Malpractice and Templates
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ORLANDO, Fla.-Technology has advanced medicine in many ways, but it has also led physicians to focus more on data than patients, said best-selling author Abraham Verghese, M.D.

Verghese, the keynote speaker Tuesday at the Institute for Healthcare Improvement's 28th annual National Forum on Quality Improvement in Healthcare in Orlando, Florida, said physicians' attention has been diverted and patients suffer as a result.

Patients don't like it when doctors break eye contact with them, said Verghese, senior associate chair, Stanford University School of Medicine. They want to feel like their doctors are paying attention to them.

But instead physicians are focused on the prompts within the electronic medical record. He said in a course of a shift it can take 16 clicks to order baby aspirin and 140 clicks to admit a patient for chest pain. It is a "4,000 click-a-day problem," he said. And this lack of interaction with patients is causing resentment. "For every hour with patients, doctors are spending two hours on the computer ... This has to change," said Verghese. "The EMR of today is a mistake of epic proportions."

The distractions have led to oversights during the physical exam, although the chart wouldn't reveal that because every check box is checked off. "I like fiction," Verghese said. "I write fiction but it has no place in the electronic medical record."

Although electronic health records (EHRs) have streamlined podiatric record-keeping, inappropriate use or an overreliance on pre-populated templates can lead to the courtroom. This attorney presents several scenarios of potential malpractice suits and outlines strategies for the judicious use of EHR.

The American Recovery and Reinvestment Act provides for financial incentives for healthcare providers who prove meaningful use of electronic health records (EHR). Meaningful Use of EHRs, as defined by HealthIT.gov, consists of using digital medical and health records to achieve the following:

• improve quality, safety and efficiency, and reduce health disparities;
• engage patients and family;
• improve care coordination, and population and public health; and
• maintain privacy and security of patient health information

Other benefits of EHRs include a printed record legible to all; electronically created and transmitted prescriptions; one comprehensive location of the patient's records for all providers; and ease of access of patient information across mobile devices.

One would think that these benefits should lead to fewer health disparities and, by extension, less malpractice litigation. I focus here on several problems that a podiatrist may encounter with malpractice litigation in the age of EHRs.

When The Record Is Not Worth The Paper It Is Printed On

Consider this scenario. You enter the examination room where your assistant has already placed the patient, sans shoes and socks, in the examining chair. The assistant has also opened the EHR for the patient and started a new encounter record for you to complete. Now you are facing your patient and exchanging pleasantries. Next to you is your screen showing the new note containing a lot of pre-populated fields from entries made at prior visits, default responses awaiting change if necessary and perhaps areas on the screen that require typing additional information. In addition to history and medications, the findings from the previous visit are already pre-populated for the present visit. There is an old paper chart for the patient but you did not pull it for the visit.

Someone told you that you should incorporate the information in the old chart into the new EHR but it did not happen. After the usual repartee, you conclude that the patient is doing as well as expected with no complications but with the usual complaints as expected following surgery three weeks earlier. There is not much to document. The note ends with a pre-populated "progressing as expected, return in two weeks or earlier if needed," which you do not change.

What was probably a seven-minute encounter with the patient (with no suggestion that you should have spent more time for a visit of this nature) results in two pages filled with a lot of words, most of which the computer placed on the page without any action other than the opening of a new encounter note. There is also some information you may or may not have entered, either by way of a pull down menu or multiple choices, and maybe some free writing via your keyboard. You say goodbye to the patient and she leaves. One of your staff cleans the room and closes your entry. The record for that visit is now complete and will live on forever somewhere inside your computer, or more likely in a cloud-based system.

A year later, the attorney representing your former patient is reviewing the record you furnished after receiving the appropriate HIPAA release. Although you think you were well served with your EHR, the attorney has a plan to show the record is not worth the paper it is printed on and will use it to strengthen the patient's claim of malpractice against you.

Incorporating Old Paper Charts Into EHRs: What You Should Know

No matter the nature of the alleged malpractice, this particular EHR scenario will likely make the podiatrist more vulnerable and less credible to a jury. The patient's attorney will first make sure he or she obtained both charts from the podiatrist. It is often the case that only the electronic notes go to the requesting attorney and these may lack consent forms, labs, biographical and history forms, patient questionnaires or the older paper chart. Assuming that claim involves information in the paper chart not carried through into the EHR, the attorney will go further in his or her analysis of both charts.

The first area vulnerable to criticism will be that nobody ever scanned the paper record into the computer system and saved it as a simple PDF document. It is even more problematic for the podiatrist if that paper record was in storage and not even on the premises of the podiatry office. It should be easy for any software to have a hot button to open a specific document or at least open a dialogue box so one can retrieve the old chart in PDF format from memory, open it and peruse it.

The attorney will proceed to compare the history and medications in the EHR to those in the paper record to see if they are consistent. The attorney will then compare exam findings for consistency. Did the podiatrist document the patient's flatfoot deformity in the paper chart but forget to get that information into the EHR? The same is true of reflexes, vascular status, range of motion and other examination findings. More often than not, the defendant in a malpractice suit will say the old record was not needed but was available if needed. The defendant will also indicate there was no set practice in place to incorporate the record - in whole or in part - into the EHR.

If there is a prior written record, it is highly likely that the patient has some, if not a long, history and for the most part, the podiatrist's memory of the patient and his or her history is more than adequate. Simply asking the patient at the beginning of the record creation if he or she has any pertinent history is usually adequate. Pulling older paper charts just to have them available, even for routine visits, is actually counterproductive and can lead to lost or misfiled records, defeating the purpose of an EHR. Going through an old record merely to compare scientific findings, which likely have no relevance, is unreasonable to expect.

While one should have a system for deciding what to forward from the old chart into the EHR, the fact remains that not doing so is irrelevant unless the claim is one for not being aware of something from the patient's past podiatric history. Absent that, the patient's attorney would just be leveling criticism for the sake of criticizing.

Recommendation: Apply a consistent formula or standard for the incorporation of older, paper records into the EHR. If it is logical, reasonable and one follows the plan consistently, a jury is more likely to accept it.

A Word Of Caution On Pre-Populated Or Cloned Responses

Another issue that exposes the podiatrist to effective criticism in front of a jury is the pre-populated information and default responses (i.e. normal findings) created each time one opens a new entry. Showing a jury that the majority of the information in the majority of visits is identical would tend to show that one created the record without regard to this patient. It is often effective to point out inconsistencies, errors or wrong information that now carries over visit to visit.

Pre-populated historical information is something not worth criticizing because a jury can easily understand the importance to have that kind of unchanging information to repeat from visit to visit. However, pre-populated complaints, symptoms, examination findings, assessments and diagnoses, and instructions are usually fraught with inconsistencies and errors.

One example is that of a patient with diabetic neuropathy yet some pre-populated portion of the chart says that in the examination the patient's feet were neurologically normal. Another example is that of a patient with longstanding hallux limitus but the range of motion findings default to normal, and the examiner leaves it that way. These kinds of inconsistencies and errors make the EHR less reliable. Accordingly, the lawyer will argue that the podiatrist is careless in his or her recordkeeping, and is therefore unreliable and less credible as a witness.

A poorly executed EHR that contains mostly default information with little applying to the patient for that visit is a serious problem. However, the first step is to determine what default information is not applicable to the patient at that time and what default information does apply.

One could argue that pre-populated historical information is very valuable and having it repeat on each visit permits one not to waste time going through prior notes. Identical examination findings are nothing unusual in podiatry. For example, muscle strength and range of motion will likely remain consistent from visit to visit. If they are not, it usually means that problem brings the patient into the office for that examination and then, based on the examination, present findings may be different from previous findings. However, just because EHRs for multiple visits appear identical, it is unfair to suggest that the podiatrist did nothing other than open a new record with the computer doing the rest.

Even if the EHR is not 100 percent accurate, a jury should be more accepting of it if they understand how the podiatrist created it. In other words, make the EHR more human. The podiatrist would be well advised to describe to the jury how he or she goes through the creation of the EHR, even printing each screen to show the menus and fields that are complete, and how he or she goes about doing so.

Recommendation: Avoid the excessive use of programs automatically designed to pre-populate information from visit to visit. No matter what the software is designed to do, know its limitations and develop a way to get an accurate record that is consistent from patient to patient.

When The EHR Is Part Of A Larger Medical Practice

Consider this scenario. Your practice is no longer a private, standalone practice with your own computer system sitting in the closet next to the X-ray machine. Instead, you have joined a comprehensive medical practice and that practice is linked to a hospital. As part of the contract, every provider in the system, including you, has to use its EHR. The practice promised you it will modify the software to make it more podiatry friendly so you have the necessary menus and multiple choices available with the terminology you use.

One of the touted benefits of EHRs is the ability for all providers for a patient to have access to everyone else's records. One can now track medications among providers to avoid conflicts and interactions that may harm the patient. Alerts are even built into the system so you cannot issue a prescription for medicine to which the patient may be allergic.

Should you have concerns being a part of this kind of healthcare system as it pertains to the EHR?

In most podiatry malpractice cases, one need not be too concerned with the patient's medical conditions unless they impact the pathology in question and its management, or the patient's injuries. For example, in a case involving a bunion correction gone bad that led to a hallux varus, the case is not likely to be impacted by the patient's thyroid condition, hypertension or the medication she takes for endometriosis. However, there are cases in which the patient's non-podiatric conditions are directly related to the podiatric treatment. There are cases in which the patient sues a podiatrist and physician together for cases involving conditions, such as diabetes and infections, which are common to both.

Prior to EHRs, the podiatrist would obtain a history and a list of medications exclusively from the patient. While medical clearances are sometimes necessary for surgery, many clearances only involve routine blood tests and an EKG, requiring little contact with the patient's physicians or his or her medical records.

However, in the scenario described above, the EHR for every one of the patient's physicians is now available to the podiatrist with one click of the mouse. The patient's attorney will argue that given the comprehensive nature of podiatry education and training, there is no reason why the podiatrist should not review the medical records of other healthcare providers.

The defendant in a case may face cross-examination on the medical courses taken during the four-year program he or she completed at the podiatry school. The school may even have a brochure that states its "curriculum is similar to those at other medical schools." This curriculum may include courses on molecular biology, chemistry, immunology, pharmacology, biochemistry, histology and gross anatomy, including full cadaver dissection, infectious diseases, pathology, pathophysiology, pharmacology, biochemistry, cell biology, genetics, physiology and biology.

After the defendant podiatrist admits taking the required podiatry courses and that he or she rotated in her three-year residency through six hospitals, a jury will be primed to believe that the podiatrist has the training and education to absorb the content of his or her patient's medical records. In fact, an attorney will argue that while the standard of care for podiatry does not include making diagnoses outside of podiatry, it is part of the podiatrist's education and training to be knowledgeable as to the meaning of diagnoses outside of podiatry that impact on foot pathologies and their management.

After establishing this foundation, the attorney will then argue that the podiatrist failed to be aware of the contents of the EHRs from the patient's other healthcare providers. For a patient with diabetes, one can prove that it was a deviation from accepted standards of care not to be aware of the patient's A1c level when it was easily available in the patient's EHR. The patient's attorney will argue that the podiatrist took this easy step and therefore deprived him- or herself of the necessary knowledge of the patient's other medical issues that contributed to the injury the patient suffered.

Similarly, the attorney will argue that the patient was relying on the fact that all of his or her healthcare was being coordinated under one roof where all providers are connected and linked to everything there is to know about the patient medically.

It is true that comprehensive EHRs as described here may change due to the nature of the podiatric practice and how it interacts with other specialties. It would be important for the podiatrist to be aware of those conditions, diseases, medications and the like that impact podiatric treatment. To counter some of the suggestions from the patient's side of a case, it might be said that if the EHR was available to the podiatrist, it was equally available to all of the other healthcare providers who are part of that system and that the patient did not sue those medical providers for not being aware of the podiatrist's course of treatment.

For example, consider a case involving a proposed surgery on a patient with diabetes whose blood sugar levels were high - surgery that one could postpone - and the other providers, despite seeing the podiatrist's notes leading up to the surgery, did not step in and recommend against the surgery. If what the patient claims is valid, then the patient should sue all the doctors for malpractice because they all knew or should have known of the high blood sugar levels and the fact that the patient was heading into surgery. The point is that it becomes unreasonable to argue that the podiatrist should be reading other providers' records if the others are not reading the podiatrist's records. Notwithstanding a defense position on the topic, the electronic availability of a patient's entire medical record will change the complexion of all practices.

Recommendation: Do take the time to review the patient's EHR as it relates to non-podiatry treatment, review the information with the patient and have a strong understanding of how that information impacts your care and treatment of the patient.

Final Recommendations

1. Know how to use your own EHR program. Know the limitations of the program. Make sure you know how to enter exactly what you want and do not allow the software to decide.
2. Use pre-populated information but on a limited basis. Keep it simple. Use it for history and medications. Permanent diagnoses (e.g., diabetes) are fine but do not allow every previous diagnosis to appear automatically for each new entry.
3. Do not use a program that automatically pre-populates examination results with normal findings. Instead, use a program that forces you to choose the correct response for each part of your examination.
4. Make good use of free typing to make up for what the program does not provide.
5. Have a formula or standard for the incorporation of old paper records into the EHR. Do not be in a position of not having a good response to the question: "So how did you go about incorporating my client's older, paper records into your EHR?"
6. Take the time to review the entire EHR if it is linked to other healthcare providers and pay particular attention to those conditions that may impact podiatric treatment.

Mr. Karam has a law practice in New York City. His focus is representing plaintiffs in medical and podiatry malpractice cases.
For further reading, see "Essential Keys To Preventing Malpractice Lawsuits" in the July 2015 issue of Podiatry Today, "Proactive Pointers For Preventing Malpractice Lawsuits" in the September 2010 issue or "Seven Keys To Preventing Malpractice Lawsuits" in the August 2007 issue.

Long gone are the days when most physicians carried patient charts into exam rooms and jotted down their findings by hand. In some ways, electronic health records (EHRs) have simplified the record-keeping process, but they also may have rendered it more complex and risky.

Research indicates that malpractice lawsuits associated with EHRs have edged upwards, intensifying the need to heed red flags. Awareness of potential problems stemming from the ins and outs of new technology can help physician practices avoid legal repercussions.

Although EHRs were cited in only 1% of a sample of lawsuits closing between 2007 and 2013, the number of EHR-related lawsuits doubled between 2013 and 2014, according to a recent analysis by The Doctors Company, a physician-owned national medical malpractice insurer in Napa, California. The insurer predicts this issue will become even more pronounced in the next few years.

"This is due in part to the reluctance of some major vendors to openly discuss design flaws and work with users to make improvements that facilitate work flow and minimize disruptive drug alerts," says David Troxel, MD, medical director of The Doctors Company.

PIAA, the trade association that represents medical liability insurers, suggests that clinicians exercise greater caution with vendor agreements. "Vendor contracts may shift liability resulting from less than ideal software design from the vendor onto the user, so we recommend that healthcare professionals read all contracts carefully," says P. Divya Parikh, MPH, vice president of research and risk management at PIAA, formerly known as the Physician Insurers Association of America, in Rockville, Maryland.

In navigating EHR systems, physicians often encounter drop-down menus that address the most common scenarios and omit less frequent ones, while some auto-correct features and auto-population of data fields-intended to speed up the process- inadvertently lead to incorrect information input, she says.

Incorrect data input and other user errors rank as the leading reason for EHR-related malpractice claims, according to The Doctors Company. From January 2007 to June 2014, 64% of the insurer's 97 closed EHR-related malpractice claims involved user errors, while 42% were attributed to system factors. (Some claims had more than one contributing element, accounting for why the two categories do not add up to 100%.)

The most frequent user mistakes stemmed from inaccurate data, hybrid health records (existing in both paper and electronic form), EHR conversion, and issues pertaining to copying and pasting information. Less common issues in this category could be traced to user error, training and education, EHR alert fatigue, and workarounds, according to the report.

A busy physician may be inclined to forego rewriting a patient's pertinent medical history and current physical findings. "It's a real temptation to copy the prior note and paste it into the current visit, and then hopefully, go through the newly pasted version and delete things that are no longer relevant, and add what's new," Troxel says.

Too often, however, disruptions impede a physician's intentions to delete extraneous information, resulting in longer notes that bury significant new details and increase their likelihood of being overlooked. "If you have any erroneous or dated information in there, it gets perpetuated and takes on a life of its own," he says.

Diagnosis failures and medication errors were the top allegations among all EHR-related claims in The Doctors Company's report. Medication mishaps involved allegedly prescribing incorrect medications, ordering an inappropriate dosage, or improperly managing the patient on the medication.

Preparing for unexpected risks

Of the system-related EHR claims, 10% were associated with technology and design issues, such as the formulary and templates not being up-to-date. Electronic systems/technology failures-which occur, for example, when lab or radiology computers are unable to communicate with the main EHR - contributed to 9% of cases.

An additional 7% of cases involved lack of an EHR alert or an alarm/decision support tool. Other complaints spanned the spectrum from faulty data routing to inadequate scope or area for documentation, to fragmentation of similar information (lab and imaging test results) being stored in different areas, according to the report. Some claims contained more than one contributing factor.

Specific internal medicine subspecialists-cardiologists, hospitalists, oncologists and gastroenterologists-were most likely to face EHR-related claims, representing 20% percent of cases all together. Family physicians and general internists were accused in 16% of cases, while obstetricians/gynecologists incurred claims in 15% of cases.

The rapidity of EHR adoption has resulted in major and often unanticipated risks. For example, without proper backup of files, losing the entire electronic copy of all medical records is within the realm of possibility. Ideally, a physician should back up data to an off-site server at least once every day, says Dean F. Sittig, PhD, co-editor of the 2015 book, "SAFER Electronic Health Records: Safety Assurance Factors for EHR Resilience."

"The more reliant you are on your computer and all the data it contains, the more precautions you have to take," says Sittig, a professor in the School of Biomedical Informatics at the University of Texas Health Science Center in Houston. Also, in performing a self-assessment of your system, "you have to be really be honest with yourself" and perhaps admit, for instance, that weekly backups are inadequate.

Information overload often results from the sheer volume of important messages a physician receives about patient care. There is also an increase in mandatory clinical documentation tasks. Adhering to Meaningful Use requirements, physicians need to indicate the smoking status-using a checkbox or some other form of structured documentation-for all patients. "The rules have changed, and there's a lot more to record now," Sittig says.

Extensive data-keeping has elevated the level of responsibility and accountability for physicians as a result of extensive EHR adoption.

There is "a lot more transparency of information that wasn't there before," says Hardeep Singh, MD, MPH, chief of the health policy, quality and informatics program at Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, and the other coauthor of SAFER Electronic Health Records. "With electronic records, physicians have to realize that now we have a window into a black box that can show who has done what and who has seen what."

An EHR can track the length of time a physician spends on various tasks, such as meeting with a patient, based on starting and signing off on a computerized note. In a situation where both the primary care physician and the specialist miss abnormal test results, the EHR can audit if one or both had reviewed the findings, Singh says.

When used correctly, EHRs actually can help physicians defend their care by documenting decisions and the rationale for making them, says Mariel Taylor, JD, a healthcare litigation attorney at Greensfelder, Hemker & Gale PC in St. Louis and a member of the American Bar Association's Medicine and Law Committee of the Torts, Trial, and Insurance Practice Section.

For example, some EHR systems prompt physicians to fill out templates or forms explaining why they are overriding each particular drug interaction alert. "That could be very helpful in their defense" if a malpractice lawsuit ensues over a patient's allergic reaction, Taylor says. Conversely, simply ignoring alerts without proper written explanation "can look bad before a jury."

Establishing guidelines for email correspondence with patients also would be a prudent measure. Taylor suggests asking patients to sign a consent form stating that e-mails don't replace office visits and are not to be used in emergencies because physicians may not see the messages in time. This lets patients know what to expect. "A patient is more likely to file a malpractice suit if they feel like their doctor ignored them or wasn't communicating with them," she says.

In making the transition from paper to electronic records, quality assurance procedures should be put in place. During the transitional period, Taylor recommends cross-checking paper and electronic records to ensure there aren't any gaps.

Physicians should select an EHR program with templates that are useful to them in accurately documenting a patient's care, rather than a system with numerous data fields that don't serve their needs. In addition, Taylor notes that "there has to be a way for the program to highlight critical findings, so they don't get lost in a big, lengthy document that contains a lot of irrelevant information."

Other useful features in some EHR systems allow for tracking a primary care physician's referrals to specialists and documenting informed patients' consent before procedures. The options vary considerably, says Adam Wright, PhD, an associate professor of medicine at Harvard Medical School who specializes in electronic health records and clinical decision support systems.

"Some have a lot of decision support built into them; others are blank canvasses or blank slates," he says. "You have to decide which things you care about." For example, an EHR system can be tailored to notify patients when they are due or overdue for colonoscopies, mammograms, Pap smears ,or flu shots.

EHRs have a ways to go in making modifications. "EHR is on a continuum, and the maturity of the electronic medical record is definitely in its infancy," says Luke Sato, MD, senior vice president and chief medical officer at CRICO/Risk Management Foundation in Cambridge, Massachusetts.

Vendors should consider building some sort of intelligence into their systems that would help a physician "identify what's critical, what's important, and what needs to be acted upon," he says. "Currently, the physician has to do all that work."

Detrimental design?

Differences in design among EHR systems also can create conundrums. As vendors try to iron out the kinks, "there's a lot of effort being put forth to keep EHRs from becoming complicated and overwhelming for healthcare professionals. Ideally, they should be more streamlined and universal," says Parikh, who also notes a growing consensus to limit the number of intrusive and distracting pop-up messages that physicians receive.

Upgrading to a newer and more user-friendly platform is fraught with challenges as well. Andrew Carroll, MD, FAAFP, of Renaissance Medical Group LLC in Chandler, Arizona, is converting to a third EHR system since opening his solo family medicine practice in 2003. Back then, there were few EHR options. Nine years later, the range of choices had greatly increased, and he switched to a new program. This summer, he changed once again.

"There's a learning curve, obviously," says Carroll, immediate past president of the Arizona chapter of the American Academy of Family Physicians. "We don't want things to fall through the cracks, so we're trying very hard to make sure that the transition to the new software is inclusive of the data we had previously." This transition has entailed paying a vendor to perform the data migration from the old system.

In Carroll's experience, "it's very important to shop as many products as you possibly can" before selecting the right one for your physician practice. "Do not make a decision based on the cost, or what your friend is using, or what the healthcare system wants you to pick," he cautions. "Make sure you pick the software that best integrates with your mode of care. Don't look for the software that you need to adapt to; look for software that adapts to you."

The EHR system in Carroll's practice includes a robust patient portal. By entering encrypted passwords, patients are able to access their own medical records at home and review his notes from their office visits. They can update their medication lists for him to approve or correct as necessary. This way, he says, "the patient is fully invested in the medical record," and any discrepancies are caught soon after they occur.

In the closing session at AHIMA's CDI Summit in Alexandria, VA, on Friday, attorney Marion Munley, Esq., a medical malpractice lawyer who delivered her presentation via Skype, shared cautionary tales and disquieting concerns about the inherent patient safety risks related to electronic health records (EHRs).

EHRs, Munley explains, "are sold as a panacea to us the consumers, but in reality there are many bugs and obstacles that need to be worked out before we're assured of patient safety."

Some high-profile cases where EHR errors led to the death of a patient include the case of an Illinois infant who was erroneously administered 60 times the prescribed dose of sodium chloride due to a conversion error in the EHR. This caused the infant to suffer a heart attack.

Another more high profile case is that of Thomas Duncan, who died from complications of Ebola in Houston, TX. According to Munley, a nurse properly documented that Duncan had been in Liberia (a risk factor for Ebola), but the treating physician wasn't able to see that in his chart. As anyone who followed the news at the time knows, Duncan was discharged but returned to the hospital a couple days later before succumbing to the disease.

As an attorney, Munley says the most common EHR and documentation errors she sees are data entry errors, copy and paste mistakes, errors related to wrong clicks, failure of a physician to verify notes, errors caused by software updates, intentional destruction of records, and mistakes precipitated by clinical decision support alert fatigue.

Training Key to Preventing EHR Malpractice Suits

EHRs are more vulnerable to patient safety errors in the time periods immediately preceding or following software updates and go-live dates, Munley said, which means staff need to be properly trained and remain vigilant during these times.

She emphasized that if harm befalls a patient due to a glitch in the technology she will look for evidence showing whether or not clinicians have reported the issue to the vendor.

"Why didn't doctors know there was a flaw? Why did they knowingly put a patient at risk? Or, if the doctor was aware of the flaw but made no attempt to have it corrected, it could be argued that he or she knowingly put the patient at risk," Munley said. "For example, if a barcode scanner has an issue, that's something that could be easily rectified. If it's not being paid attention to, there's going to be a whole lot of questions about who knew what when."

Proper training will also help protect hospitals and healthcare organizations when an e-discovery process is initiated. When Munley requests hard copies of patient records for her clients, she's not seeing the whole picture.

"Unlike paper records, changes made to EHRs cannot be observed with the naked eye," Munley said. "If a family member or attorney requests files from EHRs, the printed out version won't show the audit trail. If a member of the staff provides patients with printable versions that are incomplete, it can be detrimental to the provider's defense."

A greater percentage of doctors are unhappy with their electronic health records than five years ago, according to a survey from the American Medical Association (AMA) and AmericanEHR Partners, a free online resource for the medical community created by the American College of Physicians (ACP) and Cientes Technologies.

The 155-question online survey of 940 physicians, conducted between May 30, 2014, and July 18, 2014, found that roughly half of all respondents reported a negative impact in response to questions about how their EHR improved costs, efficiency or productivity. In particular:

• 42 percent thought their EHR system's ability to improve efficiency was difficult or very difficult
• 72 percent thought their EHR system's ability to decrease workload was difficult or very difficult
• 54 percent said their EHR system increased their total operating costs
• 43 percent said they had yet to overcome productivity challenges related to their EHR system

The survey corroborates other reports about physicians' problems with their EHRs. The AMA recently held a town hall meeting to enable physicians to voice their frustrations and launched an initiative to encourage them to "share their stories" with members of Congress.

"While EHR systems have the promise of improving patient care and practice efficiency, we are not yet seeing those effects" Shari Erickson, vice president of ACP's division of governmental affairs and medical practice, said in a statement. "We need to focus on figuring out how we can help physicians and practices to more effectively implement and use these systems."

The survey also found that primary care physicians were happier with their EHRs than specialists. This may be because they've used their systems for a longer period of time. In most cases, it takes at least three years for physicians to see the benefits of EHRs, according to the survey.

Electronic health records have potential, but their benefits won't be achieved without significant upfront costs by providers, patients and the federal government, according to a new analysis from the American Action Forum, a nonprofit think tank.

The analysis finds that the hardware, software and labor costs for a solo practitioner to transition to an EHR are about $163,765, and $233,298 for a five-person physician practice. However, physicians were not yet seeing a payoff, with increased costs at least for the first three years after adoption.

Productivity declined an average of 15 patients per doctor per quarter. However, reimbursement increased, not because of upcoding but because of the increase in billing for ancillary procedures; physicians were receiving more money for treating fewer patients, which was "not the intended result" of EHRs.

Other roadblocks negatively impact the value of EHRs, as well. The high number of physicians (60 percent) planning on replacing their systems in 2015 will delay interoperability. Information blocking also remains a problem, which will require a "complicated policy solution" to bring the players together to benefit "society as a whole."

In addition, the costs of information security are high, estimated at $50.6 billion in less than six years. And the dramatic increase in the average number of records compromised in a single security breach is "alarming" and may be a consequence of the more connected healthcare system being strived for.

"Widespread use of electronic medical records could bring beneficial change to the healthcare system in a variety of ways, largely because they are the foundational piece to many technologies and analyses that could change healthcare delivery," the authors say. "All of these potential advances could greatly improve health outcomes and help bend the healthcare cost curve. Unfortunately, these advances come with significant costs, both financially and in terms of personal privacy."

The analysis corroborates other studies that indicate EHRs have made strides but are not yet delivering as promised.

To learn more: - read the analysis

The erroneous autocorrect, the restrictive dropdown menu, the deadly software glitch: anecdotal evidence of computer foul-ups abounds in the literature on electronic health records (EHRs) and medical malpractice awards.

It may be too early to say whether EHRs have increased or decreased liability for physicians as a whole, mostly because settlements lag so many years behind treatment, but some say the technology generally reduces total medical errors (though not as much as predicted) and has no effect on insurance rates.

At the level of the individual practice, however, EHRs can increase malpractice liability-if those practices fail to recognize the major risks associated with the technology and adopt policies that minimize those risks, experts interviewed for this article said.

The fundamental transparency of EHRs makes it harder to camouflage actual mistakes, they said. It also makes it harder to camouflage sloppy work habits or even to justify good work habits that can be made to look sloppy in court. Defending malpractice lawsuits, therefore, requires not only a commitment to good care but a commitment to the unimpeachable documentation of good care.

"EHR vendors initially promised better notes with less work, but the truth has largely been the opposite. A typical physician probably needs to spend an extra working hour every day to produce records with far more extraneous information but far less core content," said James J. Stark, MD, founder of Stark Oncology Consulting, in Suffolk, Virginia.

"It is an added hour of the most tedious possible work. It generally produces no benefits to patient care, and it generates zero extra reimbursement, so there is a tremendous temptation to cut corners with copy-and-paste and other shortcuts. Physicians who want to avoid malpractice verdicts must resist that temptation. They must accept each day's wasted hour as a cost of doing business. Those who don't can rest assured that lawyers will eventually tear their records apart, creating the appearance of malpractice even in the absence of actual malpractice."

While the logic of that advice is clear, doctors, nurses, and administrators, at some point, may become so overwhelmed with professional or personal obligations that they do begin to cut corners.

Practices, therefore, must create specific policies concerning the record-keeping obligations and implement safeguards that prevent workers from shirking those obligations, experts said. Good software can certainly help. It can, for example, send out alerts when users fail to do the bare minimum, but it still takes humans to distinguish good records from the shoddy notes that can endanger a practice.

Audits Help With Troubleshooting and Training

The Oncology Institute of Hope & Innovation, an independent practice with a dozen offices in and around Los Angeles, conducts regular audits of patient records. Audits are time consuming, but they go faster with EHRs than with paper records that are stored off-site, and they minimize the risk of problems related to either lawsuits or billing.

"It's rare to find a problem, but the auditing process is still valuable for a number of reasons," said Matthew Stevens, the Oncology Institute's General Counsel and Compliance Officer. "It allows us to evaluate how well we're training people to use the software and to make improvements. It also allows us to find problems before they come up in lawsuits or billing disputes and, quite often, to correct them. Finally, it gives everyone a strong incentive to be diligent about keeping the sort of good records that impress auditors."

Early EHR advocates predicted that system users would require much less oversight by administrators and one another. They said smart software would automatically force users to keep good records (or automatically warn administrators in the event of failure), and thus reduce malpractice awards by making poor record keeping nearly impossible.

Early EHR advocates said that software would eliminate a wide range of errors that were possible with paper records, but many of their predictions have yet to come true. EHR usage is generally associated with fewer medical errors, but many mistakes that programmers promised to make "impossible" still happen.

"EHRs have truly eliminated a few simple errors, like those arising from illegible handwriting, but once you get past that, they've created trade-offs for practices to consider. If you set a system up to warn you of every possible error, you'll waste countless hours on erroneous warnings and learn to ignore the warnings. If you set the system up with virtually no warnings, you risk mistakes you could have avoided," said Sandeep S. Mangalmurti, MD, JD, the lead author of a much-cited article that warned readers of the New England Journal of Medicine back in 2010 that EHRs might end up increasing medical malpractice suits.

"The clinical decision support is even more problematic. 'Teaching' systems enough about balancing standards of care against individual patient needs has proven exponentially harder than many people anticipated. Such features probably have some value when they prompt users to consider something they'd forgotten, but we're far from the point that healthcare providers should lean heavily on the decision algorithms. We're not even at the point that EHRs can reliably spot when you mistakenly chose 'twice daily' rather than the neighboring 'daily' on a drop down menu."

A Need for More Flexibility

Another problem with the dreaded drop-down menu and other EHR features designed to prevent doctors from doing the "wrong" thing arises when physicians try to override them. Some systems make it very hard to order anything unusual, even something as small as a low dose of medication for a patient with renal or hepatic failure. Practices need to have tools that allow such decisions and convey them clearly through the system so caregivers don't mistakenly revert to defaults.

It is also highly recommended that systems have policies on documenting the reason for overriding recommendations. Each time a doctor deviates from EHR guidelines designed to reflect standards of care, the system's implicit disagreement with the decision could be used as evidence in a malpractice suit. In other words, a system acquired to reduce medical errors and defend against lawsuits could become an effective witness for the plaintiff. The only way to minimize potential damage from such evidence is to document a full understanding of the system's reasoning and produce a full explanation for the disagreement-and to do it in real time. A note typed before something goes wrong necessarily demonstrates that a doctor at least made an informed decision. A note typed afterward does not.

Indeed, according to Mangalmurti and others, time plays a greater role in guarding against EHR-related lawsuits than many physicians realize. The detail that such systems provide when users undertake any action can be extraordinarily revealing. They can, of course, show whether a physician truly did read a vital part of the record, check test results, or read an X-ray before deciding on a course of treatment. They can also reveal just how long a doctor spent studying the record and reading the X-ray before making the decision, a feature that leaves doctors open to second guessing.

Practices that wish to minimize the risk of liability related to timing need policies that demand not only that users read records fully and document their own actions thoroughly, but also that they do so within timeframes that courts typically deem reasonable. They also need training that conveys to all users just how much detail EHRs can provide about timing and how bad it looks when they do or say anything that EHR data or metadata can disprove, even if it's just misremembering how long they spent looking at something.

Mangalmurti's 2010 NEJM article warned of these risks, even though it appeared at a time when less than 10% of the nation's medical practices used anything beyond the most basic EHR systems. It anticipated an even greater risk, however, in periods of transition, when practices are just adopting new systems. Many service providers have since passed through that initial transition, but the dangers remain for the many practices that still use paper records and the many others that will switch to a new EHR.

The Unfamiliar Is a Breeding Ground for Error

"The move from familiar to new systems increases error rates in basically every human endeavor. Unfortunately, case law to date provides basically no recognition of this fact," Mangalmurti said. "As a result, practices must plan for transitions incredibly carefully. They need systems to ensure that results and orders don't fall through the cracks, and they absolutely must provide effective training to everyone. System users should be fully comfortable with their new tools before they ever use them with actual patients."

Research to date on EHR-related liability provides little systematic information about how system records are being used in lawsuits, but the literature indicates that good policy and training has protected healthcare providers against liability related to e-mail and other electronic communication. When medical offices first started to go digital, many predicted that e-mail would lead to a variety of problems that ranged from insecure communications that violated the federal Health Insurance Portability and Accountability Act to questionable diagnoses based on written complaints rather than physical examination. Medical publications echoed with warnings. Practices responded with policies and training.

That said, new communications technologies bring new dangers, and the danger that has begun to worry some attorneys who defend malpractice suits concerns record-sharing among various medical offices. Many independent practices rarely share full patient records, for the simple reason that their software tends to be incompatible, but regulations designed to encourage interoperability may soon make it easy for practices to forward entire records.

Such capacity could provide physicians with more information about their patients, information that could improve the quality of care, but it could also create monumental new obligations.

"The record for a patient with a number of conditions could easily run to hundreds or even thousands of pages. It is clearly unreasonable to expect providers to read that much material on each patient that they see throughout the day. Therefore, providers will need to develop a consistent practice with respect to how they use and maintain both the information and the physical records," said Bobbie Sprader, JD, a partner at the Ohio-based law firm of Bricker & Eckler who specializes in defending medical negligence suits.

"When it comes to charting in the electronic medical record, I think we are a long way from having identified a best practice. For now, I would advise providers to protect themselves by taking advantage of the ability to enter free text whenever they can. A full 25 pages that do nothing but record drop box selections do not explain the thinking behind a decision as well as a single precisely worded sentence. Ultimately, 1 goal of a medical record is to communicate and the best way for caregivers to communicate quality care through the medical record is to record their findings and thoughts as clearly and effectively as possible," Sprader said.

We're familiar with the multitude of laws that dictate when and how to adopt and use electronic health records. There are 2,000 statutes and regulations related to electronic health information, according to Tara Ramanathan, a public health analyst with the Centers for Disease Control and Prevention, who spoke on a May 26 webinar sponsored by the American Bar Association Health Law Section.

But now we've begun to focus more on EHRs in the other legal venue: the courtroom.

The move was inevitable.

For years, people have been lamenting the "unintended consequences" of EHRs having an adverse effect on patient safety. So it makes sense that the patients suffering these consequences would start filing medical malpractice lawsuits against the providers using the EHR. The number of EHR-related malpractice problems has hit "critical mass," according to HL7's Reed Gelzer.

Unfortunately, both humans and computers are to blame for errors. There's not only sloppy copy-and-paste, failure to review automatic fill-ins and default templates, data entry errors and lack of training; there's also technology or system failures, design flaws and lack of relevant alerts.

But EHRs are having an impact in the courtroom beyond bearing witness or party to error. Evidently, electronic medical records are viewed differently from paper records, which has far reaching consequences in a lawsuit.

"Unlike paper records, where incomplete or illegible records are expected, with EHRs they're expected to be complete and immediately accessible and portable," explained attorney Rene Quashie, with Epstein Becker Green in the District of Columbia, who also spoke on the webinar.

Perhaps more significantly, EHRs are changing the nature of malpractice litigation. For instance, EHRs hold much more data than paper records. While that seems better, it creates more complexity and increases liability because it's easier to miss a small detail buried in the data; more access to clinical information could create new legal duties to act, such as to search patient information generated by others and available via a health information exchange, Quashie said.

EHRs may even change the "standard of care" required of providers. For instance, a physician who overrides an alert could be accused of deviating from the standard of care, even if the physician is acting appropriately and/or no harm occurred. Clinical decision support guidelines, despite being input into EHRs by computer programmers--not clinicians--could "solidify" the standard of care which otherwise might be subject to debate, Quashie warned.

"Failure to use an EHR may itself constitute a deviation from the standard of care," he said.

EHRs are great tools, and have already shown potential to improve patient health and safety. But they're new tools, and not unlike any new innovation, they take some getting used to and create some road bumps along the way.

EHRs not only are transforming how healthcare is performed, they're also on the cusp of reshaping the law surrounding that care. Are they the right changes? Or do we need to take a step back and reassess them?

For example, those in the weeds of the EHR-world know that EHRs can be manipulated so that the patient's records themselves are wrong. They may not even be sufficiently reliable to be used in court. So should they influence the standard of care?

The law is ever-evolving, albeit slowly, one statute and one court decision at a time. It also lags behind innovation, as Quashie pointed out. But there' a difference between lagging behind and changing direction. If that's the case, let's hope jurisprudence is choosing wisely. - Marla (@MarlaHirsch and @FierceHealthIT)

As electronic health records become more common, they increasingly are being relied on in medical malpractice litigation, often to the detriment of the provider.

Reed Gelzer, M.D., co-facilitator of HL7 EHR Records Management and Evidentiary Support Profile Standard Workgroup and head of Newbury, New Hampshire-based consulting firm Trustworthy EHR, shared his insights on this growing problem in an exclusive interview with FierceEMR.

FierceEMR: Why are EHRs being used more often in malpractice litigation, and why are they creating more legal problems for providers than paper records?

Reed Gelzer: Until three or four years ago electronic records were not ubiquitous. Now there is critical mass. And in medical malpractice, there's also a lag in change in the legal process. The kinds of effects we predicted to occur now are occurring.

FierceEMR: What's going wrong?

Gelzer: There are design errors and human errors. For instance, a physician prescribed a medicine to which the patient was allergic; a nurse had documented the allergy, but the EHR didn't show the doctor about the allergy until after the record was completed, since the EHR needed the doctor input first to complete the record. The patient had a bad reaction and sued. It was a dysfunction in the EHR, and a lack of understanding of how the EHR worked.

Other problems stem from [misuse of] copy and paste [which creates an inaccurate record].

Another problem is gag clauses in vendor contracts. Vendors will often stipulate if you observe problems, you can't report them.

FierceEMR: You've warned before that the data in EHRs are so inaccurate that they shouldn't be used in court. Does that apply here?

Gelzer: If subjected to scrutiny, most EHRs will be found wanting--but only if someone looks. Many systems are poorly designed for simple records management support, as well as evidentiary support. But the definition of authenticity is made on the basis of legal process and varies from state to state. For example, in Minnesota records from healthcare organizations are deemed self-authenticating.

FierceEMR: How does this dovetail with the Meaningful Use program?

Gelzer: A lot of organizations have implemented EHRs under Meaningful Use and accepted money from the federal government with the assumption that EHRs were fit for use as patient records. But there's no assurance that Meaningful Use relieves [providers] from the due diligence burden that the systems work as intended. Many chose an EHR because [they believed] if it was certified, it was fit as a patient record. And that's not what it conveyed.

It's a big problem. And it's taxpayer subsidized.

This interview has been edited and condensed for clarity.

CHICAGO -- As electronic medical records (EMRs) proliferate under federal regulations, kludgey workflow processes and patient data entry quality can be problematic.

The inherent issues with EMRs -- and for the healthcare professionals required to learn them -- hasn't been lost on lawyers, who see the potential for millions of dollars in judgments for plaintiffs suing for medical negligence.

Keith Klein, a medical doctor and professor of medicine at the David Geffen School of Medicine at UCLA, described four such cases where judgments reached more than $7.5 million because the data contained in an EMR couldn't be trusted in court.

Klein, who spoke at the Healthcare Information Management Systems Society (HIMSS) conference here today, said he has served as a legal expert in more than 350 medical lawsuits in state and federal courts. And while medical malpractice cases have so far focused on physicians and hospitals, Klein said technology vendors are next on the list.

"There are attorneys now looking for a clean case to sue the vendor," he said. "This is reality. It is not theoretical. I was approached by Washington, D.C. law firm who had a very clean case for suing a vendor."

Klein declined to be an expert in the case, but the problem will persist.

EMRs require physicians to perform their own data entry, stealing precious face time with patients. What had been a note jotted into a paper record, now involves a dozen or more mouse clicks to navigate a complex EMR workflow.

Healthcare providers can be prone to taking shortcuts on entering the data or not entering it in a timely manner, Klein said. Vital sign data is often duplicated as it moves between hospital departments, but it remains part of one integral patient record.

"This is a fire hydrant," Klein said. "Try to take a drink out of it. That's what it's like trying to read an EMR."

One recent lawsuit involved a patient who suffered permanent kidney damage when he was given an antibiotic to treat what was thought to be an infection resulting in elevated creatinine levels. The patient was also suffering a uric kidney stone, which precludes the use of the antibiotic. Because of the complexity of the EHR, none of the attending physicians noticed the kidney stone.

Detracting from the EMR's validity was the fact that a date related to a previous intravenous drip was repeated over and over on all 3,000 pages of the record.

While his physicians claimed they'd documented his care properly, the EMR was so complex and filled with repetitive data, the judge found it in inadmissible. "When an electronic medical record is printed out, the amount of repetitive data in it is ridiculous," Klein said. "Attorneys are having conferences on how to attack EMRs.

"All these cases were from top vendors. We're talking about well-established ones used at Kaiser [Permanente], at the VA... and academic institutions," Klein continued. "These are not rare cases. These are common things."

In another case, the physician was accused of plagiarizing data entered from another healthcare provider because he copied and pasted basic patient information.

Rita Bowen, senior vice president of health information management for Healthport in Atlanta, a records audit management and tracking technology firm, said she's seen duplicate data, erroneous data and copied data in EMRs.

"I've seen records where someone has copied and pasted from older records, 'The IV will be removed today,' over and over again. Well, was it removed?" Bowen said, illustrating how admins may copy and paste older information into newer records.

In fact, when it comes to strong information governance, Bowen said most healthcare facilities are woefully behind in rolling out rules and standards and ensuring they're adhered to.

But the problem isn't solely human error. The way EMRs and electronic health records (EHRs) are designed can prompt error-prone entries. For example, drop down menus for diagnoses can automatically enter data if a mouse is hovered over them too long.

"We've seen 92-year-old women getting diagnosed as crack addicts because of drop down menus," she said.

While Klein and Bowen readily defend the implementation of EMRs and EHRs as both time savers and records that increase mobility and accuracy when used properly, vendors should also be working to reduce complexity and introduce safeguards.

For example, when data is copied and pasted from one page of a record to another, some EMRs highlight that entry until an attending physician or nurse has verified it.

The use and design of a provider's electronic health record can have an impact on medical malpractice litigation, as shown by the recent misdiagnosis of the first Ebola patient in the United States, according to Sharon McQuown, R.N., MSN, LNCC, with the Law Office of Frank L Branson in Dallas, Texas.

McQuown, speaking at the American Bar Association Health Law Section's 16th Annual Conference on Emerging Issues in Health Care Law in Orlando March 6, pointed out that the focus of the problem was the misdiagnosis of the patient in Texas Health Resource's emergency department (ED), which caused the patient to be discharged the same day. He returned and was admitted three days later, confirmed to have Ebola, and died shortly thereafter. The malpractice suit was filed Nov. 12 and settled that day.

Much of the misdiagnosis in the ED was attributable to the EHR, McQuown said. For instance, the physician had access to the nurse's notes, which included the information that the patient had recently been in Liberia and that his vital signs had changed, but the hospital's audit trail could not confirm whether the doctor had read that section of the EHR. The travel information also was not highlighted in the EHR.

Additionally, there was a question about whether any face-to-face communication occurred among the providers before the patient's discharge, which might have also flagged the patient's travel history and vital sign information without having to rely on the EHR.

The hospital instituted EHR changes days after the patient died, including:

• Adding a new tool in the EHR requiring a "hard stop confirmation" by the physician that he/she had been told that the patient had recently been to a country of concern
• Creating a more robust screen that draws attention to travel with a red box on top and specific identification of countries traveled
• Adding a banner alert screen if a patient is flagged for infectious disease with an alert of steps to be immediately taken
• Changing the discharge process so that discharge papers could no longer be printed early or if anything was unresolved in the document.

Last October, Texas Health Resources Chief Clinical Officer Daniel Varga testified before Congress about many of the EHR changes the health system had made in the wake of the incident.

Texas Health Resources also made non-EHR changes, such as asking about travel history within 10 minutes at triage so that a potentially infected patient could be contained sooner. It also put more emphasis on face-to-face dialogue among providers.

McQuown noted that there's still a "fluid" learning curve regarding EHRs and patient safety, such as issues with cutting and pasting or default mechanism errors.

Other studies have shown that tweaking EHRs can make them more effective. However, Texas Health Resources is not yet out of the woods; Nina Pham, one of the nurses infected with Ebola by the patient has just sued the hospital for inadequate training and other issues.

To learn more: - learn more about ABA Health Law Section events

The American Academy of Family Physicians Family Practice Management Journal has released a report that said doctors are being forced to switch electronic health records (EHRs) and there is widespread dissatisfaction among physicians who have switched.

Most respondents claim that their new EHR does not improve productivity, and only 39 percent of physicians are happy with their new systems. Physicians cite revenue, productivity losses and traumatizing EHR transitions.

Among the reasons behind switching EHRs, respondents reported that the change was often not by choice, but was forced upon them. Physicians are quoted: "We were forced to [change EHRs] as part of the larger organization. [The] decision to switch was made at executive level. [It was a] business decision by hospital owner attracted to the product's billing and financial reporting, not driven by clinical users' interests."

The survey states, "Those who were personally involved in making the switch tend to look more favorably on their new system than those who did not make their own decision... Of the 140 respondents who said they were involved in the decision to change systems, 61 percent are happy with their new EHR; of those not involved in the decision, only 19 percent are happy with their new EHR."

The authors of the report add, "While our sample is too small to suggest winners and losers in the EHR marketplace, we do see some suggestive numbers. EpicCare Ambulatory and Praxis EMR had the most net gains in customers among our respondents," they explain. However, when user satisfaction was compared between the two EHRs, the difference was compelling. Praxis EMR eclipsed Epic and outranked all other Electronic Health Records systems.

EHRs can wreak havoc on a practitioner's clinical documentation of patient care, exposing the provider to malpractice claims, warns HIT author Ron Sterling, in an article posted on hitechanswers.net.

"Regardless of the legitimacy of care and treatment, the inappropriate use of EHRs and/or EHR design vulnerabilities are exposing physicians to questions on the quality of care and physician due diligence," he writes.

Some of the EHR documentation issues cropping up that can adversely affect patient care include:

Transitioning from paper records

If the patient information transferred from paper to electronic form is not structured properly, the record will be faulty, Sterling warns. For instance, if a patient's history is not included correctly during the transfer, then it may not generate necessary clinical decision support tools, such as alerts.

Note signatures

Some EHRs automatically close a record after a set time whether or not the note has been signed; others remain open indefinitely. Both situations raise questions regarding whether the doctor authorized care.

Templates, default settings and cut and paste techniques

All of these can lead to errors by incorrectly populating a patient's record.

Patient note ammendments

An amendment made via free text may not end up showing up and refining the original note, so warnings based on the new information won't arise.

"Practices need to closely examine how the EHR is set up and used on a continual basis to maintain the efficacy of the patient records and efficiency of the practice," Sterling recommends.

The concern that EHRs and other health IT can affect patient safety has been on the forefront since the Institute of Medicine issued its report on the topic last November. A bill that would protect providers from malpractice and other liability if they used certified EHRs, entitled the Safeguarding Access for Every Medicare Patient Act is in the House Committee for Energy and Commerce.

Electronic medical records are meant to save time and money, but they also can create liability issues for doctors.

Defense attorney Catherine J. Flynn knows how electronic medical records can overwhelm - and often change - the course of a medical liability lawsuit.

In one of her cases, a New Jersey doctor being sued for medical negligence has been accused by a plaintiff's attorney of modifying a patient's electronic history. A printing glitch caused the problem, Flynn said, but the accusation has meant extra time and defense costs. Computer screen shots were reviewed, more evidence was gathered and additional arguments were made.

"This has taken a life of its own, and we've done virtually no discovery on the medical aspects of the case," she said. "The cost of the e-discovery alone is in excess of $50,000."

System breaches. Modification allegations. E-discovery demands. These issues are becoming common courtroom themes as physicians transition from paper to EMRs, legal experts say. Not only are EMRs becoming part of medical negligence lawsuits, they are creating additional liability.

Across the country, the move from paper to electronically stored health data is growing. The 2009 federal stimulus package provided federal funds for the creation of a health information technology infrastructure. Health professionals can receive up to $44,000 for Medicare or nearly $64,000 for Medicaid by adopting electronic medical records.

Studies are mixed about how EMRs will impact liability for physicians. A 2010 survey by Conning Research and Consulting, an insurance industry research firm, found that most insurers believe medical claims will rise during the move from paper to electronic records. Lawsuits probably will decrease after an adjustment period, the study said. A report in the Nov. 18, 2010, issue of The New England Journal of Medicine said doctors should expect a varied landscape of liability risks and benefits as EMR adoption unfolds.

Whatever the future holds for EMRs, it's important that doctors reduce their liability risks during system implementation, legal experts say. Being aware of potential legal pitfalls prevents doctors from falling victim to technology intended to do good - not cause hardship.

"It's all about the system that's in place and the integrity of that system," Flynn said. "You can only do what the system allows you to do. If you have a good system in place, then the doctors are protected - even from themselves."

The burden of breaches

Data breaches are among the most common reasons that electronically stored information lands doctors in court, said Lisa Gallagher, senior director for privacy and security at the Health Information and Management Systems Society, which advocates health information technology.

For example, thieves broke into the Sacramento, Calif., office of hospital system Sutter Health in October 2011, stealing monitors and a laptop containing the health information of 4 million people. Patients sued, claiming Sutter violated the state's Confidentiality of Medical Information Act. The law regulates medical data disclosures and negligent storage practices. At this article's deadline, an attorney for the plaintiffs had not returned calls seeking comment.

The Sutter Health data security office was encrypting its computers when the theft occurred, the company said in a statement.

Though federal law regulates Health Insurance Portability and Accountability Act violations and subsequent notification rules, state laws vary on reporting regulations for data breaches. Some state laws cover all electronic data, while others, such as California's, are aimed at health data.

Knowing what your state requires in the event of a data breach is essential, especially because of potential legal snares, said Richmond, Va., attorney Jonathan M. Joseph, author of Data Breach Notification Laws: A Fifty State Survey. For instance, if a New Jersey physician treats a patient from another state and a breach occurs, the doctor could be subject to notification rules in the patient's state as well as his or her own, Joseph said.

Police investigations during breaches are another challenge. Law enforcement agencies may ask doctors to delay reporting a breach to patients to not taint the investigation. Some states allow doctors immunity if they do not immediately alert patients because of an agency's request, Joseph said. But some states do not give doctors a break on notification rules.

"The problem with that is that many [investigations] may take months, and you may have to sit and ask yourself, 'Are people going to be harmed?'" he said. "You have to think, 'Should I hold onto the information, or will I be liable?'"

EMRs and new tort claims

In Oregon, health professionals have won a court victory in a data breach case. Paul v. Providence posed significant questions about how far a medical professional's responsibility extends after data is stolen.

Some patients in Oregon sued Providence Health System in 2009 after computer disks were stolen from a medical office employee's car. The disks contained unencrypted records for 365,000 patients. Patients said that because of the theft, they were exposed to past and future out-of-pocket losses associated with monitoring credit reports, and expenses associated with credit damage. A trial court ruled that the plaintiffs did not have a valid claim under state law. The plaintiffs appealed to the state's Supreme Court.

The Oregon Medical Assn., and the Litigation Center of the American Medical Association and the State Medical Societies, expressed concern that if the plaintiffs prevailed, the decision could create a new claim against doctors.

"Plaintiffs in this case ask this court to recognize a new common law tort making health care providers liable in negligence for purely economic losses and emotional distress damages arising out of the theft of patient information from health care providers, in the absence of physical injury," the Litigation Center said in a brief to the Oregon Supreme Court. "There are strong policy reasons against the creation of liability in these circumstances, especially the chilling effect it could have on the broader use of electronic medical records, which make this a subject more appropriately addressed in the legislative process."

The Oregon Supreme Court on Feb. 24 ruled the plaintiffs could not sue Providence because the patients failed to show anyone actually viewed or used their personal information.

"Although plaintiffs allege that an unknown person stole digital records containing plaintiffs' information from defendant employee's car, they do not allege that the thief or any third person actually used plaintiffs' information in any way that caused financial harm or emotional distress to them," the court wrote.

The court said the plaintiffs' claim for future financial harm also was invalid because a "threat" of future physical harm on its own, is not sufficient to constitute an actionable injury.

The decision protects health professionals from unwarranted lawsuits, said Gwen Dayton, legal counsel for the Oregon Medical Assn.

The Oregon opinion is consistent with other states' rulings in similar cases, justices said. However, states such as Maine have allowed plaintiffs to sue over personal information that is used for identify theft purposes, thus causing present financial injury.

Encrypting record systems is key to preventing possible breaches, along with recognizing any suspicious system activity, Gallagher said. "You want to be monitoring your network and [putting] technical controls in place," she said.

E-discovery is a growing area of concern, said Joshua R. Cohen, a medical liability attorney and president of the New York State Medical Defense Bar Assn. While legal requests once entailed only paper records, attorneys are now seeking every accessible electronic record, including films, lab reports, emails and phone records.

"Plaintiffs are trying to use e-discovery as a weapon of mass discovery," Cohen said.

A 2011 ruling in New York highlights how e-discovery creates a burden for doctors.

During a lawsuit against St. Luke's Hospital Roosevelt Center, a debate arose about whether the plaintiff should be allowed access to screen shots from a doctor's computer. Joan Bowman, who sued the hospital for wrongful death on behalf of her husband, wanted to see a computer template used to aid physicians in diagnoses. The hospital said the request was overly broad and oppressive.

But the Supreme Court of the State of New York ordered the release of the screen shots.

"Defendant doctors testified that they utilized these materials in coming to their diagnosis," Judge Alice Schlesinger wrote. "It is not a stretch to allow counsel to see and understand these materials."

At this article's deadline, the hospital's attorney had not returned messages seeking comment.

The case sets a precedent, said Susan Dennehy, Bowman's attorney.

"If others want to see screen shots from records, I think they'll rely on this case," she said. "It was important to see where the template led you if you put in an inaccurate chief complaint."

New Jersey attorney Michael A. Moroney said expenses can rise dramatically because of massive e-discovery requests. In some cases, practices must hire outside teams to sift through archived records, said Moroney, who counsels doctors on the legal challenges of EMRs.

"There's a ton of time involved," he said. "There's the attorney's time and then the medical staff themselves. It means we're spending tens of thousands of dollars fighting over stuff before we even get to the merits of the case."

Steering clear of legal problems

Flynn has seen more plaintiff attorneys accusing doctors of modifying electronic records, even when the changes were made innocently. It's essential to have a system that does not allow changes after a certain amount of time, she said. If modifications are allowed, the systems should show that doctors made efforts to be transparent.

Login passwords can create liability. Cohen had a case where a physician provided his login password to a resident and gave him permission to update a patient's chart while the physician was out of town. When a claim arose, it appeared that the absent doctor updated the record.

"It makes it look sloppy," Cohen said. "Before, the [absent] doctor wouldn't even have been involved in the lawsuit. Now, it creates a question of fact that we have to explain."

Doctors are busy in their daily practice, but making time to take preventive steps now may save them from EMR liability later.

"The best thing doctors can do is be ahead of the curve," Moroney said. "Because when the day comes that you are served with a complaint, one of the first things the court is going to look at is, 'How good of a policy did you have, and could you have prevented this?'"

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ADDITIONAL INFORMATION:

How to reduce EMR liability

As the number of electronic medical records increases, so do certain legal risks, medical liability experts say. Common mistakes doctors make with EMRs and how attorneys recommend that physicians reduce their liability risks:

Mistake: EMRs allow users to move quickly through patient records, but cutting and pasting information makes it easy to paste incorrect information.
Recommendation: Refrain from copying and pasting EMR data, and be cautious when moving from one patient's record to the next.

Mistake: Computer programs can help doctors make a differential diagnosis, but the templates don't often include every possible symptom and corresponding medical condition.
Recommendation: Doctors should not become overly dependent on electronic diagnosis aids. Electronic systems are no substitute for hands-on diagnosis.

Mistake: Because EMRs allow physicians to move through patient charts much more quickly than paper charts, attorneys are noticing that some doctors are not being thorough when writing notes electronically.
Recommendation: Physicians should keep meticulous electronic notes on each patient and take time to document each chart.

Mistake: Some practices can fail to safeguard electronic patient data.
Recommendation: Practices should encrypt all information on computer devices and have policy that discourages employees from taking portable devices out of the office.

Mistake: A system may not clearly indicate changes to records.
Recommendation: Physicians should install systems that show transparency when modifications are made and/or have a program lockout period where no more modifications can be made to a record.

Mistake: Doctors may fail to follow notification requirements in the event of a data breach.
Recommendation: Be clear on what your state law requires when a data breach occurs, and make sure employees follow the rules immediately.

Mistake: Doctors may destroy or delete electronic records when a lawsuit is possible.
Recommendation: If doctors suspect they are being sued, they must preserve all electronic data related to the patient in question, including emails, phone messages and computer records.

Source: Attorneys Catherine J. Flynn and Michael Moroney of Weber Gallagher Simpson Stapleton Fires & Newby LLP in New Jersey

Copyright 2012 American Medical Association. All rights reserved.

Spokesperson Says Electronic Health Records May Give Crippling Access to Physician's Actions and Increase the Need for Defensive Medicine

DELRAY BEACH, Fla., Feb 8, 2012 (GlobeNewswire via COMTEX) -- Since the American Recovery and Reinvestment Act (ARRA) passed in February 2009 and caused a digital tsunami in the healthcare industry, physicians have been scrambling to comply with the requirement to switch to electronic health record systems. (EHRs) While many in the healthcare industry laud the use of EHRs to improve quality of care and analyzing patient outcomes, Dr. Sam Bierstock, founder of Champions In Healthcare, ( www.sambierstock.com ) points out significant concerns regarding increased vulnerability to medical legal claims that may result from the use of EHRs without major tort reform that would relieve physicians of an onslaught of malpractice suits.

"EHRs unquestionably have the potential to improve patient safety and the quality of care delivered, but what few people realize is that using an EHR exposes physicians to an Orwellian level of analysis of every single act while doing their job," said Bierstock, who has advocated and pioneered the use and benefits of EHRs for more than 30 years." EHRs, however, can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document. Physicians are exposing themselves to an unacceptable level of scrutiny and analysis of their use of computers that may serve to encourage malpractice suits. Meaningful tort reform is essential to getting the maximal benefit from these wonderful systems."

According to Bierstock, the problem runs even deeper because during his career as an industry consultant with Champions in Healthcare, and as a speaker at healthcare events he has noticed that the vast majority of physicians are still not aware of the complex requirements imposed upon them by the Health Information Technology for Economic and Clinical Health (HITECH) Act even though it has been a law for more than two years.

"I talk to many physicians who have no idea they can suffer financial, civil and even criminal penalties (i.e. jail) for non-compliance.," said Bierstock. "I have been asked to speak about this topic many times, but beyond HITECH, it's my opinion that similarly, doctors and hospitals don't yet fully realize their medical legal vulnerability associated with the use of EHRs. This will be the case until there is major tort reform, which has unfortunately been thwarted by the influence of American Trial Attorneys and their associations."

Bierstock noted that in an effort to stimulate physicians and hospitals to install and use EHRs, The American Reinvestment and Recovery Act of 2009 also authorized the Centers for Medicare and Medicaid Services (CMS) to issue guidelines which define what is "Meaningful Use" of an EHR - guidelines which must be met in order for hospitals and doctors to receive financial incentive payments for using EHRs, or be penalized by having Medicare or Medicaid payments reduced for failure to meet the guidelines. Bierstock believes that if physicians are expected to embrace EHRS, they should be allowed to do so in a manner that maximizes the benefits of these systems to the delivery of care and to the benefit of their patients without worrying about giving unlimited ammunition to trial lawyers.

"Quite simply, physicians may be in a situation that leaves them vulnerable to litigation and threatens loss of their professional standing and personal assets -- all because an external evaluator may not think the physician lived up to arguable standards in the digital age," said Bierstock. "Overall, EHRs are the litigator's proverbial golden goose. They are to malpractice attorneys what the electron microscope is to microbiology."

Dr. Sam Bierstock is a physician-informaticist, featured healthcare industry speaker, and a nationally recognized authority on physician adoption of clinical technologies to improve the delivery of healthcare. He has published more than 100 articles, and appeared on every major television network and in national print media features. He first received national attention in 1996 with his good-natured and satirical lambasting of HMO's through parody songs, and was awarded the George Washington Honor Medal from the Freedoms Foundation for his work on behalf of our nations veterans, including authoring a national hit song "Before You Go" ( www.beforeyougo.us ) in tribute to our aging veterans.

To inquire about booking Dr. Bierstock for speaking engagements, contact Rob Cohen at (954) 370-7000. To interview Dr. Bierstock, contact Rhonda Price at (561) 371-9407.

(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.

Electronic health records (EHRs) are a valuable part of any medical practice, as they can help to enhance the efficiency and quality of available services. However, EHRs also track each amendment to a patient's chart, as well as allows others with access to the EHR to view when and if diagnostic test results and other pertinent information have been viewed, leaving physicians more vulnerable in the event of a malpractice lawsuit.

All EHR systems have an audit trail function, which keeps track of the date and time of all activities performed on the EHR, including queries searched and updates made to medical charts. While this can be beneficial if physicians need to reference the time they signed off on a chart or finished a dictation, it can also create a timeline that can be used against the physician should a malpractice lawsuit be filed. For example, if a physician treats a patient and months or weeks later realizes he left pertinent information off of the patient's chart and signs on to add additional information, the date and time of the amendment will be logged on the audit trail. If a malpractice lawyer accesses the patient's records later as part of a malpractice investigation, he or she could use the timeline of charting events against the physician in court.

Protecting Yourself from Malpractice Litigation

To reduce your risk of losing a malpractice lawsuit due to EHRs, consider the following tips.

• Schedule additional time to become familiar with your practice's EHRs system. Many times, EHRs open physicians up to potential malpractice suits because of errors that occur from EHR misuse, such as utilizing the wrong template when documenting a patient's symptoms. Before implementing EHRs as the main method of charting, physicians must be familiar with the technology to prevent errors in documentation.
• Adapt to changes in standards of care. Don't let fear of litigation prevent you from implementing EHRs in your medical practice. As more physicians adopt EHR and meaningful use requirements begin to take effect, physicians who choose not to adopt EHRs could face more than decreases in Medicare and Medicaid reimbursement. Because EHRs can help to improve care - helping to reduce the chances for drug reactions, for example - and are quickly becoming standard of care, you could be held liable if you do not implement EHRs.
• Explain inconsistencies in documentation. If you forget to add a detail to a patient's record, it is acceptable to log on at a later date to add the information. However, you should include a reason for the inconsistency. Simply explaining that you forgot to include a detail is sufficient and ensures that it won't look like you have something to hide.

Health care providers, policymakers, patients, and payers share the vision of a health care system powered by information technology. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 authorizes grants and incentives totaling an estimated $14 billion to $27 billion to promote "meaningful use" of electronic health records (EHRs) by providers. In the excitement over health information technology, some of the potential risks associated with it have received less attention, such as the possible effects of this technology on medical malpractice liability. Yet even now, the potential for EHRs to ameliorate some sources of stress related to liability while reinforcing others is apparent.

We explore the implications for malpractice liability of four core functionalities of EHR systems: documentation of clinical findings, recording of test and imaging results, computerized provider-order entry, and clinical-decision support. We also discuss the ramifications of secure messaging capabilities integrated into EHR systems and the overall effects that may occur as comprehensive EHR systems become standard. Our analysis is based on a review of the limited available literature on the liability implications of EHRs and a much larger body of literature on the effects of EHRs on quality of care and the role of clinical practice guidelines in malpractice litigation.

The legal implications of EHRs extend beyond changes in malpractice liability. Other important consequences include potential liability under privacy and confidentiality laws, disputes over ownership of health data, and heightened vulnerability to Medicare or Medicaid fraud claims as a result of improved information on the match between services rendered and services billed. Because others have covered such concerns well, we confine our analysis to malpractice issues.

MAJOR EHR FUNCTIONALITIES AND THEIR PREVALENCE

An array of electronic information systems is used in health care today. "Basic" EHR systems facilitate electronic access to clinical information such as patient demographic characteristics, patient encounters, and laboratory and imaging results, with some systems permitting clinicians' notes. Basic EHR systems also permit computerized provider-order entry of medications, and many systems that include computerized provider-order entry check orders against patient information to flag potential drug interactions, allergic reactions, and errors.

"Comprehensive" EHR systems include these functionalities as well as more extensive capabilities for computerized provider-order entry (such as entry of laboratory test orders and nursing orders) and clinical-decision support. Clinical-decision support may include information about relevant clinical practice guidelines, clinical reminders, and guidance and safety alerts with respect to drug doses. Sophisticated systems scan patient data to provide individualized clinical recommendations.

In 2008, a total of 11% of nonfederal U.S. hospitals had implemented basic EHR systems, and less than 2% had implemented comprehensive systems in at least one clinical unit. A much larger proportion of hospitals had implemented or begun implementation of key EHR functionalities; for example, 56% had implemented or initiated implementation of electronic systems for entry of physicians' notes, and 52% had implemented or initiated implementation of clinical-decision support systems involving practice guidelines. Among physicians whose primary practice setting was not a hospital, 21% had a basic system and 6% had a comprehensive system in 2009.11

The future of EHRs lies in greater linkages to external systems. Many EHR systems provide electronic communication among providers within the same organization; others also allow secure messaging between providers and patients. These patient–provider communications vary from routine requests to refill prescriptions to reports of symptoms requiring prompt assessment. In some instances, systems maintained by different organizations share information about patients through "health information exchange" networks (HIEs). Although currently these networks are rare, they are likely to become more common owing to the federal government's recent commitment to help states fund the development of HIEs.

The liability implications of EHRs are likely to vary over the life cycle of the adoption of these systems. We begin by examining the period of initial transition to EHRs, during which predictable implementation snags may heighten providers' liability risk. After this initial period, EHRs have the potential to reduce injuries and malpractice claims but will also create opportunities for error and will alter the context for proving and defending malpractice claims with the use of electronic information. Finally, the long-term effects of widespread adoption of EHRs include potential shifts in the legal standard of care that may not favor providers.

MEDICOLEGAL RISKS DURING IMPLEMENTATION OF EHRS

Implementing new information systems may initially elevate, rather than decrease, providers' malpractice risk. As with any new technology, the risk of error increases during the "implementation chasm," as providers move from a familiar system to a new one. Several studies have documented increases in computer-related errors, and in one case an increase in mortality, shortly after implementation of computerized provider-order entry systems.

Medical errors and adverse events may result from individual mistakes in using EHRs (e.g., incorrectly entering information into the electronic record) or systemwide EHR failures or "bugs" that create problems in care processes (e.g., "crashes" that prevent access to crucial information). The interface between paper and electronic records may also create documentation gaps or other problems that affect clinical care. As an illustration of such risks, one recent study showed a higher rate of failure to inform patients of abnormal test results in outpatient practices in which a hybrid of paper and electronic records was used than in practices in which paper or electronic records alone were used. Effective training and tailoring of new systems to existing technology can minimize the incidence of such errors, and organizations that have sufficient resources can monitor problems after implementation and adjust systems to minimize the persistence of errors. However, these measures may not prevent errors entirely, and system failures may recur long after implementation, leaving clinicians to "practice blind" until functioning is restored.

At least one legal case suggests that providers have a duty to minimize such risks during the transition period. A federal court held that a hospital that switched from a paper to an electronic system for delivering test results had a duty to "implement a reasonable procedure during the transition phase" to ensure the timely delivery of test results to physicians. The court did not elaborate on what elements are sufficient to constitute a reasonable procedure, but it found that the hospital had met its duty by establishing a protocol for the period before all physicians had completed training on the new system that required radiologists to inform the requesting physician of abnormal results by telephone and that included a procedure whereby the results were automatically printed in two locations.

LIABILITY RISKS AND BENEFITS AS HEALTH INFORMATION TECHNOLOGY SYSTEMS MATURE

After the initial implementation stage, it is unclear whether the use of EHRs is likely to increase or decrease malpractice liability overall. EHRs have frequently been touted for their potential to reduce liability, with some malpractice insurers offering discounts to providers who make the switch from paper records to EHRs.23 One recent study showed that physicians who used EHRs reported a lower number of paid malpractice claims than did those who did not use EHRs, although the association did not persist in multivariate analysis. However, EHR systems also create new legal risks.

Effects on Care Processes

EHRs hold considerable promise for preventing harmful medical errors and associated malpractice claims.25 They promote complete documentation and timely access to patient information, facilitating sound clinical decision making. The use of electronic intermediaries may decrease transcription errors, improve communication among providers, and limit the duplication of tests. Clinical-decision support systems may offer a safety net by reminding harried providers of clinical guidelines and catching errors before they cause harm. Empirical evidence suggests that comprehensive EHR systems can improve adherence to clinical guidelines and reduce rates of medication errors. EHR users overwhelmingly report improvement in the quality of care they provide. On the other hand, despite experts' optimism, there is currently no evidence that the use of EHRs reduces diagnostic errors.30,31

Although computerized provider-order entry systems can decrease some kinds of medication ordering errors, they may create vulnerability to new kinds of errors. For example, discontinuities between information systems may cause prescribed medications to be automatically and unexpectedly canceled. Poorly designed systems that default to a potentially dangerous drug dose by failing to consider clinical changes such as renal or hepatic failure can lead to harmful ordering errors if physicians fail to recalculate the dose. Fuller access to electronic patient information may tempt providers to rely on previously recorded patient histories, test results, and clinical findings rather than collect new information. Although this may reduce duplication of effort and expenditures, it may perpetuate errors and omissions from earlier encounters. Overreliance on the copying and pasting function of many documentation systems can also perpetuate earlier mistakes. Secure messaging systems and other electronic communications also have both liability risks and liability benefits. Offering medical advice without conducting a physical examination or taking a history increases the risk of an erroneous diagnostic or treatment decision. Moreover, courts have held that telephone communications between a physician and a patient can be sufficient to establish the physician–patient relationship necessary for malpractice liability. The same is likely to be true for electronic communications. Once such a relationship is established, failing to respond to patient e-mails within a reasonable period of time could constitute a violation of the standard of care. In addition, e-mail may create a written record of negligent advice. It may even constitute negligence to e-mail advice to a patient rather than examine him or her in person. Alternatively, messaging systems may help prevent medical errors and adverse events by allowing patients to easily vocalize clinically significant concerns that they do not believe warrant an office visit.

Messaging systems also affect liability risk by shaping patients' perceptions of their physician. E-mails that are responded to slowly, are answered with boilerplate language from staff members, or are otherwise unresponsive to patients' concerns are likely to provoke ire and dissatisfaction. Conversely, highly responsive physicians may strengthen their relationships with patients. This may have medicolegal benefits, since research has linked a propensity to sue with patients' satisfaction with their physician and the physician's communication skills.

To assist providers, the American Medical Association (AMA) and the American Medical Informatics Association have established ethics policies and guidelines on the use of electronic communications in clinical practice. The AMA policy states that physicians should not use electronic communications to establish physician–patient relationships - only to supplement "other, more personal, encounters." Both sets of guidelines recommend that physicians develop their own guidelines for such matters as the appropriate use of and turnaround time for e-mails. The AMA guidelines further suggest establishing a protocol for terminating e-mail relationships with patients who repeatedly violate the rules. Before initiating an e-mail relationship, providers should notify patients of their guidelines and obtain informed consent for the use of electronic communications.

Effects on the Litigation Process

In addition to affecting the risk of a lawsuit, implementation of EHRs may affect the course of malpractice litigation by increasing the availability of documentation with which to defend or prove a malpractice claim. Unlike telephone conversations, e-mail creates a written record. To the extent that the use of EHRs facilitates the entry of more extensive notes, it too may bolster the written record. Finally, EHRs record all electronic transactions, from the input of orders to time stamps of clinical activity, although they vary in their ability to produce reports of these data on demand. This information, called metadata, provides a permanent electronic footprint that can be used to track physician activity. Under federal law, metadata are discoverable in civil trials, which means that defendants must surrender them to a plaintiff's lawyers on request. State law, which governs most malpractice litigation, varies as to the discoverability and permissibility of metadata.

In some malpractice cases, the documentation within EHRs may establish a provider's culpability, whereas in others it may help mount a defense. For instance, in one case, a patient with a catastrophic operative outcome sued his surgeon for negligence. Electronic data monitors from the operating room showed that there were more than 90 minutes of gaps in the anesthesia record. The legal inquiry turned to the anesthesiologist. A deeper examination of the electronic record uncovered further discrepancies. Though it was unclear whether errors were made in patient treatment, the collective weight of the discrepancies became difficult to defend in court, and the anesthesiologist settled the case.

Metadata can be used to authenticate the EHR - for example, to verify that an EHR was modified at the time of treatment rather than later.44 Typically, this should bolster the defendant's ability to rely on the EHR when defending against a malpractice claim. However, if the record was modified at an inappropriate time, metadata can raise questions about falsification of records, even in the absence of actual wrongdoing. In the aforementioned case, metadata revealed that the anesthesiologist wrote his postoperative note minutes after the operation began. This appearance of impropriety probably helped the plaintiff secure a settlement. The hospital later discovered that its anesthesiologists commonly recorded standard notes, such as their presence at the patient's emergence from anesthesia, during less hectic parts of the procedure.43,45 Whereas in the pre-electronic age such a practice posed little risk of liability, the availability of metadata changes the game.

LONG-TERM EFFECTS ON THE STANDARD OF CARE

To prove medical malpractice, a plaintiff must establish the applicable standard of care and prove that the defendant caused injury by falling short of that standard. As the use of EHRs spreads, it may reshape medical liability by altering the way in which courts determine the standard of care and by changing the standard of care itself.

Clinical-decision support systems may help drive this transformation. In a malpractice suit, each side presents expert testimony to define the applicable standard of care. Expert witnesses may rely solely on their own judgment and experience or invoke external evidence of the standard of care, such as clinical practice guidelines. Courts have permitted this use of practice guidelines and would probably also admit clinical-decision support systems as evidence of the standard of care, if an expert attests that they reflected reasonable and customary care. A physician's departure from the clinical-decision support protocols could then be used as evidence of negligence.

Like practice guidelines, clinical-decision support protocols could establish a more accurate definition of the standard of care than would emerge from the clash of expert opinions alone. However, they have limited ability to anticipate the myriad clinical scenarios that physicians encounter. Physicians routinely override even relatively simple clinical-decision support protocols, such as drug-allergy alerts, for clinically appropriate reasons.

Overriding a system default that arguably represents the standard of care creates an electronic record that physicians may need to justify in court. For example, in some clinical-decision support systems, simultaneous use of clopidogrel and aspirin requires physicians to overrule safety protocols protecting against excessive anticoagulation, even though the simultaneous use of the two drugs is generally indicated for patients with myocardial infarction. In the rare case in which a hemorrhage develops in a patient, a deliberate suspension of safety protocols could resonate poorly with juries. Overreliance by courts and juries on recommendations embedded in clinical-decision support systems could result in increased and sometimes inappropriate liability when providers depart from clinical-decision support protocols. Some, but not all, EHR systems prompt clinicians to document their reasons for overriding clinically significant alerts.

The growth of HIEs and the subsequent accessibility of external medical records may also substantively change the standard of care. Without HIEs, a provider has limited ability to examine a patient's records from another provider. Perhaps recognizing this, at least two courts have declined to impose a legal duty to obtain and review prior medical records. HIEs provide easy access to this information, possibly increasing the liability risk for providers who fail to take advantage of that access. It is unclear whether courts would require physicians to routinely perform comprehensive reviews of external EHRs, but in cases in which a patient mentions a relevant piece of his or her medical history and the provider fails to review an easily accessible external EHR, liability could well result.

This prospect reflects a deeper concern about health information technology: will the practice environment evolve along with the information environment to allow physicians to make use of the available information resources? The time constraints of typical office visits, for example, may hinder a thorough examination of voluminous EHRs. Under such constraints, key information may be missed in a sea of new electronic data, much of which is of dubious clinical significance. The legal standard of care in malpractice cases is meant to reflect reasonable care, but what appears to be reasonable may differ from the perspective of a layperson, who is convinced of the easy accessibility of electronic information, and the physician, who has the challenge of examining both the patient and his electronic dossier in a 15-minute visit.

Finally, as the use of EHRs grows, failure to adopt an EHR system may constitute a deviation from the standard of care. The standard of care is usually defined by reference to what is customary among physicians in the same specialty in similar settings. Once a critical mass of providers adopts EHRs, others may need to follow. If EHRs do indeed improve quality of care, many legal scholars would applaud this development, since it exemplifies the ability of tort law to spur providers to practice more safely. This "deterrence" notion, however, assumes that the cost–benefit ratio of technology is reasonable, so that injuries are prevented at an efficient cost. Empirical evidence evaluating this assumption is mixed.

CONCLUSIONS

Providers can expect a varied and shifting landscape of medical liability risks and benefits as the adoption of EHRs unfolds. Whether these developments improve the performance of the medical liability system remains to be seen. Electronic documentation is likely to bolster the accuracy of courts in determining liability by enhancing the evidence available to evaluate claims. Less clear at this early stage is whether EHRs will lead courts to recognize changes in the legal standard of care - and if so, whether these changes are socially desirable. It is also unknown how the law may evolve to allocate liability fairly among individual clinicians, EHR developers, and provider organizations that select and implement EHR systems. Liability that arises primarily because of poorly designed EHR systems arguably should rest with those in control of system architecture and implementation, not end users. However, in many cases, suboptimal design may set the stage for user errors, complicating the assignment of fault. In addition, some contracts between provider organizations and EHR developers reportedly include provisions protecting the developer from liability arising from the use of the EHR system.

Health care professionals and provider organizations can actively manage EHR-associated risks. First, they can decline to sign contractual provisions that immunize the system developer. Second, they can select systems that are designed to minimize the risk of user error or misuse and maximize the ease of record retrieval. This requires that organizations invest effort early to ensure that the EHR system is customized to the practice patterns of their clinical staff - for example, ensuring that clinical-decision support alerts and medication-dose defaults are sensible.

Third, organizations that adopt EHRs can ensure that clinicians receive thorough training, including education about organizational expectations regarding the use of the system. Hospitals can monitor the use of the system after implementation for obvious problems. Physicians, for their part, must be willing to climb the learning curve. Understanding how using EHRs may help protect them from liability, and how misuse or nonuse may increase liability risk, should motivate them to do so.

Fourth, organizations can ensure that practice conditions are such that the use of the new technology can be maximized. Identification of appropriate practice conditions will require organizations to work closely with their care teams to identify existing barriers to the optimal use of EHRs, whether these involve the length of office visits, the placement of computer terminals, problems accessing external records, or other factors. Fifth, managing patients' expectations about secure messaging and accessing of EHRs is pivotal. Finally, when physicians serve as experts in malpractice litigation, they can educate liability insurers and courts about the limitations of clinical-decision support systems and the appropriateness of departures from them in certain situations.

In evaluating whether to invest in EHR technologies, provider organizations must weigh the substantial up-front cost and possible risks against the potentially sizeable, but uncertain, long-run benefits. The malpractice implications of EHRs should be included in future discussions of risks and benefits. Although there is currently little research quantifying the risks and benefits with respect to liability, we are optimistic that they will ultimately weigh in favor of the implementation of EHRs. Regardless, it is likely that EHRs are here to stay. As the use of EHRs becomes commonplace, the legal standard of care will evolve, and latecomers to the EHR table may be called to account.

Supported in part by an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation, Princeton, NJ (to Dr. Mello).
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
We thank Ashish Jha for comments on an early draft of the manuscript.
SOURCE INFORMATION
From the Department of Medicine, New York University Medical Center, New York (S.S.M.); and the Department of Health Policy and Management, Harvard School of Public Health, Boston (L.M., M.M.M.).
Address reprint requests to Dr. Mello at the Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave., Boston, MA 02115, or at mmello@hsph.harvard.edu.

The two sides to using electronic medical records

With more than 75,000 medical liability lawsuits filed annually, does the electronic medical record (EMR) provide physicians with some security against an action? It certainly can. But with new rules and regulations on protecting patient information, can an EMR put physicians at risk for additional liability? Almost certainly, yes.

According to Douglas W. Lundy, MD, chair of the AAOS Medical Liability Committee, "If we are less than diligent in our choice of an EMR system, its customization, and its use, it may become our enemy-decreasing care quality and increasing traditional tort and regulatory liability. The EMR is a double-edged sword. We need to learn its pitfalls and use it as carefully as we do our instruments in the operating room."

Reducing risk with EMRs

Over the next 5 years, using an EMR will become the standard of practice for physicians. Imagine a trial attorney asking a physician on the stand: "Why don't you use an EMR when the technology is known to improve patient documentation and can help avoid adverse drug interactions?"

An EMR can help prevent adverse events through improved documentation of the patient encounter, a reduction in medication errors through computerized physician order entry (e-prescribing), and improved tracking of lab tests combined with better patient follow-up communications. These benefits positively impact patient care, patient adherence to treatment, and outcomes ( Table 1).

Better patient care documentation

An EMR can enable physicians to create more accurate documentation compared to the typical free-form, paper-based patient record. The EMR template provides a roadmap to documenting the patient interview, physical examination, analysis of studies, differential diagnosis, and final diagnosis.

Templates make it possible to document findings that are complete and accurate for each patient. A template detailing a comprehensive orthopaedic examination of the knee is much more extensive than a brief handwritten summary. This wealth of information enables a systematic review of findings during the entire patient care continuum. It can be critical to the orthopaedic surgeon who must mount a defense against a medical liability claim-with one exception. When using an EMR, the surgeon should never "clone" patient documentation notes from an earlier appointment.

EMR software-used correctly and with complete, accurate documentation-better prepares an orthopaedist to make a defense against allegations of improper care. Information that might have been missing in a paper record can easily be found with the EMR template.

William J. Mallon, MD, a member of the AAOS EMR Project Team, reports, "In our practice, referring physicians, my partners, and I have seen substantial limitations in standard EMR-generated notes. Templates can solve the issue of creating text-like notes that look like a typical doctor's note with all the necessary information."

Most EMR systems will require the creation of several different templates to address different patient populations and problems. Documenting findings about a child's metatarsus adductus requires a different template than the one used for an adult patient with patellar chondromalacia.

(See the online version of this article at www.aaosnow.org for two sample templates developed by Dr. Mallon.)

Using an incorrect template, however, may lead to incorrect documentation of findings, and attorneys will certainly take advantage of this mistake if an adverse event occurs. Similarly, cloning notes from previous appointments may also create problems.

"Attorneys tell me that they think EMR systems produce poorly written and hard-to-interpret notes that improve the likelihood of a decision in favor of the patient for an adverse event. Most doctors dislike EMR-generated notes for similar reasons," says Dr. Mallon.

"If all the notes look alike because they've been 'cloned' from one visit to the next," he continues, "attorneys may say that the doctor really never did the exam or the documented test. They may postulate that the physician simply filled in the blanks and did not actually complete some or all of the exam."

Improving patient relations, communications

When used correctly, the EMR can improve patient relations and patient/physician communication. The immediate access to patient data enables physicians to focus on the patient rather than fumbling through paper files for information from previous appointments.

EMR systems include secure e-mail functions that can improve patient communications between visits. Patients can follow up with their physician through e-mail reporting. This additional communication helps ensure patient adherence to treatment and may reduce the likelihood of a medical liability claim.

Physician-to-physician communications may also be enhanced through EMR technology. Accurate and complete information sharing improves documentation of the patient's problem as well as follow-up communication. Using secure e-mail, a physician may notify a patient of new information received from another physician. This also enhances patient relations.

New liability problems on the horizon

At the same time, the Health Information Technology for Economic and Clinical Health Act (HITECH) creates new responsibilities for orthopaedic surgeons using an EMR system. These include increased requirements for data security, breach of privacy reporting, and auditing access to electronic data files.

Orthopaedic practices will need to develop new policies and procedures regarding access to patient information for physicians and other practice personnel. Agreements will be needed with outside businesses such as external laboratories, hospitals, and others. New security controls focusing on access to unencrypted or encrypted patient data will be necessary.

Avoiding a data breach is paramount. In developing necessary policies and procedures, practices should take the following issues into consideration:

• Passwords for log-in and log-off to data files
• Second defense authentication methods
• Unoccupied workstation security
• Use of shared workstations
• Auditing log-ins for accessing patient data
• Standards for data exchange between covered entities
• Locking out or suspending access privileges

HITECH also increases compliance requirements under the Health Insurance Portability and Accountability Act (HIPAA) in the following ways:

Requiring the Department of Health and Human Services (HHS) to investigate and impose penalties for violations that are determined to be "willful neglect"

• Requiring HHS to audit covered entities for compliance
• Assessing both individual and organizational accountability
• Increasing penalties for violations to a maximum of $1.5 million per entity per year
• Creating the potential for prosecution for criminal violations
• Enabling civil damages for patients 'injured' by HIPAA violation
• Requiring that you contact each patient if a breach of confidentiality occurs

The HITECH Act also expands patients' rights to obtain an accounting of disclosures of their health information. This requirement places an added burden on physician practices and, according to the Medical Group Management Association (MGMA), will be "extremely difficult to achieve without an enormous outlay of resources."

According to MGMA, the Act requires physicians who use an electronic health records system to include administrative data-such as disclosures for treatment, payment, and healthcare operations-in response to patient requests for an accounting of their protected health information.

Two sides of the story

Using an EMR for patient care documentation and patient relations has both positives and negatives. Physicians and practice executives are investing more and more time learning about the pros and cons of the EMR. The American Recovery and Reinvestment Act, the HITECH Act, and new HIPAA requirements are driving this interest. By making meaningful use of an EMR, beginning in 2011, orthopaedic practices have the potential to receive a federal subsidy of up to $44,000 per physician. Failure to make meaningful use by 2014 may result in a reduction in Medicare payments in 2015.

S. Jay Jayasankar, MD, sums up the positives and negatives, "EMR is neither boon nor bane. If you continue your excellent clinical and communication skills and use EMR with appropriate templates and features, it can be your trusted aide to increase patient safety, care quality, and patient satisfaction and compliance. Remember the 'garbage in, garbage out' principle."

Template: Final POV – Total Knee Arthroplasty (PDF)
Template: First Office Visit – Rotator Cuff

Howard Mevis is director of the AAOS electronic media, evaluation programs, course operations, and practice management group. He can be reached at mevis@aaos.org

Editor's Note: Articles labeled Orthopaedic Risk Manager are presented by the Medical Liability Committee under the direction of contributing editor S. Jay Jayasankar, MD.

Articles are provided for general information and are not legal advice; for legal advice, consult a qualified professional.

E-mail your comments to feedback-orm@aaos.org or contact this issue's contributors directly.

Bottom line

• Focus on the patient, not the software.
• Ensure complete, accurate documentation using patient- and problem-specific templates.
• Keep patients engaged in their care.
• Review and update data security and patient information confidentiality policies and procedures.

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The United States is about to invest nearly $50 billion in health information technology (HIT) in an attempt to push the country to a tipping point with respect to the adoption of computerized records, which are expected to improve the quality and reduce the costs of care.1 A fundamental question is how best to design electronic health records (EHRs) to enhance clinicians' workflow and the quality of care. Although clinical documentation plays a central role in EHRs and occupies a substantial proportion of physicians' time, documentation practices have largely been dictated by billing and legal requirements. Yet the primary role of documentation should be to clearly describe and communicate what is going on with the patient.

Electronic prescribing appears to reduce the rate of medication errors, but the other benefits of electronic records are less clear.2 We must ensure that electronic clinical documentation works effectively to improve care if more benefits are to be achieved. Yet many questions about it persist. For example, can it be leveraged to improve quality without adversely affecting clinicians' efficiency? Will the quality of electronic notes be better than that of paper notes, or will it be degraded by the widespread use of templates and copied-and-pasted information?

A fundamental part of delivering good medical care is getting the diagnosis right. Unfortunately, diagnostic errors are common, outnumbering medication and surgical errors as causes of outpatient malpractice claims and settlements.3 EHRs promise multiple benefits, but we believe that one key selling point is their potential for preventing, minimizing, or mitigating diagnostic errors. Admittedly, evidence to support the existence of such a benefit is currently lacking, and our hypothesis runs counter to the sentiments and claims of many physicians, who argue that electronic documentation in its current incarnation is time-consuming and can degrade diagnostic thinking - by distracting physicians from the patient, discouraging independent data gathering and assessment, and perpetuating errors.4 But we envision a redesigned documentation function that anticipates new approaches to improving diagnosis, not one that relies on the putative "master diagnosticians" of past eras. The diagnostic process must be made reliable, not heroic, and electronic documentation will be key to this effort. Systems developers and clinicians will need to reconceptualize documentation workflow as part of the next generation of EHRs, and policymakers will need to lead by adopting a more rational approach than the current one, in which billing codes dictate evaluation and management and providers are forced to focus on ticking boxes rather than on thoughtfully documenting their clinical thinking.

There are numerous ways in which EHRs can diminish diagnostic errors (see table). The first lies in filtering, organizing, and providing access to information. Making accurate diagnoses has always depended on thoroughness in gathering the patient's history, findings from the physical examination, and other data. Because information from patients' previous clinical encounters and tests will be more readily available with electronic than paper records, shifting to electronic systems could substantially improve clinicians' knowledge about the patient. The problem of having too much information is now surpassing that of having too little, and it will become increasingly difficult to review all the patient information that is electronically available. However, one virtue of computerized systems is that they can display recorded information in various formats. Designers will need to leverage the "visual affordance" capabilities of EHRs to facilitate the aggregation, trending (of a patient's weight or renal function, for instance), and selective emphasis or display of data so as to facilitate rapid judgments.

Leveraging Electronic Clinical Documentation to Decrease Diagnostic Error Rates
Role for Electronic Documentation	Goals and Features of Redesigned Systems
Providing access to information	Ensure ease, speed, and selectivity of information searches; aid cognition through aggregation, trending, contextual relevance, and minimizing of superfluous data.
Recording and sharing assessments	Provide a space for recording thoughtful, succinct assessments, differential diagnoses, contingencies, and unanswered questions; facilitate sharing and review of assessments by both patient and other clinicians.
Maintaining dynamic patient history	Carry forward information for recall, avoiding repetitive patient querying and recording while minimizing copying and pasting.
Maintaining problem lists	Ensure that problem lists are integrated into workflow to allow for continuous updating.
Tracking medications	Record medications patient is actually taking, patient responses to medications, and adverse effects to avert misdiagnoses and ensure timely recognition of medication problems.
Tracking tests	Integrate management of diagnostic test results into note workflow to facilitate review, assessment, and responsive action as well as documentation of these steps.
Ensuring coordination and continuity	Aggregate and integrate data from all care episodes and fragmented encounters to permit thoughtful synthesis.
Enabling follow-up	Facilitate patient education about potential red-flag symptoms; track follow-up.
Providing feedback	Automatically provide feedback to clinicians upstream, facilitating learning from outcomes of diagnostic decisions.
Providing prompts	Provide checklists to minimize reliance on memory and directed questioning to aid in diagnostic thoroughness and problem solving.
Providing placeholder for resumption of work	Delineate clearly in the record where clinician should resume work after interruption, preventing lapses in data collection and thought process.
Calculating Bayesian probabilities	Embed calculator into notes to reduce errors and minimize biases in subjective estimation of diagnostic probabilities.
Providing access to information sources	Provide instant access to knowledge resources through context-specific "infobuttons" triggered by keywords in notes that link user to relevant textbooks and guidelines.
Offering second opinion or consultation	Integrate immediate online or telephone access to consultants to answer questions related to referral triage, testing strategies, or definitive diagnostic assessments.
Increasing efficiency	More thoughtful design, workflow integration, and distribution of documentation burden could speed up charting, freeing time for communication and cognition.

The second way in which EHRs can foster thoughtful assessment is by serving as a place where clinicians, together with patients, document succinct evaluations, craft thoughtful differential diagnoses, and note unanswered questions. Free-text narrative will often be superior to point-andclick boilerplate in accurately capturing a patient's history and making assessments, and notes should be designed to include discussion of uncertainties. Documentation of clinicians' thinking must be facilitated by streamlined text-entry tools such as voice recognition. Exam-room layouts, screen placement, and workflow should be redesigned to enable patients and physicians to work together on the same side of the screen. Follow-up questions should be documented in ways that facilitate tracking and sharing with future providers and consultants.

Third, EHR systems should facilitate the documentation of evolving history and ongoing assessment. Rather than requiring a record to start from scratch with each new physician or encounter, electronic notes should follow an evolutionary paradigm- especially for chronic conditions. Putting this strategy into effect will require us to go beyond reflex criticism of copy-andpaste methods to a search for creative approaches - based on functions such as annotation, tracking of changes, and threads - that not only enable information to be carried forward but also allow it to be continuously refined and updated.

Fourth, a better approach to managing problem lists is needed. The failure to effectively integrate the creation, updating, reorganization, and inactivation of items on problem lists into the clinician's workflow has been one of the great failures of clinical informatics. Although such lists are vital for ensuring that important problems are not overlooked, clinicians will not maintain them unless they are made more useful and easier to incorporate into clinical conversations and documentation. Tools for easily reordering these lists and allowing specific providers (for instance, specialists or nonphysician staff members) to work selectively with a subset of problems are necessary features that most current EHRs lack.

Fifth, EHRs should ensure failsafe communication and action in the areas of ordering tests and tracking the results. These steps are central to diagnosis, yet current systems often separate these functions from clinical note taking. Tracking tests is integral to documenting the acknowledgment and assessment of results and the subsequent actions taken and is vital to ensuring that important results don't fall through the cracks. Better tools are needed to efficiently weave results management into EHR documentation and workflow and to link laboratory results to problem lists and medications.

Sixth, electronic systems should incorporate checklist prompts to make sure that key questions are asked and relevant diagnoses considered. Despite renewed interest in safety checklists, diagnostic checklists have so far been neither clinically helpful nor widely used. Yet human memory alone cannot guarantee that key questions will be asked and important diagnoses considered and accurately weighed. Decision-support software and predictive models have also had limited use to date, but both could become important if their design were more practical and evidence-based - if, for example, they automatically generated differential diagnoses that facilitated both documentation and decision making.

Finally, electronic systems should do more to help with follow-up and the systematic oversight of feedback on diagnostic accuracy.5 Clinicians need a reliable, automatic follow-up system that goes beyond the provision of simple, one-size-fits-all instructions to "return in 4 months" or "call if not better." For example, a button embedded in a note might activate automated followup calls after a physician-specified interval. Computerized documentation could also be used to educate patients about symptoms to watch for. Automated feedback that spans patients and providers could convert our current "open-loop" system, in which feedback is often lacking, to one in which outcomes can be used to systematically learn from diagnostic decisions and errors.

Clinicians need to take back ownership of the medical record as a tool for improving patient care; such a move could have many benefits, including reducing the frequency of diagnostic errors. External requirements for EHRs should be minimized, and physicians, members of their support staff, and patients should be engaged in reengineering documentation, with the goal of building a more distributed, reliable, and content-rich yet succinct and efficient system. Diagnosing illness is one of our most important professional responsibilities, and patients justifiably expect us to perform this difficult task well. Electronic documentation represents a pivotal tool that can help us to fulfill this responsibility.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
From the Division of General Internal Medicine, Brigham and Women's Hospital (G.D.S., D.W.B.), Partners HealthCare Information Systems (D.W.B.), Harvard Medical School (G.D.S., D.W.B.), and the Department of Health Policy and Management, Harvard School of Public Health (D.W.B.)- all in Boston.
1. United States Congress. American Recovery and Reinvestment Act of 2009/Division B/Title IV Health Information Technology for Economic and Clinical Health Act. (Accessed March 4, 2010, at https://en.wikisource.org/wiki/American_Recovery_and_Reinvestment_Act_of_2009/Division_B/Title_IV.)
2. Stead WW, Lin HS, eds. Computational technology for effective health care: immediate steps and strategic directions. Washington, DC: National Academies Press, 2009.
3. CRICO Harvard Risk Management Foundation. Diagnosis: 64% of claims from these four high-risk areas. (Accessed March 4, 2010, at https://www.rmf.harvard.edu/high-risk-areas/diagnosis/index.aspx.)
4. Hartzband P, Groopman J. Off the record - avoiding the pitfalls of going electronic. N Engl J Med 2008;358:1656-8.
5. Schiff GD. Minimizing diagnostic error: the importance of follow-up and feedback. Am J Med 2008;121:Suppl:S38-S42.
Copyright 2010 Massachusetts Medical Society.

The New England Journal of Medicine
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Copyright 2010 Massachusetts Medical Society. All rights reserved.

An estimated 85,000 medical lawsuits are filed annually, which include those against hospitals and individual physicians. One of the highly-touted benefits of electronic medical records (EMRs) is the potential to help prevent malpractice incidents and medical errors. By providing better documentation, automatically checking for medication errors and drug interactions, providing failsafe systems to track test results and follow-up with patients, EMRs can dramatically reduce the risk of malpractice.

While the benefits of EMRs are far greater than the cons, no road is without stumbling blocks. A physician who is not careful when using the EMR could increase his malpractice liability.

Some of the possible malpractice risks are shown below.

Too Much Information

Because EMRs allow physicians to document easily, paragraphs of information can be generated with a few keystrokes or even a checkmark. Doctors can describe a comprehensive examination in great detail using predesigned templates. Lists of negative findings can appear, neatly printed, with the push of a button.

This bevy of information may help the physician breeze through an insurance audit; however, all of this information can also create pitfalls.

Pages of repetitive documentation can be more time-consuming to review than brief, handwritten notes. When important information is embedded in paragraphs of boilerplate, it can easily be overlooked. The chance of missing critical data increases.

Overlooking important information is, of course, a significant cause of malpractice. A positive finding embedded in a string of negative findings can easily be missed. To avoid skipping over important information, positive findings must be documented in a way to enable the reader to find them quickly - either by highlighting them or placing them in a separate section of the record.

Wrong Template Can Bollix Up the Chart

EMRs contain different templates for various types of specialists and types of visits. Templates are helpful for documenting repetitive acts. However, inadvertently using the wrong template can cause potential malpractice problems.

For example, when a neurologist reviewed his records of a neurologic examination of a 1-year-old boy, the neurologist, who had just converted to a new EMR system, recorded, among other findings, that the baby boy was oriented as to time, place, and person. Such a test cannot apply to small children. Needless to say, the neurologist used his template for a normal neurologic examination, without considering that some of the language wasn't suitable for a year-old child.

Fortunately the case did not evolve into a malpractice suit. Imagine the difficulty the neurologist would have had trying to defend himself from charges of documenting findings that were not medically possible to ascertain.

Changing the Standard of Care

Offices that don't adopt technology integrating clinical practice, documentation, and billing procedures may face malpractice exposure. Insurers, including Medicare, continue to ramp up their auditing activities. When a doctor's medical record documentation doesn't match CPT codes, demands for huge repayment follow.

Failure to incorporate EMR into a practice may, in the not-too-distant future, be considered a deviation from recognized standards. When an EMR could, arguably, have avoided an adverse result, trial lawyers will be arguing that physicians were obligated to use this new technology. Because EMR systems can catch medication errors and adverse drug interactions, track test results and patient follow-up, and make it far easier for a physician to access and review medical history, failure to embrace it could be problematic.

As the EMR technology becomes pervasive, failure to use it to avoid medical errors may also lead to malpractice claims. It will not be too long before EMR becomes the "standard of care."

Attention to the Patient

Some physicians who do not yet use an EMR have expressed concern that working with an EMR could divert their attention from patient signs and symptoms. They worry that this could potentially lead to a greater malpractice risk. Proper training and ease of use are essential elements of any successful EMR system. Doctors must be sure to have sufficient training and experience using the EMR before widespread implementation. During the initial implementation period, physicians should schedule additional time during office hours to address their use of the EMR, so that inattention and missed symptoms do not occur.

Conclusion

No doctor can ignore the growing pressures to start using an EMR. With the Obama administration avidly promoting healthcare information technology, and tens of thousands of dollars at stake in incentives and future penalties for doctors, more physicians will be implementing EMRs in the coming years. Under the recently passed American Recovery and Reinvestment Act, physicians who demonstrate meaningful use of EMR by 2011 will be eligible for full federal subsidies of up to $44,000. Failure to implement EMR by 2014 may also result in increased malpractice premiums and increased exposure to malpractice claims, as well as a reduction in Medicare reimbursement, beginning in 2015.

As with all other aspects of their practice, doctors need to be careful and vigilant when using an EMR. Although it's inviting to let templates do much of the heavy lifting, physicians need to be cognizant of the information contained within them, and to not blindly follow templates.

Each morning I have pushed to my email a list of the recent Internal Medicine articles from Medscape (WebMD). When I saw the headline about malpractice dangers of the EMR I expected more fuel for my lawyer phobia. However, Steven K. Stern, Esq., a healthcare attorney with offices in five states, made a few good points:

• Too much information: The use of templates can bury positive findings beneath volumes of pre-configured boiler plate and can therefore be more easily overlooked. He suggests that positive findings be highlighted or repeated in a separate section of the note.
• Wrong template: He illustrates the problem with the example of a neurologist who used an adult exam template for an infant. The exam included the statement that the patient was oriented to "time, place, and person" clearly not appropriate verbiage for an infant.
• Changing standard of care: As clinical decision support becomes more sophisticated and more widely implemented will failure to use an EMR become a deviation from recognized standards?
• Attention to the patient: Will the task of utilizing the EMR distract the physician from the real task of attending to signs and symptoms?

Wow, not what I expected from the title. Attorney Kern made very legitimate clinical observations. He suggests vigilance when using the EMR especially if inexperienced or poorly trained. For twenty years I dictated into templates ("physical examination normal, except…"), but I dictated in front of the patient. Not infrequently the patient would correct an addition or omission. I would love to see a study on the accuracy of documentation into EMR templates.

The challenge remains for physician users of the EMR to treat it with the same respect as for any other technical instrument of care. It is also a challenge for designers to make the EMR user friendly and relevant.

Greatness is more than potential. It is the execution of that potential. Beyond the raw talent. You need the appropriate training. You need the discipline. You need the inspiration. You need the drive.

Eric A. Burns, GossamerCommons, 08-12-05