For The Defense, July 2010 - DRI Today

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M E D I C A L L I A B I L I T Y A N D H E A LT H C A R E L A Warticle will use “EHR” as a general term forelectronic charting as used in the HITECHAct.Implementing new health-care relatedinformation- technology processes, however,is complicated further due to themultiplicity of EHR vendor solutions available—over200—and very little in the wayof standards. For years, the EHR field hadThe federal governmentseems to be creatingdemand for EHR systemsthat are certified orotherwise meet thisminimum, “meaningfuluse,” functionality criteria.been the metaphorical Wild West, with fewmandated guidelines about how a productfunctioned, communicated with otherproducts, or secured its data. Certifyingorganizations, such as the CertificationCommission for Healthcare InformationTechnology, endeavored to fill the gap bydeveloping some minimum standardsregarding functionality, security, andinteroperability of EHR systems. Suchefforts were limited—only applying if asoftware vendor sought to voluntarily seekcertification or a purchaser required certification.Also, various health-care relatedinformation- technology organizations,such as the American Health InformationManagement Association, have tried tobridge the gap of best practices related tosoftware implementation and use.In February 2009, the ARRA mandatedthe development of “meaningful use” criteriato ensure minimal functional andsecurity standards in EHR systems. For ahealth care provider to be eligible for stimulusfunds, a provider will have to demonstrate“meaningful use” of an EHR system.The federal government seems to be creatingdemand for EHR systems that are certifiedor otherwise meet this minimum,40 n For The Defense n July 2010“meaningful use,” functionality criteria.On December 30, 2009, the first iterationof the “meaningful use” criteria was published,with further updates from the Centerfor Medicare and Medicaid Servicesto come. The “meaningful use” criteriaoutlined the technological objectives, features,and measures to gauge whether aparticular EHR system qualified under thestatute during Stage I implementation ofthe HITECH Act (2011). The current listincludes objectives such as using computerprovider order entry, drug- allergy checks,and e- prescribing, among many others.The important point about these developingEHR functional standards is thathealth care and medical liability attorneysneed to understand that an EHR system inone practice may not mean or do the samething in another practice. Until you becomefamiliar with the health-care informationtechnologyused in your client’s practice,you can make few assumptions about howa product functions, communicates withother products, or secures protected medicaldata. For that reason, counsel for healthcare providers often find that in defendingmedical liability and health care casesinvolving data stored in an EHR system,it has become increasingly important topartner with clients’ information technologyemployees or consultants to clarify thetechnical issues and interoperability associatedwith the specific software involved.Also, just because a medical office practiceis small, it does not mean that the practicewill employ an unsophisticated EHRsystem. Large institutions may share oreven mandate the use of particular EHRsoftware to best coordinate care amongaffiliated providers. A large institutionlikely chose EHR software that served itsown clinical and economic needs. A smallmedical provider might have adopted a verysophisticated EHR application, possiblywithout having the same level of resourcesto deal with technical problems than youwould expect in a large institution.In any event, it is clear that given healthcare providers’ growing obligations relatedto the use and storage of medical information,choosing the wrong EHR softwaremay create liability issues for our clients.Without technical, EHR- system guidelinesthat have been aligned to comply withhealth care regulations, e- discovery rules,and other laws, this liability will likely persistfor years to come.The Evolving Standards of Carefor Clinical DocumentationThe clinical world is in a state of massivetransition centered on electronicdocumentation. It would be easy to underestimatethis shift, to assume that it simplyinvolves copying existing paper chartingand “translating” it into a legible, electronicform. EHR software does not merelyput printed progress notes onto a computerscreen. It can store a person’s lifetime medicalhistory in one central repository. WithEHR software, a clinician can harvest apatient’s pertinent, clinical history fromprior encounters with other health careproviders and marshal them for presentuse. Critical lab data and vitals can triggerimmediate alerts to a clinician in realtime. EHR software automatically can flagcontraindicated medications, preventinga clinician from even prescribing particularmedicines. An office practice and medicalcenter a hundred miles away from oneanother can instantly share up-to-dateinformation on a mutual patient so that bythe time the patient has traveled from thepractice to the medical center, the medicalcenter has the latest office visit record in thepatient’s chart. Specialists from around theworld can now use health care technologyto collaborate on patient care, which previouslymight have been cost prohibitive.I cannot say enough about the potential,transformative benefits of this technology.More to the point, EHR is simply nota passive tablet on which to record medicaldata. EHR can actively coordinate the datadrawn from clinical care.What effect will health-care informationtechnologyadvances have on the standardsof care for clinical documentation? Anearly Oklahoma state court case, Johnsonv. Hillcrest Health Center, Inc., 70 P.3d 811(Okla. 2003), pondered the same questionseven years ago in a way that illuminatesthe present discussion. The case involveda motion for summary judgment broughtby the defendant, a hospital, in a medicalmalpractice case. The basic claim wasthat the hospital’s employees had negligentlyfailed to chart critical lab results inthe paper clinical record. The twist in thecase was that the information was reported
in the hospital’s electronic health record.Interestingly, the court in the Johnson casesuggested that what the average reasonableperson would conclude was the standardof care for clinical documentation practicesmay have shifted between 1997 and2003 given the then increasing supportand reliance on health-care informationtechnologyin the medical field.The health care industry has progressedmuch farther down the information technologytrack in 2010. This is in large partdue to the economic incentives in the stimulusfunds and exemptions to the Stark Law,which governs Medicare and Medicaid physicianself- referrals. State and federal mandatesmay increasingly prompt informationtechnology reliance, as may economic penaltiesimposed on providers, scheduled tobegin in 2015, for not meaningfully usingEHR systems or other forms of health-careinformation- technologies. Once the mandatedeadlines have come and gone, by theend of this decade, or if most health careproviders and institutions have voluntarilyadopted EHRs for clinical documentation,then failing to use the documentation technologycould conceivably be offered as evidenceof a deviation from the standards ofcare for clinical documentation.It seems the standards of care for clinicaldocumentation may have come full circlesince the Johnson case. In 1997, an averageperson may have found that the standardsof care for clinical documentation requireddocumentation in a paper as opposed toelectronic form. In 2003, the court in Johnsonnoted that due to the emerging use ofEHRs the standard perhaps had shiftedtoward considering computer-based documentationas an equivalent substitute forpaper charting. In 2010, given the advancesin health-care informationtechnology andgeneral reliance on it in the industry, wecertainly are approaching the other end ofthe spectrum, where electronic documentationmay be seen as most crucial.Once we do reach that point, it seemslogical that a liability inquiry will turnto how information technology has beenused by clinicians and whether that useitself comports with the standard of carefor maintaining and using medical records.Although actual case law may not exist onthese nitty- gritty, technical- clinical issuesat present, a great deal of ink has been spenton the risk management and health informationmanagement to describe the dangersof using templates, or copying andpasting information into an her system,providers sharing logins, providers modifyingor deleting electronic entries afterthe fact of treatment, and other user- relatedissues. For the most part, juries may end updeciding what sorts of EHR practices constitutereasonable, clinical standards ofcare for clinical documentation.The EHR as the Clinical“Source of Truth”Health care institutions do not operate inan entirely paper or electronic existence.Inevitable paper processes still persist inevery hospital system in the country. Mosthealth care institutions employ a hybridmodel in which both electronic and paperprocesses coexist. Making sure that healthcare providers query the correct electronicand paper sources to locate all necessaryclinical information certainly is challenging.Unfortunately, health care institutionsoften have and maintain more than twoconcurrent sources of medical information.Both systemic and user-based challengesmay prevent a clinician from accessing therelevant patient data when needed.System ErrorIf choosing an EHR software from the hundredsof vendors, which may or may notcomply with the various legal obligationsplaced on a provider, is itself a liability concern,then imagine a modern health careinstitution that maintains several EHR systems.For example, an Emergency Departmentmay have a unique system, Labor& Delivery another, and Radiology yetanother. Given the multiplicity of systems,it may take a great deal of technical effortto ensure that medical data in an electronicchart provides a uniform, “source oftruth” about a patient that all practitionerscan rely on in life or death medical situations.When technical means cannot cen-For The Defense n July 2010 n 41
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