Princess Health and HIMSS 2016 Presentation: Plaintiff's Lawyers Are The Cause of EHR Problems. They're Using Pristine, White-as-the-Blowing-Snow EHRs as "An Opportunity for Litigation". Princessiccia
evidence spoliation Greg Goth healthcare IT evidentiary issues Healthcare IT News healthcare IT risk Mary Re Knack Ogden Murphy Wallace Reed GelzerIn perhaps the most ill-informed, perverse rationalization/defense of bad health IT I've seen to date, the following appeared in an article about an upcoming HIMSS presentation (Healthcare Information and Management Systems Society's health IT mega-industry trade show, http://www.himssconference.org).
I remind readers of the definition of bad health IT coined by myself and Australian polymath/informatics scientist Dr. Jon Patrick in 2012, as at my Drexel University College of Computing and Informatics website "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/:
To this definition I should add "that does not support evidentiary trustworthiness."
The article tries to make the case that Plaintiff's lawyers are "targeting" the innocent EHR:
The article continues:
A group of colluding plaintiff's lawyers "see the medical record as an opportunity for litigation?" This statement appears to say, in the words of a colleague, "it's those $%$%# plaintiff's attorneys again, preying on our worthy docs and hospitals and their good intentions with HIT for the nation's good."
Ms. Knack seems to veer in the direction of the Defense side as at http://www.omwlaw.com/seattle-attorneys/m-re-knack/:
The reality in my direct experience is different. Starting after the EHR-related injury and demise of my mother in 2010, I began lending my medical informatics expertise to lawyers as an Independent Expert Witness towards deciphering and authenticating the legible gibberish that often passes for "medical records." In working with and speaking at national meetings to Plaintiff's lawyers at their invitation, I find that the only thing plaintiff's lawyers see EHRs as is a badly-designed tool that causes or contributes to medical malpractice itself by disrupting doctors and nurses, and befuddles any reader, attorney or clinician, regarding the true course of clinical events.
They see, in my experience, bad health IT not as an "opportunity for litigation", but as an impediment to knowing the facts of the case, and a cause of unnecessary patient harm.
(In fact, in late 2014 I spoke to U.S. House members at the Capitol on just those issues, accompanied by several Plaintiff's attorneys who'd seen horrible patient harms as a result of bad health IT, begging the congresspeople to investigate and take action.)
An early quote in the article is, I'm sure, an inadvertent but an outright condemnation of the health IT industry:
It's bad enough that EHR vendors did not build the software with clinicians and clinical care in mind, resulting in a Complaint Letter from almost 40 medical societies to HHS one year ago (see my Jan. 28, 2015 post "'Meaningful Use' not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html, which contains a link to the aforementioned medical societies letter).
Ms. Knack now avers that EHR vendors did not build the software with adequate due diligence towards evidentiary/litigation matters.
In other words, the software is not designed to produce court-ready records that can be easily shown to be complete, free from alteration, and trustworthy in order to meet the business record exception to hearsay (Also known as the Business Entry Rule, this exception to the evidentiary rule, which excludes hearsay from a trial, allows business records to be admitted if the proper foundation is laid to show the document is reliable, https://www.law.cornell.edu/wex/business_records_exception).
I take great issue with the declaration that such evidentiary faults were incorporated "quite naturally" by the vendors. It's not like medical malpractice is a State Secret, and the need for records trustworthiness kept under cover by the National Security Agency.
I thus feel compelled to correct Ms. Knack's statement to read as follows:
Next:
In fact, the arrangement of data on the screens is often very, very bad in terms of understanding the patient (e.g., see my Dec. 6, 2013 post "EHR Pastel Madness: Cognitive Overload in Critical Care" at http://hcrenewal.blogspot.com/2013/12/ehr-pastel-madness-cognitive-overload.html). Usability of most commercial EHRs leaves much to be desired, and that does not involve paper printouts.
That said, I do agree with Ms. Knack that paper printouts - the reams and reams that come out of these systems even after short hospitalizations - are often informationally cryptic, sloppy, filled with distracting irrelevancy, and tiring to use. See my Feb. 27, 2011 post "Electronic Medical Records: Two Weeks, Two Reams" at http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html for instance. (Indeed, my own mother's thousands of pages are a nightmare, even for me who trained in the paper days at the very hospital in which those records were generated, was there almost every day observing events of my mother's care in 2010-11, and who is a Medical Informatics specialist).
This raises the following questions:
(Note, an anecdote regarding the health IT Industry in the U.S.: the cardiology information system I developed, linked to above in the 2nd bullet point, was seen in 2000 by German engineers at Siemens Healthcare Erlangen as exemplary, and they offered me a position to further develop it, that I declined due to a simultaneous superior offer from Merck Research Labs. However, in 2007 when I again spoke to Siemens, this time to Americans at the former Shared Medical Systems in Malvern, PA that had been acquired by Siemens, they found a system that actually produced clear, detailed outputs in a critical care area and was in use at the time in a major healthcare system in the region "impractical" - and never followed up with me. Pearls before....)
Making matters far worse for the EHR sellers and those who actually bought and implemented these cybernetic behemoths, the issues of record evidentiary fitness do not just concern litigation. That's just the tip of the iceberg:
A colleague, EHR/HIT Systems and Policy Analyst Dr. Reed Gelzer (https://www.linkedin.com/in/reed-gelzer-4410899) also points out that:
A cavalier approach to evidentiary fitness thus is a gargantuan, bull-in-a-china-shop intrusion of information technology medical amateurs into the clinical setting. The harm that is/will be caused goes far beyond the trial court.
Then this:
In other words, Plaintiffs lawyers get a pile of evidentiary crap that is, in fact, often confusing (even to a Medical Informatics specialist/physician such as myself), and, evil upon evil, they question whether there's been any alteration or withholding of an alterable electronic record under sole control of the defendant, to prejudice plaintiffs and advantage defendant.
Medical record alteration is, unfortunately, not that uncommon. See the search https://www.google.com/search?q=medical+record+alteration&ie=utf-8&oe=utf-8, for instance.
EHRs have a huge vulnerability in that regard. Plaintiff attorneys are rightly being diligent in questioning the trustworthiness of records. As it is legally incumbent upon the producer of records to prove they are what they purport to be, and since hospitals and medical professionals have an inherent conflict of interest in producing records that could damage their defense regarding malpractice, in my view the Courts should be as diligent as well before allowing records to be admitted as trustworthy business records.
Last quote from the article:
No, in reality they (rightly) have to defend their decisions to acquire, implement, and fail to remediate bad health IT that produces crap outputs.
More on evidentiary issues below. First, an aside. It seems to me - if one wants to speak about liability, aside from medical malpractice - that there's significant grounds for product liability lawsuits regarding these IT systems being unfit for purpose, as well as corporate liability for failure of officers with a fiduciary responsibility to perform due diligence on these critical medical records apparatuses.
Further, if the printouts are bad compared to the screens, then it seems incumbent on hospitals to produce for legal and clinical purposes the actual screens. Ultra-clear screenshots can be accomplished with ordinary off-the-shelf cellphones and no special conditions, as in the example I just took, unaltered, of the screen I am composing this essay on:
Let's get down to the real problems with EHRs and evidentiary issues.
It's not "certain plaintiffs' lawyers � a kind of group of them who communicate with each other � seeing the medical record as an opportunity for litigation."
It's negligent and opportunistic EHR vendors, complacent hospital officers, and a legislative and justice system that needs education as to clinical and evidentiary problems caused by the prior two groups.
Here's more on the true problems:
Electronic medical records (EMRs or EHR, for electronic health record) came about as a result of a belief by pioneers in the field of Medical Informatics at organizations such as Harvard, the University of Utah, and others, as early as the 1950�s, that computers could streamline storage and retrieval of needed medical information, help standardize the language used in medical record-keeping (thus helping the accuracy and portability of records), provide automated computer-generated alerts and reminders, and solve the issue of illegible handwriting.
The term �EMR� itself is an anachronism. EMR systems today are no longer just electronic filing systems replacing the paper chart, as they were early in their development. They are now integrated systems for order entry, results reporting, alerts and reminders, etc. They are now, in effect, enterprise clinical resource �nervous systems� for control of the clinical activities of a hospital or clinic. All transactions related to care must increasingly pass through EMR systems as an intermediary between clinicians and patients. The records of such transactions are increasingly only in electronic form.
Importantly, EMR technology is not regulated in any meaningful way, as is IT in other sectors, such as the pharmaceutical industry (where the FDA provides regulation of quality and security of systems used to store and manipulate clinical trial data and drug manufacturing), the aviation industry (where the FAA regulates safety and testing to assure freedom from potentially catastrophic malfunctions), and other mission critical sectors of industry.
There is no regulatory pre-market or postmarket surveillance of EMR systems in place regarding reliability, safety, information security and other areas as there is in other healthcare sectors, and efforts to have such regulation initiated by the FDA and others have been resisted by the health IT industry.
Some examples of EMR hazards can be found in the article �E-Health Hazards: Provider Liability and Electronic Health Record Systems� by attorney Sharona Hoffman & engineer Andrew Podgurski, Case Western University (freely available at http://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=1813&context=btlj).
Without regulation of EMRs, critical issues have been neglected, such as the optimal presentation and understandability by doctors and nurses of EMR outputs (often created using templates, checklists, menus etc. of various kinds) and of the need for assurance that information in EMR systems is complete unaltered, and trustworthy.
Critically, the electronic record is a malleable and ephemeral record of events, backed up by an equally malleable and ephemeral electronic audit trail, both under the sole control of a defendant hospital or clinic.
--------------------------------------------------------
The largest problem I've seen in Discovery is hospital and defense resistance towards production of the one item in electronic records that can allay legitimate concerns about withholding or alteration (and I say "can" because the industry has also been negligent in audit trail implementation and security): the audit trail.
An audit trail (sometimes called an audit log) is an automatically generated accounting of who accessed an electronic record, when, and the actions they took, such as document creation, alteration or deletion.
An audit trail is the only way to authenticate electronic medical records as complete, free from alteration, and trustworthy. An audit trail is akin to a banking statement, but instead of tracking monetary deposits, withdrawals and other financial changes, it tracks deposits, withdrawals and changes to clinical medical information. Without an audit log, the record is not authenticatable as complete and free from alteration. Absence of an audit log would leave the electronic medical record subject to undetectable tampering or selective information withholding. Its production is essential for evidentiary purposes, without exception.
Audit logs track changes within a record chronologically by capturing data elements, such as date, time, and user stamps, for each update to an EHR. An audit log can be used to analyze historical patterns that can identify data inconsistencies.
EMRs are vulnerable to manipulation. Electronic data are not tangible. Electronic data are invisible bits of data on some electronic storage media such as magnetic disk. As such, data can be manipulated on that media. Detection of omissions, erasures, and alterations that would characterize tampering with paper records is not available with printouts of electronic medical records. The audit trail replaces those visual cues.
The only way to tell if electronic records have been altered or partially withheld is via an electronic audit trail that can track creation of, and changes to, the record content.
Literature supports the necessity of reviewing an audit trail to ensure a complete medical record.
From "ELECTRONIC HEALTH RECORDS SYSTEMS: TESTING THE LIMITS OF DIGITAL RECORDS� RELIABILITY AND TRUST", Drury, Gelzer, and Patricia Trites, Ave Maria Law Review, Summer 2014, pg. 263, free at http://lr.avemarialaw.edu/Content/articles/v12i2.Gelzer.pdf:
(See my Dec. 10, 2013 post "44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html for more on the latter point and the referenced OIG report.)
In summary, it sounds like HIMSS attendees are going to hear a misdirecting presentation from, what appears to me, apologists for gross EHR defects due to industry and hospital negligence, with the blame being shifted to a patient's only hope for fair addressing of malpractice - the Plaintiff's Bar.
I consider this disappointing.
Finally, not all counsel on the defense side take anti patient-rights stances on these matters. While I don't agree with everything in it, and have some points of significant disagreement, I've found the 2014 book "Electronic Medical Records and Litigation" by attorney Matthew Keris of defense firm Marshall Dennehey Warner Coleman Goggin useful. I think there's realistic acknowledgement in the book of the ill effects of bad health IT, without internecine barrister-barrister attacks.
Finally, I am an independent expert witness in healthcare informatics, meaning I will work with defense when the facts and evidence merit. In my presentations to lawyers, I include slides geared to defense. In part these slides advise defense counsel that through their efforts in advising their clients, they hold the key, through advice rendered, to the prevention of bad health IT from ever seeing the light of day in hospitals, and thus from causing or contributing to medical malpractice, patient harm and death, and evidentiary mayhem.
I wish more of that advice-giving would occur.
-- SS
I remind readers of the definition of bad health IT coined by myself and Australian polymath/informatics scientist Dr. Jon Patrick in 2012, as at my Drexel University College of Computing and Informatics website "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/:
Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.
To this definition I should add "that does not support evidentiary trustworthiness."
The article tries to make the case that Plaintiff's lawyers are "targeting" the innocent EHR:
Amid surge in malpractice lawsuits, EHRs often targeted in litigation, attorney says
Healthcare IT News, Feb. 4, 2016
Greg Goth
http://www.healthcareitnews.com/news/amid-surge-malpractice-lawsuits-ehrs-often-targeted-litigation-attorney-says
Byline: Providers often wind up defending their electronic health records, rather than what got them sued in the first place, Mary Re Knack will explain at HIMSS16
The article continues:
As if healthcare executives don't have enough worries about implementing electronic health records, yet another issue is starting to ramp up.
"What's been happening more frequently in the last few years is that certain plaintiffs' lawyers � a kind of group of them who communicate with each other � have started to see the medical record as an opportunity for litigation," said Mary Re Knack, a Seattle-based attorney for the firm Ogden Murphy Wallace.
Knack will be presenting an exploration of these emerging litigation troubles in the session "Just Press Print: Challenges in Producing EHRs in Litigation" with colleague Elana R. Zana at HIMSS16, beginning in late February.
A group of colluding plaintiff's lawyers "see the medical record as an opportunity for litigation?" This statement appears to say, in the words of a colleague, "it's those $%$%# plaintiff's attorneys again, preying on our worthy docs and hospitals and their good intentions with HIT for the nation's good."
Ms. Knack seems to veer in the direction of the Defense side as at http://www.omwlaw.com/seattle-attorneys/m-re-knack/:
Ms. Knack is a member of the Healthcare and Litigation Departments. Her practice focuses on healthcare, insurance, product liability, mass tort, and civil matters. Ms. Knack provides a wide range of legal services to members of the healthcare industry including negotiating and structuring arrangements, business, regulatory, confidentiality and privacy-related compliance services including HIPAA and state laws, licensing and risk management related services, and related investigations.
The reality in my direct experience is different. Starting after the EHR-related injury and demise of my mother in 2010, I began lending my medical informatics expertise to lawyers as an Independent Expert Witness towards deciphering and authenticating the legible gibberish that often passes for "medical records." In working with and speaking at national meetings to Plaintiff's lawyers at their invitation, I find that the only thing plaintiff's lawyers see EHRs as is a badly-designed tool that causes or contributes to medical malpractice itself by disrupting doctors and nurses, and befuddles any reader, attorney or clinician, regarding the true course of clinical events.
They see, in my experience, bad health IT not as an "opportunity for litigation", but as an impediment to knowing the facts of the case, and a cause of unnecessary patient harm.
(In fact, in late 2014 I spoke to U.S. House members at the Capitol on just those issues, accompanied by several Plaintiff's attorneys who'd seen horrible patient harms as a result of bad health IT, begging the congresspeople to investigate and take action.)
An early quote in the article is, I'm sure, an inadvertent but an outright condemnation of the health IT industry:
Electronic health record design is paramount among those issues, Knack said, because EHR vendors quite naturally did not build the software with litigation in mind.
It's bad enough that EHR vendors did not build the software with clinicians and clinical care in mind, resulting in a Complaint Letter from almost 40 medical societies to HHS one year ago (see my Jan. 28, 2015 post "'Meaningful Use' not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html, which contains a link to the aforementioned medical societies letter).
Ms. Knack now avers that EHR vendors did not build the software with adequate due diligence towards evidentiary/litigation matters.
In other words, the software is not designed to produce court-ready records that can be easily shown to be complete, free from alteration, and trustworthy in order to meet the business record exception to hearsay (Also known as the Business Entry Rule, this exception to the evidentiary rule, which excludes hearsay from a trial, allows business records to be admitted if the proper foundation is laid to show the document is reliable, https://www.law.cornell.edu/wex/business_records_exception).
I take great issue with the declaration that such evidentiary faults were incorporated "quite naturally" by the vendors. It's not like medical malpractice is a State Secret, and the need for records trustworthiness kept under cover by the National Security Agency.
I thus feel compelled to correct Ms. Knack's statement to read as follows:
Electronic health record design is paramount among those issues, Knack said, because EHR vendors quite negligently did not build the software with litigation in mind.
Next:
"The data is all stored behind these templates, and depending on what you are trying to look at, whether it's a summary or lab reports or such, the data then populates the template on a screen. But when you print it, it doesn't print out as cleanly or as nicely,� Knack said.
In fact, the arrangement of data on the screens is often very, very bad in terms of understanding the patient (e.g., see my Dec. 6, 2013 post "EHR Pastel Madness: Cognitive Overload in Critical Care" at http://hcrenewal.blogspot.com/2013/12/ehr-pastel-madness-cognitive-overload.html). Usability of most commercial EHRs leaves much to be desired, and that does not involve paper printouts.
That said, I do agree with Ms. Knack that paper printouts - the reams and reams that come out of these systems even after short hospitalizations - are often informationally cryptic, sloppy, filled with distracting irrelevancy, and tiring to use. See my Feb. 27, 2011 post "Electronic Medical Records: Two Weeks, Two Reams" at http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html for instance. (Indeed, my own mother's thousands of pages are a nightmare, even for me who trained in the paper days at the very hospital in which those records were generated, was there almost every day observing events of my mother's care in 2010-11, and who is a Medical Informatics specialist).
This raises the following questions:
- Why doesn't that paper "print out as cleanly or nicely" as the (already problematic) screens?
- Who designed the systems this way? Again in my own experience as a developer and CMIO, it is not hard to produce quality output, see for instance my report at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story
- Who approved the purchase of these systems whose paper output is not "clear and nice"? It's not as if hospitals don't have HIM medical record experts, legal counsel, and others to have demanded better;
- Who implemented the systems as such?
- Who complacently leaves them in the condition of producing bad paper printouts?
(Note, an anecdote regarding the health IT Industry in the U.S.: the cardiology information system I developed, linked to above in the 2nd bullet point, was seen in 2000 by German engineers at Siemens Healthcare Erlangen as exemplary, and they offered me a position to further develop it, that I declined due to a simultaneous superior offer from Merck Research Labs. However, in 2007 when I again spoke to Siemens, this time to Americans at the former Shared Medical Systems in Malvern, PA that had been acquired by Siemens, they found a system that actually produced clear, detailed outputs in a critical care area and was in use at the time in a major healthcare system in the region "impractical" - and never followed up with me. Pearls before....)
Making matters far worse for the EHR sellers and those who actually bought and implemented these cybernetic behemoths, the issues of record evidentiary fitness do not just concern litigation. That's just the tip of the iceberg:
A colleague, EHR/HIT Systems and Policy Analyst Dr. Reed Gelzer (https://www.linkedin.com/in/reed-gelzer-4410899) also points out that:
Records management fitness is required also for:
1. Accurate clinical quality measures
2. Regulatory reporting
3. Alternate payment model services reporting
4. Release of Information for business associates of all kinds, including transitions of care
5. Valuation of clinical organizations in mergers and acquisitions
6. Data quality assurance for each and every potential end-use of clinical information that is dependent on narrative notes (all forms of workload coding/RVUs, episode-of-care costing, etc.)
7. Risk Management of all types, not just medmal. (Including D&O - Directors & Officers - as well as the secondary and re-insurers)
A cavalier approach to evidentiary fitness thus is a gargantuan, bull-in-a-china-shop intrusion of information technology medical amateurs into the clinical setting. The harm that is/will be caused goes far beyond the trial court.
Then this:
... One of these obvious challenges in trying to review somebody's care is how do you see it? How do you even read what the care was? Who did what? And when?
"You may have a case that's very straightforward medical malpractice, but because of the way the medical records get printed out, the same piece of data may appear in five places. Somebody who looks at it, whose goal is to show how it's confusing, can then start to challenge the care that was given based on the fact the medical record is confusing,� Knack explained. �They can take another step, and that is questioning whether the data in the medical record is accurate or if it has been changed."
In other words, Plaintiffs lawyers get a pile of evidentiary crap that is, in fact, often confusing (even to a Medical Informatics specialist/physician such as myself), and, evil upon evil, they question whether there's been any alteration or withholding of an alterable electronic record under sole control of the defendant, to prejudice plaintiffs and advantage defendant.
Medical record alteration is, unfortunately, not that uncommon. See the search https://www.google.com/search?q=medical+record+alteration&ie=utf-8&oe=utf-8, for instance.
EHRs have a huge vulnerability in that regard. Plaintiff attorneys are rightly being diligent in questioning the trustworthiness of records. As it is legally incumbent upon the producer of records to prove they are what they purport to be, and since hospitals and medical professionals have an inherent conflict of interest in producing records that could damage their defense regarding malpractice, in my view the Courts should be as diligent as well before allowing records to be admitted as trustworthy business records.
Last quote from the article:
... As a result, Knack said, a healthcare provider can find itself in litigation that is ostensibly about the care provided, when in actuality that organization has to "defend how the medical record works."
No, in reality they (rightly) have to defend their decisions to acquire, implement, and fail to remediate bad health IT that produces crap outputs.
More on evidentiary issues below. First, an aside. It seems to me - if one wants to speak about liability, aside from medical malpractice - that there's significant grounds for product liability lawsuits regarding these IT systems being unfit for purpose, as well as corporate liability for failure of officers with a fiduciary responsibility to perform due diligence on these critical medical records apparatuses.
Further, if the printouts are bad compared to the screens, then it seems incumbent on hospitals to produce for legal and clinical purposes the actual screens. Ultra-clear screenshots can be accomplished with ordinary off-the-shelf cellphones and no special conditions, as in the example I just took, unaltered, of the screen I am composing this essay on:
 | ||||
| Cellphone screenshot: Click to enlarge |
Let's get down to the real problems with EHRs and evidentiary issues.
It's not "certain plaintiffs' lawyers � a kind of group of them who communicate with each other � seeing the medical record as an opportunity for litigation."
It's negligent and opportunistic EHR vendors, complacent hospital officers, and a legislative and justice system that needs education as to clinical and evidentiary problems caused by the prior two groups.
Here's more on the true problems:
Electronic medical records (EMRs or EHR, for electronic health record) came about as a result of a belief by pioneers in the field of Medical Informatics at organizations such as Harvard, the University of Utah, and others, as early as the 1950�s, that computers could streamline storage and retrieval of needed medical information, help standardize the language used in medical record-keeping (thus helping the accuracy and portability of records), provide automated computer-generated alerts and reminders, and solve the issue of illegible handwriting.
The term �EMR� itself is an anachronism. EMR systems today are no longer just electronic filing systems replacing the paper chart, as they were early in their development. They are now integrated systems for order entry, results reporting, alerts and reminders, etc. They are now, in effect, enterprise clinical resource �nervous systems� for control of the clinical activities of a hospital or clinic. All transactions related to care must increasingly pass through EMR systems as an intermediary between clinicians and patients. The records of such transactions are increasingly only in electronic form.
Importantly, EMR technology is not regulated in any meaningful way, as is IT in other sectors, such as the pharmaceutical industry (where the FDA provides regulation of quality and security of systems used to store and manipulate clinical trial data and drug manufacturing), the aviation industry (where the FAA regulates safety and testing to assure freedom from potentially catastrophic malfunctions), and other mission critical sectors of industry.
There is no regulatory pre-market or postmarket surveillance of EMR systems in place regarding reliability, safety, information security and other areas as there is in other healthcare sectors, and efforts to have such regulation initiated by the FDA and others have been resisted by the health IT industry.
Some examples of EMR hazards can be found in the article �E-Health Hazards: Provider Liability and Electronic Health Record Systems� by attorney Sharona Hoffman & engineer Andrew Podgurski, Case Western University (freely available at http://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=1813&context=btlj).
Without regulation of EMRs, critical issues have been neglected, such as the optimal presentation and understandability by doctors and nurses of EMR outputs (often created using templates, checklists, menus etc. of various kinds) and of the need for assurance that information in EMR systems is complete unaltered, and trustworthy.
Critically, the electronic record is a malleable and ephemeral record of events, backed up by an equally malleable and ephemeral electronic audit trail, both under the sole control of a defendant hospital or clinic.
--------------------------------------------------------
The largest problem I've seen in Discovery is hospital and defense resistance towards production of the one item in electronic records that can allay legitimate concerns about withholding or alteration (and I say "can" because the industry has also been negligent in audit trail implementation and security): the audit trail.
An audit trail (sometimes called an audit log) is an automatically generated accounting of who accessed an electronic record, when, and the actions they took, such as document creation, alteration or deletion.
An audit trail is the only way to authenticate electronic medical records as complete, free from alteration, and trustworthy. An audit trail is akin to a banking statement, but instead of tracking monetary deposits, withdrawals and other financial changes, it tracks deposits, withdrawals and changes to clinical medical information. Without an audit log, the record is not authenticatable as complete and free from alteration. Absence of an audit log would leave the electronic medical record subject to undetectable tampering or selective information withholding. Its production is essential for evidentiary purposes, without exception.
Audit logs track changes within a record chronologically by capturing data elements, such as date, time, and user stamps, for each update to an EHR. An audit log can be used to analyze historical patterns that can identify data inconsistencies.
EMRs are vulnerable to manipulation. Electronic data are not tangible. Electronic data are invisible bits of data on some electronic storage media such as magnetic disk. As such, data can be manipulated on that media. Detection of omissions, erasures, and alterations that would characterize tampering with paper records is not available with printouts of electronic medical records. The audit trail replaces those visual cues.
The only way to tell if electronic records have been altered or partially withheld is via an electronic audit trail that can track creation of, and changes to, the record content.
Literature supports the necessity of reviewing an audit trail to ensure a complete medical record.
From "ELECTRONIC HEALTH RECORDS SYSTEMS: TESTING THE LIMITS OF DIGITAL RECORDS� RELIABILITY AND TRUST", Drury, Gelzer, and Patricia Trites, Ave Maria Law Review, Summer 2014, pg. 263, free at http://lr.avemarialaw.edu/Content/articles/v12i2.Gelzer.pdf:
... EHRs can be designed, configured, implemented, and used to render false representations in the course of �regular business.� This, then, is a principal distinguishing aspect of EHRs that tests the boundaries of current evidentiary procedures that presume their reliability and trustworthiness is no worse than other records management systems. In their current unregulated, non-standardized states where the current primary market drivers of their use exclude prior inspection against long-standing records management requirements, they illustrate the necessity of scrutiny of all outputs produced for rendering into legal proceedings. This necessity arises not simply from substantial possibility of legally dubious record management processes, but also the possibility that reliability supports, such as audit trails and near and long-term records management functions, may themselves be missing, difficult to use, or of uncertain veracity as verified by the OIG [Dept. of Health and Human Services, Office of Inspector General] survey.
(See my Dec. 10, 2013 post "44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html for more on the latter point and the referenced OIG report.)
In summary, it sounds like HIMSS attendees are going to hear a misdirecting presentation from, what appears to me, apologists for gross EHR defects due to industry and hospital negligence, with the blame being shifted to a patient's only hope for fair addressing of malpractice - the Plaintiff's Bar.
I consider this disappointing.
Finally, not all counsel on the defense side take anti patient-rights stances on these matters. While I don't agree with everything in it, and have some points of significant disagreement, I've found the 2014 book "Electronic Medical Records and Litigation" by attorney Matthew Keris of defense firm Marshall Dennehey Warner Coleman Goggin useful. I think there's realistic acknowledgement in the book of the ill effects of bad health IT, without internecine barrister-barrister attacks.
Finally, I am an independent expert witness in healthcare informatics, meaning I will work with defense when the facts and evidence merit. In my presentations to lawyers, I include slides geared to defense. In part these slides advise defense counsel that through their efforts in advising their clients, they hold the key, through advice rendered, to the prevention of bad health IT from ever seeing the light of day in hospitals, and thus from causing or contributing to medical malpractice, patient harm and death, and evidentiary mayhem.
I wish more of that advice-giving would occur.
-- SS
