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死于千次點擊:電子病歷問題在哪

美國政府曾經聲稱,病歷電子化后,醫療系統將更完善、更安全,費用也會更親民。十年之間花費了360億美元,系統卻還是一團糟,根源在于數字革命出了問題。就此,《財富》雜志和《凱撒健康新聞》展開了聯合調查。

47歲的安妮特·莫納切利曾經在佛蒙特州當律師,后來轉行當旅店老板。最近她頭頂陣陣發疼,調整姿勢后疼痛反而加劇,感覺不像平常的偏頭痛。2012年11月底,她兩次前往斯托家庭診所求醫,但疼痛并未好轉。

兩個月后,莫納切利死于腦動脈瘤。盡管出現了種種癥狀,也及時看了醫生,但一直沒有做檢查和診斷,一直到她去世前幾天被送往急診才確診。

莫納切利的丈夫起訴了醫生的工作單位斯托家庭診所,該診所擁有聯邦資格認證。佛蒙特州新聘的檢察官助理歐文·福斯特獲指定為政府辯護。盡管看起來是一起典型的醫療事故案例,但福斯特即將有大發現。他的老板,美國律師克里斯蒂娜·諾蘭稱之為“醫療欺詐的新領域”,并提出同類案件第一起訴訟,也獲得了佛蒙特州有史以來最高額的經濟賠償。

福斯特從莫納切利的病歷開始研究,發現一個難題。政府在法庭文件中聲稱,她的醫生考慮過動脈瘤的可能性,為了排除,醫生已經要求通過診所的軟件系統進行頭部掃描。理論上,該項檢測會發現莫納切利大腦出血。但醫生的指令并未進入檢測室,壓根就沒有發出去。

醫院的軟件是由eClinicalWorks (eCW)開發的電子病歷系統,簡稱EHR。eCW是美國病歷軟件主要銷售商之一,目前在美國有85萬專業用戶。沒過多久福斯特便收集到一份令人不安的報告,由消費者維權機構商業改進會提交的投訴,主要關于eCW用戶面板出現的問題,還整理了全國各地提交的法律訴訟,說明公司的技術并沒有聲稱的先進。

在此之前,福斯特和大多數美國人一樣,對電子病歷幾乎一無所知,但他很快就收集到了eCW 軟件存在重大問題的線索,其中一些問題可導致安妮特·莫納切利之類患者面臨危險。

確鑿的證據來自于2011年對該公司提出的指控。布蘭登·德萊尼原先是英國警察,轉行為成為電子病歷專家,2010年紐約市聘用他負責賴克斯島的eCW系統啟動工作。賴克斯島是個監獄,當時關有10多萬名囚犯。德萊尼入職不久便發現系統出現許多令人不安的問題,也成了他控告的基礎。指控稱,系統里病人的服藥清單不可靠,處方藥開不出來,已經停用的藥物會顯示為近期正在服用。有時電子病歷列出一位患者的服藥情況,備注卻是醫生給另外一名患者寫的內容,如此一來很容易誤診或開錯藥。2010年約有30000種處方缺少準確的開始和停藥日期,可能引起用藥不足或用藥過量問題。德萊尼總結說,eCW的系統并未準確跟蹤檢測結果,據他統計有1884次檢測沒給結果。

2015年,佛蒙特州正式啟動了聯邦調查。

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.

圖片來源:Photograph by The Voorhes for Fortune

政府發現,eCW系統當中面條一般混亂的代碼錯漏百出,修復一個故障就會冒出另外一個。舉個例子,用戶界面提供了要求檢測或調出診斷圖像的方法,但用起來經常失靈。軟件可以檢測并警告用戶某些藥物相互作用存在風險,但醫生并不知情,只要藥品訂單是個性化定制的,警報就會停止?!熬秃帽任以陂_車,收音機開著,雨刷也在工作,我一打轉向燈,剎車突然失靈了?!备K固卣f。

政府稱,eCW系統沒有采用標準藥物代碼,有時連實驗室和診斷代碼也沒有采用。

此案未提交陪審團審理。2017年5月,eCW 因涉嫌“虛假陳述”和向推廣其產品的客戶提供回扣支付了1.55億美元與政府和解,其中一名醫生從中賺了數萬美元。盡管和解金額創下紀錄,但公司否認行為不當。多次要求eCW置評均未獲回復。

如果說,故事結局出人意料,那就是:美國政府提供資金幫助軟件應用,而且資金一直沒斷?;蛘邞撜f:其實你一直在資助該軟件。

說到這里,是個奇怪、悲傷,而且令人惱火的故事。焦點并不是一場訴訟,也不是一項草率的技術。確切地說,這是個容易出現問題的行業,而且以非常私人的方式與每個人生活相連。故事的核心是價值3.7萬億美元卻徘徊在十字路口的醫療系統。最后是一系列無意中產生的后果,一項看起來引領時代潮流的大創意導致的意外死亡。

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.

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虛擬魔術子彈

電子病歷本應發揮巨大作用,讓藥物更安全,提供更優質的護理,給患者更多權利,甚至還能省錢。支持者宣稱,將來研究人員可以利用系統內的大數據來找出最有效的治病方法,同時大幅減少醫療差錯。相應地,患者也可以擁有真正便攜的病歷,瞬息之間就能向全國任何地方的醫生和醫院發送病史,急診室搶救面臨生死抉擇時,病歷堪稱至關重要。

但是,距前美國總統奧巴馬與聯邦政府簽署加速病歷數字化的法律已經十年,聯邦政府也已經大筆投入360億美元,卻拿不出什么像樣的成果?!秳P撒健康新聞》和《財富》雜志聯合采訪了超過100位醫生、患者、IT專家和管理人員、醫療政策負責人、律師、政府高級官員以及好幾家電子病歷供應商的代表,其中還包括兩家公司的首席執行官。采訪揭露了一次不幸錯失的良機:現在美國成千上萬的電子病歷并未形成電子信息生態,仍然處在雜亂無章且不連貫的狀態。此外,推廣電子病歷還將醫療機構與幾乎難以忍受的技術強行捆綁,將電子病歷行業年銷售額推上了130億美元。

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,喬·拜登看著貝拉克·奧巴馬簽署《美國復蘇和再投資法》,其中包括推廣電子病歷。圖片來源:Charles Ommanney—Getty Images

從一方面來看,努力已經實現目標,現在96%的醫院采用了電子病歷,2008年只有9%。但在大多數其他方面,新技術遠未達到目標。醫生抱怨系統笨拙不直觀,還有花費在點擊、打字和應付麻煩的大量時間,比花在病人身上的時間還長。與全球聯網的ATM不一樣,電子病歷系統有700多家供應商,相互之間并不通氣,也就是說醫生傳輸醫療數據還是得用傳真和CD-ROM。同時,患者想查看病歷仍然不方便,就是做不到。

許多人說,電子病歷的初衷是改善收費,而不是加強病患護理,所以并未降低成本,“費用上調”更容易,也就是賬單支出上升(不過有些人說系統偵測欺詐行為也更容易)。

更嚴重的是,《凱撒健康新聞》和《財富》雜志長達數月的聯合調查發現,政府提倡的電子病歷并沒有簡化醫療流程,而是導致了大量未知的安全風險。調查發現上千份與軟件故障、用戶失誤或其他缺陷有關,涉及病人死亡、重傷和僥幸脫險的驚人報告。多數資料淹沒在政府資助和私人資料堆里,鮮為人知。

導致問題更復雜的是根深蒂固的保密政策,因為一直保密,所以公眾很難得知軟件故障問題。電子病歷供應商經常強制執行合同的“限制條款”,阻止采購方就安全問題和糟糕的軟件安裝情況發聲,不過有些客戶已經向法院起訴表達不滿。此外,原告稱醫院經常拼命扣留受影響患者或家人的病歷。兩位坦誠指出電子病歷問題的醫生事后要求報道中不要泄露姓名,補充說他們工作的醫療機構禁止告訴外界。檢察官助理福斯特說,“一道沉默之墻” 保護著電子病歷供應商。

雖然軟件減少了手寫時代一些常見的臨床差錯,但華盛頓特區梅德斯塔健康中心的研究員拉吉·拉特瓦尼記錄了一些與電子病歷有關的錯誤新方式,他認為新出現的問題很危險而且其實可以預防?!拔覀儾荒茉谌珖疾⒁罅⒓唇鉀Q問題,其他地方的患者可能受到同樣問題的影響,不應該發生?!彼硎?。

大衛·布魯門撒爾曾經在奧巴馬政府擔任全國醫療信息技術協調人,也是電子病歷計劃的設計者之一。他向《凱撒健康新聞》和《財富》雜志承認,電子病歷“沒有發揮潛力。也基本沒有人會說發揮了潛力”。

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)與扎克·海廷格博士研究眼動追蹤,從中了解醫生如何使用電子病歷系統。圖片來源:Photograph by T.J. Kirkpatrick for Fortune

2017年1月,前總統奧巴馬在接受美國之音采訪時也指出,電子病歷是他最令人失望的工作之一。他嘆道,“事實上還是有成堆的文件工作……醫生還得輸入資料,護士把所有時間浪費在管理工作上。我們投入大筆資金想鼓勵所有人數字化,趕上世界其他地區,現實比預期中困難得多?!?/p>

西瑪·維爾瑪是醫療保險和醫療補助服務中心(CMS)主管,負責監督現在的電子病歷工作。她對花費數十億美元研發的軟件卻無法共享數據感到不寒而栗,這是座無路可去的電子橋梁?!肮谈鞣N開發了系統,可能運轉順利,也可能有問題?!苯衲?月她在接受《凱撒健康新聞》和《財富》雜志采訪時表示,“但我們沒有考慮過各系統如何相互連接。這才是最大的漏洞?!?

該倡議的諸位支持者當中,可能沒有人比前副總統喬·拜登更難過。2017年在華盛頓醫療領導者的一次會議上,他痛斥將兒子博的病歷從一家醫院轉到另外一家醫院令人崩潰?!傲钊苏痼@的是,我兒子跟第四期膠質母細胞瘤斗爭了一年?!?拜登說,“我連他的病歷都拿不到。我還是美利堅合眾國的副總統……簡直是一場噩夢。我們的醫療系統竟然差到這種地步,真是荒謬,太荒謬了?!?!-- cend -->

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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無路可去的橋梁

拜登會告訴你,其實最初的設想很智能。數字化浪潮幾乎席卷了每個行業,一方面是顛覆,有些時候也提升了效率。也許各行業中沒有比醫療更值得數字化。之前,生命檢測和可能挽救生命的數據被鎖在一堆堆文件里,堆放在全國各地的醫生辦公室。

記錄放在鋼柜子里幾乎毫無價值,人人也都同意,尤其是在iPhone剛出現的時期。批評家說,問題在于政策制定者如何改變利用方式。

“每個想法都是善意的,可能會帶來社會效益,但各種想法結合起來同時加在醫生身上,會嚴重影響實際業務?!必愃挂陨信畧淌箩t療中心的首席信息官約翰·哈蘭卡說。他曾經在喬治·W·布什和貝拉克·奧巴馬領導下的電子病歷標準委員會任職?!霸诿绹?,每個病人問診時間有11分鐘,要表現出同理心,要眼神交流,輸入大約100條數據,還得從不犯錯。這是不可能的!”

《凱撒健康新聞》和《財富》雜志調查了20多起醫療過失案件,其中電子病歷要么涉嫌導致傷害,要么存在不當改動,要么向患者隱瞞不合格的護理。這種情況下,審判前經常會達成和解,附加以嚴格的保密承諾,所以經常沒法判斷訴訟的法律意義。電子病歷供應商也經常在合同里明確規定,即所謂的“免責條款”,如果此后醫院因醫療事故遭起訴,即使與技術問題有關也不必承擔責任。

但就像法比安·羅尼斯基的案例,有些訴訟確實能讓隱匿的真相浮出水面,非常有說服力。

羅尼斯基在控訴中稱,2015年3月2日下午他由救護車送抵位于圣莫尼卡的普羅維登斯圣約翰醫療中心。這名年輕的律師已經嚴重頭疼兩天,發燒到頭暈眼花,連告訴911接線員地址都困難。

醫生懷疑是腦膜炎,于是進行脊椎穿刺。第二天,一名傳染病專家在醫院的電子病歷系統里下令做關鍵的實驗室檢測,排查脊髓液中有沒有病毒,也包括單純皰疹。

這套價值數百萬美元的電子病歷系統由Epic系統公司制造,一些人認為該公司堪稱醫療軟件領域的凱迪拉克,安裝時間約在四個月前。雖然指令出現在Epic的屏幕上,卻沒有傳到實驗室。根據2017年2月羅尼斯基在洛杉磯高等法院提起的訴訟,事實證明Epic的軟件與實驗室的軟件未實現完全“對接”。他聲稱,檢測結果和診斷被推遲了幾天。在這期間,他因皰疹性腦炎出現了不可逆轉的腦損傷。起訴書稱,由于該差錯,醫生對羅尼斯基使用名叫阿昔洛韋的藥物出現延誤,而服用該藥可能大大降低羅尼斯基的大腦受損。

Epic否認其軟件應承擔責任或存在缺陷。該公司表示,醫生發送指令時沒有按對按鈕,醫院(而非Epic)已經配置與實驗室的接口。法庭記錄顯示,Epic是美國最大的電子病歷制造商之一,也是美國大多數精英醫療機構的主要供應商,2018年7月悄悄支付了100萬美元和解。醫院和兩名醫生總共支付了750萬美元,另有一個針對第三名醫生的案件正在審理中。34歲的羅尼斯基正在努力恢復生活,他拒絕置評。

數據顯示,發生在羅尼斯基或安妮特·莫納切利身上的事件其實很常見,有點出人意料。類似案例中,關于誰應該承擔責任的來回討論實際上只是問題的一部分:系統經常很混亂(而且正確操作的培訓很缺乏),結果是出了錯各方都不認。很難說清楚從哪里開始算人為失誤,從哪里開始算技術上的缺陷。

電子病歷承諾將患者所有記錄存在同一處,但通常這就是問題。有些信息很關鍵,或者時效很重要,卻常常被淹沒在海量數據中。在快速的醫療決策中,在復雜的下拉菜單里,很有可能遺漏關鍵信息。

13歲的布魯克·迪利普蘭對乳制品過敏,醫院卻提供了含有益生菌的牛奶。根據她母親提起的訴訟,兩劑藥導致她陷入“完全呼吸窘迫”,導致肺萎陷。12歲的羅里·斯坦頓在體育課上刮傷了手臂,急診室的醫生根據電子病歷上并不完整的檢測結果讓他出院,之后他死于膿毒癥。還有42歲的托馬斯·埃里克·鄧肯,2014年他從達拉斯一家出現埃博拉病毒的醫院回家。雖然有一名護士在電子病歷中寫到他最近去過利比里亞,而當時利比里亞正流行埃博拉病毒,醫生卻沒有看到這段信息。一周之后鄧肯去世。

許多類似案件最終訴諸法律。通常情況下,醫生和護士會指責病歷系統中的技術問題。電子病歷供應商指責人為錯誤。與此同時,案件不斷增多。

Quantros是一家私人醫療分析公司,聲稱已經記錄2007年到2018年18000起與電子病歷的安全事件,其中3%導致患者受到傷害,其中包括7例死亡事件。 Quantros的一位主管稱死亡數字被“嚴重低估”。

2016年,位于華盛頓特區的患者安全監督機構The Leapfrog Group進行的一項研究發現,醫院電子病歷系統中的藥方,也是政府要求認證的一項功能,在每個系統中通常配置不同。測試模擬中,39%的病例未能標記潛在有害的藥方,其中13%的案例可能致命。

過去幾年里,皮尤慈善信托基金會開展了一項電子病歷安全項目,主要為了解決可用性和將正確的病歷與患者匹配等問題??雌饋硎且粋€簡單的任務,但即便同一家電子病歷供應商制造的系統也經常失敗。根據皮尤的說法,在一些機構中,匹配準確率只有50%?;颊咭舶l現了問題。1月凱撒家庭基金會的一項調查發現,五分之一的患者發現電子病歷中存在錯誤。

負責認證醫院的聯合委員會已經就一些問題提出警告,包括電子病歷和醫療設備警報當中85%到99%的誤報。(俄勒岡健康與科學大學的研究人員進行的一項研究估計,在重癥監護室工作的臨床醫生每天可能受到多達7000個被動警報影響。)過度警告可能引起危險。2014年至2018年期間,委員會統計了170份志愿報告,內容是警報管理和警報疲倦對患者造成傷害,警報疲倦是指醫護人員因為受到過多不必要的警告影響,忽略了偶爾有意義的信息。170起案例中,101起導致患者死亡。

賓夕法尼亞患者安全局是一家獨立的全國機構,負責收集有關負面事件的信息,2016年1月至2017年12月期間,共統計了775起與醫療IT技術相關的“實驗室檢測問題”。

當然了,在手抄筆錄的時代存在大量醫療差錯。例如,當醫院工作人員誤解醫生潦草的字跡或看錯圖表,就會引發致命后果??纯船F在有多少醫生更愿意人工操作而不使用電子病歷,或許可以說明一些問題。亞倫·扎卡里·赫廷格是華盛頓梅德斯塔醫療中心的急診內科醫師,他表示跟其他醫生分享重要的患者信息時,都會把信息寫在白板上或紙巾上,然后放在同事的電腦鍵盤上。

美國食品藥物管理局(FDA)沒有強制就電子病歷安全事件上交報告,與醫療設備相關的事件須上報。但在FDA Maude的負面事件數據庫中,相關事件的數量出現激增,目前該數據庫已經成為關于各種系統警告的專門公告板。

令情況更加復雜的是,醫療機構幾乎總是根據自身要求定制整體的電子病歷系統。定制行為導致每個系統都很特別,很難與其他系統比較,反過來也導致錯誤的來源難以判定。

馬丁·馬卡里是約翰·霍普金斯大學的外科腫瘤學家,也是2016年一項被廣泛引用的研究合著者,該研究將醫療差錯列為美國第三大死因。他認為,電子病歷安全性方面有所改善,包括最近一些有助于抑制阿片類藥物流行的調整。但是他表示,“我們只是把一些問題換成了另一些。過去跟手寫的潦草字跡和信息丟失斗爭?,F在問題變成寫處方和開藥時有沒有弄錯病人,系統提示并不明確?!?/p>

約瑟夫·施耐德是得州大學西南醫學中心的兒科醫生,他認為紙質病歷到電子病歷好比從馬車變成汽車。但他補充說,“但醫學上的‘汽車’才剛發展到20世紀60年代,還沒有安全帶和安全氣囊?!?

施耐德回憶起一件事,當時他的同事不明白為什么很多筆記會莫名其妙消失。他們仔細研究了幾個星期才發現問題根源,因為醫生一直輸入大括號符號,也就是{},連供應商代表也不知道使用該括號會刪除中間的文本。(施奈德說,電子病歷制造商最初指責醫生有問題。)

從國家護士聯合會到得州醫學會,再到食品與藥品管理局內部的領導人,長期以來陣營廣泛的聯盟一直呼吁監督電子病歷安全問題。其中最直言不諱的是拉特瓦尼,他領導著梅德斯塔全國醫療人為因素中心,一個30人的研究所,致力于優化醫療技術的安全性和可用性。拉特瓦尼早年從事國防工業,研究過信息顯示直觀性問題。他說,2012年前往梅德斯塔就職時,對醫療“使用的[數字]接口類型”感到震驚。

去年發表在《衛生事務》雜志上的一項研究中,拉特瓦尼及其同事研究了2012至2017年三家兒科醫院的用藥錯誤。研究人員發現,其中3243人部分是由于電子病歷的“可用性問題” ,其中大約五分之一可能導致患者受傷?!霸愀獾慕涌谠O計和執行不當都可能導致差錯,有時甚至導致死亡,這種情況令人難以置信,也完全可以解決?!彼f?!拔覀儾粦撟尣∪艘虼耸艿絺??!?

通過眼睛跟蹤技術,拉特瓦尼用視頻展示了兩家美國領先的電子病歷系統上執行基本任務時多么容易犯錯誤。例如,急診室醫生開泰諾時會看到下拉菜單,其中列出了86個選項,許多與當前患者無關。醫生必須仔細閱讀清單,以免點錯劑量或服藥方式,許多人確實會點錯。一項估計顯示,約1000個藥方里,醫生不小心選擇了栓劑(系統內縮略為“PR”)的劑量,而不是片劑(“OR”)劑量。這點差錯還不至于傷害病人,但其他藥品出現差錯可能會傷害到病人,而且發生過。

今年早些時候,梅德斯塔人類因素中心與美國醫學協會共同發起了網站和公眾意識宣傳活動,呼吁人們對不斷蔓延的差錯加強關注。他們將電子病歷的縮寫“EHR”改為“經常出錯”(Errors Happen Regularly)的縮寫,還向國會提出請愿。拉特瓦尼正在推動成立中央數據庫,以跟蹤相關差錯和負面事件。

其他人則轉向社交媒體發泄。蘭德公司的健康政策研究員馬克·弗里德伯格也是執業初級護理醫師,他在推特上主持標簽-#EHRbuglist,鼓勵醫護人員說倒苦水。上個月,推特上出現一個嚴厲批評Epic公司的戲謔賬戶,剛注冊五天粉絲就超過8,000人。第一條推文就模仿了Epic霸道的口吻:“我發現有個醫生跟病人眼神有接觸。此類恐怖行徑必須停止?!?/p>

盡管電子病歷系統被指罪行多多,主要問題在于經常疏忽導致用戶遇上更大的麻煩。

以路易斯安那州奧奇納醫療系統的醫療助理林恩·喬文為例。在一項尚未審理的2015年訴訟中,喬文聲稱Epic的軟件未能就用藥發出關鍵警告;喬文出現血栓的風險很高,盡管病歷中有記錄,但醫院進行心臟手術后給她開了限制血液流動的藥。她得了壞疽,下肢和前臂截肢。(奧奇納醫療系統稱,雖然無法對訴訟中的案例發表評論,但“仍會努力保障患者安全,堅信通過電子病歷技術可以做得更好?!盓pic拒絕置評。)

該訴訟稱由于存在“大量重復數據”, Epic軟件“查看和理解起來都極其復雜”,許多醫生也有類似抱怨。喬文說,醫療費用已經超過100萬美元,而且將永久殘疾。訴訟還稱,丈夫理查德為了照看她,不得不提前從肯納市的工作中退休。各方均拒絕置評。

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.

****

職業倦怠蔓延

麻木的重復、框里打鉤和無休止的下拉菜單,都組成了拉特瓦尼所說的“認知負擔”,重壓之下現在的醫生疲憊不堪,越來越多人選擇提前退休。

近年來,“醫生職業倦怠”已經迅速上升到醫學議程的首位。2018年梅里特-霍金斯一項調查發現,多達78%的醫生出現了倦怠癥狀。1月,哈佛公共衛生學院和其他機構視之為“公共衛生危機”。

阿希什·賈阿哈佛大學研究的共同作者之一,他認為主要原因是“設計糟糕的電子病歷增加……要求醫生把越來越多的時間花在沒法直接幫助患者的事情上?!?/p>

很少有人否認美國醫療系統快速數字化已經實現行業轉型。隨著電子病歷普及,醫學的面貌和感覺也發生了變化?,F在醫生都在打字,看電腦屏幕比看病人要多?;颊卟⒉幌矚g這種變化。對醫生來說,每天的開始和結束都是面對著屏幕,導致的結果可能是完全麻木。

“坐在病人面前要做的事情太多了,一共可能只有7到11分鐘,哪有時間認真傾聽呢?”約翰-亨利·普菲弗林是醫學人類學家,主要為患上職業倦怠的醫生提供咨詢?!叭绻氵M入醫學領域的原因是為了互動,在現有系統里你只是個工具,是非人性化的?!彼l現電子病歷轉型過程中有許多醫生離職?!斑@是一場災難?!彼f。

賓夕法尼亞州一家醫院系統Wellspan的醫生兼首席信息官哈爾·貝克說,除了使醫患關系復雜化,電子病歷某些方面的特點也導致行醫更加困難?!搬t生得在病歷和病人之間不斷轉換?!彼赋鲞@點很不正常,也存在潛在危險?!伴_車時可不能發短信。我還沒有見過首席執行官主持董事會會議時還要做會議記錄,當然,我也沒有聽說過法官審判時還要擔任速記員。但在醫學領域,我們已經要求醫生從手寫改為[電腦輸入]病歷,電腦界面又相當復雜?!?/p>

雖然坐診期間醫生可能一直在打字,但醫生普遍表示此后還得多花好幾個小時,不管是午飯期間還是深夜,才能完成筆記,跟上電子病歷(發送轉診,回應患者,解決代碼問題)。是的,電子病歷并沒有減少文書工作,系統只是把卷頭工作轉移到網上,而且花的時間非常多。根據2017年的《家庭醫學研究年鑒》,醫生在電子病歷上每天花費約6個小時,其中44%的時間花在文書和行政工作上,比如賬單和代碼。

對于所謂的睡衣工作時間,一分錢補償也沒有,平均每位醫生下班后還要為電子病歷工作1.4小時。

也有許多醫生認識到這項技術的價值。2018年斯坦福醫學院對全國醫師調查中,60%的參與者表示電子病歷改善了患者護理。同時約有59%的人表示,電子病歷需要“徹底調整”,系統降低了職業滿意度(54%)和臨床療效(49%)。

初步研究中,拉特瓦尼發現醫生對使用電子病歷有典型的生理反應:壓力。他和團隊跟蹤臨床醫生工作時,使用一系列傳感器監測醫生上班時的心率和其他生命體征。醫生的心率只在兩種情況下高達每分鐘160次:跟患者互動時,以及使用電子病歷時。

“一切都是如此繁瑣?!钡每怂_斯州阿靈頓的家庭醫學博士卡拉·迪克說?!芭c紙面上的圖表相比,電子病歷速度很慢,查找時必須放大縮小?!彼忉屨f,放大縮小過程中很容易弄錯病歷?!拔叶紱]法數有多少次因為弄錯圖表取消指令?!?

在羅德島,一位急診室醫生每天開布洛芬都很煩躁,看似很簡單的事卻要點很多次鼠標。每次只要她給女性患者開基本的止痛藥布洛芬,無論患者是9歲還是68歲,都有彈窗跳出來警告她給孕婦服用藥物可能造成危險。醫院不許醫生評論系統,只能多點幾次讓警告消失?!斑@還是只是冰山一角?!彼f。

最讓醫生擔心的是,勤勉、善意的醫生也容易犯下嚴重的差錯。她指出,每個班次的急診醫生平均會點擊鼠標4000次,做任何事情4000次都不出錯的幾率很小?!败浖缑娣浅;靵y,又很難用?!彼a充說?!胺稿e幾乎不可避免……不是疏忽的問題,而是工具太糟糕了?!?

許多電子病歷制造商也承認,醫生的疲勞真實存在,表示正在盡可能減輕負擔,改善用戶體驗。山姆·巴特勒是肺部重癥監護專家,2001年加入總部位于威斯康星州的Epic,專門負責改善體驗的工作。如果每個星期醫生的收件夾里信息超過100封(類似于電子郵件收件箱),倦怠的可能性更高。巴特勒的研究小組還分析了醫生的電子筆記,比起九年前長度已經變為兩倍,是世界上其他地區的三到四倍。他說,Epic利用類似觀察結果改善客戶體驗。但他表示要徹底解決還是很困難,因為醫生“對每件事都有不同的看法”。(《凱撒健康新聞》和《財富》雜志多次要求采訪Epic的首席執行官朱迪絲·??思{,但公司拒絕安排。然而,2月??思{在一次行業采訪中表示,將醫生倦怠歸咎于電子病歷并不公平,還引用了一項研究表明,職業倦怠與電子簡歷滿意度之間幾乎沒有相關性。其他供應商高管指出,已經認識到可用性問題,正在努力解決相關問題。)

“并不是說我們是一群不會利用技術的路德分子(指強烈反對機械和自動化的人——譯者注),”羅德島急診醫生表示?!拔易约河衖Phone和一臺電腦,原本工作得很正?!,F在給我們極其繁瑣又容易出錯的工具,還是政府強制要求的。真的沒有時間慢慢等。每個人都得參與進去,找到自己的工作方式,還要在慢慢磨死人的系統上花費數千萬美元?!?!-- cend -->

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.”

****

360億美元和變化

美國病歷電子化的推動是在非常低潮的時刻,即2008年的金融危機。當年12月初,奧巴馬當選后不到四個星期就提出了雄心勃勃的經濟復蘇計劃。 “我們將確保美國每個醫生辦公室和醫院里都用上尖端技術和電子病歷,減少繁瑣程序,防止醫療失誤,每年節省數十億美元?!彼谝淮螐V播講話中說。該想法在華盛頓很流行。眾議院前議長紐特·金里奇總喜歡說,查詢聯邦快遞包裹比查病歷容易。奧巴馬前任總統喬治·W·布什也曾經提出建立全國性醫療系統。他沒有投入多少資金,但創立了做事的機構:國家協調員辦公室(ONC)。

在經濟衰退最嚴重之際,自命不凡的電子病歷項目就像萬事俱備只欠東風,只有支持紙質病歷的游說團會反對。2009年2月,議會通過了《關于促進經濟與臨床健康的健康信息科技法案》(HITECH Act),為醫療信息技術制定了很多大規模刺激計劃。目標不僅是讓醫院和醫生接受電子病歷,還有應用之后提供更好的醫療服務。因此,議會設計了“胡蘿卜加大棒”的方法:醫生只有在政府認證系統內成為“實際用戶”,才有資格獲得聯邦補貼(一段時間內總額高達64000美元)。供應商則須開發符合政府要求的系統。

不過,時間很緊迫。刺激經濟的需要意味著醫療系統要迅速采用電子病歷?!坝纱颂岢隽司薮蟮碾y題”,法扎德·莫斯塔薩里說,2009年他加入國家協調員辦公室擔任副主任,2011年擔任負責人領導。打造有用互通的全國性病歷系統的想法“在短時間內完全不可能實現”。

現實障礙并未阻止聯邦層面的規劃者追求宏偉目標。每個人都對電子病歷抱有巨大期望。食品與藥品管理局希望系統能跟蹤醫學植入設備的唯一標識符,疾病控制中心希望系統支持疾病監測,醫療保險和醫療補助服務中心則希望系統囊括質量指標等等?!爱敃r匯集了經委員會探討考慮過的想法,都很正確?!?莫斯塔薩里說,“問題就在于,所有想法都很正確?!?/p>

然而,并不是每個人都同意所有想法都正確。不久之后,“實際使用” 成為許多繁瑣政府計劃的貶義代稱,實際上就是讓醫生做一些無聊的事,比如每次就診時都要勾選病人吸煙狀況的方框。

當時的電子病歷供應商圈子是收入20億美元的行業,雖然對一系列需求很不滿,卻因為政府360億美元的投資賺了一筆。正如電子病歷供應商NextGen 健康中心的首席執行官拉斯蒂·弗朗茨所說:“整個行業的情況是,‘支票就掛在面前,必須達到這些要求才能拿到,所以就這么做吧?!?/p>

哈蘭卡在布什政府和奧巴馬政府中均積極支持該倡議,他認為快速啟動的壓力主要因為愿望清單太過分?!?8個月內就要從規定變為可實際使用的產品,太快了?!彼f,“就好比讓九個女人一個月內生個孩子?!?

一些參與該項目的人承認,實際推進過程并不像預期一樣容易或無縫,但他們認為這不是重點。奧巴馬于2009年任命安尼斯·喬普拉為美國第一位首席技術官,他表示該項支出只是“首付”,最終目標是從根本上改變美國醫學,搭建數字基礎設施,支持基于醫療服務質量和結果的新型支付方式。

鮑勃·科徹是一名醫生,也是風險投資公司維納克的明星投資人,2009年至2011年他曾經在奧巴馬政府擔任醫療和經濟政策顧問。他不僅為奧巴馬政府推出該政策辯護,還表示不同意認為政府倡議完全失敗的說法?!半娮硬v已經完全達到宣傳和期望?!彼f,強調說電子病歷也是技術基礎,將支持一系列創新,患者可以從智能手機上訪問醫療記錄,也可以協助人工智能進行醫療調查。有些人就指出,系統收集醫療數據方面的價值是紙質病歷無法實現的,例如密歇根州弗林特市的兒童因為受污染的水而中毒。

但魯斯蒂·弗蘭茨聽到關于電子病歷的信息截然不同,更重要的是,抱怨都來自于客戶。

這位工程師曾經在斯坦福大學求學,2015年在NextGen擔任首席執行官,而NextGen在醫生辦公市場的電子病歷方面是每年銷售達5億美元的重量級公司。不過他收到的產品反饋并不友好。在拉斯維加斯曼德勒海灣度假村,他第一次站在臺上面對成千上萬的 NextGen客戶,當時他上任才四個月。他告訴《凱撒健康新聞》和《財富》雜志:“人們排著隊在麥克風上對我們喊:‘沒有提供穩定的軟件!高管團隊找不到人!服務體驗非常糟糕!’”(他現在將該事件稱為“吐槽大會?!保?/p>

職業生涯大部分時間里,弗蘭茨一直在醫療行業跳來跳去。在醫療設備公司工作時,他對電子病歷大躍進充滿嫉妒和敬畏?!靶袠I先是經歷了達爾文式自然發展,然后趕上了經濟刺激計劃?!备ヌm茨說,他指責政府采取的監管措施太過簡單?!败浖腿婚g啟動,實在過于倉促所以沒能支持治療?!彼f。 “只是支持了公司爭取激勵。我工作的公司也串通其中?!?/p>

說是串通可能都寬容了些?!秳P撒健康新聞》和《財富》雜志發現針對該公司的一系列訴訟案,從蒙大拿州的白硫磺泉鎮到威斯康星州的到尼爾斯維爾。2013年,俄亥俄州貝爾方丹的瑪麗 ·魯坦醫院在聯邦法院起訴NextGen(之前叫Quality Systems),聲稱于2011年安裝存在“重大缺陷”的軟件,使用過程中遇到數百個問題。

醫院聘請的一位顧問評估了NextGen的系統,撰寫了60頁的報告并提交法院,他指出“許多功能缺陷”,稱該軟件“不符合預期目的?!?顧問寫道,一些患者信息記錄得不準確,可能“導致重大的治療風險,至少會造成不便,最嚴重的情況是造成醫療事故甚至死亡?!鳖檰枅蟾孢€指出,瑪麗·魯坦醫院遇到的問題包括軟件會隨機改變患者的性別,或檢查后丟失醫生的觀察結果。他發現,該公司解決問題有時要花費數月。據報道,有一個與醫生筆記有關的IT票據會莫名其妙地自行刪除,據說要10個月才能解決。(該顧問還指出,安裝 NextGen軟件的其他醫院中似乎也出現了類似問題 。)

俄亥俄州的醫院為電子病歷系統支付了超過150萬美元,聲稱公司違反了合同。NextGen回應稱,對訴訟中提出的索賠提出異議,2015年便已解決相關問題,而且“法院就指控并未調查出違法事實?!贬t院拒絕發表評論。

從那時起,政府認定NextGen的軟件符合刺激計劃的要求。到2016年, NextGen 已經擁有超過19,000名獲得聯邦政府補貼的用戶。

2017年12月,佛蒙特州牽頭的聯邦調查NextGen幾個月之后,美國司法部也傳喚了該公司。弗蘭茨告訴《凱撒健康新聞》和《財富》雜志,NextGen正積極配合調查?!肮緵]有欺騙之舉,不過四年前還沒產生效果?!彼f。弗蘭茨還強調自己任職期間NextGen實現了“迅速發展”,2017年以來獲得了五項行業獎項,并且客戶“反應非常積極”。

Allscripts是另外一家領先的電子病歷供應商,從刺激計劃中受益,也被眾多不滿的客戶起訴,2012年前格倫·圖爾曼一直擔任公司領導。他承認在該行業迅速推出市場比其他事都重要。

“當時情況很混亂。結果讓人意想不到?!?圖爾曼說?!八泄径荚谡f,這次是難得的擴大市場份額的機會,要傾盡全力,有問題以后再回頭解決?!惫咎峤蛔C券交易委員會的文件顯示,司法部已經對其開展民事調查。Allscripts在一封電子郵件中表示,無法對進行中的調查發表評論,但司法部的民事調查與其在調查開始后收購的業務有關。

推廣方面大部分混亂之所以發生,是因為聯邦政府對急于通過刺激計劃賺錢的公司控制很少。就像一場淘金熱,似乎任何系統推廣時都可以自稱已獲“聯邦政府批準”。醫生可以在好事多超市和沃爾瑪的山姆會員店購買折扣軟件。eClinicalWorks 出售的“turnkey”系統價格為11,925美元,然后根據政府的激勵措施賺錢。

2009年頂級供應商像搖滾樂團一樣,在全國舉行了一次“激勵之旅”,一共走了約30個城市。每到一處都向出席推介會的醫生提供“個性化分析”,介紹政府的激勵措施能幫著賺多少錢。電子病歷銷售方跟制藥公司套路一樣,都選在豪華酒店的高級晚宴上吸引醫生。一家頗具進取精神的軟件公司還推出了“以舊換新”活動,只要醫生愿意將當前使用的病歷系統換成新款,就能獲得3,000美元獎勵。Athenahealth則在豪華酒店舉辦“僅限邀請出席”的晚宴,主要向醫生介紹如何利用刺激措施獲得更多報酬,爭取有希望的獎勵等等。Allscripts提供了免費的購買計劃,幫助醫生“將電子病歷方面的投資回報最大化?!保ˋthenahealth公司發言人表示,該公司的“晚餐本質上是教育,主要幫助醫生了解政府的計劃?!?Allscripts沒有直接回答有關推廣活動的問題,但表示因為“向全球數十萬名護理人員提供軟件和服務感到自豪?!保?/p>

電子病歷本來應該降低醫療成本,至少可以防止重復檢查。但隨著聯邦政府開啟刺激計劃,許多人對能否真正節約成本表示懷疑。即便國會審計師逐步揭開真相,支持者還是大肆宣揚節約了800億美元的成本。陪審團尚未給出定論,不過人們越來越懷疑數字革命可能鼓勵過度支付和新型欺詐和濫用,從而導致醫療成本提升。

2012年9月,媒體報道暗示一些醫生和醫院使用新技術不當地提高收費,這種做法被稱為“費用上調”,當時衛生和公共服務部負責人凱瑟琳·西貝利厄斯和司法部部長埃里克·霍爾德警告業界不要“耍弄系統”。

還有越來越多證據表明,一些醫生和醫療系統可能夸大了對新技術的使用情況以爭取刺激資金,可能存在針對醫療保險和醫療補助的巨大欺詐,解決起來可能要很多年。2017年6月,衛生和公共服務部檢察長估計,醫療保險官員向醫院和醫生提供了超過7.29億美元的補貼,醫院和醫生并不配收到這些錢。

每個州管理自己的醫療補助計劃,表現也沒好到哪里。根據檢察長報告,審計17個州計劃時發現有14個州已經超額支付,超過6600萬美元。

上個月,參議院財政委員會主席愛荷華州共和黨參議員查爾斯·格拉斯利嚴厲批評稱,醫療保險和醫療補助服務中心只追回了虛假付款中一小部分,他稱之為“往大海里吐痰”。

由于電子病歷供應商競相爭取刺激資金,也被指犯下了驚人且傷及病人的欺詐行為。除了美國政府與eClinicalWorks 達成價值1.55億美元的虛假申報案 之外,聯邦政府也與另外一家大型供應商,總部位于坦帕的Greenway Health 達成就類似指控達成和解。今年2月,該公司與政府達成和解,金額剛超過5700萬美元,既未否認也未承認存在不法行為?!斑@些都是企業貪婪的案例,公司把利潤看得比什么都重要?!狈鹈商刂莸穆摪顧z察官克里斯蒂娜·諾蘭表示,其辦公室負責相關案件。(Greenway Health回應稱,沒有處理指控或達成和解,但表示“將努力成為質量、合規性和透明度方面的領導者?!保?!-- 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.”)

****

巴別塔

2017年年初 ,新上任的醫療保險和醫療補助服務中心主管西瑪·維爾瑪走了一大圈,專門傾聽。她走遍了美國各地的醫療機構,不管是在大城市和農村小診所,從一線醫生口中聽到的是,人人都討厭電子病歷?!搬t生倦怠是實際存在的?!彼嬖V《凱撒健康新聞》和《財富》雜志。醫生談到了從其他系統和醫療機構獲取信息的困難,也抱怨了政府的報告要求,認為種種要求很麻煩而且沒有意義。

2017年夏的一天,之前她聽到的抱怨突然跟自己密切相關。一次家庭度假后回印第安納波利斯的路上,身為醫生的丈夫倒下了。接下來幾個小時極為瘋狂,這位醫療保險和醫療補助服務中心主管接到了急救人員和醫生幾個電話,問她知不知道丈夫的病史,有沒有可幫助挽救生命的信息。她立刻打電話問印第安納州給丈夫治過病的醫生,原本應該是完整的信息,她卻只能拼命拼湊各種零碎信息。還好她丈夫保住了性命,但從中可看出現有醫療信息生態中固有的功能障礙和危險。

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.

醫療保險和醫療補助服務中心主管西瑪·維爾瑪正負責研究醫療“信息阻斷”,壓制言論的條款等。圖片來源:Photograph by T.J. Kirkpatrick for Fortune

HITECH Act最初愿景的關鍵部分便是電子病歷之間應該交流,政府要求各系統最終要實現互通。

愿景的制定者沒有預料到的是與之相悖的商業激勵措施。信息自由交流意味著患者可以在任何地方接受治療。雖然可能不愿承認,但許多醫療機構都不愿意將病人送到競爭對手的醫生診所或醫院。此類失去的收入還有個專門術語:“泄漏?!眹栏窨刂苹颊叩牟v是一種預防方式。

布魯門撒爾說,病歷數據具有大量的專有價值,目前他在從事健康研究的慈善機構英聯邦基金會擔任負責人。讓醫院放棄病歷數據“就像要求亞馬遜與沃爾瑪分享數據一樣?!彼f。

布魯門撒爾承認,未能及時掌握不正當的業務情況,也沒有預見到讓各系統互相溝通面臨的挑戰。他補充說,強制互通有些早,全國90%的醫療機構還沒有搭建起系統,也沒有數據可交換的時候下達指令似乎不現實?!爱敃r我們有個說法,就是互通之前得先得運轉起來?!彼f。

由于對各系統溝通缺乏真正的激勵,行業發展得頗為坎坷。一些醫療機構與其他機構有選擇鏈接,或加入區域交流,但并不穩定。2013年,一個由Cerner支持名為 CommonWell的互通網絡成立,但Epic等大公司并沒有加入。 (“剛開始,沒人邀請也沒人允許Epic加入?!?Epic研發部高級副總裁蘇斯米特·拉那說。CommonWell counters執行董事吉廷·阿斯納尼表示,“我們反復邀請了各大電子病歷供應商……還向Epic多次發出公開和私下邀請?!?)

然后,隨后Epic支持了另外一項同樣的工作。

去年春天, 維爾瑪努力推動分享工作,后來又承諾對抗“信息阻斷”,威脅對行為不當者實施處罰。她承諾減少醫生的文件負擔,不再保護電子病歷行業壓制言論的條款。至少在減少醫生負擔方面,“人們一致認為有必要,而且應該由政府推動?!彼f。去年夏天出現了進步的跡象,Epic和Cerner兩家行業巨頭終于開始分享信息,雖然只是剛起步。

然而,只要一涉及患者,真正的分享就會叫停。盡管聯邦要求醫療機構向病人及時提供病歷,且病人可以選擇格式,費用要低(政府建議收取6.50美元的固定費用或更低),但病人想拿到病歷還是非常艱難。2017年耶魯研究人員的一項研究發現,美國83家頂級醫院中只有53%提供表格,供患者選擇如何獲得完整病歷。不到一半的醫院通過電子郵件發送病歷。其中一家醫院收取超過500美元的費用。

有時,僅僅想查看病歷都會引發訴訟。塔爾薩的律師詹妮弗·德·安吉利斯就經常指控醫院扣押客戶的病歷。她說,醫院方面稱想查看病歷要么支付高額費用,要么得獲得法院指令。德·安吉利斯補充說,有時懷疑病歷已經被篡改以掩飾醫療差錯。

可以看看5歲的烏里亞·R·羅奇,2014年10月2日他的手意外砸到學校一扇門上,手指出現挫傷和割傷。五天后,修復手術出現問題,麻醉導致出現永久性腦損傷。羅奇住院期間22天內,Epic電子病歷訪問超過76,000次,他父母提起的訴訟辯稱,許多條目已經被“修改、調整,可能在麻醉出現意外后刪除”。醫院否認存在不當行為。2016年11月該案件結案,條款保密。

接受采訪的其他十幾位律師提到了類似問題,特別是在爭取查看電子“審計線索”時。法院記錄顯示,一些案件中政府律師拒絕提交聯邦醫院的電子文件。俄克拉荷馬州的律師拉塞爾·烏斯爾頓便遇到了這種情況,他代理的是一名懷孕的青少年,曾經在俄克拉荷馬州塔利希納的Choctaw國家醫療中心住院。當時18歲的謝爾比·卡紹爾懷孕40多周。2017年她對美國政府提起的訴訟中稱,醫生沒有進行剖腹產手術,所以嬰兒出生時腦部受損。訴狀稱,嬰兒出生10個小時后癲癇發作,并且“可能永遠不能走路、說話、吃飯,以及享受其他正常生活”。雖然聯邦政府要求醫院為患者和家人提供電子病歷,但烏斯爾頓必須獲得法院命令才能查看嬰兒完整的醫療檔案。政府律師否認存在疏忽,該案尚未解決。

“只要能瞞住,他們就拼命隱瞞?!睘跛範栴D說?!跋肽玫讲v極為困難,大多數律師都無力承擔相關費用?!彼f

然而,即便是聯邦政府高管可能也拿不到病歷。那年夏天西瑪·維爾瑪的丈夫病愈出院時,只拿到幾份文件和一張存有醫學圖像的CD-ROM,仍然缺少關鍵檢測結果和監測數據。維爾瑪說:“出院到現在,仍然沒找到信息?!币呀涍^去快兩年了。(財富中文網)

本文另一版本發表于2019年4月的《財富》雜志,標題為《死于千次點擊》。

譯者: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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