public view. EHR vendors often impose contractual “gag clauses” that discourage buyers from speaking out about safety issues and disastrous software installations—though some customers have taken to the courts to air their grievances. Plaintiffs, moreover, say hospitals often fight to withhold records from injured patients or their families. Indeed, two doctors who spoke candidly about the problems they faced with EHRs later asked that their names not be used, adding that they were forbidden by their health care organizations to talk. Says Assistant U.S. Attorney Foster, the EHR vendors “are protected by a shield of silence.”

Though the software has reduced some types of clinical mistakes common in the era of handwritten notes, Raj Ratwani, a researcher at MedStar Health in Washington, D.C., has documented new patterns of medical errors tied to EHRs that he believes are both perilous and preventable. “The fact that we’re not able to broadcast that nationally and solve these issues immediately, and that another patient somewhere else may be harmed by the very same issue—that just can’t happen,” he says.

David Blumenthal, who, as Obama’s national coordinator for health information technology, was one of the architects of the EHR initiative, acknowledges to KHN and Fortune that electronic health records “have not fulfilled their potential. I think few would argue they have.”

梅德斯塔健康中心的拉吉·拉特瓦尼(站立者)与扎克·海廷格博士研究眼动追踪,从中了解医生如?#38382;?#29992;电子病历系统。?#35745;?#26469;源:Photograph by T.J. Kirkpatrick for Fortune

2017年1月,前总统奥巴马在?#37038;?#32654;国之音采访时也指出,电子病历是他最令人失望的工作之一。他叹道,“事实上还是有成堆的文件工作……医生还得输入资料,护?#22570;?#25152;有时间浪费在管理工作上。我们投入大笔资金想鼓励所有人数字化,赶上世界其他地区,现?#24403;仍?#26399;中困难得多。”

西玛·维尔玛是医疗保险和医疗补助服务中心(CMS)主管,负责监督现在的电子病历工作。她对花费数十亿美元研发的软件?#27425;?#27861;共享数据感到不寒而栗,这?#20146;?#26080;路可去的电子桥梁。“供应商各种开发了系统,可能运转顺利,也可能有问题。”今年2月她在?#37038;堋?#20975;撒健康新闻》和《财富》杂志采访时表示,“但我们没有考虑过各系统如何相互连?#21360;?#36825;才是最大的漏?#30784;!?

该倡议的诸位支持者当中,可能没有人比前副总统乔·拜登更难过。2017年在华盛顿医疗领导者的一次会议上,他痛斥将儿子博的病历从一家医院转到另外一家医院令人崩溃。“令人震惊的是,我儿子跟第四期胶质?#36214;?#32990;瘤斗争了一年。” 拜登说,“我连他的病历都拿不?#20581;?#25105;还是美利坚合众国的副总统……简直是一场噩梦。我们的医疗系统竟然差到这种地步,真是?#25343;?#22826;?#25343;?#20102;。”

The former President has likewise singled out the effort as one of his most disappointing, bemoaning in a January 2017 interview with Vox “the fact that there are still just mountains of paperwork?…?and the doctors still have to input stuff, and the nurses are spending all their time on all this administrative work. We put a big slug of money into trying to encourage everyone to digitalize, to catch up with the rest of the world?…?that’s been harder than we expected.”

Seema Verma, the current chief of the Centers for Medicare and Medicaid Services (CMS), which oversees the EHR effort today, shudders at the billions of dollars spent building software that doesn’t share data—an electronic bridge to nowhere. “Providers developed their own systems that may or may not even have worked well for them,” she tells KHN and Fortune in an interview this February, “but we didn’t think about how all these systems connect with one another. That was the real missing piece.”

Perhaps none of the initiative’s former boosters is quite as frustrated as former Vice President Joe Biden. At a 2017 meeting with health care leaders in Washington, he railed against the infuriating challenge of getting his son Beau’s medical records from one hospital to another. “I was stunned when my son for a year was battling Stage 4 glioblastoma,” said Biden. “I couldn’t get his records. I’m the Vice President of the United States of America?…?It was an absolute nightmare. It was ridiculous, absolutely ridiculous, that we’re in that circumstance.”

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无路可去的桥梁

拜登会告诉你,其实最初的设想很智能。数字化浪潮几乎席卷了每个行业,一方面是颠覆,?#34892;?#26102;候也提升了效率。也许各行业中没有比医疗更值得数字化。之前,生命检测和可能挽救生命的数据被锁在一堆堆文件里,堆放在全国各地的医生办公室。

记录放在?#27490;?#23376;里几乎毫无价值,人人也都同意,尤其是在iPhone刚出现的时期。批评家说,问题在于政策制定者如何改变利用方?#20581;?/p>

“每个想法都是善意的,可能会带来社会效益,但各种想法结合起来同时加在医生身上,会?#29616;?#24433;响?#23548;?#19994;务。”?#27492;?#20197;色?#20449;?#25191;事医疗中心的首席信息官约?#30149;?#21704;兰卡说。他曾经在乔治·W·布什和贝拉克·奥巴马领导下的电子病历标准委员会任职。“在美国,每个病人问诊时间有11分钟,要表现出同理心,要眼神交流,输入大约100条数据,还得从不犯错。这是不可能的!”

《凯撒健康新闻》和《财富》杂志调查了20多起医疗过失案件,其中电子病历要么涉嫌导?#24459;?#23475;,要么存在不当改动,要么向患者隐瞒不合格的护理。这种情况下,审判前经常会达成和解,附加以严格的保密?#20449;担?#25152;以经常没法判断诉讼的法律意义。电子病历供应商也经常在合同里明确规定,?#27492;?#35859;的“免责条款?#20445;?#22914;果此后医院因医疗事故遭起诉,即使与技术问题有关也不必承担责任。

但就像法比?#30149;?#32599;尼斯基的案例,?#34892;?#35785;讼确?#30340;?#35753;隐匿的真相浮出水面,非常有说服力。

罗尼斯基在控诉中称,2015年3月2日下午他由救护车送抵位于圣莫尼卡的?#31456;?#32500;登斯圣约翰医疗中心。这名年轻的律师已经?#29616;?#22836;疼两天,发烧到头晕眼花,连告诉911接线员地址都困难。

医生怀疑是?#38405;?#28814;,于是进行脊椎穿刺。第二天,一名传染病专家在医院的电子病历系统里下令做关键的实验室检测,排查脊髓液中有没有病毒,也包括单纯疱疹。

这?#20934;?#20540;数百万美元的电子病历系统由Epic系统公司制造,一些人认为该公司堪称医疗软件领域的凯迪拉克,安装时间约在四个月前。虽然指令出现在Epic的屏幕上,却没有传到实验室。根据2017年2月罗尼斯基在洛杉矶高?#30830;?#38498;提起的诉讼,事实证明Epic的软件与实验室的软件未实现完全“对?#21360;薄?#20182;声称,检测结果和诊断被推迟了几天。在这期间,他因疱疹?#38405;?#28814;出现了不可逆转?#21738;运?#20260;。起诉书称,由于该差错,医生?#26376;?#23612;斯基使用名叫阿昔洛韦的药物出现延误,而服用该药可能大大降低罗尼斯基的大脑受损。

Epic否认其软件应承担责?#20301;?#23384;在缺陷。该公司表示,医生发送指令时没有按对按钮,医院(而非Epic)已经配置与实验室的接口。法庭记录显示,Epic是美国最大的电子病历制造商之一,也是美国大多数精英医疗机构的主要供应商,2018年7月?#37027;?#25903;?#35835;?00万美元和解。医院和两名医生总共支?#35835;?50万美元,另有一个针对第三名医生的案件正在审理中。34岁的罗尼斯基正在努力?#25351;?#29983;活,他拒绝置评。

数据显示,发生在罗尼斯基或安妮特·莫纳切利身上的事件其实很常见,有点出人意料。类似案例中,关于谁应该承担责任的来回讨论?#23548;噬现?#26159;问题的一部分:系统经常很混乱(而且正确操作的培训很缺乏),结果是出了错各方都不认。很难说清楚从哪里开始算人为失误,从哪里开始算技术上的缺陷。

电子病历?#20449;?#23558;患者所有记?#21363;?#22312;同一处,但通常这就是问题。?#34892;?#20449;息很关键,或者时效很重要,却常常被淹没在海量数据中。在快速的医疗决策中,在复杂的下拉菜单里,很有可能遗漏关键信息。

13岁的布鲁克·迪利普兰对乳制品过敏,医院却提供了含有益生菌的牛奶。根据她母亲提起的诉讼,两剂药导致她陷入“完全呼吸窘迫?#20445;?#23548;致肺萎陷。12岁的罗里·斯坦顿在体育课上刮伤了手臂,急诊室的医生根据电子病历上并不完整的检测结果让他出院,之后他死于脓毒症。还有42岁的?#26032;?#26031;·埃里克·邓肯,2014年他从达拉斯一家出现埃博拉病毒的医院回家。虽然有一名护士在电子病历中写到他最近去过利比里亚,而当时利比里亚正流行埃博拉病毒,医生却没有看到这段信息。一周之后邓肯去世。

许多类似案件最终诉诸法律。通常情况下,医生和护士会指责病历系统中的技术问题。电子病历供应商指责人为错误。与此同时,案件不断增多。

Quantros是一家私人医疗分析公司,声称已经记录2007年到2018年18000起与电子病历的安全事件,其中3%导致患者受到伤害,其中包括7例死亡事件。 Quantros的一位主管称死亡数字被?#25226;现?#20302;估”。

2016年,位于华盛顿特区的患者安全监督机构The Leapfrog Group进行的一项研究发现,医院电子病历系统中的药方,也是政府要求?#29616;?#30340;一项功能,在每个系统中通常配置不同。测?#38405;?#25311;中,39%的病例未能标?#20052;?#22312;有害的药方,其中13%的案例可能致命。

过去几年里,皮?#21364;?#21892;信托基金会开展了一项电子病历安全项目,主要为了解决可用性和将正确的病历与患者匹配等问题。看起来是一个简单的任务,但即便同一家电子病历供应商制造的系统也经常失败。根据皮尤的说法,在一些机构中,匹配准确?#25163;?#26377;50%。患者也发现了问题。1月凯撒家庭基金会的一项调查发现,五分之一的患者发现电子病历中存在错误。

负责?#29616;?#21307;院的联合委员会已经就一些问题提出警告,包括电子病历和医疗设备警报当中85%到99%的误报。(俄勒冈健康与科学大学的研究人员进行的一项研究?#20848;疲?#22312;重症监护室工作的临床医生每天可能受到多达7000个被动警报影响。)过度警告可能引起危险。2014年至2018年期间,委员会统计了170份志愿报告,内容是警报管理和警报疲倦对患者造成伤害,警报疲倦是指医护人员因为受到过多不必要的警告影响,忽略了?#32423;?#26377;意义的信息。170起案例中,101起导致患者死亡。

宾夕法尼亚患者安全局是一家独立的全国机构,负责收集有关?#22909;?#20107;件的信息,2016年1月至2017年12月期间,共统计了775起与医疗IT技术相关的“实验室检测问题”。

当然了,在手抄?#20107;?#30340;时代存在大量医疗差错。例如,当医院工作人员误解医生潦草的字迹或看错?#24613;恚?#23601;会引发致命后果。看看现在有多少医生更愿意?#26031;?#25805;作而不使用电子病历,或许可以?#24471;?#19968;些问题。亚伦·扎卡里·赫廷格是华盛顿梅德斯塔医疗中心的急诊内科医师,他表示跟其他医生分享重要的患者信息时,都会把信息写在白板上或纸巾上,然后放在同事的电脑键盘上。

美国?#31216;?#33647;物管理局(FDA)没有强制就电子病历安全事件上交报告,与医疗设备相关的事件须上报。但在FDA Maude的?#22909;?#20107;件数据库中,相关事件的数量出现激增,目前该数据库已经成为关于各种系统警告的专门公告板。

令情况更加复杂的是,医疗机构几乎总是根据自身要求定制整体的电子病历系统。定制行为导致每个系统都很特别,很难与其他系统比较,反过来也导致错误的来源难以判定。

马丁·马卡里是约?#30149;?#38669;普金斯大学的外科肿瘤学家,也是2016年一项?#36824;?#27867;引用的研究合著者,该研究将医疗差错列为美国第三大死因。他认为,电子病历安全性方面有所改善,包括最近一些有助于?#31181;?#38463;片类药物流行的调整。但是他表示,“我们只是把一些问题换成了另一些。过去跟?#20013;?#30340;潦草字迹和信息丢失斗争。现在问题变成写处方和开药时有没?#20449;?#38169;病人,系统提示并不明确。”

约瑟夫·施耐德是得州大学西南医学中心的儿科医生,他认为纸质病历到电子病历好?#21364;?#39532;?#24403;涑善?#36710;。但他补充说,“但医学上的‘汽车’才刚发展到20世纪60年代,还没有安全带和安全气囊。”

施耐德回忆起一件事,当时他的同事不明白为什么很多?#22987;?#20250;莫名其妙消失。他?#20146;?#32454;研究了几个星期才发现问题根源,因为医生一直输入大括?#27431;牛?#20063;就是{},连供应商代表也不知道使用?#32654;?#21495;会删除中间的文?#23613;#?#26045;奈德说,电子病历制造商最初指责医生有问题。)

从国?#19968;?#22763;联合会到得州医学会,再到?#31216;?#19982;药品管理局内部的领导人,长期以来阵营广泛的联盟一直呼吁监督电子病历安全问题。其中最直言不讳的是拉特瓦尼,他领导着梅德斯塔全国医疗人为因素中心,一个30人的研究所,致力于优化医疗技术的安全性和可用性。拉特瓦尼早年?#37038;?#22269;防工业,研究过信息显示直观性问题。他说,2012年前往梅德斯塔就职时,对医疗“使用的[数字]接口类型”感到震惊。

去年发表在《卫生事务》杂志上的一项研究中,拉特瓦尼及其同事研究了2012至2017年三家儿科医院的用药错误。研究人员发现,其中3243人部分是由于电子病历的“可用性问题” ,其中大约五分之一可能导致患者受伤。“糟糕的接口设计和执行不当都可能导致差错,有时甚至导致死亡,这种情况令人难以置信,也完全可以解决。”他说。“我们不应该让病人因此受到伤害。”

通过眼睛跟踪技术,拉特瓦尼用视频展示了两家美国领先的电子病历系统?#29616;?#34892;基本任务时多么容易犯错误。例如,急诊室医生开泰诺时会看到下拉菜单,其中列出了86个选项,许多与当前患者无关。医生必须仔细阅读清单,以免点错剂量或服药方式,许多人确实会点错。一项?#20848;?#26174;示,约1000个药方里,医生不小心选择了栓剂(系统内缩略为“PR?#20445;?#30340;剂量,而不是片剂(“OR?#20445;?#21058;量。这点差错还不至于伤害病人,但其他药品出现差错可能会伤害到病人,而且发生过。

今年早些时候,梅德斯塔?#27515;?#22240;素中心与美国医学协会共同发起了网站和公众意识宣传活动,呼吁人们对不?#19979;?#24310;的差错加强关注。他们将电子病历的缩?#30784;癊HR”改为“经常出错?#20445;‥rrors Happen Regularly)的缩写,还向国会提出请?#28014;?#25289;特瓦尼正在推动成立中央数据库,以跟踪相关差错和?#22909;?#20107;件。

其他人则转向社交媒体发泄。兰德公司的健康政策研究员马克·弗里德伯格也是执业初级护理医师,他在推特?#29616;?#25345;标签-#EHRbuglist,鼓励医护人员说倒苦水。上个月,推特上出现一个严厉批评Epic公司的戏?#25910;?#25143;,刚注册五天粉丝?#32479;?#36807;8,000人。第一条推文就模仿了Epic霸道的口吻:“我发现有个医生跟病人眼神有接触。?#27515;?#24656;怖行径必须停止。”

尽管电子病历系统被指罪行多多,主要问题在于经常疏忽导致用户遇上更大的麻?#22330;?/p>

以路?#23039;?#23433;那州奥奇纳医疗系统的医疗助理林恩·乔文为例。在一项尚未审理的2015年诉讼中,乔文声称Epic的软件未能就用药发出关键警告;乔文出现血栓的风险很高,尽管病历中有记录,但医院进行心脏手术后给她开了限制血液流动的药。她得了坏疽,下肢和前臂截肢。(奥奇纳医疗系统称,虽然无法对诉讼中的案例发表评论,但“仍会努力保障患者安全,坚信通过电子病历技术可以做得更好。”Epic拒绝置评。)

该诉讼称由于存在“大量重复数据?#20445;?Epic软件?#23433;?#30475;和理解起来?#25216;?#20854;复杂?#20445;?#35768;多医生也有类似抱怨。乔文说,医疗费用已经超过100万美元,而?#21307;?#27704;久残?#30149;?#35785;讼还称,丈夫理查德为了照?#27492;?#19981;得不提前从肯纳市的工作中退休。各方均拒绝置评。

A Bridge to Nowhere

As Biden will tell you, the original concept was a smart one. The wave of digitization had swept up virtually every industry, bringing both disruption and, in most cases, greater efficiency. And perhaps none of these industries was more deserving of digital liberation than medicine, where life-measuring and potentially lifesaving data was locked away in paper crypts—stack upon stack of file folders at doctors’ offices across the country.

Stowed in steel cabinets, the records were next to useless. Nobody—particularly at the dawn of the age of the iPhone—thought it was a good idea to leave them that way. The problem, say critics, was in the way that policymakers set about to transform them.

“Every single idea was well-meaning and potentially of societal benefit, but the combined burden of all of them hitting clinicians simultaneously made office practice basically impossible,” says John Halamka, chief information officer at Beth Israel Deaconess Medical Center, who served on the EHR standards committees under both George W. Bush and Barack Obama. “In America, we have 11 minutes to see a patient, and, you know, you’re going to be empathetic, make eye contact, enter about 100 pieces of data, and never commit malpractice. It’s not possible!”

KHN and Fortune examined more than two dozen medical negligence cases that have alleged that EHRs either contributed to injuries, had been improperly altered, or were withheld from patients to conceal substandard care. In such cases, the suits typically settle prior to trial with strict confidentiality pledges, so it’s often not possible to determine the merits of the allegations. EHR vendors also frequently have contract stipulations, known as “hold harmless clauses,” that protect them from liability if hospitals are later sued for medical errors—even if they relate to an issue with the technology.

But lawsuits, like that filed by Fabian Ronisky, which do emerge from this veil, are quite telling.

Ronisky, according to his complaint, arrived by ambulance at Providence Saint John’s Health Center in Santa Monica on the afternoon of March 2, 2015. For two days, the young lawyer had been suffering from severe headaches while a disorienting fever left him struggling to tell the 911 operator his address.

Suspecting meningitis, a doctor at the hospital performed a spinal tap, and the next day an infectious disease specialist typed in an order for a critical lab test—a check of the spinal fluid for viruses, including herpes simplex—into the hospital’s EHR.

The multimillion-dollar system, manufactured by Epic Systems Corp. and considered by some to be the Cadillac of medical software, had been installed at the hospital about four months earlier. Although the order appeared on Epic’s screen, it was not sent to the lab. It turned out, Epic’s software didn’t fully “interface” with the lab’s software, according to a lawsuit Ronisky filed in February 2017 in Los Angeles County Superior Court. His results and diagnosis were delayed—by days, he claims—during which time he suffered irreversible brain damage from herpes encephalitis. The suit alleged the mishap delayed doctors from giving Ronisky a drug called acyclovir that may have minimized damage to his brain.

Epic denied any liability or defects in its software; the company said the doctor failed to push the right button to send the order and that the hospital, not Epic, had configured the interface with the lab. Epic, among the nation’s largest manufacturers of computerized health records and the leading provider to most of America’s most elite medical centers, quietly paid $1 million to settle the suit in July 2018, according to court records. The hospital and two doctors paid a total of $7.5 million, and a case against a third doctor is pending trial. Ronisky, 34, who is fighting to rebuild his life, declined to comment.

Incidents like that which happened to Ronisky—or to Annette Monachelli, for that matter—are surprisingly common, data shows. And the back-and-forth about where the fault lies in such cases is actually part of the problem: The systems are often so confusing (and training on them seldom sufficient) that errors frequently fall into a nether zone of responsibility. It can be hard to tell where human error begins and the technological shortcomings end.

EHRs promised to put all of a patient’s records in one place, but often that’s the problem. Critical or time-sensitive information routinely gets buried in an endless scroll of data, where in the rush of medical decision-making—and amid the maze of pulldown menus—it can be missed.

Thirteen-year-old Brooke Dilliplaine, who was severely allergic to dairy, was given a probiotic containing milk. The two doses sent her into “complete respiratory distress” and resulted in a collapsed lung, according to a lawsuit filed by her mother. Rory Staunton, age 12, scraped his arm in gym class and then died of sepsis after ER doctors discharged the boy on the basis of lab results in the EHR that weren’t complete. And then there’s the case of Thomas Eric Duncan. The 42-year-old man was sent home in 2014 from a Dallas hospital infected with Ebola virus. Though a nurse had entered in the EHR his recent travel to Liberia, where an Ebola epidemic was then in full swing, the doctor never saw it. Duncan died a week later.

Many such cases end up in court. Typically, doctors and nurses blame faulty technology in the medical-records systems. The EHR vendors blame human error. And meanwhile, the cases mount.

Quantros, a private health-care analytics firm, said it has logged 18,000 EHR-related safety events from 2007 through 2018, 3% of which resulted in patient harm, including seven deaths—a figure that a Quantros director says is “drastically underreported.”

A 2016 study by The Leapfrog Group, a patient-safety watchdog based in Washington, D.C., found that the medication-ordering function of hospital EHRs—a feature required by the government for certification but often configured differently in each system—failed to flag potentially harmful drug orders in 39% of cases in a test simulation. In 13% of those cases, the mistake could have been fatal.

The Pew Charitable Trusts has, for the past few years, run an EHR safety project, taking aim at issues like usability and patient matching—the process of linking the correct medical record to the correct patient—a seemingly basic task at which the systems, even when made by the same EHR vendor, often fail. At some institutions, according to Pew, such matching was accurate only 50% of the time. Patients have discovered mistakes as well: A January survey by the Kaiser Family Foundation found that one in five patients spotted an error in their electronic medical records.

The Joint Commission, which certifies hospitals, has sounded alarms about a number of issues, including false alarms—which account for between 85% and 99% of EHR and medical device alerts. (One study by researchers at Oregon Health & Science University estimated that the average clinician working in the intensive care unit may be exposed to up to 7,000 passive alerts per day.) Such over-warning can be dangerous. Between 2014 and 2018, the commission tallied 170 mostly voluntary reports of patient harm related to alarm management and alert fatigue—the phenomenon in which health workers, so overloaded with unnecessary warnings, ignore the occasional meaningful one. Of those 170 incidents, 101 resulted in patient deaths.

The Pennsylvania Patient Safety Authority, an independent state agency that collects information about adverse events and incidents, counted 775 “laboratory-test problems” related to health IT between January 2016 and December 2017.

To be sure, medical errors happened en masse in the age of paper medicine, when hospital staffers misinterpreted a physician’s scrawl or read the wrong chart to deadly consequence, for instance. But what is perhaps telling is how many doctors today opt for manual workarounds to their EHRs. Aaron Zachary Hettinger, an emergency medicine physician with MedStar Health in Washington, D.C., says that when he and fellow clinicians need to share critical patient information, they write it on a whiteboard or on a paper towel and leave it on their colleagues’ computer keyboards.

While the FDA doesn’t mandate reporting of EHR safety events—as it does for regulated medical devices—concerned posts have nonetheless proliferated in the FDA MAUDE database of adverse events, which now serves as an ad hoc bulletin board of warnings about the various systems.

Further complicating the picture is that health providers nearly always tailor their one-size-fits-all EHR systems to their own specifications. Such customization makes every one unique and often hard to compare with others—which, in turn, makes the source of mistakes difficult to determine.

Martin Makary, a surgical oncologist at Johns Hopkins and the coauthor of a much-cited 2016 study that identified medical errors as the third leading cause of death in America, credits EHRs for some safety improvements—including recent changes that have helped put electronic brakes on the opioid epidemic. But, he says, “we’ve swapped one set of problems for another. We used to struggle with handwriting and missing information. We now struggle with a lack of visual cues to know we’re writing and ordering on the correct patient.”

Joseph Schneider, a pediatrician at UT Southwestern Medical Center, compares the transition we’ve made, from paper records to electronic ones, to moving from horses to automobiles. But in this analogy, he adds, “Our cars have advanced to about the 1960s. They still don’t have seat belts or airbags.”

Schneider recalls one episode when his colleagues couldn’t understand why chunks of their notes would inexplicably disappear. They figured out the problem weeks later after intense study: Physicians had been inputting squiggly brackets—{}—the use of which, unbeknownst to even vendor representatives, deleted the text between them. (The EHR maker initially blamed the doctors, says Schneider.)

A broad coalition of actors, from National Nurses United to the Texas Medical Association to leaders within the FDA, has long called for oversight on electronic-record safety issues. Among the most outspoken is Ratwani, who directs MedStar Health’s National Center on Human Factors in Healthcare, a 30-person institute focused on optimizing the safety and usability of medical technology. Ratwani spent his early career in the defense industry, studying things like the intuitiveness of information displays. When he got to MedStar in 2012, he was stunned by “the types of [digital] interfaces being used” in health care, he says.

In a study published last year in the journal Health Affairs, Ratwani and colleagues studied medication errors at three pediatric hospitals from 2012 to 2017. They discovered that 3,243 of them were owing in part to EHR “usability issues.” Roughly one in five of these could have resulted in patient harm, the researchers found. “Poor interface design and poor implementations can lead to errors and sometimes death, and that is just unbelievably bad as well as completely fixable,” he says. “We should not have patients harmed this way.”

Using eye-tracking technology, Ratwani has demonstrated on video just how easy it is to make mistakes when performing basic tasks on the nation’s two leading EHR systems. When emergency room doctors went to order Tylenol, for example, they saw a drop-down menu listing 86 options, many of which were irrelevant for the specified patient. They had to read the list carefully, so as not to click the wrong dosage or form—though many do that too: In roughly one out of 1,000 orders, physicians accidentally select the suppository (designated “PR”) rather than the tablet dose (“OR”), according to one estimate. That’s not an error that will harm a patient—though other medication mix-ups can and do.

Earlier this year, MedStar’s human-factors center launched a website and public awareness campaign with the American Medical Association to draw attention to such rampant mistakes—they use the letters “EHR” as an initialism for “Errors Happen Regularly”—and to petition Congress for action. Ratwani is pushing for a central database to track such errors and adverse events.

Others have turned to social media to vent. Mark Friedberg, a health-policy researcher with the RAND Corporation who is also a practicing primary care physician, champions the Twitter hashtag #EHRbuglist to encourage fellow health care workers to air their pain points. And last month, a scathing Epic parody account cropped up on Twitter, earning more than 8,000 followers in its first five days. Its maiden tweet, written in the mock voice of an Epic overlord, read: “I once saw a doctor make eye contact with a patient. This horror must stop.”

As much as EHR systems are blamed for sins of commission, it is often the sins of omission that trip up users even more.

Consider the case of Lynne Chauvin, who worked as a medical assistant at Ochsner Health System, in Louisiana. In a still-pending 2015 lawsuit, Chauvin alleges that Epic’s software failed to fire a critical medication warning; Chauvin suffered from conditions that heightened her risk for blood clots, and though that history was documented in her records, she was treated with drugs that restricted blood flow after a heart procedure at the hospital. She developed gangrene, which led to the amputation of her lower legs and forearm. (Ochsner Health System said that while it cannot comment on ongoing litigation, it “remains committed to patient safety which we strongly believe is optimized through the use of electronic health record technology.” Epic declined to comment.)

Echoing the complaints of many doctors, the suit argues that Epic software “is extremely complicated to view and understand,” owing to “significant repetition of data.” Chauvin says that her medical bills have topped $1 million and that she is permanently disabled. Her husband, Richard, has become her primary caregiver and had to retire early from his job with the city of Kenner to care for his wife, according to the suit. Each party declined to comment.

****

职业倦怠蔓延

麻木的重?#30784;?#26694;里打钩和无休止的下拉菜单,都组成?#27515;?#29305;瓦尼所说的“?#29616;?#36127;担?#20445;?#37325;压之下现在的医生疲惫不堪,越来越多人选择提前退休。

近年来,“医生职业倦怠”已经迅速上升到医学议程的首位。2018年梅里特-霍金斯一项调查发现,多达78%的医生出现?#21496;?#24608;症状。1月,哈佛公共卫生学院和其他机构视之为“公共卫生危机”。

阿希?#30149;ぜ职?#21704;佛大学研究的共同作者之一,他认为主要原因是“设计糟糕的电子病历增?#21360;?#35201;求医生把越来越多的时间花在没法直接帮助患者的事情上。”

很少有人否认美国医疗系统快速数字化已经实?#20013;?#19994;转型。随着电子病历普及,医学的面貌和感觉也发生了变化。现在医生都在打字,看电脑屏幕比看病人要多。患者并不?#19981;?#36825;种变化。对医生?#27492;担?#27599;天的开始和结束都是面对着屏幕,导致的结果可能是完全麻?#23613;?/p>

?#30333;?#22312;病人面前要做的事情太多了,?#36824;?#21487;能只有7到11分钟,哪有时间认真倾听呢?”约翰-亨利·普?#32856;?#26519;是医学?#27515;?#23398;家,主要为患?#29616;?#19994;倦怠的医生提供咨询。“如果你进入医学领域的原因是为了互动,在现有系统里你只是个工具,是非人性化的。”他发现电子病历转型过程中?#34892;?#22810;医生离职。“这是一场灾难。”他说。

宾夕法尼亚州一家医院系统Wellspan的医生兼首席信息官哈尔·贝克说,除了使医患关系复杂化,电子病历某些方面的特点也导致行医更加困难。“医生得在病历和病人之间不断转换。”他指出这点很不正常,也存在潜在危险。“开车时可不能发短信。我还没有见过首席执行官主持董事会会议时还要做会议记录,当然,我也没有听说过法官审判时还要担任速记员。但在医学领域,我们已经要求医生?#37038;中?#25913;为[电脑输入]病历,电脑界面又相当复杂。”

虽然坐诊期间医生可能一直在打字,但医生普遍表示此后还得多花好几个小时,?#36824;?#26159;午饭期间还是深夜,才能完成?#22987;牵?#36319;上电子病历(发送转诊,回应患者,解决代码问题)。是的,电子病历并没有减少文书工作,系?#25345;?#26159;把卷头工作转移到网上,而且花的时间非常多。根据2017年的《家庭医学研究年鉴?#32602;?#21307;生在电子病历上每天花费约6个小时,其中44%的时间花在文书和行政工作上,比如账单和代码。

对于所谓的睡衣工作时间,一分钱补偿也没有,平均每位医生下班后还要为电子病历工作1.4小时。

也?#34892;?#22810;医生认识到这项技术的价值。2018年斯坦福医学院对全国医师调查中,60%的参与者表示电子病历改善了患者护理。同时?#21152;?9%的人表示,电子病历需要“彻底调整?#20445;?#31995;统降低了职业满意度(54%)和临床疗效(49%)。

初步研究中,拉特瓦尼发现医生对使用电子病历有典型的生理反应:压力。他和团队跟踪临床医生工作时,使用一系列传感器监测医生上班时的心率和其他生命体征。医生的心?#25163;?#22312;两种情况下高达每分钟160次:跟患者互动时,以及使用电子病历时。

“一切都是如此繁琐。”?#27599;?#33832;斯州阿灵顿的家庭医学博?#38752;?#25289;·迪克说。“与纸面上的?#24613;?#30456;比,电子病历速度很慢,查找时必须放大缩小。”她解释说,放大缩小过程中很容易弄错病历。“我都没法数有多少次因为弄错?#24613;?#21462;消指令。”

在罗德岛,一位急诊室医生每天开布洛芬都很烦躁,?#27492;?#24456;简单的事却要点很多次鼠标。每次只要她给女性患者开基本的止痛药布洛芬,无论患者是9岁还是68岁,?#21152;?#24377;窗跳出来警告她给孕妇服用药物可能造成危险。医院不许医生评论系统,只能多点几次让警告消失。“这还是只是冰山一角。”她说。

最让医生担心的是,勤勉、善意的医生也容易犯下?#29616;?#30340;差错。她指出,每个班次的急诊医生平均会点击鼠标4000次,做任?#38382;?#24773;4000次都不出错的几率很小。“软件界面非常混乱,又很难用。”她补充说。“犯错几乎不可避免……不是疏忽的问题,而是工具太糟糕了。”

许多电子病历制造商也承认,医生的疲劳真实存在,表示正在尽可能减轻负担,改善用户体验。?#20389;貳?#24052;特勒是肺部重症监护专家,2001年加入总部位于威斯康星州的Epic,专门负责改善体验的工作。如果每个星期医生的收件夹里信息超过100封(类似于电子邮件收件箱),倦怠的可能性更高。巴特勒的研究小组还分析了医生的电子?#22987;牵?#27604;起九年前长度已经变为两倍,是世界上其他地区的三到四?#19969;?#20182;说,Epic利用类似观察结果改善客户体验。但他表示要彻底解决还是很困难,因为医生“对每件事?#21152;?#19981;同的看法”。(《凯撒健康新闻》和《财富》杂志多次要求采访Epic的首席执行官朱迪丝·福克纳,但公司拒绝安排。然而,2月福克纳在一次行业采访中表示,将医生倦怠归咎于电子病历并不公平,还引用了一项研究表明,职业倦怠与电子简历满意度之间几乎没有相关性。其他供应商高管指出,已经认识到可用性问题,正在努力解决相关问题。)

?#23433;?#19981;是说我们是一群不会利用技术的路德分子(指强烈反对机械和自动化的人——译者注),”罗德岛急诊医生表?#23613;!?#25105;自己有iPhone和一台电脑,原本工作得很正常。现在给我们极其繁琐又容易出错的工具,还是政府强制要求的。真的没有时间慢慢等。每个人都得参与进去,?#19994;?#33258;己的工作方式,还要在慢慢磨死人的系统上花费数千万美元。”

An Epidemic of Burnout

The numbing repetition, the box-ticking, and the endless searching on pulldown menus are all part of what Ratwani calls the “cognitive burden” that’s wearing out today’s physicians and driving increasing numbers into early retirement.

In recent years, “physician burnout” has skyrocketed to the top of the agenda in medicine. A 2018 Merritt Hawkins survey found a staggering 78% of doctors suffered symptoms of burnout, and in January the Harvard School of Public Health and other institutions deemed it a “public health crisis.”

One of the coauthors of the Harvard study, Ashish Jha, pinned much of the blame on “the growth in poorly designed digital health records?…?that [have] required that physicians spend more and more time on tasks that don’t directly benefit patients.”

Few would deny that the swift digitization of America’s medical system has been transformative. With EHRs now nearly universal, the face and feel of medicine has changed. The doctor is now typing away, making more eye contact with the computer screen, perhaps, than with the patient. Patients don’t like that dynamic; for doctors, whose days increasingly begin and end with such fleeting encounters, the effect can be downright deadening.

“You’re sitting in front of a patient, and there are so many things you have to do, and you only have so much time to do it in—seven to 11 minutes, probably—so when do you really listen?” asks John-Henry Pfifferling, a medical anthropologist who counsels physicians suffering from burnout. “If you go into medicine because you care about interacting, and then you’re just a tool, it’s dehumanizing,” says Pfifferling, who has seen many physicians leave medicine over the shift to electronic records. “It’s a disaster,” he says.

Beyond complicating the physician-patient relationship, EHRs have in some ways made practicing medicine harder, says Hal Baker, a physician and the chief information officer at WellSpan, a Pennsylvania hospital system. “Physicians have to cognitively switch between focusing on the record and focusing on the patient,” he says. He points out how unusual—and potentially dangerous—this is: “Texting while you’re driving is not a good idea. And I have yet to see the CEO who, while running a board meeting, takes minutes, and certainly I’ve never heard of a judge who, during the trial, would also be the court stenographer. But in medicine?…?we’ve asked the physician to move from writing in pen to [entering a computer] record, and it’s a pretty complicated interface.”

Even if docs may be at the keyboard during visits, they report having to spend hours more outside that time—at lunch, late at night—in order to finish notes and keep up with electronic paperwork (sending referrals, corresponding with patients, resolving coding issues). That’s right. EHRs didn’t take away paperwork; the systems just moved it online. And there’s a lot of it: 44% of the roughly six hours a physician spends on the EHR each day is focused on clerical and administrative tasks, like billing and coding, according to a 2017 Annals of Family Medicine study.

For all that so-called pajama time—the average physician logs 1.4 hours per day on the EHR after work—they don’t get a cent.

Many doctors do recognize the value in the technology: 60% of participants in Stanford Medicine’s 2018 National Physician Poll said EHRs had led to improved patient care. At the same time, about as many (59%) said EHRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54%) as well as from their clinical effectiveness (49%).

In preliminary studies, Ratwani has found that doctors have a typical physiological reaction to using an EHR: stress. When he and his team shadow clinicians on the job, they use a range of sensors to monitor the doctors’ heart rate and other vital signs over the course of their shift. The physicians’ heart rates will spike—as high as 160 beats per minute—on two sorts of occasions: when they are interacting with patients and when they’re using the EHR.

“Everything is so cumbersome,” says Karla Dick, a family medicine doctor in Arlington, Texas. “It’s slow compared to a paper chart. You’re having to click and zoom in and zoom out to look for stuff.” With all the zooming in and out, she explains it’s easy to end up in the wrong record. “I can’t tell you how many times I’ve had to cancel an order because I was in the wrong chart.”

Among the daily frustrations for one emergency room physician in Rhode Island is ordering ibuprofen, a seemingly simple task that now requires many rounds of mouse clicking. Every time she prescribes the basic painkiller for a female patient, whether that patient is 9 or 68 years old, the prescription is blocked by a pop-up alert warning her that it may be dangerous to give the drug to a pregnant woman. The physician, whose institution does not allow her to comment on the systems, must then override the warning with yet more clicks. “That’s just the tiniest tip of the iceberg,” she says.

What worries the doctor most is the ease with which diligent, well-meaning physicians can make serious medical errors. She notes that the average ER doc will make 4,000 mouse clicks over the course of a shift, and that the odds of doing anything 4,000 times without an error is small. “The interfaces are just so confusing and clunky,” she adds. “They invite error?…?it’s not a negligence issue. This is a poor tool issue.”

Many of the EHR makers acknowledge physician burnout is real and say they’re doing what they can to lessen the burden and enhance user experience. Sam Butler, a pulmonary critical care specialist who started working at Epic in 2001, leads those efforts at the Wisconsin-based company. When doctors get more than 100 messages per week in their in-basket (akin to an email inbox), there’s a higher likelihood of burnout. Butler’s team has also analyzed doctors’ electronic notes—they’re twice as long as they were nine years ago, and three to four times as long as notes in the rest of the world. He says Epic uses such insights to improve the client experience. But coming up with fixes is difficult because doctors “have different viewpoints on everything,” he says. (KHN and Fortune made multiple requests to interview Epic CEO Judith Faulkner, but the company declined to make her available. In a trade interview in February, however, Faulkner said that EHRs were unfairly blamed for physician burnout and cited a study suggesting that there’s little correlation between burnout and EHR satisfaction. Executives at other vendors noted that they’re aware of usability issues and that they’re working on addressing them.)

“It’s not that we’re a bunch of Luddites who don’t know how to use technology,” says the Rhode Island ER doctor. “I have an iPhone and a computer and they work the way they’re supposed to work, and then we’re given these incredibly cumbersome and error-prone tools. This is something the government mandated. There really wasn’t the time to let the cream rise to the top; everyone had to jump in and pick something that worked and spend tens of millions of dollars on a system that is slowly killing us.”

****

360亿美元和变化

美国病历电子化的推动是在非常?#32479;?#30340;时刻,即2008年的金融危机。当年12月初,奥巴马当选后不到四个星期就提出了雄心勃勃的经济?#27492;?#35745;划。 “我们将确保美国每个医生办公室和医院里都用上尖端技术和电子病历,减少繁琐程序,防止医疗失误,每年节省数十亿美元。”他在一次广播?#19981;?#20013;说。该想法在华盛顿很流行。众议院前议长纽特·金里奇总?#19981;?#35828;,查询联邦快递包裹比查病历容易。奥巴马前任总统乔治·W·布什也曾经提出建立全国性医疗系统。他没有投入多少资金,但创立了做事的机构:国家协调员办公室(ONC)。

在经济衰退最?#29616;?#20043;际,自命不凡的电子病历项目就像万事俱备只欠东风,只有支持纸质病历的游说团会反对。2009年2月,议会通过了《关于促进经济与临床健康的健康信息科技法案?#32602;℉ITECH Act),为医疗信息技术制定了很多大规模刺激计划。目标不仅是让医院和医生?#37038;?#30005;子病历,还有应用之后提供更好的医疗服务。因此,议会设计了“胡萝卜加大棒”的方法:医生只有在政府?#29616;?#31995;统内成为“?#23548;?#29992;户?#20445;?#25165;有资格获得联邦?#22266;?#19968;?#38382;?#38388;内总额高达64000美元)。供应商则须开发符合政府要求的系统。

?#36824;?#26102;间很紧迫。刺激经济的需要意味着医疗系统要迅速采用电子病历。“由此提出?#21496;?#22823;?#21738;?#39064;?#20445;?#27861;扎德·莫斯塔萨里说,2009年他加入国家协调员办公?#19994;?#20219;副主?#21361;?011年担任负责人领导。打造有用互通的全国性病历系统的想法“在短时间内完全不可能实现”。

现实障碍并未阻止联邦层面的规划者追求宏伟目标。每个人都对电子病历抱有巨大期望。?#31216;?#19982;药品管理局希望系统能跟踪医学植入设备的唯一标?#26007;?#30142;病控制中心希望系?#25345;?#25345;疾病监测,医疗保险和医疗补助服务中心则希望系统囊括质量指标等等。“当时汇集?#21496;?#22996;员会探讨考虑过的想法,都很正确。” 莫斯塔萨里说,“问题就在于,所有想法都很正确。”

然而,并不是每个人都同意所有想法都正确。不久之后,“?#23548;?#20351;用” 成为许多繁琐政府计划的贬义代称,?#23548;?#19978;就是让医生做一些无聊的事,比如每次就诊时?#23478;?#21246;选病人吸烟状况的方框。

当时的电子病历供应商圈子是收入20亿美元的行业,虽然对一系?#34892;?#27714;很不满,却因为政府360亿美元的投资赚了一?#30465;?#27491;如电子病历供应商NextGen 健康中心的首席执行官拉斯蒂·弗朗茨所说:“整个行业的情况是,‘支票就挂在面前,必须达到这些要求才能拿到,所以就这么做吧。’”

哈兰卡在布什政府和奥巴马政府中均积极支持该倡议,他认为快速启动的压力主要因为愿望清单太过分。“18个月内就要从规定变为可?#23548;?#20351;用的产品,太快了。”他说,“就好比让九个女人一个月内生个孩子。”

一些参与该项目的人承认,?#23548;释平?#36807;程并不像预期一样容易或无缝,但他们认为这不是重点。奥巴马于2009年任命安尼斯·乔普拉为美国第一位首席技术官,他表示该项支出只是“首付?#20445;?#26368;终目标是从根本上改变美国医学,搭建数字基础设施,支持基于医疗服务质量和结果的新型支付方?#20581;?/p>

鲍勃·科彻是一名医生,也是风险投资公司维纳克的明星投资人,2009年至2011年他曾经在奥巴马政府担任医疗和经济政策顾问。他不仅为奥巴马政府推出该政策辩护,还表示不同意认为政府倡议完全失败的说法。“电子病历已经完全达到宣传和期望。”他说,强调说电子病历也是技术基础,将支持一系列创新,患者可以从智能手机上访问医疗记录,也可以协助?#26031;?#26234;能进行医疗调查。?#34892;┤司?#25351;出,系统收集医疗数据方面的价值是纸质病历无法实现的,例如密歇根州弗林特市的儿童因为受污染的水而中?#23613;?/p>

但鲁斯蒂·弗?#21363;奶?#21040;关于电子病历的信息截然不同,更重要的是,抱怨都来自于客户。

这位工程师曾经在斯坦福大学求学,2015年在NextGen担?#38382;?#24109;执行官,而NextGen在医生办公市场的电子病历方面是每年销售达5亿美元的重?#32771;?#20844;司。?#36824;?#20182;收到的产品反馈并不友好。在拉斯维加斯曼德勒海湾度假村,他第一次站在台上面对成千上万的 NextGen客户,当时他上任才四个月。他告诉《凯撒健康新闻》和《财富》杂志:“人们排着队在麦克风上对我们?#22467;骸?#27809;有提供稳定的软件!高管团队?#20063;?#21040;人!服务体验非常糟糕!’?#20445;?#20182;现在将该事件称为?#24052;?#27133;大会。?#20445;?/p>

职业生涯大部分时间里,弗?#21363;?#19968;直在医疗行业跳来跳去。在医疗设备公司工作时,他对电子病历大跃进充满嫉妒和?#27425;貳!?#34892;业先是经历了达尔文式自然发展,然后赶上?#21496;?#27982;刺激计划。?#22791;ダ即?#35828;,他指责政府采取的监管措施太过简单。“软件猛然间启动,实在过于?#25191;?#25152;以没能支持治疗。”他说。 “只是支持了公司争取激励。我工作的公司也串通其中。“

说是串通可能都宽容了些。《凯撒健康新闻》和《财富》杂志发现针对该公司的一系列诉讼?#31119;用?#22823;拿州的白硫磺泉镇到威斯康星州的到尼尔斯维尔。2013年,俄亥俄州贝尔方丹的玛丽 ·?#31243;?#21307;院在联邦法院起诉NextGen(之前叫Quality Systems),声称于2011年安装存在“重大缺陷”的软件,使用过程中遇到数百个问题。

医院聘请的一位顾问评估了NextGen的系统,撰写了60页的报告并提交法院,他指出“许多功能缺陷?#20445;?#31216;该软件?#23433;?#31526;合预期目的。” 顾问写道,一些患者信息记录得不准确,可能“导致重大的治疗风险,至少会造成不便,最?#29616;?#30340;情况是造成医疗事故甚至死亡。?#24811;?#38382;报告还指出,玛丽·?#31243;?#21307;院遇到的问题包括软件会随机改变患者的性别,或检查后丢失医生的观察结果。他发现,该公司解决问题有时要花费数月。据报道,有一个与医生?#22987;?#26377;关的IT票据会莫名其妙地自行删除,据说要10个月才能解决。(该顾问还指出,安装 NextGen软件的其他医院中似乎也出现?#27515;?#20284;问题 。)

俄亥俄州的医院为电子病历系?#25345;Ц读?#36229;过150万美元,声称公司违反了合同。NextGen回应称,对诉讼中提出的索赔提出异议,2015年便已解决相关问题,而且“法院就指控并未调查出违法事实。”医院拒绝发表评论。

从那时起,政府认定NextGen的软件符合刺激计划的要求。到2016年, NextGen 已经拥有超过19,000名获得联邦政府?#22266;?#30340;用户。

2017年12月,佛?#21830;?#24030;牵头的联邦调查NextGen几个月之后,美国司法部也传唤了该公司。弗?#21363;?#21578;诉《凯撒健康新闻》和《财富》杂志,NextGen正积极配?#31995;?#26597;。“公司没有欺骗之举,?#36824;哪?#21069;还没产生效果。”他说。弗?#21363;?#36824;强调自己任职期间NextGen实现了?#25226;?#36895;发展?#20445;?017年以来获得了五项行业奖项,并且客户“反应非常积极”。

Allscripts是另外一家领先的电子病历供应商,从刺激计划中受益,也被众多不满的客户起诉,2012年前格伦·图尔曼一直担任公司领导。他承认在该行业迅速推出市场比其他事都重要。

“当时情况很混乱。结果让人意想不?#20581;!?图尔曼说。“所有公司都在说,这次是难得的扩大市场份额的机会,要倾尽全力,有问题以后再回?#26041;?#20915;。”公司提交证券交易委员会的文件显示,司法部已经对其开展民事调查。Allscripts在一封电子邮件中表示,无法对进行中的调查发表评论,但司法部的民事调查与其在调查开始后?#23637;?#30340;业务有关。

推广方面大部分混乱之所以发生,是因为联邦政府对急于通过刺激计划赚钱的公司控制很少。就像一场淘金热,似乎任何系统推广时都可以自称已获“联邦政府批准”。医生可以在好事多超市和沃尔玛的?#20389;?#20250;员店购买折扣软件。eClinicalWorks 出售的“turnkey”系统价格为11,925美元,然后根据政府的激励措施赚钱。

2009年顶级供应商像摇滚乐团一样,在全国举行了一次“激励之旅?#20445;还?#36208;了约30个城市。每到一处都向出席?#24179;?#20250;的医生提供“个性化分析?#20445;?#20171;绍政府的激励措施能帮着赚多少钱。电子病历销售方跟制药公司套路一样,都选在豪华酒店的高级晚宴上吸引医生。一?#31227;木?#36827;取精神的软件公司还推出了“以旧换新”活动,只要医生愿意将当前使用的病历系统换成新款,就能获得3,000美元奖励。Athenahealth则在豪华酒店举办“仅限邀请出席”的晚宴,主要向医生介绍如何利用刺激措施获得更多报酬,争取有希望的奖励等等。Allscripts提供了免费的购买计划,帮助医生“将电子病历方面的投资回报最大化。?#20445;ˋthenahealth公司发言人表示,该公司的?#24052;?#39184;本质上是教育,主要帮助医生了解政府的计划。” Allscripts没有直接回答有关推广活动的问题,但表示因为“向全球数十万名护理人员提供软件和服务感到?#38498;馈!保?/p>

电子病历本来应该降低医疗成本,至少可以防止重复检查。但随着联邦政府开启刺激计划,许多人?#38405;?#21542;真正节约成本表示怀疑。即便国会审计师逐步揭开真相,支持者还是大?#21015;?#25196;节约了800亿美元的成?#23613;?#38506;审团尚未给出定论,?#36824;?#20154;们越来?#20132;?#30097;数字革命可能鼓励过度支付和新型欺诈和滥用,从而导致医疗成本提升。

2012年9月,媒体报道暗示一些医生和医院使用新技术不当地提高收费,这种做法被称为“费用?#31995;鰲保?#24403;时卫生和公共服务部负责人凯瑟琳·西贝利厄斯和司法部部长埃里克·霍尔德警告业界不要“耍弄系统”。

还有越来越多证据表明,一些医生和医疗系统可能夸大了对新技术的使用情况以争取刺激资金,可能存在针对医疗保险和医疗补助的巨大欺诈,解决起来可能要很多年。2017年6月,卫生和公共服务部检察长?#20848;疲?#21307;疗保?#23637;?#21592;向医院和医生提供了超过7.29亿美元的?#22266;?#21307;院和医生并不配收到这些钱。

每个州管理自己的医疗补助计划,表现也没好到哪里。根据检察长报告,审计17个州计划时发现有14个州已经超额支付,超过6600万美元。

上个月,?#25105;?#38498;财政委员会主席爱荷华州共和党?#25105;?#21592;查尔斯·格拉斯利严厉批评称,医疗保险和医疗补助服务中心只追回了虚假付款中一小部分,他称之为“往大海里吐?#24608;薄?/p>

由于电子病历供应商?#21512;?#20105;取刺激资金,也被指犯下?#21496;?#20154;且伤及病人的欺诈行为。除了美国政府与eClinicalWorks 达成价值1.55亿美元的虚假申报案 之外,联邦政府也与另外一家大型供应商,总部位于坦帕的Greenway Health 达成就类似指控达成和解。今年2月,该公司与政府达成和解,金额刚超过5700万美元,既未否认也未承认存在不法行为。“这些都是企业贪婪的案例,公司把利润看得比什么都重要。”佛?#21830;?#24030;的联邦检察官?#27515;?#26031;蒂娜·诺?#24613;?#31034;,其办公室负责相关案件。(Greenway Health回应称,没有处理指控或达成和解,但表?#23613;?#23558;努力成为质量、合规性和?#35813;?#24230;方面的领导者。?#20445;?!-- cend -->

$36 Billion and Change

The effort to digitize America’s health records got its biggest push in a very low moment: the financial crisis of 2008. In early December of that year, Obama, barely four weeks after his election, pitched an ambitious economic recovery plan. “We will make sure that every doctor’s office and hospital in this country is using cutting-edge technology and electronic medical records so that we can cut red tape, prevent medical mistakes, and help save billions of dollars each year,” he said in a radio address. The idea had already been a fashionable one in Washington. Former House Speaker Newt Gingrich was fond of saying it was easier to track a FedEx package than one’s medical records. Obama’s predecessor, President George W. Bush, had also pursued the idea of wiring up the country’s health system. He didn’t commit much money, but Bush did create an agency to do the job: the Office of the National Coordinator (ONC).

In the depths of recession, the EHR conceit looked like a shovel-ready project that only the paper lobby could hate. In February 2009 legislators passed the HITECH Act, which carved out a hefty chunk of the massive stimulus package for health information technology. The goal was not just to get hospitals and doctors to buy EHRs, but rather to get them using them in a way that would drive better care. So lawmakers devised a carrot-and-stick approach: Physicians would qualify for federal subsidies (a sum of up to nearly $64,000 over a period of years) only if they were “meaningful users” of a government-certified system. Vendors, for their part, had to develop systems that met the government’s requirements.

They didn’t have much time, though. The need to stimulate the economy, which meant getting providers to adopt EHRs quickly, “presented a tremendous conundrum,” says Farzad Mostashari, who joined the ONC as deputy director in 2009 and became its leader in 2011: The ideal—creating a useful, interoperable, nationwide records system—was “utterly infeasible to get to in a short time frame.”

That didn’t stop the federal planners from pursuing their grand ambitions. Everyone had big ideas for the EHRs. The FDA wanted the systems to track unique device identifiers for medical implants, the CDC wanted them to support disease surveillance, CMS wanted them to include quality metrics, and so on. “We had all the right ideas that were discussed and hashed out by the committee,” says Mostashari, “but they were all of the right ideas.”

Not everyone agreed, though, that they were the right ideas. Before long, “meaningful use” became pejorative shorthand to many for a burdensome government program—making doctors do things like check a box indicating a patient’s smoking status each and every visit.

The EHR vendor community, then a scrappy $2 billion industry, griped at the litany of requirements but stood to gain so much from the government’s $36 billion injection that it jumped in line. As Rusty Frantz, CEO of EHR vendor NextGen Healthcare, put it: “The industry was like, ‘I’ve got this check dangling in front of me, and I have to check these boxes to get there, and so I’m going to do that.’?”

Halamka, who was an enthusiastic backer of the initiative in both the Bush and Obama administrations, blames the pressure for a speedy launch as much as the excessive wish list. “To go from a regulation to a highly usable product that is in the hands of doctors in 18 months, that’s too fast,” he says. “It’s like asking nine women to have a baby in a month.”

Several of those who worked on the project admit the rollout was not as easy or seamless as they’d anticipated, but they contend that was never the point. Aneesh Chopra, appointed by Obama in 2009 as the nation’s first chief technology officer, called the spending a “down payment” on a vision to fundamentally change American medicine—creating a digital infrastructure to support new ways to pay for health services based on their quality and outcomes.

Bob Kocher, a physician and star investor with venture capital firm Venrock, who served in the Obama administration from 2009 to 2011 as a health and economic policy adviser, not only defends the rollout then but also disputes the notion that the government initiative has been a failure at all. “EHRs have totally lived up to the hype and expectations,” he says, emphasizing that they also serve as a technology foundation to support innovation on everything from patients accessing their medical records on a smartphone to A.I.-driven medical sleuthing. Others note the systems’ value in aggregating medical data in ways that were never possible with paper—helping, for example, to figure out that contaminated water was poisoning children in Flint, Mich.

But Rusty Frantz heard a far different message about EHRs—and, more important, it was coming from his own customers.

The Stanford-trained engineer, who in 2015 became CEO of NextGen, a $500-million-a-year EHR heavyweight in the physician-office market, learned the hard way about how his product was being viewed. As he stood at the podium at his first meeting with thousands of NextGen customers at Las Vegas’s Mandalay Bay Resort, just four months after getting the job, he tells KHN and Fortune, “People were lining up at the microphones to yell at us: ‘We weren’t delivering stable software! The executive team was inaccessible! The service experience was terrible!’” (He now refers to the event as “Festivus: the airing of the grievances.”)

Frantz had bounced around the health care industry for much of his career, and from the nearby perch of a medical device company, he watched the EHR incentive bonanza with a mix of envy and slack-jawed awe. “The industry was moving along in a natural Darwinist way, and then along came the stimulus,” says Frantz, who blames the government’s ham-handed approach to regulation. “The software got slammed in, and the software wasn’t implemented in a way that supported care,” he says. “It was installed in a way that supported stimulus. This company, we were complicit in it too.”

Even that may be a generous description. KHN and Fortune found a trail of lawsuits against the company, stretching from White Sulphur Springs, Mont., to Neillsville, Wis. Mary Rutan Hospital in Bellefontaine, Ohio, sued NextGen (formerly called Quality Systems) in federal court in 2013, arguing that it experienced hundreds of problems with the “materially defective” software the company had installed in 2011.

A consultant hired by the hospital to evaluate the NextGen system, whose 60-page report was submitted to the court, identified “many functional defects” that he said rendered the software “unfit for its intended purpose.” Some patient information was not accurately recorded, which had the potential, the consultant wrote, “to create major patient care risk which could lead to, at a minimum, inconvenience, and at worst, malpractice or even death.” Glitches at Mary Rutan included incidents in which the software would apparently change a patient’s gender at random or lose a doctor’s observations after an exam, the consultant reported. The company, he found, sometimes took months to address issues: One IT ticket, which related to a physician’s notes inexplicably deleting themselves, reportedly took 10 months to resolve. (The consultant also noted that similar problems appeared to be occurring at as many as a dozen other hospitals that had installed NextGen software.)

The Ohio hospital, which paid more than $1.5 million for its EHR system, claimed breach of contract. NextGen responds that it disputed the claims made in the lawsuit and that the matter was resolved in 2015 “with no findings of fact by a court related to the allegations.” The hospital declined to comment.

At the time, as it has been since then, NextGen’s software was certified by the government as meeting the requirements of the stimulus program. By 2016, NextGen had more than 19,000 customers who had received federal subsidies.

NextGen was subpoenaed by the Department of Justice in December 2017, months after becoming the subject of a federal investigation led by the District of Vermont. Frantz tells KHN and Fortune that NextGen is cooperating with the investigation. “This company was not dishonest, but it was not effective four years ago,” he says. Frantz also emphasizes that NextGen has “rapidly evolved” during his tenure, earning five industry awards since 2017, and that customers have “responded very positively.”

Glen Tullman, who until 2012 led Allscripts, another leading EHR vendor that benefited royally from the stimulus and that has been sued by numerous unhappy customers, admits that the industry’s race to market took priority over all else.

“It was a big distraction. That was an unintended consequence of that,” Tullman says. “All the companies were saying, This is a one-time opportunity to expand our share, focus everything there, and then we’ll go back and fix it.” The Justice Department has opened a civil investigation into the company, Securities and Exchange Commission filings show. Allscripts says in an email that it cannot comment on an ongoing investigation, but that the civil investigations by the Department of Justice relate to businesses it acquired after the investigations were opened.

Much of the marketing mayhem occurred because federal officials imposed few controls over firms scrambling to cash in on the stimulus. It was a gold rush—and any system, it seemed, could be marketed as “federally approved.” Doctors could shop for bargain-price software packages at Costco and Walmart’s Sam’s Club—where eClinicalWorks sold a “turnkey” system for $11,925—and cash in on the government’s adoption incentives.

The top-shelf vendors in 2009 crisscrossed the country on a “stimulus tour” like rock groups, gigging at some 30 cities, where they offered doctors who showed up to hear the pitch “a customized analysis” of how much money they could earn off the government incentives. Following the same playbook used by pharmaceutical companies, EHR sellers courted doctors at fancy dinners in ritzy hotels. One enterprising software firm advertised a “cash for clunkers” deal that paid $3,000 to doctors willing to trade in their current records system for a new one. Athenahealth held “invitation only” dinners at luxury hotels to advise doctors, among other things, how to use the stimulus to get paid more and capture available incentives. Allscripts offered a no-money-down purchase plan to help doctors “maximize the return on your EHR investment.” (An Athenahealth spokesperson says the company’s “dinners were educational in nature and aimed at helping physicians navigate the government program.” Allscripts did not respond directly to questions about its marketing practices, but says it “is proud of the software and services [it provides] to hundreds of thousands of caregivers across the globe.”)

EHRs were supposed to reduce health care costs, at least in part by preventing duplicative tests. But as the federal government opened the stimulus tap, many raised doubts about the promised savings. Advocates bandied about a figure of $80 billion in cost savings even as congressional auditors were debunking it. While the jury’s still out, there’s growing suspicion the digital revolution may potentially raise health care costs by encouraging overbilling and new strains of fraud and abuse.

In September 2012, following press reports suggesting that some doctors and hospitals were using the new technology to improperly boost their fees, a practice known as “upcoding,” then–Health and Human Services chief Kathleen Sebelius and Attorney General Eric Holder warned the industry not to try to “game the system.”

There’s also growing evidence that some doctors and health systems may have overstated their use of the new technology to secure stimulus funds, a potentially enormous fraud against Medicare and Medicaid that likely will take many years to unravel. In June 2017, the HHS inspector general estimated that Medicare officials made more than $729 million in subsidy payments to hospitals and doctors that didn’t deserve them.

Individual states, which administer the Medicaid portion of the program, haven’t fared much better. Audits have uncovered overpayments in 14 of 17 state programs reviewed, totaling more than $66 million, according to inspector general reports.

Last month Sen. Charles Grassley, an Iowa Republican who chairs the Senate Finance Committee, sharply criticized CMS for recovering only a tiny fraction of these bogus payments, or what he termed a “spit in the ocean.”

EHR vendors have also been accused of egregious and patient-endangering acts of fraud as they raced to cash in on the stimulus money grab. In addition to the U.S. government’s $155 million False Claims Act settlement with eClinicalWorks noted above, the federal government has reached a second settlement over similar charges against another large vendor, Tampa-based Greenway Health. In February, that company settled with the government for just over $57 million without denying or admitting wrongdoing. “These are cases of corporate greed, companies that prioritized profits over everything else,” says Christina Nolan, the U.S. attorney for the District of Vermont, whose office led the cases. (In a response, Greenway Health did not address the charges or the settlement but said it was “committing itself to being the standard-bearer for quality, compliance, and transparency.”)

****

巴别塔

2017年年初 ,新上任的医疗保险和医疗补助服务中心主管西玛·维尔玛走了一大圈,专?#24472;?#21548;。她走遍了美国各地的医疗机构,?#36824;?#26159;在大城市?#22242;?#26449;小诊所,从一线医生口中听到的是,人人都讨厌电子病历。“医生倦怠是?#23548;?#23384;在的。”她告诉《凯撒健康新闻》和《财富》杂志。医生谈到了从其他系统和医疗机构获取信息的困难,也抱怨了政府的报告要求,认为种种要求很麻烦而且没有意义。

2017年夏的一天,之前她听到的抱怨突然跟自?#22909;?#20999;相关。一次家庭度假后回印第安纳波利斯的路上,身为医生的丈夫倒下了。接下来几个小时极为疯狂,这位医疗保险和医疗补助服务中心主管接到了急救人员和医生几个电?#22467;?#38382;她知不知道丈夫的病史,有没有可帮助挽救生命的信息。她立刻打电话问印第安纳州给丈夫治过病的医生,原本应该是完整的信息,她却只能拼命?#21019;?#21508;种零碎信息。还好她丈夫保住了性命,但从中可看出现有医疗信息生态中固有的功能障碍和危险。

Tower of Babel

In early 2017, Seema Verma, then the country’s newly appointed administrator, went on a listening tour. She visited doctors around the country, at big urban practices and tiny rural clinics, and from those frontline physicians she consistently heard one thing: They hated their electronic health records. “Physician burnout is real,” she tells KHN and Fortune. The doctors spoke of the difficulty in getting information from other systems and providers, and they complained about the government’s reporting requirements, which they perceived as burdensome and not meaningful.

What she heard then became suddenly personal one summer day in 2017, when her husband, himself a physician, collapsed in the airport on his way home to Indianapolis after a family vacation. For a frantic few hours, the CMS administrator fielded phone calls from first responders and physicians—Did she know his medical history? Did she have information that could save his life?—and made calls to his doctors in Indiana, scrambling to piece together his record, which should have been there in one piece. Her husband survived the episode, but it laid bare the dysfunction and danger inherent in the existing health information ecosystem.

医疗保险和医疗补助服务中心主管西玛·维尔玛正负责研究医疗“信息阻断?#20445;?#21387;制言论的条款等。?#35745;?#26469;源:Photograph by T.J. Kirkpatrick for Fortune

HITECH Act最初愿景的关键部分便是电子病历之间应该交流,政府要求各系统最终要实现互通。

愿景的制定者没有预?#31995;?#30340;是与之相悖的商业激励措施。信息?#26434;?#20132;流意味着患者可以在任何地方?#37038;?#27835;疗。虽然可能不愿承认,但许多医疗机构都不愿意将病人送到竞争对手的医生诊所或医院。?#27515;?#22833;去的收入还有个专门术语:“泄漏。”严格控制患者的病历是一种预防方?#20581;?/p>

布鲁门撒尔说,病历数据具有大量的专有价值,目前他在?#37038;?#20581;康研究的慈善机构英联邦基金会担任负责人。让医院放弃病历数据“就像要求亚马逊与沃尔玛分享数据一样。”他说。

布鲁门撒尔承认,未能及时掌握不正当的业务情况,也没有预见到让各系统互相沟通面临的挑?#20581;?#20182;补充说,强制互通?#34892;?#26089;,全国90%的医疗机构还没有搭建起系统,也没有数据可交换的时候下达指令似乎不现实。“当时我们有个说法,就是互通之前得先得运转起来。”他说。

由于对各系统沟通缺乏真正的激励,行业发展得颇为?#37096;馈?#19968;些医疗机构与其他机构有选择链接,或加入区域交流,但并不稳定。2013年,一个由Cerner支持名为 CommonWell的互通网络成立,但Epic?#21364;?#20844;司并没有加入。 (?#26696;?#24320;始,没人邀请也没人?#24066;鞥pic加入。” Epic研发部高级副总裁苏斯米特·拉那说。CommonWell counters执行董事吉廷·阿斯纳尼表示,“我们反复邀请了各大电子病历供应商……还向Epic多次发出公开和私下邀请。” )

然后,随后Epic支持了另外一项同样的工作。

去年春天, 维尔玛努力推动分享工作,后来又?#20449;?#23545;抗“信息阻断?#20445;?#23041;胁对行为不当者实施处罚。她?#20449;导?#23569;医生的文件负担,不再保护电子病历行业压制言论的条款。至少在减少医生负担方面,“人们一致认为有必要,而且应该由政府推动。”她说。去年夏天出现了进步的迹象,Epic和Cerner两家行业巨?#20998;?#20110;开始分享信息,虽然只是刚起?#20581;?/p>

然而,只要一涉及患者,真正的分享就会?#22411;!?#23613;管联邦要求医疗机构向病人及时提供病历,且病人可以选择格式,费用要?#20572;?#25919;府建议收取6.50美元的固定费用或更?#20572;?#20294;病?#35772;?#25343;到病历还是非常艰难。2017年耶鲁研究人员的一项研究发现,美国83家顶级医院中只有53%提供表格,供患者选择如?#20301;?#24471;完整病历。不到一半的医?#21644;?#36807;电子邮件发送病历。其中一家医院收取超过500美元的费用。

有时,仅仅想查看病历都会引发诉讼。塔尔萨的律师詹妮弗·德·安吉利斯就经常指控医院扣押客户的病历。她说,医院方面称想查看病历要么支付高额费用,要么?#27809;?#24471;法院指令。德·安吉利斯补充说,有时怀疑病历已经被篡改以?#35857;?#21307;疗差错。

可以看看5岁的乌里亚·R·罗奇,2014年10月2日他的手意外?#19994;?#23398;校一?#35753;?#19978;,手指出现挫伤和割伤。五天后,修复手术出现问题,麻醉导致出现永久?#38405;运?#20260;。罗奇住院期间22天内,Epic电子病历访问超过76,000次,他?#25913;?#25552;起的诉讼辩称,许多条目已经被“修改、调整,可能在麻醉出现意外后删除”。医院否认存在不当行为。2016年11月该案件结?#31119;?#26465;款保密。

?#37038;?#37319;访的其他十几位律师提到?#27515;?#20284;问题,特别是在争取查看电子“审计线索”时。法院记录显示,一些案件中政府律师拒绝提交联邦医院的电子文件。俄?#27515;?#33655;马州的律师拉塞尔·乌斯尔顿便遇到了这种情况,他代理的是一名怀孕的青少年,曾经在俄?#27515;?#33655;马州塔利希纳的Choctaw国家医疗中心住院。当时18岁的谢尔比·卡绍尔怀孕40多周。2017年她对美国政府提起的诉讼中称,医生没有进行剖腹产手术,所?#26434;?#20799;出生时脑部受损。诉状称,婴儿出生10个小时后癫痫发作,并且“可能永远不能走路、说话、吃饭,以及享受其他正常生活”。虽然联邦政府要求医院为患者和家人提供电子病历,但乌斯尔顿必须获得法院命令才能查看婴儿完整的医疗档案。政府律师否认存在疏忽,该案尚未解决。

“只要能瞒住,他们就拼命隐瞒。”乌斯尔顿说。“想拿到病历极为困难,大多数律师都无力承担相关费用。”他说

然而,即便是联邦政府高管可能也拿不到病历。那年夏天西玛·维尔玛的丈夫病愈出院时,只拿到几份文件和一张存有医学图像的CD-ROM,仍然缺少关键检测结果和监测数据。维尔玛说:“出院到现在,仍然没?#19994;?#20449;息。”已经过去快两年了。(财富中文网)

本文另一版本发表于2019年4月的《财富》杂志,标题为《死于千次点击》。

译者:MS

The notion that one EHR should talk to another was a key part of the original vision for the HITECH Act, with the government calling for systems to be eventually interoperable.

What the framers of that vision didn’t count on were the business incentives working against it. A free exchange of information means that patients can be treated anywhere. And though they may not admit it, many health providers are loath to lose their patients to a competing doctor’s office or hospital. There’s a term for that lost revenue: “leakage.” And keeping a tight hold on patients’ medical records is one way to prevent it.

There’s a ton of proprietary value in that data, says Blumenthal, who now heads the Commonwealth Fund, a philanthropy that does health research. Asking hospitals to give it up is “like asking Amazon to share their data with Walmart,” he says.

Blumenthal acknowledges that he failed to grasp these perverse business dynamics and foresee what a challenge getting the systems to talk to one another would be. He adds that forcing interoperability goals early on, when 90% of the nation’s providers still didn’t have systems or data to exchange, seemed unrealistic. “We had an expression: They had to operate before they could interoperate,” he says.

In the absence of true incentives for systems to communicate, the industry limped along; some providers wired up directly to other select providers or through regional exchanges, but the efforts were spotty. A Cerner-backed interoperability network called CommonWell formed in 2013, but some companies, including dominant Epic, didn’t join. (“Initially, Epic was neither invited nor allowed to join,” says Sumit Rana, senior vice president of R&D at Epic. Jitin Asnaani, executive director of CommonWell counters, “We made repeated invitations to every major EHR?…?and numerous public and private invitations to Epic.”)

Epic then supported a separate effort to do much the same.

Last spring, Verma attempted to kick-start the sharing effort and later pledged a war on “information blocking,” threatening penalties for bad actors. She has promised to reduce the documentation burden on physicians and end the gag clauses that protect the EHR industry. Regarding the first effort at least, “there was consensus that this needed to happen and that it would take the government to push this forward,” she says. In one sign of progress last summer, the dueling sharing initiatives of Epic and Cerner, the two largest players in the industry, began to share with each other—though the effort is fledgling.

When it comes to patients, though, the real sharing too often stops. Despite federal requirements that providers give patients their medical records in a timely fashion, in their chosen format, and at low cost (the government recommends a flat fee of $6.50 or less), patients struggle mightily to get them. A 2017 study by researchers at Yale found that of America’s 83 top-rated hospitals, only 53% offer forms that provide patients with the option to receive their entire medical record. Fewer than half would share records via email. One hospital charged more than $500 to release them.

Sometimes the mere effort to access records leads to court. Jennifer De Angelis, a Tulsa attorney, has frequently sparred with hospitals over releasing her clients’ records. She says they either attempt to charge huge sums for them or force her to obtain a court order before releasing them. De Angelis adds that she sometimes suspects the records have been overwritten to cover up medical mistakes.

Consider the case of 5-year-old Uriah R. Roach, who fractured and cut his finger on Oct. 2, 2014, when it was accidentally slammed in a door at school. Five days later, an operation to repair the damage went awry, and he suffered permanent brain damage, apparently owing to an anesthesia problem. The Epic electronic medical file had been accessed more than 76,000 times during the 22 days the boy was in the hospital, and a lawsuit brought by his parents contended that numerous entries had been “corrected, altered, modified and possibly deleted after an unexpected outcome during the induction of anesthesia.” The hospital denied wrongdoing. The case settled in November 2016, and the terms are confidential.

More than a dozen other attorneys interviewed cited similar problems, especially with gaining access to computerized “audit trails.” In several cases, court records show, government lawyers resisted turning over electronic files from federally run hospitals. That happened to Russell Uselton, an Oklahoma lawyer who represented a pregnant teen admitted to the Choctaw Nation Health Care Center in Talihina, Okla. Shelby Carshall, 18, was more than 40 weeks pregnant at the time. Doctors failed to perform a cesarean section, and her baby was born brain-damaged as a result, she alleged in a lawsuit filed in 2017 against the U.S. government. The baby began having seizures at 10 hours old and will “likely never walk, talk, eat, or otherwise live normally,” according to pleadings in the suit. Though the federal government requires hospitals to produce electronic health records to patients and their families, Uselton had to obtain a court order to get the baby’s complete medical files. Government lawyers denied any negligence in the case, which is pending.

“They try to hide anything from you that they can hide from you,” says Uselton. “They make it extremely difficult to get records, so expensive and hard that most lawyers can’t take it on,” he said.

Nor, it seems, can high-ranking federal officials. When Seema Verma’s husband was discharged from the hospital after his summer health scare, he was handed a few papers and a CD-ROM containing some medical images—but missing key tests and monitoring data. Says Verma, “We left that hospital and we still don’t have his information today.” That was nearly two years ago.

A version of this article appears in the April 2019 issue of Fortune with the headline “Death by a Thousand Clicks.”

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