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Praxis EMR - Why Templates Don't Work Articles - EHR Intelligence

How EHR Operational Failures Impact Primary Care Physicians

Although these EHR operational failures run rampant throughout the industry, researchers said they can be easily fixed through EHR optimization.

Information overload, information scatter, and delegating EHR tasks are common operational failures that physicians are suffering from on a daily basis, according to a study published in the Annals of Family Medicine.

Physicians need well-functioning operational and EHR systems to ensure that patient needs can be met at the correct time. But all too often, those EHR systems fail to meet provider needs.

According to the study authors, operational failures are system-level errors in the supply of information, equipment, and materials to health care personnel.

"These failures have been well-studied in the hospital literature, revealing that cumulative time losses associated with even minor recurrent failures are significant," the authors explained. "By degrading individual and organizational performance, operational failures complicate the delivery of high-quality care, with multiple adverse consequences for patient safety and experience, efficiency, and worker satisfaction."

Most operational failures are manageable and can be improved through EHR optimization or redesign. Because they’re mostly fixable, it is important to recognize and address these failures.

However, operational failures are mostly recognized in hospital research literature, rather than primary care literature, according to the authors.

"This is problematic because failings that affect the ability to provide safe, high quality care are likely to be highly consequential in primary care, where the majority of health care contacts occur and where escalating workload, unprecedented levels of stress, and a crisis in recruitment and retention are major threats to sustainability," they continued.

In 2017, researchers sifted through seven databases in an attempt to see how operational failures in primary care impact the work of primary care physicians.

Ninety-five pieces of healthcare literature tied to their general definition of an operational failure. The majority of these pieces were related to technology, information, coordination, and compensatory labor.

Researchers found that there was a gap between what physicians perceived they should be doing and what they were actually doing. Most of these issues stemmed from operational failures that were out of their hands.

One author described it as "work-as-imagined" and "work-as-done."

A main failure was described as "information overload" while the clinician reviewed patient health information.

According to the study, physicians received approximately daily 60 EHR alerts from other clinicians. Although most were not deemed important, physicians said these notifications made them experience anxiety about missing critical patient information.

Physicians also suffered "information scatter," which occurred when EHRs were cluttered with entries from other clinicians. Physicians had trouble finding patient information and were forced to ask patients for their information, rather than being able to efficiently find the information in the EHR. This process is redundant and not always comforting to the patient.

Due to operational failures, mostly from the EHR, physicians took over tasks that roughly 80 percent of their assistants or other clinicians could complete, according to the authors.

EHR adoption gave physicians more work that clinicians were unlikely to delegate tasks to other staff members. Administrative tasks that were once delegated, such as obtaining insurance authorization and contacting laboratories for test results, are now completed by physicians, which can lead to physician burnout.

"Our synthesis of the literature demonstrates that operational problems in primary care configure the work of primary care physicians, requiring them to engage in compensatory labor to safeguard patient care," the authors concluded.

"Future research must look more closely at the primary care work environment to determine which operational failures have the highest impact and which to prioritize for improvement. Practice and policy should recognize the significance and impacts of system-level operational failures on the work of physicians and the experiences and outcomes of patients."

Praxis EMR - Why Templates Don't Work Articles - Physicians Practice

Six EHR-related malpractice landmines to avoid

EHRs are increasingly leading to malpractice lawsuits. While EHR-related lawsuits still make up only a small number of lawsuits, user error is the cause of 64 percent of EHR-related malpractice claims, according to the Doctors Company. Practices need to focus on eliminating several common problems, mostly tied to user actions, which have led to the majority of EHR-related suits.

Here are six EHR landmines physicians should avoid.

Common EHR-Related Malpractice Problems


  1. Copy and Paste
    • Many doctors are tempted to copy a note from a prior encounter and make changes as appropriate. This leads to a few potential problems.
    • Sometimes physicians forget to update the note with the appropriate changes when copying and pasting, says David Troxel, MD, medical director and secretary of the Doctor's Company board of governors.

  2. Drop-down menus
    • Drop-down menus can often be the source of a user error that leads to a malpractice suit. Not only can users click the wrong thing in the menu, such as the wrong patient symptom, but these menus lead to structured information that physicians can easily overlook when reviewing a note.

  3. Use of templates
    • Jeffrey Kagan, MD, a Newington, Ct.-based internist, has experience reviewing malpractice cases for attorneys. One trend he has seen related to EHR-induced malpractice suits comes from template use. "Templates are supposed to help us do something more comprehensive, but often our templates have a lot of old information that carries forward," he says.
    • In order to avoid falling into this trap, Kagan advises physicians to proofread and modify templates if they are going to be used.

  4. Alert Fatigue
    • The e-prescribing module in an EHR is a potential landmine for malpractice. Alerts indicating when there is a problem with medication dosage or drug-drug interaction will pop up as practitioners are inputting data into the EHR. As a result, doctors get annoyed and develop alert fatigue, and they just turn the alerts off.
    • While this is understandable, turning off the alerts could mean a potential significant problem could go undetected.

  5. Clinical Decision Support Alerts
    • Another prompt that goes ignored, often to the determinant of the patient and the doctor, are clinical decision support (CDS) alerts. These are clinically relevant educational materials that come up as the practitioner is documenting in the EHR. Practitioners should ignore these at their own peril, Troxel says. If anything, physicians should document the reason why they overrode the CDS alert.

  6. Missing Information
    • The idea of physicians missing a vital piece of information in the EHR can be either a user or a technical error. These types of problems are most likely to crop up when a physician is using a new system.
Praxis EMR - Why Templates Don't Work Articles - FierceHealthcare

Variation in physician EHR documentation can put patient safety at risk: study

It's well documented that physicians are frustrated with the design of electronic health records (EHR) and the time they spend inputting information into the systems.

One major factor contributing to this inefficiency: the variation in how physicians document patient data.

This variation-which leads to physicians searching different places in the chart for information or documenting the same information multiple times-is impeding safe and effective use of EHRs, according to a study published in the Journal of General Internal Medicine.

The researchers analyzed data of 170,000 patient encounters led by 800 physicians in 237 practices and also interviewed 40 physicians in 10 primary care practices. The study was led by researchers at the University of Michigan Health System, the University of Michigan Medical School and the Center for Clinical Informatics and Improvement Research at the University of California San Francisco.

The research team found substantial variation in the documentation for five categories of clinical information as a result of optionality in the EHR design and varied implementation practices for the IT systems.

Rather than following best practices, physicians are documenting based on "idiosyncratic" choices facilitated by the multiple options available in the EHR to document each category of information, according to physicians who took part in the study.

As an example, during a patient exam, a problem or diagnosis can be documented in the review of systems, the problem list, the assessment and diagnosis, or in all three categories, according to the study.

This variation can lead to substantial costs for practices in the long run as it takes longer for physicians to find information, impacting the delivery of high-quality care, according to the study.

It also can lead to challenges with interpreting information, potentially causing patient harm as in the case of a physician missing a diagnosis by looking in the wrong field.

"Our results revealed that such variation jeopardizes the efficient and possibly safe delivery of care," the study authors said.

This lack of standardization in EHR documentation could also impede efforts for healthcare organizations to move forward with precision medicine and data analytics projects as these efforts rely on complete and accurate EHR data, the study authors said.

The variation in how physicians document in the EHR is often due to physicians' preferences for structured or unstructured documentation, according to the physicians who took part in the study.

The medical director at one practice, who was also a practicing physician, explained that when documenting the history of present illness the EHR allowed users to choose between a structured template that would generate a note and an unstructured template with a single free-text field.

"It really depends on the provider whether they check more boxes or if they type more," the physician said, according to the study.

Allowing physicians to document either in free-text fields or via structured data entry gives the documenting physician more flexibility but impairs the ability of future users to search and find information, the study authors said.

Many physicians pointed to a lack of training when the EHR system was first implemented that led to physicians documenting differently. One physician suggested that people developed different documentation behaviors in her practice because their training occurred entirely on video, instead of in-person.

These varying documentation styles can have substantial negative effects on the experience of documenting care, physicians said, such as over-documenting or putting the same information in multiple places to ensure future users could find the information.

In practices where users did not take extra time to complete documentation, the consequence was extra effort to search for information after the visit. As one physician noted, although these recurring inefficiencies were "only a few seconds, it adds up," according to the study.

And these inconsistencies with documentation, typically when documenting patient problems, interferes with the quality of care, physicians said.

As one physician noted, different preferences for maintaining the problem list created longer lists with "junk" information. "You may not know of something that's important...if there's a lot of irrelevant information," the physician said. "It makes it harder to know what's a real problem versus what's transient," according to the study.

In contrast, physicians from a practice that perceived very little variation in EHR documentation attributed the consistency to clearly articulated documentation procedures learned during implementation.

The study authors provide several strategies for practices to mitigate these problems. Practices should focus on targeted user training during implementation to articulate the effects of documentation decisions and regular practice meetings to develop consensus around documentation.

However, these strategies are not in widespread use because variation in EHR documentation "manifests as small, frequent annoyances rather than substantial, salient problems," the study authors said.

Going forward, third-party stakeholders-in particular, payers and policymakers-may need to draw attention to the downstream costs of variation in EHR documentation and create incentives that motivate practices to pursue more standardized documentation.

Praxis EMR - Why Templates Don't Work Articles - Fortune

Death by a Thousand Clicks: Where Electronic Health Records Went Wrong

The U.S. government claimed that turning American medical charts into electronic records would make health care better, safer, and cheaper. Ten years and $36 billion later, the system is an unholy mess: Inside a digital revolution gone wrong. A joint investigation by Fortune and Kaiser Health News.

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.

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.

I - 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.

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 inflation (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."

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."

II - 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 policy¬makers 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 short¬comings 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.

III - 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.

IV - Fortune's fourth annual Brainstorm Health conference will be held April 2–3 in San Diego.

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."

V - $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 Athena¬health 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.")

VI - Tower of Babel

In early 2017, Seema Verma, then the country's newly appointed CMS 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.

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."

This story is part of an ongoing series investigating the government's rollout of electronic health records. Read part two: "No Safety Switch: How Lax Oversight of Electronic Health Records Puts Patients at Risk"

Praxis EMR - Why Templates Don't Work Articles - Medical Economics

EHR documentation challenges remain

Thomas Payne, MD, FACP, attending physician in the General Internal Medicine Center at the University of Washington Medical Center-Roosevelt in Seattle, dictates notes into a recorder between patient appointments, recording notes on one patient before seeing the next.

He then uses speech-recognition software to move those recorded notes into his electronic health record (EHR) system.

Payne said his system ensures he gets to his notes quickly after each visit, and saves him time. "I do leave the clinic sooner than my colleagues do, by 30 minutes or so," he said.

Although Payne acknowledged that his process "might not be the right choice for every primary care provider," he does see an overall need to develop better practices around documentation.

"Documentation is one of the most time-consuming parts of a doctor's day, particularly in primary care. It's an area ripe for improvement," said Payne, who is also medical director for IT services at the University of Washington School of Medicine and board chair for the American Medical Informatics Association (AMIA).

The rapid rise of EHRs has brought with it both changes and challenges in how physicians record and share their patient notes. Leaders in the medical community have found that when it comes to aiding documentation, the systems need to do a better job.

The Report of the AMIA EHR 2020 Task Force on the Status and Future Direction of EHRs cited the need for EHRs to "simplify and speed documentation," through other members of the care team entering the information, automatic data capture by devices or other information systems, and even having patients enter data themselves.

Payne said most EHRs aren't designed to support documentation in a way that works well for physicians and their staff.

For example, he said many doctors record their notes in narrative form, writing down information that while not necessarily related to what brought a patient in for that particular visit is important to document the patient's overall well-being.

However, Payne said most EHRs want doctors to check boxes or use drop-down fields to add details about a patient; EHRs generally can't take the information recorded in narrative form and use it to populate the preset fields. That means doctors recording the same information multiple times, moving from one field to another on their computer screens.

"That's not particularly satisfying nor is it the best use of that physician's time," Payne said.

Opportunities for improvement

The Accreditation Association for Ambulatory Health Care (AAAHC) in its Quality Roadmap 2016 also singled out issues with documentation, saying it's an area that offers opportunities for improvement.

Cheryl Pistone, the AAAHC's clinical director for ambulatory accreditation said the organization found that a physician's EHR frequently didn't have documentation from external providers nor did it always have enough information in particular circumstances. Namely, EHRs did not contain enough documentation on patients' allergic reactions to medicine nor did they contain updated medication information. Additionally, EHRs do not always contain adequate details on small procedures, such as removing a small growth, done by physicians in their offices.

Pistone said EHRs should be configured to require physicians to add details about allergic reactions and then automatically populate that information in the multiple places within the medical record where it is needed.

EHRs should also be configured to enable doctors to easily enter information in narrative form. Then the EHR should use artificial intelligence (AI) and analytics to populate, parse and present data for physicians when and where they need it, Payne said.

Payne pointed out that leading EHR vendors as well as other software makers are developing and beginning to deploy more of these technologies, while technologies that support interoperability, such as the growing use of the Fast Healthcare Interoperability Resources (FHIR) standard, are speeding advancements on that front.

Improvements are long overdue, experts said.

"Documentation is a great example of where a problem exists today and where the pace of technology improvements is not as great as everyone hoped," said Payne.

Praxis EMR - Why Templates Don't Work Articles - Healthcare Informatics

Small Physician Practice Leaders: EHRs Cost us Money

A study of small physician practice decision makers found that electronic health records (EHRs) will reduce the number of patients seen per day, thereby reducing the practice's revenue.

The survey, published recently in the American Health Information Management Association's Perspectives in Health Information Management publication, included 15 U.S. physicians who have been in their practice for at least five years. None of the survey respondents were in practices with more than four physicians, and all of them were considered "decision makers" in their respective practice.

The respondents reached a consensus that EHRs would reduce the number of patients seen per day, thereby reducing their revenue. Although the panelists limited their discussion on the effect of patient outcomes, their most dominant concern was the loss of face-to-face time with the patient. They felt that the use of an EHR would reduce the focus on the patient and potentially cause physicians to miss medical conditions.

According to recent statistics from the Office of the National Coordinator for Health IT, as of 2015, nearly 9 in 10 (87 percent) of office-based physicians had adopted any EHR, over 3 in 4 (78 percent) had adopted a certified EHR and over half (54 percent) adopted a "basic EHR." Since 2008, office-based physician adoption of any EHRs has more than doubled.

Indeed, a decrease in patient volumes (47 percent of respondents) and a decrease in patient face-to-face time (53 percent) were the two most pressing concerns when asked, "How do you believe the implementation of an electronic health record system would affect the management of small physician practices? Consider the entire practice operations, including but not limited to the patients, the physicians, and the financial implications to the practice." At no point in the study did any panelist state that their practice saw an increase in volume.

What's more, one-third of respondents reported that EHRs could force small businesses out of practice due to cost issues. One panelist noted a recent decision to close their practice and move to a hospital system because they felt their small practice was no longer viable. Others mentioned colleagues who had retired or joined another practice or hospital to avoid the complications and cost of the EHR.

That being said, on the optimistic front, the panelists felt that given sufficient software features and transfer protocols, the cost for medical record management could potentially decrease. Examples of features mentioned were automated processes, streamlined record transfers, and optimized patient portals. Panelists shared that providing a better system for remote access as well as the potential to interact with the patient via a portal system had the potential to improve patient care and possibly reduce unneeded visits for questions that could be handled via messaging.

Security issues relating to hacking and data mining evolved in later rounds as panelists were concerned that technology and legislation had not caught up with the potential security concerns. Several indicated that breaches could result in significant loss of privacy at a level previously unseen.

In the end, panelists felt that vendors did not provide realistic outcome scenarios, leading several of the respondents to state that vendors were "simply salespeople" and were not concerned with how the technology would affect physicians. Improvements in patient volumes as a result of specialized training remain a viable research interest. Vendors may reap better sales outcomes if they shift their focus from sales to implementation, the researchers noted.

"The results of this study indicate an avenue for EHR vendors to develop educational avenues to teach physicians how to optimize the EHR as well as to share success stories that demonstrate improved financial impact," the researchers concluded. They added, "Even with a strong government push for the use of the EHR, physician and patient acceptance and participation will be critical to its ongoing success. At present, neither party is fully on board with the new direction of healthcare delivery, although each remains vitally important. Despite the investments in EHRs and the increase in their adoption, patient engagement continues to lag."

Praxis EMR - Why Templates Don't Work Articles - EHR Intelligence

Improving Clinical Data Integrity through EHR Documentation

Quality EHR documentation can support improvements to patient outcomes when done right.

Source: Thinkstock

Findings from a recent EHR usability study conducted by the National Institute of Standards and Technology (NIST) once brought to the fore the problem of clinical documentation in the digital age of healthcare.

The study of EHR use, particularly copy-and-paste functionality, led to three major findings. First, clinicians participating in the study were concerned about EHR data integrity as a result of copying and pasting information. Second, clinicians identified entering the wrong information into the wrong record as a high potential risk. Third, participants reported that over documentation introduced challenges to accessing "accurate, relevant and timely information on a patient" at the point of care.

Despite its intended purpose to improve the ease and efficiency of clinical documentation, NIST concluded that the copy-and-paste functionality "has introduced overwhelming and unintended safety-related issues into the clinical environment."

Concerns about the accuracy and quality of EHR documentation are nothing new. In a 2013 update to 2007 guidance on EHR documentation integrity, a workgroup convened by the American Health Information Management Association (AHIMA) called for safeguards to ensure electronic documentation did not undermine patient care.

"Without safeguards in place, records could reflect an inaccurate picture of the patient's condition, either at admission or as it changes over time," the AHIMA workgroup wrote. "The provider must understand the necessity of reviewing and editing all defaulted data to ensure that only patient-specific data for that visit is recorded, while all other irrelevant data pulled in by the default template is removed."

What's more, the authors of the EHR documentation guidance emphasized the urgency of addressing how the use of automated EHR functions could compromise the integrity of clinical health data.

"Data quality and record integrity issues must be addressed now, before widespread deployment of health information exchange (HIE)," they maintained. "Poor data quality will be amplified with HIE if erroneous, incomplete, redundant, or untrustworthy data and records are allowed to cascade across the healthcare system."

More recently, research has pointed to a potential disconnect between patient-reported and provider-record health data. Researchers at the University of Michigan sought to investigate whether patient-reported eye symptoms were recorded as part of clinical documentation in EHR systems. Comparing eye symptom questionnaire (ESQ) and EHR documentation, Valikodath et al. found a "substantial discrepancy" between the two.

"Discordance in symptom reporting could be because of differences in terminology of symptoms between the patient and clinician or errors of omission, such as forgetting or choosing not to report or record a symptom," they wrote. "Perhaps a more bothersome symptom is the focus of the clinical encounter, and other less onerous symptoms (e.g., glare) are not discussed (or documented). However, even for the exclusive sensitivity analysis, we show that the ESQ and the EMR are inconsistently documented."

While discrepancies in patient- and provider-reported documentation were relatively harmless and did not directly impact patient safety, their existence does raise questions about data accuracy and completeness.

ROOT CAUSES OF EHR DOCUMENTATION PROBLEMS

The benefits of EHR use more generally range from timely access to clinical data and alerts to avoid medical errors to care coordination and improved billing and coding. EHR documentation is the means of realizing these benefits.

"Documentation is often the communication tool used by and between providers. Documenting a patient's record with all relevant and important facts, and having that information readily available, allows providers to furnish correct and appropriate services that can improve quality, safety, and efficiency," the Centers for Medicare & Medicaid stated in a 2015 fact sheet on EHR technology.

In that same guidance, the federal agency identified a handful of common EHR challenges that healthcare organizations and providers need to address. For EHR documentation in particular, these challenges include an inability to log clinicians entering data, cloning data from record to record, and upcoding to receive higher payment.

A year later, CMS released guidance focused specifically on preserving EHR documentation integrity with an emphasis on helping prevent fraud, abuse, and improper payments.

"Providers and others should use program integrity-related EHR software features and capabilities to ensure the integrity of the EHR documentation. Some EHR features may create information integrity concerns; however, providers and others can mitigate these concerns by implementing proper policies and processes," the federal agency concluded.

Where the CMS recommendations for EHR documentation integrity fall short is in identifying and remediating the root cause of these inaccurate, incomplete, or unreliable information within a patient's EHR.

Around the same time, both the American Medical Association (AMA) and American Medical Informatics Association (AMIA) (among others) set out to improve future EHR use by recommending changes to EHR design that address the causes of poor EHR documentation.

For the latter, the first area of EHR improvement necessary involved simplifying and speeding documentation and included two recommendations germane to EHR documentation improvement.

The first was decreasing data entry burden on clinicians by allowing other members of the care team to enter data into the EHR:

"Physicians' time investment in patient care documentation has doubled in the last 20 years, by some measures, possibly consuming up to half of a physician's day. Time requirements for nursing documentation have also changed, as has documentation workflow. The growth in documentation burden is associated with changes in Medicare reimbursement rules, potentially overly strict interpretations of those rules by compliance officers, concerns about malpractice litigation, and other factors. The introduction of EHRs has magnified these problems and the amount of time providers spend on documentation."

AMIA cited the increasing documentation burden on clinicians as the impetus behind the use of copy-and-paste functionality and the resulting bloat in EHR documentation.

"Clinicians remain uncertain regarding who can and cannot enter data into each patient's record, placing a tremendous data entry burden on providers, the most expensive members of the care team. Clinician time is better spent diagnosing and treating patients," the association argued. "Regulatory guidance that stipulates that data may be populated by others on the care team, including patients, would reduce this burden."

The second recommendation called for separating data entry from data reporting:

"Templates are often used to capture data as discrete observations, in place of free-text narratives. The resulting documentation sometimes has limited relevance to the visit being documented, and important aspects of patients' stories can only be effectively captured by narratives. Compared to human narrative, purely coded templates neither distinguish informational wheat from chaff, nor capture the subtle details of each patient's unique circumstances. Further, coded templates impede effective clinician communication."

According to AMIA, EHR documentation requirements were responsible for making structured data preferable to unstructured data.

Similarly, AMA released guidance for improving EHR usability that included an emphasis on reducing clinical documentation demands on clinicians.

The first of eight total recommendations centered on improving physician-patient interactions by removing EHR technology and data entry as an obstacle to face-to-face communication. AMA traces the problem to EHR design not based on clinical workflows:

"The ways that EHRs structure information, process data and generate clinical reminders (e.g. "popups") too often detracts from physician time with a patient. For EHR users, inflexible software with cumbersome menus or poor graphical user interface configurations leads to excessive clicking and scrolling which increases the administrative time spent during patient visits compared to use of paper charts. Contributing to this problem, many existing EHRs grew out of practice management systems, in which billing and claims are the primary focus and performed by nonclinical staff whose workflow requirements differ significantly from clinicians."

In a similar vein, AMA also called on EHR developers to focus on EHR designs that help reduce the cognitive workload existing systems impose on end users:

"Today's EHRs create a tension between unstructured and structured data that many physicians believe degrades the quality of their clinical care narrative. This tension has compelled physicians and others to enter data into EHRs without regard to the value, or lack thereof, created through this substantial additional work. The overall workload - reading, writing, thinking and navigating the system - in EHRs is not well balanced. Many physicians find that the quality of the clinical narrative in paper charts are more succinct and reflective of the patient's perspective and physician's thought process. In contrast, unlike paper charts, EHRs favor structured data capture in the form of drop-down menus and templates that can interfere with the creation of a coherent narrative."

The solution to these and the other EHR usability challenges comes down to user-centered design with clinicians provide substantial input into how developers go about designing their EHR technology.

SOLUTIONS FOR IMPROVING EHR DOCUMENTATION

Solutions to clinical documentation problems fall into two general categories: technical and administrative.

Beginning with the latter, healthcare organizations of any side need to establish business practices supporting quality clinical documentation. And the guidance from AHIMA guidance from 2013 still holds true in laying out for primary conditions necessary for maintaining EHR documentation integrity:

  • Desire and commitment to conduct business and provide care in an ethical manner
  • Purchasing systems that include functions and capabilities to prevent or discourage fraudulent activity
  • Implementing and using policies, procedures, and system functions and capabilities to prevent fraud
  • Inclusion of an HIM professional such as a record content expert on the IT design and EHR implementation team to ensure the end product is compliant with all billing, coding, documentation, regulatory, and payer guidelines

As for technical solutions to EHR documentation pitfalls, the AHIMA recommendations align well with those identified by CMS in 2016, both of which call for capabilities in EHR technology that require user authentication and access management, allow for the tracking of user activities (e.g., audit logs), and restrict alterations to user auditing files.

These technical recommendations, however, fail to address EHR documentation challenges to clinical productivity. A growing body of evidence points to the potential for natural language processing technologies to reduce burdens associated with clinical documentation.

"We found that a pure protocol of NLP Entry as well as hybrid protocols (involving both NLP Entry and Standard Entry) showed promise for EHR documentation, relative to Standard Entry alone (Standard-Standard Entry)," Kaufman et al. observed in JMIR Medical Informatics.

In an interview CHRISTUS Health in early 2016, CMIO Luke Webster credited natural language processing as a key component of clinical documentation improvement efforts at the Texas health system. In many cases, physicians were unaware that their dictation was running through a voice recognition engine and being transcribed before a human transcriptionist reviewed and finalized the documentation.

"One of the hopes (and obviously the plans that we have in place) is to leverage that foundational technology to improve clinical documentation real-time, such as prompting providers as they document," said Webster.

While natural language processing could ease EHR documentation burdens on providers, it requires the implementation of more technology. An easier solution could be in the form of rethinking workflows for clinical documentation as Mississippi's Memorial Hospital of Gulfport CMIO David Northington, MD, explained last year:

"Before going into a patient's room, I sit down in front of the computer, I view other physicians' notes (inpatient/outpatient), I review the results on the patient, I put in my mind what this patient should look like if I hadn't seen them before. Then I go into the patient's room and talk about my findings, concerns, and listen to what they are telling me. Then I go back out, open up the chart, start my ordering and documentation process before finishing it. So it's three times that I'm really working on this patient to create one document. You can imagine the future - and we're starting to see this in some rooms we're working with - doing this all in front of the patient with an interactive system that is recognizing the conversation that we're having with the patient and showing them what's going on from the CAT scans or lab reports, and as you walk out the door that document is completed. You're learning, studying, and communicating with patients.

That's the next generation of the EHR. That's a much more efficient way that takes it down from doing it three times to one time. That hasn't been completely embraced yet, but that's where I imagine we're going when you really start getting return on investment."

A combination of these administrative and technical solutions will be necessary to ensure that EHR documentation benefits patients in the here and now as well as those receiving care in the future.

Praxis EMR - Why Templates Don't Work Articles - American Academy of Orthopaedic Surgeons

Is your EMR fueling risky record keeping?

Not all timesavers are helpful

Simply implementing an electronic medical record (EMR) system won't necessarily reduce your risk of an audit. On the contrary, if you don't use the system's documentation features properly, EMRs may actually increase your risk of an audit.

Bubble sheets

Bubble sheets-preprinted response sheets similar to those used in academic testing or research surveys-are used in some EMR systems for patients to report their family and medical history. According to documentation guidelines, anyone can provide or collect past family and social history, but the physician must sign off on the form before it's entered into the record. Unfortunately, in many busy offices, the physician simply scans the bubble sheet before signing it.

"This might save time, but it's essentially creating an invalid document," said Mary LeGrand, RN, MA, CPC, CCS-P, a consultant with KarenZupko & Associates.

In one orthopaedic group, a bubble sheet listed possible symptoms such as fractures, joint pain, or spasms, but did not include an option for 'no complaints.' Additionally, the directions were unclear so that patients didn't realize they were supposed to select all that applied.

Ms. LeGrand explained, "Because the bubble sheet had no negative response option, the EMR was automatically generating a note stating 'negative for joint pain, muscle pain'-even though the patient hadn't specifically responded to anything on the bubble sheet."

In this case, the practice should have insisted the EMR vendor add a 'yes/no' option for all values under each system or provided a 'no complaints' option for each. (See sample PDF)

Collecting family history on bubble forms can also be an issue. "In a busy practice, proper collection of family history is sometimes overlooked," Ms. LeGrand said. "That's bad enough when the history is saved on paper, but in the electronic world, it's even more dangerous. An EMR system that automatically populates information indicates there was some kind of response when, in fact, no information was ever obtained from the patient."

Don't be swayed by code calculators

Some vendors will claim that the EMR system will 'code' for you and help your practice make more money. Don't count on it.

For example, one orthopaedic group noticed an increased number of high-level evaluation and management (E/M) codes after their EMR system went live. "They looked at the algorithm on the medical decision-making component and realized it was simply incorrect," Ms. LeGrand said.

The system's incorrect logic prompted it to suggest an incorrect, higher level E/M code. When the practice did an internal audit and recognized the inaccuracy, the billing team began to override the suggested code and bill the correct code.

At issue is the logic behind the code calculator itself. "Suggesting code levels that don't match the documentation can put a practice at risk," Ms. LeGrand warned.

Practices should be concerned about this issue, according to consultant Kim Pollock, RN, MBA, CPC. "Over the past 3 years, the percentage of 99214 and 99215 codes processed by Medicare has increased in almost all specialties." According to an article in Part B News, the "proliferation" of EMR systems "allows easier documentation," thereby justifying higher E/M levels. It's likely Medicare may target these code levels for an audit sooner rather than later.

When shopping for an EMR system, ask the vendor to create a chart note using documentation from visits with patients who have conditions commonly seen in your practice. This will enable you to ensure that your "pick list" selections result in accurate documentation.

Test documentation workflow

"I advise clients not to go live until all the customization is done and tested, and everyone understands how the EMR will affect patient flow and documentation workflow," Ms. LeGrand said. "Physicians really need to access the system before it goes live and understand how it will change their workflow, and the flow of information in the practice. Otherwise, significant backlogs may occur."

For example, backlogs can occur if the person creating the task list is not computer savvy or if the practice has insufficient staff to enter required health history information to open a visit note before a patient encounter.

Each practice will have to identify workflow changes and make the necessary adjustments. Because the vendor or information technology (IT) department rarely understands the nuances of orthopaedics, they won't be able to help modify daily close processes or documentation/sign-off processes. Doctors, staff, and managers must pay attention to how the EMR will change the workflow and adjust processes.

In a "worst-case" scenario, the workflow in an EMR system could be so labor-intensive that documentation doesn't get done at all.

The bottom line is this: Customizing an EMR and modifying processes and information workflow will take much longer than most practices expect. But, taking these important steps will reduce risk exposure and improve EMR success.

"Take the time to understand your documentation baseline, know your processes, and understand all the information flow points that are going to change," advised Ms. LeGrand. "Otherwise, you'll be sorry in the long run."

Cheryl Toth is a consultant with KarenZupko & Associates, Inc). She can be reached at (312) 642-5616 begin_of_the_skype_highlighting (312) 642-5616 end_of_the_skype_highlighting or ctoth@karenzupko.com

5 tips for minimizing EMR documentation risk

  • Have a third party review your documentation before you go live.
    Getting an outside opinion will save money and reduce risk. Ideally, the audit should occur during the planning and implementation process, and it should include a baseline reading of E/M code usage so that you can compare it to coding and documentation after the system goes live.

  • Carve out plenty of time for customizing visit templates.
    Practices must review and customize the stock templates provided by the vendor. Otherwise, the system will create multi-page, rote notes that don't necessarily document what was actually done. Once you customize the vendor templates for common conditions, create additional templates for every condition you treat.

  • Verify the coding calculator algorithms.
    Orthopaedists rarely can support the use of code 99215. If your EMR system's coding algorithm is consistently upgrading E/M codes, you may need to adjust the algorithm.

  • Review notes 'pulled forward' from previous visits.
    Messy documentation can signal red flags to auditors, attorneys, and other chart reviewers. Make sure to review every note and every visit-just as you would in a paper chart world.

  • Ignore vendor promises of "boost your coding revenue!" and "download and implement our system in 24 hours!"
    Despite what vendors may tell you, you will not be up and running in 2 weeks. Planning and implementation are hard work and customizing your visit templates takes many hours. Even if you do everything right, full implementation will take 6 to 12 months after you go live; complete adoption of the EMR can take 18 to 24 months.
Praxis EMR - Why Templates Don't Work Articles - Cooperative of American Physicians

Do Not Let an EHR Template Determine Your Standard of Care

If you are contemplating the purchase of an Electronic Health Record (EHR) system, it is important that you and/or your physicians take time to review each system's medical record templates. Many systems have predetermined templates that allow minimal customization. Other systems offer greater customization options for a higher price. The important thing to keep in mind is that an EHR template is nothing more than a boilerplate, written by a third party or "expert" to input clinical data. The inflexibility of this template presents series of fundamental problems that will crop up during everyday use, specifically:

  1. The template is someone else's thought process and incorporates assumptions about what you think and how you should practice medicine.
  2. The template is generated to cover a wide variety of practices and encounters, making it very general.
  3. Templates tend to take a cookie-cutter or one size fits all approach, with no regard for age appropriateness or target patient population.
  4. Some templates allow very little room for free text, thus limiting the information wich can be entered.

One of the biggest dangers presented by templates is that they may set the standard of care to wich the physician may be held. Acceptance of an EHR template may be viewed as your standard of care. Therefore, when choosing an EHR system, physicians should consider the following:

  1. Does the system allow you to use your own forms?
  2. Can you mirror the way you practice today and improve it?
  3. What is the cost for customization of templates?
  4. Does the system have an e-Prescribing function?
  5. Does it provide for secure messaging?
  6. What will the vendor charge for modifying a template?

The bottom line is that you should select an EHR system that best fits the needs of your practice or medical group, and that closely mirrors your practices current templates.

Authored by
Ann Whitehead, RN, JD
CAP Risk Management & Patient Safety Department

Praxis EMR - Why Templates Don't Work Articles - UC Davis

UC Davis study finds e-medical records have varying effects on productivity

The introduction of electronic medical records in hospitals and clinics - dubbed the "silver bullet" of health care reform - appears to have varying effects on different types of primary care physicians, a UC Davis study has found.

"Our research suggests that a 'one-size-fits-all' design does not work - the ideal technology design should vary by physicians' requirements and work-flow demands," said Hemant Bhargava, associate dean and professor of management and computer science at the UC Davis Graduate School of Management.

Bhargava and his research colleagues recently completed a study of a multimillion-dollar information technology project installed at six primary care offices from 2003 to 2006. The offices were part of a large primary care physician network affiliated with an academic medical center.

The study, one of the first to measure the impact of electronic medical record-keeping on doctors' productivity, was conducted with Abhay Mishra, an assistant professor of health administration at Georgia State University, and research assistant Shuang Liu, a Ph.D. student in applied mathematics at UC Davis.

The system that was studied digitized patient records and allowed for electronic prescriptions and messaging.

The federal government has shown its support for developing electronic health records by setting aside $19.2 billion in stimulus funds to help pay for such conversions across the country.

"Prior to our study," Bhargava said, "there was controversy regarding the benefits of health care IT investments. In fact, there was some anecdotal evidence that these technologies reduced physician productivity."

For the study, researchers analyzed the impact the technology had on physician productivity, collecting data on work hours and output before and after the introduction of EMR technology. The data was collected for about 100 physicians spread across three primary care categories - internal medicine, pediatrics and family practice - and six clinics.

The researchers found that the initial implementation of the EMR system resulted in a 25 percent to 33 percent drop in physician productivity. While significant, the drop was anticipated, Bhargava said.

"Initially, physicians and their staff had to learn the system," he explained. "After a month of utilization, physicians and their staff became more comfortable with the technology and productivity overall increased to just below starting levels, with interesting variations by unit."

Over the next few months, the researchers found that the impact of the new technology on productivity varied by physician group. Internal medicine units adjusted to the new technology and experienced a slight increase in productivity. In contrast, pediatricians and family practice doctors did not return to their original productivity levels and experienced a slightly lower productivity rate.

"These differences by unit suggest that there is a mismatch between technology design and the work-flow requirements and health administration expectations for individual care units," Bhargava said.

The findings, he explained, can be more easily understood by breaking EMR technology use into two categories - information review and information entry.

The use of electronic medical records makes information review - patient history, notes from previous visits, charts of test data and radiological images - more efficient. These features are useful to internal medicine doctors, who tend to see a greater proportion of ill patients.

In contrast, pediatricians' work tends to involve more information entry and documentation for which EMR technology can be more time-consuming.

Bhargava suggests vendors and medical centers consider implementing different versions of electronic record keeping systems, tailoring the user interface, information entry and visualization features for different groups of physicians.

About UC Davis

For more than 100 years, UC Davis has engaged in teaching, research and public service that matter to California and transform the world. Located close to the state capital, UC Davis has more than 32,000 students, more than 2,500 faculty and more than 21,000 staff, an annual research budget that exceeds $684 million, a comprehensive health system and 13 specialized research centers. The university offers interdisciplinary graduate study and more than 100 undergraduate majors in four colleges - Agricultural and Environmental Sciences, Biological Sciences, Engineering, and Letters and Science. It also houses six professional schools - Education, Law, Management, Medicine, Veterinary Medicine and the Betty Irene Moore School of Nursing.

Media contact(s):

  • Hemant Bhargava, Graduate School of Management, (530) 754-5961 , hemantb@ucdavis.edu
  • News Service, (530) 752-1930
Praxis EMR - Why Templates Don't Work Articles - KevinMD.com

Do electronic medical records decrease liability risk?

Doctors are pushed to adopt electronic medical records harder than ever before.

However, costs are often the prohibitive obstacle, and whether the current generation of EMRs improve patient care remains in question.

But what about liability? Surely, more complete, legible medical records would reduce the risk of being sued. Right?

Well, it's not that cut and dry.

In a story from American Medical News, doubts remain as to whether EMRs reduce the risk of being sued. The biggest problem is that most EMR charts are template-driven, meaning that superfluous, and sometimes inaccurate, information often creeps into a documented patient visit.

Several lawyers acknowledge further downsides, including, "the default settings of an EMR could present fewer opportunities for physicians to add information to medical records," and, "EMRs also could provide too much information. For example, risk could increase if the EMR generates alerts or supplementary information and physicians don't act upon them."

(The reference to "adding information" is, I believe, a reference to the fact that EMRs discourage free-texting, as opposed to adding information after the fact.)

Current electronic medical records have a hard time talking to one another, which is essential to realizing their potential to reduce medical errors and improve patient outcomes. Until they do, the effect of EMRs on reducing medical malpractice is tepid at best.

Praxis EMR - Why Templates Don't Work Articles - ModernMedicine

The problem with EHRs and coding

This article originally published in Medical Economics

Key Points

  • Ineffective policies from numerous key organizations have contributed to widespread EHR compliance problems.
  • Well-intended physicians are being victimized when audits reveal their EHRs have allowed non-compliant claims.
  • Audited practices have been fined between $50,000 and $175,000 per physician for their inadvertent infractions.


Today's political and economic environment has focused a spotlight on healthcare reform and the promotion of health information technology in particular. The Obama administration has promised to invest $10 billion per year over the next five years on HIT, including electronic health records. Senator Max Baucus, chairman of the Senate Finance Committee, says HIT represents "the beginning of healthcare reform and a key part of the economic recovery."

The Centers for Medicare & Medicaid Services (CMS) is also exerting increasing pressure on physicians to purchase HIT: financial incentives for using electronic prescribing through 2013 and rising penalties to practices that fail to employ this technology starting in 2012. The administration's stimulus package provides incentives for implementing and using certified EHR systems, while those practices that don't adopt these systems by 2014 will receive reductions in reimbursement.

Health policy advocates justifiably point to a myriad of potential benefits that should result from the widespread implementation of EHRs, from safe storage of health information to electronic sharing of clinical information. The knowledge shared through this access to patients' medical data promises to improve patient safety and reduce costs associated with duplicate and/or unnecessary tests and treatments. Electronic prescribing further promises to reduce medication errors, ranging from drug interactions to misinterpreted handwriting.

Most physicians who introduce EHR systems into their practices seek promised advantages for enhancing quality care and patient safety through the systems' touted data storage and retrieval characteristics. Electronic records offer immediate access to patients' documents and data.

Likewise, most physicians include among their highest priorities the goal of compliant evaluation and management (E/M) coding. Physicians believe they have a right to expect that these sophisticated and costly systems will ensure that they achieve compliant documentation and coding, thereby "making any E/M problems go away."

However, something has gone awry to create an environment that leaves well-intended physicians victimized when government audits reveal their software systems have allowed-even facilitated-submission of non-compliant and potentially fraudulent claims for E/M services. In the midst of increasing storm warnings of non-compliant designs, physicians are increasingly vulnerable to severe financial penalties.

This devastating storm has been developing for many years, often bolstered by an unintended lack of effective policies from several organizations that should have the best interests of physicians, patients, and the healthcare system at their core-organizations such as CMS, the Certification Commission for Healthcare Information Technology (CCHIT), and the U.S. Department of Health and Human Services (HHS), as well as EHR software vendors and physician training institutions (for more information).

Gathering Storm Clouds

Analyses of problems with EHR systems by physicians and their practice managers consistently reveal that the overwhelming preponderance of their challenges relate to the rarely discussed data-entry characteristics of the electronic history and physical (H&P), not to the heralded data-storage and retrieval features of their systems. One physician personally reported that "The software forces me to enter clinical information in a preloaded format; when I see a patient three weeks later, I cannot find any individualized details of the previous visit or understand why I did what I did."

In April 2008, a study published in the New England Journal of Medicine reported similar problems, pointing out that "Notes that are meant to be focused and selective have become voluminous and templated, distracting from the key cognitive work of providing care. Such charts may satisfy the demands of third-party payers, but they are the product of a word processor, not of physicians' thoughtful review and analysis. They may be 'efficient' for the purpose of documentation but not for creative clinical thinking."

The study also reported an example of the consequences of these problems: "A colleague at a major cancer center that recently switched to electronic medical records said that chart review during rounds has become nearly worthless. He bemoaned the vain search through meaningless repetition in multiple notes for the single line that represented a new development . . . Ironically, he has started to handwrite a list of new developments on index cards so that he can refer to them at the bedside."

Too often, these problems have proven insurmountable. At the Second HIT Summit in 2005, Mark McClellan, MD (then the administrator of CMS), reported "40 percent of attempted implementations fail." According to the April 1, 2006, issue of CIO Magazine, "The [Health and Human Services] department itself has acknowledged that the failure rate for EHR system implementation is 30 percent to 50 percent. Some healthcare network providers claim it is as high as 70 percent."

These electronic H&P challenges can manifest in one or more of four interrelated areas:

  1. Integrity of the clinical information recorded
  2. Usability, quality of the clinical care and workflow guided by the record
  3. Malpractice protection
  4. Evaluation and management (E/M) compliance.

When audits reveal lack of compliant documentation generated by physicians using an electronic H&P, the findings can be viewed as the "canary in the coal mine" to warn of additional impending dangers related to data integrity, quality of care, and malpractice protection.

During the last several years, a significant number of articles have pointed out compliance problems intrinsic to the majority of current EHR systems. Chief among these relate to coding engines that fail to consider medical necessity, which CMS describes as "the overarching criterion for payment," and certain types of data-entry functionality that result in "cloned documentation," in which the records of every visit read almost word-for-word the same except for minor variations confined almost exclusively to the chief complaint.

Physicians have long been counseled that a well-documented medical record provides the best defense in the event of a claim of medical liability. The June 2008 issue of the Journal of AHIMA quoted EHR legal expert Patricia Trites on the potential danger of electronic systems that permit copying of near-identical documentation into large numbers of patient records: "From a medical-legal standpoint, what would [lawyers] do when they [see] this chart?" she asks. "They are going to rip it apart."

In 2007, HHS and the Office of the National Coordinator for Health Information Technology (ONCHIT) published an extensive report on "Recommended requirements for enhancing data quality in electronic health record systems." The section that reviews E/M documentation features (and analyzes current certification criteria for these EHR features) advises that "EHRs provide a variety of tools that enable a provider to be more efficient when documenting an encounter . . . These tools include the use of defaults, templates, copying, and others. The report then continues with the warning: "[These tools] can be extremely helpful if used correctly; however, the tools can also open the EHR [system] up to fraud or abuse."

The problem that physicians face is that most current EHR system designs have failed to incorporate protections to ensure the correct use of these shortcut tools. Without such "error proofing," it is not feasible for physicians, while concentrating on patient care, to differentiate the settings in which these various tools can be used compliantly from those circumstances in which their use could lead to pliant or even fraudulent documentation.

The Perfect Storm Converges

Let's summarize. Where are the storm fronts forming this perfect storm coming from? An EHR system "weather map" reveals the following:

  • Physicians whose conventional medical education lacked training in the relationship of compliance to quality care and also failed to provide medical record tools that promote compliant (and efficient) documentation and coding
  • Time constraints imposed by significantly constricted reimbursement environment
  • Powerful incentives for purchase and implementation of EHR systems
  • Software systems that a) may have coding engines that fail to account for medical necessity; b) may have designs that automatically guide physicians to create records with high levels of documented care for every visit; c) may have shortcut documentation tools that create "automated" documents, identified by HHS as "having the potential for fraud and abuse"; and d) therefore consistently derive and recommend submission of high-level E/M codes for almost every patient encounter
  • Accurate Medicare or Office of the Inspector General (OIG) auditors reviewing medical records of the practices whose recently implemented medical records have drawn their attention by consistently submitting claims for high levels of E/M care.

Ms. Grider, Ms. Linker, and Ms. Thurston are three compliance experts who were called in to assist different physician groups during federal and state audits of those groups' electronic H&P records, conducted either by individual Medicare Carriers, Recovery Audit Contractors (RACs), or the Office of the Inspector General of the HHS. In each of the four cases, the audits revealed pliant E/M claims that were submitted as a consequence of physicians using their EHRs in accord with their particular designs for E/M documentation and coding.

The four practices employed between 1 and 10 physicians. The government audit evaluated between 20 and 100 charts per physician, and the percentage of charts failing audit for each physician ranged from 20 to 95 percent.

As a result of these findings, each practice was assessed a significant penalty for pliant documentation and coding. For the practice with the lowest percentage of failed audits, the final determination required repayment to Medicare of approximately $50,000 per physician. For the other three practices, the repayments ranged from $150,000 to $175,000 per physician. For at least one of the practices, the audit also imposed an administrative requirement of prepayment review for 100 percent of all future Medicare claims.

Even though each practice was using a different EHR, there was remarkable similarity in the design and functionality limitations identified as the causes of their compliance problems:

  • All of the systems had designs that failed to meet all of Current Procedural Terminology's and Documentation Guidelines for Evaluation and Management Services' published requirements for compliant documentation of medical history, physical examination, medical decision-making, and nature of the presenting problem(s) (which is the E/M system's measure of medical necessity)
  • Each of the systems included three or more types of data-entry functionality that has been consistently identified as having the potential to promote non-compliant or even fraudulent documentation
  • The E/M coding engines of all four systems failed to consider the three levels of risk in decision-making, failed to consider medical necessity in determining appropriate code levels, and failed to recognize the critical role of medical necessity in guiding medically indicated levels of care, documentation, and coding.

The authors who reviewed the records and audits for these practices observed that while many EHRs present one or more mechanisms to automate documentation of required history and examination elements, from both the compliance and the data-integrity perspective, automation is not documentation.

The added danger is that such automated documentation can also distort physicians' optimal care and workflow, and destroy data integrity. For example, in one of the reviewed practices, use of the EHR's preloaded macros for the physical examination actually created automatic documentation indicating that females had received prostate exams and males had negative pap smears.

The outcomes of these federal audits have been devastating, emotionally as well as financially, for the physicians and staffs of the practices involved. The failure of the EHR systems to provide for compliant E/M documentation and coding, as well as protections against overcoding and undercoding, led to statistically remarkable increases in the percentage of claims submitted with level 4 and level 5 codes. This increase drew the attention of government auditors, and the medical records created using these systems most often could neither support the levels of care submitted (primarily due to documentation shortcuts creating "cloned" records) nor the medical necessity for providing such high levels of care (due to failure to consider the nature of the presenting problem).

The overall conclusion derived from these reviews is that electronic record systems should provide sophisticated designs and functionality based on physicians' optimal patient-care workflow. They should be required not only to guide physicians in providing high-quality care and creating compliant documentation, but to protect against designs that have the potential to disrupt optimal care and/or generate non-individualized and non-compliant medical documents.

How to Avoid the Perfect Storm

The causes of this perfect storm must be identified and eliminated. In response to these imminent dangers, practices that are currently using EHRs should obtain assistance from E/M compliance experts. They should insist that their vendors eliminate all non-compliant documentation and coding functionality related to their systems' electronic H&P, replacing such features with effective documentation tools that are usable, efficient, and compliant.

Similarly, when practices investigate the possibility of purchasing an EHR system, they should include experts in compliance and quality documentation on their evaluation team. As a condition for purchase, they should also require that these systems be usable for their physicians, efficient, contain only compliant documentation and coding tools, provide only for recording of individualized, meaningful, and reliable clinical information, and promote the quality-care process.

Figure 1 illustrates a sample blueprint for certifying that electronic H&P designs are "operable as well as interoperable." It presents standards that meet physicians' common criteria for effective medical records. These standards advocate for creative designs that not only promote quality care and meaningful documentation, but that protect against non-compliant documentation and distorted care. Physicians and practice managers would do well to require that EHR systems meet such criteria before purchase or implementation.

The Role of EHR Stakeholders

It is incumbent upon physicians' professional societies to seek the assistance of compliance experts and initiate policies that require corrective action for the underlying causes of these currently identified EHR system problems. This effort can include the following initiatives:

  • Physician training institutions (medical schools and residency programs) should reinforce their current training for a comprehensive medical evaluation with training in E/M compliance and with provision of efficient documentation tools that physicians can use to provide these comprehensive levels of care within the time constraints of residency and medical practice
  • EHR software vendors must provide systems whose design and functionality have the capability to guide physicians to effective care and compliant documentation, including elimination of all potentially non-compliant functionality. Further, if CCHIT does not incorporate criteria to certify these requirements, the medical societies themselves may need to establish them and provide substantive review
  • CMS must meet its own standards for compliance by requiring its fiscal intermediaries (i.e., carriers) to employ only auditing and coding tools that are compliant with the established standards in CPT and Documentation Guidelines. It must also institute a policy requiring designs to be compliant and audit-protected as a condition for EHR systems to be eligible for CMS's payment-incentive programs
  • CCHIT has a responsibility that certification should provide meaningful protection to physicians (for systems that ensure compliance) and patients (for systems that guide and promote an optimal-care process). It should therefore incorporate high-quality criteria for functionality and compliance of the electronic H&P. These and all other criteria should be reviewed and authenticated by a consortium of medical societies and coding-compliance societies
  • HHS and the ONCHIT should modify their focus, supplementing concerns for potential fraud and abuse with an even greater focus on standards that protect physicians from non-compliant software designs and from educational approaches that impair their abilities to practice the optimal-care process that is the core of their training and their ethic.

A Clarion Call

As the Obama administration provides incentives for the much-needed adoption of electronic health records, it must provide protections that guarantee not only the sharing of information, but also that the process of gathering this information and the quality of the information recorded are optimized. Recent audits by federal agencies confirm the warnings about E/M compliance dangers accompanying documentation shortcuts introduced by many current EHR software designs. These audits are a clarion call for stakeholders to eliminate the problems they have created, however unintended. Stakeholders must structure an environment in which physicians receive appropriate training with effective and compliant documentation tools, in which software systems provide only compliant designs and protect against improper documentation, and in which governmental agencies eliminate non-compliant practices in their own organizations and mandate compliant designs in the software systems they are advocating and promoting.

Stephen Levinson, MD, is the author of the books Practical E/M and Practical EHR. He has long focused on the interplay between compliance and quality patient care, medical ethics and integrity, and the health of the healthcare system.Deborah Grider is president of the American Academy of Professional Coders National Advisory Board. Robin Linker is executive director of operations and auditing for the Association of Healthcare Auditors and Educators, and CEO of Robin Linker & Associates Inc. Susan Thurston is executive director of education for the Association of Health Care Auditors and Educators, and CEO of Coders Connection Inc.

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Praxis EMR - Why Templates Don't Work Articles - The New England Journal of Medicine

Off the Record - Avoiding the Pitfalls of Going Electronic

Many of us remember searching frantically for a lost chart or misfiled laboratory result in the wee hours of the morning as we cared for a sick patient in the emergency ward, or requesting in vain the most recent note from a specialist about a patient who returned to our office after a consultation. The ultimate goal of the electronic medical record - a technological solution being championed by the Bush administration, the presidential candidates, and New York Mayor Michael Bloomberg, as well as Google, Microsoft, and many insurance companies - is to make all patient information immediately accessible and easily transferable and to allow its essential elements to be held by both physician and patient. The history, physical exam findings, medications, laboratory results, and all physicians' opinions will be collected in one place and available at a single keystroke. And there is no doubt that these records offer many benefits. We worry, however, that they are being touted as a panacea for nearly all the ills of modern medicine. Before blindly embracing electronic records, we should consider their current limitations and potential downsides.

As we have increasingly used electronic medical records in our hospital and received them from other institutions, we've noticed several serious problems with the way in which notes and letters are crafted. Many times, physicians have clearly cut and pasted large blocks of text, or even complete notes, from other physicians; we have seen portions of our own notes inserted verbatim into another doctor's note. This is, in essence, a form of clinical plagiarism with potentially deleterious consequences for the patient. Residents, rushing to complete numerous tasks for large numbers of patients, have sometimes pasted in the medical history and the history of the present illness from someone else's note even before the patient arrives at the clinic. Efficient? Yes. Useful? No. This capacity to manipulate the electronic record makes it far too easy for trainees to avoid taking their own histories and coming to their own conclusions about what might be wrong. Senior physicians also cut and paste from their own notes, filling each note with the identical medical history, family history, social history, and review of systems. Though it may be appropriate to repeat certain information, often the primary motivation for such blanket copying is to pass scrutiny for billing. Unfortunately, these kinds of repetitive notes dull the reader, hiding the important new data.

Writing in a personal and independent way forces us to think and formulate our ideas. Notes that are meant to be focused and selective have become voluminous and templated, distracting from the key cognitive work of providing care. Such charts may satisfy the demands of third-party payers, but they are the product of a word processor, not of physicians' thoughtful review and analysis. They may be "efficient" for the purpose of documentation but not for creative clinical thinking. Similarly, electronic medical records can reproduce all of a patient's laboratory results, often dropping them in automatically. There is no selectivity, because it takes human effort to wade through all the data and isolate the information that is pertinent to the patient's current problems. Although the intent may be to ensure thoroughness, in the new electronic sea of results, it becomes difficult to find those that are truly relevant.

A colleague at a major cancer center that recently switched to electronic medical records said that chart review during rounds has become nearly worthless. He bemoaned the vain search through meaningless repetition in multiple notes for the single line that represented a new development. "It's like `Where's Waldo?'" he said bitterly. Ironically, he has started to handwrite a list of new developments on index cards so that he can refer to them at the bedside.

True, handwriting in charts is sometimes illegible and can lead to miscommunication. It might seem that the printed (or at least typed) word, which we are all conditioned to respect, would always be more definitive and have more impact than text written by hand. But we have observed the electronic medical record become a powerful vehicle for perpetuating erroneous information, leading to diagnostic errors that gain momentum when passed on electronically.

An advertisement from a health care network touts the electronic medical record as the avatar of "High Performance Medicine." The ad, whose headline reads "Medicine That Doesn't Forget," shows a country doctor carrying a black bag. "Remember when physicians knew everything about their patients and carried all that they needed in a little black bag?" the ad asks. The electronic medical record, it asserts, "is the modern physician's equivalent of that little black bag. Only better." But the attempt to link this form of technology with nostalgia for the family doctor who spent time in extended conversation and care seems rather incongruous. Indeed, this humanistic depiction of the electronic medical record contrasts sharply with the experience of many patients who, during their 15-minute clinic visit, watch their doctor stare at a computer screen, filling in a template. This is perhaps the most disturbing effect of the technology, to divert attention from the patient. One of our patients has taken to calling another of her physicians "Dr. Computer" because, she said, "He never looks at me at all - only at the screen." Much key clinical information is lost when physicians fail to observe the patient in front of them.

The worst kind of electronic medical record requires filling in boxes with little room for free text. Although completing such templates may help physicians survive a report-card review, it directs them to ask restrictive questions rather than engaging in a narrative-based, open-ended dialogue. Such dialogue can be key to making the correct diagnosis and to understanding which treatment best fits a patient's beliefs and needs. One pediatrician told us that after electronically verifying use of seat belts, bicycle helmets, and other preventive measures, she has scant time to explore clinical issues. Electronic medical records may help to track outcomes and adherence to guidelines, but they may also force doctors to give "standard" rather than "customized" care.

These problems, we believe, will only worsen, for even as we are pressed to see more patients per hour and to work with greater "efficiency," we must respond to demands for detailed documentation to justify our billing and protect ourselves from lawsuits. Though the electronic medical record serves these exigencies, it simultaneously risks compromising care by fostering a generic approach to diagnosis and treatment.

We are not Luddites, opposed to all technological interventions; we can see that electronic medical records have many benefits. Mountains of paper are replaced by the computer screen, with rapid access to complete and organized information, with risks such as dangerous drug interactions automatically flagged. But we need to learn how to use this powerful tool in the way that is best for patient care, regardless of whether it's the most "efficient" way.

We should instruct house staff that they must create independent, personal notes by talking to the patient and verifying the medical history themselves. We should discuss with payers what constitutes real documentation of time and effort rather than sleight of hand. We should use electronic formats that require us to select and insert specific, relevant laboratory results.

Perhaps most important, we should be cautious in using templates that constrain creative clinical thinking and promote automaticity. We must be attentive to the shift in focus demanded by electronic medical records, which can lead clinicians to suspend thinking, blindly accept diagnoses, and fail to talk to patients in a way that allows deep, independent probing. The computer should not become a barrier between physician and patient; as medicine incorporates new technology, its focus should remain on interaction between the sick and the healer. Practicing "thinking" medicine takes time, and electronic records will not change that. We need to make this technology work for us, rather than allowing ourselves to work for it.

Drs. Hartzband and Groopman report holding stock in Microsoft and Google.

Source Information

Dr. Hartzband is an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School, and Dr. Groopman is a hematologist–oncologist at Beth Israel Deaconess Medical Center and a professor of medicine at Harvard Medical School - both in Boston.

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