Informed consent prior to a procedure should be documented in the patients chart and visible on an audit trail.
by Dr. Aikaterina Assimacopoulos
Informed consent is a must prior to any elective procedure. After all risks, benefits and alternatives (r/b/a’s) are thoroughly explained consent can be given. An informed patient is one who understands the nature and purpose of the procedure as well as postoperative expectations of pain, recovery time, need for physical therapy, and any changes to physical appearance. Signed consent should be found in the patients EMR.
Informed Risk Assessment
Common surgical risks include the risk of infection, bleeding or damage to surrounding organs. If a minimally invasive approach is planned, the possibility to convert to an open procedure should be discussed. If the patient is to have an exploratory surgery, a risk is the possibility that nothing is found on exploration. In some cases, there is a potential the surgeon recognizes additional measures must be taken upon viewing the patient’s anatomy. In these cases, the surgeon is usually aware of this potential and should obtain consent and discuss r/b/a’s.
The benefit or likelihood of a positive outcome should be clearly and realistically defined. The patient should be aware of any alternative options and their r/b/a’s. This includes both more conservative methods of treatment such as medications, physical therapy, or injections as well as any alternative surgical approaches that may vary in method or invasiveness. For example, a vaginal vs. abdominal approach to hysterectomy or LINX vs. Nissen fundoplication methods for gastroesophageal reflux.
A signed consent form and statement should be uploaded in the chart. For example, “r/b/a’s discussed, patient expressed understanding, all questions asked and answered” should be documented in the chart. However, this does not necessarily mean the patient was properly informed. Often this statement is included as part of a provider’s template, without being consciously documented. Therefore, this raises the question of whether or not the conversation actually took place.
Because this discussion is verbal, it is difficult to use an audit trail to prove whether appropriate informed consent was obtained. However, an audit trail can be used to analyze other aspects of preoperative care which, if deficient, or incomplete, could support the notion informed consent was deficient as well.
What to look for in an audit trail
If surgical complications arose and the physician was concerned about the preoperative care provided, the physician could enter the patient chart after the fact and make additions to the patient’s chart. This is why it is necessary to get an audit trail that extends through the date the EMR is generated. Providers can alter a patients EMR at any time. These changes might not be visible on the EMR but will be on the audit trail.
In most cases, evidence of the following actions should exist in both the printed patient chart and the audit trail:
A clinic visit in which the patient’s need for surgery is assessed.
Any attempt to manage symptoms with more conservative first-line measures. For example, prescription orders or referrals to physical therapy or a pain specialist.
A diagnosis made prior to surgery and added to the patient’s problem list.
In some cases, evaluation of the patient’s personal risk due to any comorbid conditions is done using a ‘risk calculator’ and results should be documented.
A preoperative physical/assessment for higher risk patients.
A complete history and physical note (H&P) within the 30 days prior to surgery.
Procedure-specific labs and imaging which should be viewed by the surgeon prior to surgery.
Judge James O’Hara writes order in full support of the law to release all of patients audit trail information to them. This was in response to the case of Angela Prieto vs. Rush University Medical Center in Chicago.
Cook County Circuit Court Judge James N. O’Hara wrote a Memorandum Order for the case of Angela Prieto vs. Rush University Medical Center (“RUMC”) and other defendants. The 23-page order highlights some important federal statutes, such as HIPAA and the HITECH Act. This established a legal basis for a plaintiff to receive their complete electronic medical record. Judge O’Hara implements a severe sanction that effectively was a default judgement leaving only the dollar amount of financial award to be determined by the jury.
Plaintiff, Angela Prieto, on behalf of her son alleged that RUMC “negligently caused [her son] to suffer from hypoxic ischemic encephalopathy and respiratory distress syndrome during birth.” The case was originally filed in 2018. The request for production of electronic health records was originally filed in January of 2019. Plaintiff requested RUMC to produce the complete and unaltered EMR and audit trail. As of January 2022, there were three repeated requests from Prieto for RUMC to produce the complete EMR audit trail.
Audit Trails in EMR
The use of Electronic Medical Records (“EMR”) also known as Electronic Health Records (“EHR”) is mandatory to comply with requirements that health care providers maintain electronic medical records for patients. Every hospital, doctors office, or any medical practice in the United States must be compliant. The transition to using EMR began in 1992. Electronic medical records became mandatory since the start of 2014 through the American Recovery and Reinvestment Act.
All EMR systems are required by federal law to have an audit trail system built in. Audit trails show any deletions or edits that may not be part of the finalized medical record. A complete EMR audit trail shows all entry, access or modifications made to a patient’s chart. EMR audit trail productions should include all available records from the initial patient encounter until the date of production.
Audit Trail Manipulation
Health care providers often limit their production of audit trail records to the date the patient left the health care facility. However, this practice is problematic. When a patient’s EMR is modified after a Plaintiff files litigation and requests their complete EMR with audit trail records, manipulation of the Plaintiff’s medical records after that date can’t be detected. It is a common practice for healthcare providers to only produce the finalized patient EMR chart. This omits the revision history, a clear indicator of when the patient’s EMR was modified, by whom, from where, what time, and the specific redline changes that were made, as is required by any HIPAA compliant EMR system.
Electronic Health Records and EMR revision history must be retained by any HIPAA compliant EMR software system.
As Judge O’Hara put it in his order, “The term ‘Audit Trail’ refers to the part of the patient’s EHR that displays any person logging in to the record to modify the record, correct the record, add to the record, alter the record, revise the record, complete the record, put finishing touches on the record, and any other entry or access into the medical record, or any other name synonymous with the reflection of who, when and what a person did in relation to the Electronic Health Record.”
Request for ‘a complete, unaltered EHR Audit Trail’
He went on to discuss the EMR audit trail request in this specific case stating, “…requests asked for ‘a complete, unaltered EHR’…Prieto also requested ‘a complete, unaltered Audit Trail… in native format.’” This is a typical wording of requests for EHR or EMR Audit Trails that many healthcare providers fail to produce the first time. Instead, healthcare providers often send incomplete audit trails filtering out certain information.
…inspection revealed many aspects of the audit trail and EHR discovery that were either withheld, misrepresented or otherwise not produced…
Judge James O’Hara
When the Defendant in this case failed to produce the Plaintiff’s complete electronic medical records, including a complete audit trail and EMR revision history as requested, Judge O’Hara granted “a motion for in camera, on-site inspection of the auditing systems at RUMC…” Judge O’Hara actually attended the onsite inspection himself. The date for the on-site inspection with the judge was set and O’Hara wrote of it, “…inspection revealed many aspects of the audit trail and EHR discovery that were either withheld, misrepresented, or otherwise not produced…”
Federal Laws Pertaining to EHR Audit Trail Production
Judge O’Hara listed the federal law governing audit trails. “Congress enacted the Health Insurance Portability and Accountability Act (“HIPAA”) to ‘improve the efficiency and effectiveness of the health care system, by encouraging the development of a health information system through the establishment of standards and requirements for the electronic transmission of certain health information,’” O’Hara quoted from HIPAA. He then continued, “In response to HIPAA, the Department of Health and Human Services (“HHS”) published HIPAA’s right of access rule: ‘Except as otherwise provided… an individual has a right of access to inspect and obtain a copy of protected health information about the individual in a designated record set, for as long as the protected health information is maintained in the designated record set.’”
HITECH & THE Cures Acts
O’Hara went on to quote, “the HITCH Act in 2009, Congress ‘expanded HIPAA to include individuals’ rights to obtain electronic health records and added a stronger privacy and security requirements to protect health information.’” He continued on, “The Cures Act would later respond to a growing concern that healthcare software developers and provided sought to restrict the amount and types of information accessible to individuals by adding ‘information blocking’ provisions – to further encourage the broad access to patients’ own health information.” Healthcare providers often cite the “Designated Record Set” as not including the EMR audit trail or revision history.
U.S. Department of Health and human services (“HHS”)
Judge O’Hara continued to quote the rules of HHS in regards to a patient’s EHR audit trail production, “‘Individually identifiable health information’ is further defined as information created by a health care provider that relates to the provision of health care to an individual, among other things, that can be used to identify the patient. Id. In sum, audit trail information is included in the patient’s right of access if it is created or used by the healthcare provider, can be used to help treat or identify the patient, relates to the provision of health care to the patient, and is maintained in electronic media.”
The Alleged Burden of Producing the Complete Medical Record
The supposed time burden for the medical facility to produce the EHR Audit Trail and revision history is a major objection provided to the court as a defense to the request for a Plaintiff’s complete electronic medical record. Judge O’Hara addresses that point in stating, “HHS has acknowledged that this imposes a heavy burden on healthcare providers… However, the national policy is that this burden cannot overcome the patient’s right of access… HHS went even further to impose a scheme of penalties for entities that disobey this national policy.”
Federal law says that audit trail data… is included in the patients right of access
Judge James O’Hara
Judge O’Hara finalized his section on the law by stating, “In sum, federal law says that audit trail data, including metadata associated with a patient’s EHR, is included in the patient’s right of access and that it constitutes information blocking to refuse to produce such data.”
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Electronic Medical Records Unraveled!
EMR Audit Trails as produced by Healthcare Providers during medical malpractice discovery frequently filter out the important history of the patient’s medical record. Learn how to compel discovery of the patient’s complete EMR revision history and the complete audit trail.
Hiring an expert in electronic medical records (EMR’s) will help uncover record manipulation that will assist law professionals in winning medical malpractice cases for their clients. Check out this blog to see how a Kentucky woman waged a monumental fight against the medical system that failed her!
A site visit by an expert pays off, a Computer Forensic Expert Finds the Smoking Gun in the Electronic Medical Record (EMR) audit trail!
Kim Johnson noticed a lump on her right breast and because her mother died of breast cancer she feared the worst. In January 2015, she went to Fleming County Hospital in Flemingsburg, Kentucky, to get a mammogram. When she received a letter from the hospital that proved she had “no evidence of cancer”, this Kentucky mother of eight breathed a huge sigh of relief. Several months had passed and the lump continued to grow so she decided to get a second opinion. She was horrified to learn she has stage 4 cancer.
Sadly, Fleming County Hospital had sent the wrong letter, giving Johnson the all-clear instead of directing her to return for a follow-up examination. In September 2016, Johnson filed a lawsuit against the hospital claiming doctors misdiagnosed her, and that two employees deleted evidence of the letter saying she didn’t have cancer. How did she know this?
She hired a digital forensic expert!
Ms. Johnson and her lawyer’s hired a digital forensic expert skilled in examining EMR audit trails. During a court-ordered on-site visit, they found employee EMR entries that edited the history and deleted the evidence of the erroneous letter claiming that she was cancer-free.
In the wake of the misdiagnosis by the hospital, Ms. Johnson is left with a long battle with cancer. If her cancer would have been recognized at an earlier stage her quality of life would have been different as a result. She trusted the system and it failed her.
Who protects the patient? The HIPPA law ensures accountability
Required by the Health Insurance Portability and Accountability Act (HIPAA), hospitals and healthcare providers are to maintain an audit trail of all access, entry, and modification of the patient’s EMR to ensure accountability. Hiring a computer forensics expert that has experience with examining Health Information Systems (HIS) and the related EMR audit trails that can make or break your case. Call Enigma Forensics staff today if you think you may have a case requiring similar assistance. 312-668-0333.
Have you or someone you know been involved in medical injury or accident? Do you want to win your case? Or…If you’re an attorney and have questions about a case involving medical malpractice, read this blog and contact Enigma Forensics for the “W”.
Were you or a loved one involved in a medical accident or injury? Are you an attorney who is representing an injured client?
If the answer is yes, take immediate action and file a Discovery request or subpoena to access all of your Electronic Medical Records (EMR). Why is this important? In order to prove injury or malpractice and win your case it’s imperative to discover what took place and the actions that caused an event. Your electronic medical records or EMR audit trail will document what transpired. EMR audit trails will include prescriptions, tests, treatments, transfers, operation notes, nurse practitioners and doctors notes and a ton more. Electronic Health Records (EHR) are rich with data information describing the care that was provided and decisions that were made good or bad. Some medical record systems such as Epic have sticky notes that are traditionally not part of the formal patient permanent electronic record. Those sticky notes are required to be stored by the Health Insurance Portability and Accountability Act (HIPPA), but are not part of the discharge report showing the patient electronic medical record history. The data does exist and working with a qualified medical record forensic expert can help you to gain a more complete record of the patient encounter with the health care provider.
What else does Electronic Medical Records (EMR) include?
Electronic Medical Records and the patient medical record audit trail include the original record and will note any modifications. It will also preserve dates, times, who accessed the record and whether the record was printed, viewed, deleted or otherwise modified. Many of the systems today, such as; Epic, Cerner, Meditech, All Scripts and others have reports that can be downloaded to reveal vital information about who has authorization to access and audit electronic health records.
Medical dictations are another vital piece to the puzzle. Dictation files are sometimes sent to third party transcription service providers as raw audio files called WAV files. After the WAV files are received they are typically transcribed to text files and fed back into the electronic health record software system. When modification of the patient medical record occurs after an injury or malpractice took place, comparing the transcription WAV files to the produced chart may help reveal alteration to the patient medical records.
Patient Electronic Medical Charts are often Incomplete. You could lose your case!
When electronic medical record discovery requests are made by plaintiffs to healthcare providers, it is common that the production lacks the complete patient medical record history. Healthcare providers facing litigation commonly provide a minimal amount of data in an often useless format. The form of production is often scanned copies of previously printed our documents or charts. Codewords for health care providers, departments and procedures often make interpretation even more challenging. Having an experience EMR computer forensics expert can help provide a more accurate interpretation of the complete Electronic Health Record (EHR) for the harmed patient.
The Health Insurance Portability and Accountability Act of 1996, or HIPAA is a federal law which requires your medical records to be retained for six years at a federal level. However, most states also have their own medical retention laws which can be more stringent than HIPAA stipulates. Check out this government website to learn about how different states interpret this governance. https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
How important are faxes? This could win your case!
In some cases, Electronic Medical Records (EMR) are faxed to outside providers either to or from your primary physician. Software vendors such as Forward Advantage provide automated faxing capabilities integrating with the existing health care information management systems and patient medical records. It’s vital you request all communication between facilities to help prove or disprove what and when medical knowledge was presented to the provider to make an informative decision relatable to an event.
Let’s say you have already requested an EMR audit trail for a patient. Did you know that the Electronic Medical Records (EMR) audit trail you received contains cryptic codes that you will not be able to comprehend. It’s extremely helpful to request all of the underlying data dictionaries that will provide the definition of the codes used referring to the friendly name, including, the healthcare provider’s name, department, computer used to access the EMR, procedures, treatments, tests ordered, drugs prescribed and lab results.
Did you know that medical data is required to be retained for six years?
Do you want to to win your case! You need Enigma Forensics experts on your team! Hire a professional forensic expert to assist in writing a Discovery request to obtain, preserve and analyze ALL of the electronic medical records and to help you obtain the complete EMR audit trail. We can help uncover the truth of what took place and help tell the court the story about what happened to you or your client.
Call Enigma Forensics at 312-668-0333 to schedule a complimentary phone call to discovery how we can assist.
EMR or EHR are synonymous. Both are medical records. The electronic medical records or EMR reveal an audit trail of what transpired during a medical or health visit. Each record is unique and tells a story about the patient. We are experts that can assist you to win your case!
Electronic data records are taking the place of the old school hard copy files and completely revolutionizing the way data is gathered and stored. Electronic Health Records (EHR) or Electronic Medical Records (EMR) are synonymous with each other. (EHR) is data that includes the patient’s vital information such as an address, medical history, allergies, immunizations, lab tests results, radiology images, and vital signs, also, personal statistics like age, weight, sexual orientation, and insurance information. (EMR) is an individual’s private health data that is stored in a protected database only accessible to medical personnel in compliance with The Health Insurance Portability and Accountability Act (HIPAA) regulations. EHR’s or EMR’s make patient charting easier and results in fewer errors and keeps this delicate personal information private and secure.
Medical data can be manipulated!
Medical data can be altered and inserted into EMR systems and made to look like it was there all the time or not there at all. Medical malpractice lawyers rely on EMR audit trails to tell the story of either side of a case; the plaintiff or the defendant. Medical records are marked by metadata or raw data. This data is developed separately from the EMR system making manipulation detection visible by reviewing the raw data and the database logs. Metadata can also be described as underlying data, like a digital footprint that creates an audit trail. In order to analyze raw data, you will need to hire Enigma Forensics; we are experts in the field of electronic medical records (EMR) or (EHR).
During a forensic review of EHR’s or EMR’s, we can authenticate or reveal backdating, back charting, data editing, or falsification of records. We have been on both sides of medical malpractice cases and almost always save our client a considerable sum of money. We work closely with the attorneys involved to help with eDiscovery verbiage and assist with what to look for.
An electronic medical record (EMR) audit trail is a log file required by HIPAA of all electronic medical record software systems. The EMR audit trail documents all points of access of a patient electronic medical record system including any actions to modify, view, print or amend the record by replacing or adding new data.
Electronic Medical Record (EMR) Audit Trails are key to effective electronic discovery during medical malpractice litigation. Renowned EMR Computer Forensics Expert, Lee Neubecker interviews Insurance Defense Attorney Bill McVisk who usually helps defend hospitals embroiled in medical malpractice litigation. McVisk discusses common areas of confusion during discovery of patient medical records. Neubecker relays some of his past experiences helping plaintiffs uncover important medical records that are often hidden from plaintiffs during discovery. Enigma Forensics has assisted counsel with conducting depositions relating to Electronic Health Records (EHR) and EMR. The two discuss how electronic medical record systems have often made the process of discovery more difficult and confusing to attorneys and litigants.
The transcript of the interview follows:
The transcript of the interview follows:
Lee Neubecker: Hi. I’m here today with Bill McVisk. He’s a patient medical records expert, a litigator. He works with hospitals that are dealing with EMR-related patient medical records and whatnot. I had him on my show today because I want to talk a little bit about electronic medical records. Bill, they said that electronic medical records were going to revolutionize everything and make everything so much better. What’s the reality of what’s happened since we’ve brought about medical records?
Bill McVisk: A lot of EMR has been great. I mean, there’s an ability of doctors to provide records to other people that they couldn’t have done before. There’s the ability, for instance, of a radiologist to look at a film that was taken, and he can be in San Diego, and the patient can be in New York, and it still works. The problems, though, there are some problems. I mean, the biggest problem I see is that anyone who’s ever gone to a doctor’s… the doctors are focused on their computers instead of focusing on the patient. What they’re doing is hitting all sorts of drop-down menus and stuff, and I think we’re losing something from the standpoint of presenting physicians and nurses in malpractice cases. It creates a situation where you don’t really get a sense of exactly what that nurse or doctor is thinking, and so the records just aren’t quite as helpful in medical malpractice cases as they used to be. On the upside, we can read them now, whereas in the past we had to worry about doctors’ handwriting.
Lee Neubecker: Yeah. I know from experience working as a EMR, a patient medical record expert, that discovery can often become challenging. When an attorney is preparing a witness for deposition related to patient medical records, what are some of the things that you look for and care about in that process?
Bill McVisk: Well, the first thing, quite frankly, is to make sure I have the entire record. I can’t tell you how often I’m getting records where I get part of the record, and for some reason, I don’t know if it’s stored on a different server or what, I’m not getting all of the record. I may get all the physician’s part of the record but not the nurse’s part of the record, and obviously, that’s essential. Other problems, like when I’m preparing a witness for a deposition, the big problem is that they’re not used to seeing these records printed out. I mean, in the past, they would look at the chart, it would be exactly the same as the chart they were looking at in the hospital. Now, they are looking at the chart on a computer screen when they’re in the hospital, but when you’re preparing them for a deposition, you’ve got a paper chart, and the paper chart prints out terribly. Every time there’s a slight change of any kind in the record from one minute to the next, the chart prints out the page again and again and again, so there’s all this stuff, and it’s just getting the nurses and the doctors to know where in the chart their entry is going to be makes it a little bit harder.
Lee Neubecker: Yeah. I have experience working with that, and I know that HIPAA requires that every instance of that medical record, pre-editing and post-editing, that that data be preserved and discoverable, but in reality, a lot of the software packages, they only have reports that run the last version, so to get into the true audit trail, you often have to get into the database backend to get access to that information.
Bill McVisk: Well, and I think audit trails are the other aspect of things that makes it a little bit harder in this situation. In the past, we basically, I could give the original medical record to the plaintiff’s attorney to inspect. If somebody had erased something or done something like that, it’d be pretty obvious. I would hopefully know about it before the plaintiff’s attorney would know about it. Then I’d deal with that. But, it may not be obvious now because people can go in, change records, and now, if an audit trail is suddenly showing me, “Oh, my god, somebody was in and did something “to the record,” and it’s two or three weeks after the treatment was over, or, say, two or three hours after a terrible incident occurred, that’s going to make it look concerning. So I think from our standpoint, it’s a matter of making sure healthcare providers are aware of how to do it in a way that isn’t going to look like you’re trying to fake or lie.
Lee Neubecker: And there’s a big difference between accessing a medical record, and editing it.
Bill McVisk: Right.
Lee Neubecker: That’s where sometimes attorneys on both sides become confused about the significance of what’s happening with the patient record.
Bill McVisk: Right. I mean, records get accessed all the time. Maybe it’s to prepare for a deposition. You have to access the record to look at it. Maybe it’s because there’s followup treatment and you need to access the record. That happens all the time, but sometimes, on these audit trails, it’s not always easy. Is this just an access, or is somebody going in and changing something?
Lee Neubecker: And there’s a whole other layer, too. I know from my experience working with many of the packages that the hospitals often use systems that have something known as sticky notes, where they can put comments about a patient. There’s a wide perception that those notes aren’t discoverable. Just because the software doesn’t have a report that will run it, doesn’t mean that if someone like me is coming in, and I get access to the backend database, those comments about the patient and whatnot become apparent. But unfortunately, it’s difficult to get at that data if you don’t know what you’re looking for.
Bill McVisk: And that creates a real problem if you’re defending the hospital, because if I don’t know about these sticky notes in the beginning, first of all, I’m not going to be thinking, “Oh, my goodness.” Then, if you come and discover them, it obviously is going to be, “Oh. I was trying to hide those notes,” or, “The hospital was trying to hide those notes,” which is always the worst thing you can do as a defendant in litigation. And they’re clearly, if there’s something about a patient in those notes, it’s almost never privileged, it is discoverable, and it should be provided immediately.
Lee Neubecker: Also, you know, there’s a tendency I see for the hospitals to try to cover things up. Do you think that there’s some value in bringing in, when you’re defending a hospital, your own forensic expert to dig around and find out what’s really happening?
Bill McVisk: See, I don’t think the hospitals are intentionally trying to cover stuff up. I really don’t think that’s, I’ve almost never seen that happen. There may be, you know, one or two, but in most of these cases, I think the hospitals are trying to find out what the truth is. That being said, the hospital may not be aware that some of these things, because the risk management for the hospital might not be fully aware of all of the situations that are involved in electronic medical records, and yes, at that point, it may be a good idea for me just to have somebody like you go through those records, let me know. Before I produce them to the plaintiff, I would like to know what’s out there.
Lee Neubecker: It would probably be a lot more useful for you to get just a listing of the changes on the record so you’re not looking at the whole document, but maybe here’s a first instance, and then change one, change two, change three, so you can see before text, after text.
Bill McVisk: Sure.
Lee Neubecker: That’s the type of thing that, unfortunately, there’s not canned reports that are in the software that do that. I think that could be by design of the software makers because they don’t want to make it worse for their clients, the hospitals, but it’s certainly possible that it’s just something that was never asked for.
Bill McVisk: That’s quite possible, and I don’t know any of these software makers, but to me, it would be really helpful to know what those are. Of course, that does make it more discoverable, easily discovered by the plaintiff’s attorneys, but on the other hand, I as a defense attorney need to know about it, and if there’s a change that’s improper, I need to know about it right away.
Lee Neubecker: Yeah. What kind of problems can occur when different providers have different EMR systems?
Bill McVisk: Well, that can create problems of a number of ways. Sometimes, the software of one hospital doesn’t communicate with the software of another. There have been situations, for instance, where a physician enters an order for something to happen, and then because of the software problems, it doesn’t get to the provider who’s supposed to do it, and they don’t know that they’re supposed to do it. That creates serious problems for patient care. And similarly, it’s like, if a hospital is discharging a patient to a nursing home, and they want the nursing home to have a certain specific type of care regimen afterward, that can create problems if they don’t communicate well.
Lee Neubecker: Well, thanks a bunch, Bill, for being on the show. I appreciate it.
By James G. Meyer* Jonathan P. Tomes** and Lee Neubecker*** As published: Vol. 101 #8, August 2013. Copyright by the Illinois State Bar Association www.isba.org
Doctor and hospital records are changing. The paper medical records that we have been familiar with, along with the rest of the “written” world, are becoming electronic —that is, written, maintained, and retrieved as digital data.
Because of many emerging “after entry” benefits, federal and state governments, insurance companies, and medical institutions are heavily promoting the adoption of Electronic Medical Records (“EMR”). For example, the HITECH Act (American Recovery and Reinvestment Act of 2009) includes both incentives and penalties in its calculations to encourage adoption of electronic records, versus continued use of paper records. The Act allows benefits of up to $44K per physician under Medicare or up to $65K over six years under Medicaid for adoption of electronic records. Additionally, Congress decreased Medicare/Medicaid reimbursements to doctors who fail to use electronic medical records by 2015 for covered patients.
This change in medical record keeping and changes in the laws and regulations associated with electronic medical record keeping are creating significant changes in what and how information may become evidence in litigation.
Attorneys who deal with medical records in any type of litigation should be aware of the changes in the following areas:
I. Electronic Medical Records and HIPAA
II. PHI as Electronically Stored Information
III. What is Discoverable: Metadata and Computer Forensics
IV. A Word about Encryption
V. Discoverability and Admissibility of Electronic Medical Records and Metadata
I. ELECTRONIC MEDICAL RECORDS AND HIPAA
Before the advent of electronic medical records, The Illinois Administrative Code itemized the minimum requirements for the content, management, and administration of medical records.
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) sets out a comprehensive set of rules, safeguards, and definitions that are, effectively, applicable to most health care providers that use computers and electronic storage devices to store or transmit patient medical records. Excepted from the statute are institutions that do not transmit billing transmissions to and from Medicare/Medicaid or other health plans, an uncommon circumstance. With the HITECH Act’s incentives to use electronic health records, more and more providers will do so.
What we have understood to be doctor and hospital medical records, HIPAA defines more comprehensively as health information: “any information, whether oral or recorded in any form or medium, that:
i. Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and
ii. Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.”
Under HIPAA, Protected Health Information(“PHI’) is “individually identifiable health information” that is:
i. Transmitted by electronic media;
ii. Maintained in electronic media; or
iii. Transmitted or maintained in any other form or medium.”
II. PHI AS ELECTRONICALLY STORED INFORMATION
To understand where and how EMR systems “transmit” and “maintain” PHI, it is helpful to use the terminology of computer experts. From their viewpoint, HIPAA’s PHI is Electronically Stored Information (“ESI”).
ESI is data stored, processed, retrieved or transferred by “Electronic Storage Devices.” Electronic Storage Devices – a subclass of Electronic Media – are commonly known as diskettes, Flash Drives and CD/DVD Disk media. Both Electronic Storage Devices and Electronic Media are capable of containing ESI (thus PHI).
Electronic Storage Devices capable of storing ESI can be classified into two main categories – Non-Volatile Electronic Storage Devices and Volatile Electronic Storage Devices.
Non-Volatile Electronic Storage Devices store data on a more or less permanent basis, but can often be deleted or destroyed. These can be grouped into several categories – Primary Storage Devices, Secondary Storage Devices, Offline Backup/Archival, and “In the Cloud.” Examples of each are:
Primary Storage Devices
(1) Hard Disk Drives
(2) Disk Media
(3) ROM / PROM / EPROM
(4) Solid State Drives (Flash Storage)
(5) SIM Cards
(6) Multi Media Cards (SD, SDHC, SDXC, SDIO, and Others)
(7) Smart Cards, Chip Cards or Integrated Circuit Card
(8) Paper Based Storage (Punch Cards, Bar Codes, Scantron)
Secondary Storage Devices
(1) USB Thumb Drives / Flash Drives
(2) External Hard Disk Drives
(3) Disk Media (Floppy Disk, CD, DVD, Blue Ray)
(4) Radio-Frequency Identification (RFID) Tags
Offline Backup / Archival
(1) Magnetic Tape
(2) Disk Media (Floppy / CD / DVD / Blue Ray)
(3) Bar Code Paper Records
(4) CD / DVD Disk Media
In the Cloud (Utilizes all types of Storage)
Volatile Electronic Storage Devices retain a good deal of ESI for a discrete period of time, e.g. until such time that the Volatile source loses power. The RAM in a computer is an example of Volatile Electronic Storage Devices.
ESI may be transmitted between Electronic Storage Device sources via the internet, extranets, infrared, radio, Wi-Fi, Satellite, Cable, Broadband, cellular, leased lines, barcode, dial-up telephone lines, private networks, connected external devices, and devices that are physically moved from one location to another using magnetic tape, disc, or compact disc media.
A patient’s PHI maintained in any of these Electronic Storage Devices or transmitted by any of these means of electronic transmission are potential sources of discoverable information. Smart phones and PDAs are increasingly used in association with electronic health data. Industry sources estimate that “in 2010, more that 50 percent of physicians were using smartphones or PDAs on a regular basis in clinical decision making.” As an indication of how important mobile devices have become in healthcare, the Healthcare Information and Management Systems Society (“HIMSS”), a leading non-profit industry group, has formed a separate entity, mHIMSS, to focus exclusively on the use of mobile and wireless technologies in healthcare.
III. WHAT IS DISCOVERABLE: METADATA AND COMPUTER FORENSICS
The Department of Health and Human Services (“DHHS”) regulations implementing HIPAA govern PHI with both a Privacy Rule and a Security Rule. As their names imply, the rules require adoption of enumerated standards and safeguards so that covered entities protect a patient’s electronic (and paper) medical records from unauthorized access, tampering, or destruction.
Attorneys that have been involved with medical records in litigation since the enactment of HIPAA and the implementation of the DHHS regulations are generally aware that the Privacy Rule enumerates the ways to obtain PHI from health care providers during discovery by the use of written authorization or subpoena.
In addition to delineating how to obtain PHI, HIPAA’s Privacy Rule also requires that covered entities have procedures in place to give individuals an accurate accounting of disclosures of their PHI in cases in which an accounting is required.
HIPAA’s Security Rule requires that a covered entity “ensure the confidentiality, integrity and availability of all electronic PHI the covered entity creates, receives, maintains or transmits”. The standard specifically defines “confidentiality” as “the property that data or information is not made available or disclosed to unauthorized persons or processes” and “integrity” as “the property that data or information have not been altered or destroyed in an unauthorized manner.”
In order to implement the Privacy and Security Rules, HIPAA requires covered entities to use “audit controls,” such as “hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information” and to “implement procedures to regularly review records of information system activity, such as audit logs, access reports and security tracking reports.” The Metadata generated by these audit control systems, about the access and use of a patient’s records and the use and operation of the computer device maintaining or transmitting the records, is typically not part of the formal medical record. But it can often be a gold-mine of important information that would not otherwise be obtainable in discovery.
For example, Metadata in the form of an audit log or audit trail may be helpful with faulty or incomplete memories. An audit trail is a record of who, when, where, how and sometimes why a person used a computer program or accessed a patient’s medical record. Typically, the identity of the user who accesses the patient’s record, the time of access, the terminal or device used for access, the action taken by the user (i.e., viewing the record, changing the record), and the substance of anything added to the record and any changes or corrections made by the user are recorded in the Metadata which can be reproduced in the form of an audit trail or log. In a case known to the authors, a hospital audit trail produced during discovery, showing the “terminal identifier” for an EMR entry (the unique number assigned to each computer terminal in the EMR system) resulted in a nurse changing her testimony when it disclosed she was using a computer terminal in another part of the hospital, and was not with the patient, as she had testified.
Metadata, such as in an audit trail, is captured automatically by the EMR system. As a result, the audit trail should correspond, entry by entry, to the patient’s medical chart or record. If an entry in the audit trail shows data was added, changed or deleted, a corresponding entry should appear in the patient’s chart, and vice versa.
Metadata found in a forensic image of a medical record may be more helpful. A “forensic image” is not simply a copy of the electronic record; it is a bit-for-bit copy of all sectors of the media involved and must be done properly. In a case known to the authors, the analysis of the Metadata on a video disk of a surgical procedure produced during discovery showed that the several of the video clip files in the series of video files that were generated during the procedure were deleted, with the remaining video clips renumbered in an apparent attempt to conceal what transpired during the missing video clips. An analysis of the DICOM video clip embedded Metadata within the contents of each of the DICOM video files revealed the original clip sequence numbers were different for the last few video clips. The file Metadata compared to the DICOM video clip embedded Metadata implied an intentional manipulation of the data in order to alter the events that actually occurred.
IV. A WORD ABOUT DATA ENCRYPTION
Data encryption does not ensure the confidentiality or integrity of PHI. HIPAA’s data encryption standards allow health care providers, health insurance companies and business associates who transmit, store or access protected health information in electronic form to utilize a standardized level of data encryption when encryption is reasonable and appropriate. The Advanced Encryption Standard (AES) is an Federal Information Processing Standards (FIPS) approved cryptographic algorithm used to protect electronic data and is quite prevalent in the healthcare industry to secure data-at-rest, data-in-motion and data-in-transit.
PHI data is vulnerable when actively used and stored in volatile memory. Much of a patient’s information is stored unencrypted in volatile memory when a computer device is actively working with a patient’s record or following the access of a patient’s record until such time that the data is discarded automatically or the computer device shuts off. Anyone with physical or network access to the device or a strong hacker skill set would have a reasonable opportunity to capture the non-encrypted information stored in volatile memory.
Another vulnerable area of risk is when PHI is in transit without the appropriate encryption safeguards. Encrypted ESI using today’s standards is unlikely to be compromised while in a data-at-rest, data-in-motion and data-in-transit state. But, ESI containing PHI is unencrypted at the point of service on a portable or fixed computing device. These devices are sometimes not properly secured with the appropriate physical and network security protections required, providing an opportunity to manipulate the unencrypted data.
V. Discoverability and Admissibility of Electronic Medical Records and Metadata
Illinois Supreme Court Rules make electronic data discoverable. Under Rule 201, “General Discovery Provisions,” discoverable “documents” include “all retrievable information in computer storage.” Rule 214, “Discovery of Documents, Objects, and Tangible Things,” specifically requires production of “all retrievable information in computer storage in printed form.”
Medical records have long been admissible as an exception to the hearsay rule. Before adoption of the Illinois Rules of Evidence (effective January 1, 2011), Illinois Supreme Court Rule 236(b), as amended in 1992, was generally accepted as permitting the admission into evidence of medical and hospital treatment records, in written or computer form, as business records. That rule is silent, however, as to computer generated “data” or “data compilations.” Any confusion in that regard seems resolved in the new Rules of Evidence.
In the first instance, much of the Metadata recorded in an electronic medical record may not be hearsay at all. Rule 801 defines a hearsay “statement” as the oral or written assertion or conduct of a “person.” Automatically imprinted Metadata, is not the assertion or conduct of a person. See, People v. Holowko, 486 N.E.2d 877, 109 Ill. 187 (1985) (recognizing the difference between computer stored information, which may be hearsay, and computer generated information, which is not hearsay). Recorded Metatdata in an EMR system is similar to images recorded on surveillance cameras, which are not hearsay. People v. Tharpe-Williams, 676 N.E. 2d 717, 286 Ill. App. 3d 605 (1997). Because Metadata involves no human input in its creation, other than the actions taken by the user in creating or manipulating the file or record referenced by the Metadata, it is non-hearsay evidence.
To the extent that Metadata does include human input, the new rules provide a hearsay exception for “a memorandum, report, record, or data compilation, in any form, of acts, events, conditions, opinions, or diagnoses” kept as part of a regularly conducted business activity. In addition, the new rules make “writings” and “recordings,” defined to include “numbers . . . set down by . . . magnetic impulse, mechanical or electronic recording, or other form of data compilation,” admissible as “duplicates” or when offered “in the form of a chart, summary, or calculation.”
Although Illinois decisions on the admission of electronic data are not as common as cases in the federal courts, Illinois cases predating the new rules have approved its admission. See, for example, Bachman v. General Motors, 776 N.E.2d 262, 332 Ill.App.3d 760, 267 Ill. Dec. 125 (2002), (approving admission of data retrieved from an automobile crash sensor in a personal injury case).
Medical records are in a state of transition from paper records to electronic data. Being aware of the changes to HIPAA, the HITECH Act, the DHHS Privacy Rule and Security Rule, and the capabilities of computer forensics, are necessary in dealing with electronic medical records as evidence.
*James G. Meyer is an attorney who practices in the law firm of Ialongo & Meyer in Chicago.
**Jonathan P. Tomes is an attorney admitted in Illinois, Missouri, Kansas, and Oklahoma who practices in the law firm of Tomes & Dvorak, Chartered, in Overland Park, Kansas, and consults around the country on HIPAA and the HITECH Act. He has also served as an expert witness on HIPAA, medical records, and the Federal Tort Claims Act in cases in Illinois, Washington, DC, and Colorado.
***Lee Neubecker is a computer forensics expert and the principal of Enigma Forensics, a Chicago based computer forensics & expert witness consulting firm.
 We mean “EMR” to include Electronic Medical Records (digital information created, gathered, managed and consulted by clinicians and staff within one health care organization), Electronic Health Records (“EHR”) (digital information that may be operated by clinicians and staff across more than one healthcare organization – sometimes referred to as “interoperability”) and Personal Health Records (“PHR”) (digital information that can be accessed and created by patients themselves). See, http://www.healthit.gov/providers-professionals/faqs/what-difference-between-personal-health-record-electronic-health-record
 U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services, 42 C.F.R. Parts 412, 413, 422, et seq., Medicare and Medicaid Programs; Electronic Health Records Incentive Program; Final Rule; Title XIII of the American Recovery and Reinvestment Act of 2009, the Health Information Technology for Economic and Clinical Health Act, Subtitle A, Part 2, Subtitle C (hereinafter “HITECH Act”).
 77 Ill. Admin. Code § 250.1510(b)(2).
 Public Law 104-191, 110 Stat. 1396 (1996).
 45 C.F.R. §160.103.
 Id. (Note that PHI may also consist of paper records and oral communications).
 storage media
 The National Institute of Standards and Technology (“NIST”) of the U.S. Department of Commerce has defined cloud computing as follows:
Cloud computing has been defined by NIST as a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or cloud provider interaction.
Peter Mell, Tim Grance, The NIST Definition of Cloud Computing, Version 15, October 7, 2009 at http://csrc.nist.gov/groups/SNS/cloud-computing. More and more large health care providers are hiring outside hosts to maintain their electronic health records “in the cloud,” using large companies like Google, Microsoft, or Amazon or smaller companies that provide hosting only for medical records.
 Putzer, J. MD, Park, Y, Are Physicians Likely to Adopt Emerging Mobile Technologies? Attitudes and Innovation Factors Affecting Smartphone Use in the Southeastern United States, Perspectives in Health Information Management, Spring 2012. p. 2, at http://www.perspectives.ahima.org/attachments/article/241/ArePhysiciansLikelyTo AdoptEmergingMobileTechnologies_final.pdf (last visited January 14, 2013).
 http://www.mhimss.org/about-us (last visited February 25, 2013).
 45 CFR §164.500, Subpart E, Privacy of Individually Identifiable Health Information. (The Privacy Rule applies to both paper and electronic medical records.)
 45 CFR §164.302, Subpart C, Security Standards for Protection of Electronic Protected Health Information.
 45 CFR §164.502 Uses and disclosures of protected health information: general rules.
“(a) Standard. A covered entity may not use or disclose protected health information, except as permitted or required by this subpart or by subpart C of part 160 of this subchapter.”
 45 CFR §164.306 Security standards: general rules.
“(a) General requirements. Covered entities must do the following:
(1) Ensure the confidentiality, integrity, and availability of all electronic protected health information he covered entity creates, receives, maintains, or transmits.”
 See generally, 45 CFR §§ 164.506, 164.508, 164.510, 164.512.
 Ill. Sup. Ct. Rule 214. The Committee Comments to Rule 214 further clarify. “The first paragraph has also been amended to require a party to include in that party’s production response all responsive information in computer storage in printed form. This change is intended to prevent parties producing information from computer storage or computer discs or in any other manner that tends to frustrate the party requesting discovery from being able to access the information produced. Rule 201(b) has also been amended to include in the definition of ‘documents’ all retrievable information in computer storage, so that there can be no question but that a producing party must search its computer storage when responding to a request to produce documents pursuant to this rule.”
 Illinois Rule of Evidence 801(a).
 See generally, The Sedona Conference Commentary on ESI Evidence & Admissibility 10 (2008).
 Illinois Rule of Evidence 803(6) “Records of Regularly Conducted Activity.”
 Illinois Rule of Evidence 1001.
 Illinois Rule of Evidence 1003.
 Illinois Rule of Evidence 1006.
Reprinted with permission of the Illinois Bar Journal,
Vol. 101 #8, August 2013. Copyright by the Illinois State Bar Association www.isba.org