Learn what details to provide when hiring a data forensic expert during medical malpractice litigation to increase efficiency and cost effectiveness.
Prepare a summary of the following:
Develop timeline of notable events
Organize case documents and provide to your experts
Copy of the Complaint
Requests to produce
Interrogatories filed
Replies to Interrogatories
EMR Produced
Audit Logs Produced
Ask Your EMR Data Expert to Prepare the EMR for efficient review by attorneys & medical experts
OCR the produced EMR (Allows for keyword searching)
Convert the EMR to a spreadsheet format where practical
Identify key events and providers
Consider filtering for key dates, workers, or concepts
Produce subset pdf documents / spreadsheets that are more easily reviewable
Consider having pivot tables created showing overviews
In-Person Direct access provides additional information
Routing History
What the notes looked like at various points in time
Access to deleted records
Communications between healthcare workers
Example Screenshots from Popular HIS Systems follow
Enigma Forensics EMR Data Forensics Experts provide detailed analysis and interpretation of an EMR Audit Trail to assist Medical Malpractice Attorneys during litigation. We help win cases! Hire an Expert (HAE)! Call 312-668-0333
Epic software is used by many hospitals that is HIPPA compliant. It is used to track all additions, modifications, and ensures the complete patient history is recorded. Check out this blog to learn more about EPIC software!
EPIC software is used by many hospitals to track patient care and manage the overall patient experience. When something goes wrong during a patient stay that leads to long-term injuries or death of the patient, it is highly common that medical malpractice litigation ensues.
Health Information Personal Privacy Act, HIPPA
The Health Information Personal Privacy Act, commonly referred to as HIPPA, places several important requirements on health care providers. HIPPA requires that all access to a patient’s electronic medical record commonly referred to as EMR, track all addition, modifications, and allow access while ensuring the complete revision history of the EMR is maintained.
EMR Audit Log
Audit logs or audit trails are required to ensure that reconstruction of the complete revision history can be established. EPIC printed reports of patient’s EMR can be produced using various filters that result in a less than complete production of the patient’s full electronic medical records. Some of the filters that are routinely used include:
Date filter to show only the time the patient was receiving care at the healthcare provider
Production of only non-confidential notations
Production of only the final version of the EMR without the detailed revision history
Filter notes exclusive to the named defendant health care providers
Filter by department
These filters described previously when used in producing a patient’s EMR result in an incomplete production of the EMR.
Sticky Notes
EPIC has a communication platform known as Sticky Notes. This serves as an instant messaging mode of communication between healthcare workers discussing a specific patient. EPIC lacks a report that can allow easy printing or export of these notes. This creates a common misperception among health providers that these notes are not part of the legal discoverable record. In fact, there are other ways to access these sticky notes, which are an important part of documenting the patient care provided. An in-person inspection of the EMR using a camera to record the user’s screen can allow for obtaining these important communications. These sticky notes are part of the EMR and are subject to preservation by HIPPA.
On-Site Inspection
During an onsite inspection to obtain the complete EMR, it is important to ensure that the user accessing EPIC has full administrative rights to the system. In some health care organizations, sticky notes may be accessible only to physicians. Regardless, obtaining these important communications can be a vital source of information to reveal important events leading up to a lifelong injury or death.
Enigma Forensics has assisted in numerous medical malpractice cases working with either the plaintiff or defendant’s side of litigation. Our experts dig through each record to analyze ultimately to find the “smoking gun!” We call ourselves the data detectives! If you are working on a medical malpractice case and would like to win, call Enigma Forensics at 312-668-0333.
To learn more about Electronic Medical Records check out these blogs.
Why is the Health Insurance Portability and Accountability Act of 1996 so important? It keeps our healthcare systems in check! Check out this video with transcripts to learn how it affects patient’s rights to request their own Electronic Medical Records (EMR’s).
Lee Neubecker: So HIPAA is the Health Insurance Portability and Accountability Act of 1996 and why this is important is all the hospital information system providers, have to certify that their software is HIPAA compliant. Otherwise, the hospitals receiving Medicare reimbursement wouldn’t be able to use the software. So, the presumption should be that any healthcare organization that is receiving Medicare funding is compliant with the rules of HIPAA and we’ll talk through what that requires here.
HIPAA Audit Trail Requirements: EMR / EHR
Application audit trail audit trails
EMR Opened / Accessed
EMR Closed
EMR Created
EMR Edited (Original and Replacement Value) with last update time
EMR Deleted
System level audit trails
Successful or unsuccessful logon event by username
Date and time of each logon or logoff attempt
Specific device used to logon
Application user successfully or unsuccessfully accessed
User audit trails
Monitor and log user activity in an ePHI application
Record events initiated by the user
Commands directly initiated by the user
Log access to ePHI files and resources
Healthcare organizations must retain records at least six years
States with stricter retention requirements must be honored
First, HIPAA requires that there be application audit trails that show when the EMR was open, accessed, closed, created, edited, the original value, replacement value, who updated it? When, from what computer, whether it was deleted? Your system-level audit trails, which has to do with the logons of the user to the system when they logged on, what computer was at the nurses’ station? Was it the computer that was actually bedside with the patient? So all of that can be relevant, especially in establishing whether or not a healthcare provider was with the patient at an important time.
User audit log trails monitor the user activity within a specific EPHI application. It records events, what commands were issued, and so on. Healthcare organizations must retain these records for at least six years and typically, if there’s an issue where litigation is involved at the point in time that they’re notified, their risk management committee will collect the records and make preservation of the available data. Some states have stricter retention requirements beyond six years and in those cases, the state rules should apply according to HIPAA.
HIPAA Audit Trail Requirements: Must Track
Each time a user logins
Whenever changes are made to databases
When new users are added
Access levels for each user
File access by users
Logins to operating systems
Firewall logs
Anti-malware logs
Other requirements of HIPAA include the following.
When a user logs on when changes are made to the databases, when users are added, access level for each user, what rights they have, the file access by the user. Logins to the operating system, firewall logs, anti-malware logs and more. So there’s a lot of requirements that hospitals are compliant and other health care organizations that are receiving Medicare funding follow these requirements.
Example Audit Trail: Meditech
Example Audit Trail
Lee Neubecker:
Here’s an example of what an audit trail log looks like. I know it’s probably a little bit difficult to see all of this but what we see, this one’s Meditech. What you’ll see here is there’s a run date, the date and time the report was run, the runtime, the username, the specific database being accessed, and who the patient was. Then across the top, you have different data columns such as date, time, the user. What action, were they modifying, exporting, viewing? The description of the action? Then you have the device being used to access it. It also shows here that there’s a confidential flag and certain records which may or may not be produced. And then there’s the ability for someone to, you know, Dr. Smith could enter something and emulate another user and you don’t often see the notion that someone else emulated another user when you’re viewing the progress note or printed chart. So the audit trail is important. Now, unfortunately, this audit trail doesn’t show you the specific changes being made and oftentimes, what’s necessary is you actually have to get a direct in-camera inspection of the Meditech or other HIS system to be able to record and document what the care provider sees.
Watch other videos making up this 4 part series, Unlocking the EMR Audit Trail.
Where does one start when requesting Electronic Medical Records or EMR’s? Enigma Forensics has created a process for you to follow to help navigate to trial or settlement.
Process of Navigating to Trial or Settlement
Lee Neubecker: So now I’m going to a little bit about the overview and process of working one of these cases with electronic medical records, such as myself. And typically, the cases start off with the need to make the request for the complete electronic medical record. Oftentimes, attorneys contact us when this has already been done but they suspect that the data is deficient in some way or fabricated.
So, we often will review the records produced, identify examples or problems with filters, anything that looks suspect, and then assist with drafting a supplemental request to produce.
If the supplemental materials are produced, we review that. We look for deficiencies in the records, and oftentimes there will still remain deficiencies. So in that case, we have to spend time analyzing the EMR and working on a report of sorts that shows examples of what’s missing. And at that point in time, we’re trying to compel the judge to order an inspection. On the converse side, if we’re working for the hospital, we’ll be looking through the EMR and often reporting to them whether or not there was a fabrication by hospital staff and that’s important for insurance carriers because they want to understand what the risk is if they litigate a case to trial. And it may be more advantageous to simply settle the case if there are some problems in the EMR.
So after we’ve drafted the motion to compel, well, typically, we write an affidavit in support of the motion to compel an onsite direct inspection. That motion gets filed by the attorney with our affidavit attached and then there’s a hearing. These days, the hearings tend to be on Zoom telephonically, and oftentimes the judge will ask questions. Essentially when we’re doing an onsite, what we want is we want to be able to see the entire record of the patient as the physician can see it, the communications between providers, and the complete revision history. This often requires videoing or taking photos of the data to capture data that are not easily printed from current reports with the HIS system.
So when the onsite inspection happens, it’s not uncommon that there will be multiple experts there. I’ve been hired to observe an inspection by a plaintiff counsel that is seeking to look at the EMR. In that role, I’m looking to just document and understand how they’re requesting the data, whether data is being withheld despite the onsite, and to advise my client in terms of what the data is that was produced and whether there are any issues with it. The onsite inspection isn’t where the analysis happens. It’s usually an effort to try to dump all the data out, run reports, make sure the settings are documented appropriately, and really that the only filter being used is the filter for the patient. There should be no other need to filter anything. Those records are the patient’s records. They have a right to that content and this process is one that is going to become much more common as we continue with the understanding of medical records and audit trails becoming more prevalent. After the onsite inspection, there’s a need to review that data. Oftentimes normalize it again, compare it against earlier produced EMR. That analysis might document that early on, that the health care organization was willfully holding back information that was key and important. And so, in instances where that happens, there’s a need to write a report to document those changes or deficiencies. And long before the trial happens and the reports issued, the expert witness that you use is your EMR expert will have to be deposed most likely. And what I usually find, at least in cases I’ve been involved with is that the cases typically settle after the deposition. Because at that point in time, you’re really looking at what does the factual record reflects? There are not so many opinions so much as there are facts. In some cases, there are opinions about why does the chart shows lots of entries that all were created days after discharge and they’re all unrounded hours with no minutes. In a situation like that, my opinion would be that’s likely fabrication because usually if you’re entering notes and other procedures contemporaneous to events, you’re going to have randomization of the minutes and everything is not going to be stacked up at zero, zero minutes on the hour.
So if a case is going to trial, there’s a need to prep your EMR expert, to let them review the timeline, the earlier affidavits in the data that was collected so that they’re prepared for trial. In most cases, so cases tend to settle and they usually settle after the onsite inspection and collection of data. Sometimes they’ll settle much earlier. I’ve seen cases settled as soon as I get involved and help with writing a request for supplemental production but sometimes the cases go on further. In my experience, the further along through this process the plaintiff gets, if we’re able to identify willful withholding of records, the settlement offer tends to be much higher.
1. Request Patient’s Complete EMR
Provide the complete EMR audit trail for [Patient Name] detailing any health care provider’s access, review, modification, printing, faxing, or deletion activities in a comma delimited format with any and all corresponding native files or records that may relate to the patient as required by the HIPAA § 164.312(a)(1).
Audit trail should include the complete revision history of the EMR
Provide the name of all medical software applications utilized to store EMR
Provide the data dictionary for each software application containing EMR
Provide all User and Administrator Manuals for each EMR software application
So, I gave an overview of this. There are slides here that I’ll walkthrough. I want to have plenty of time for questions. So, I’m not going to read each of these but in summary, you want to make sure that you’re getting all the data and there’s an outline here, if you email [email protected], she can send you a complimentary sample request for EMR that helps you form that request. Obviously, you may want to retain us to help you tweak that for your specific circumstances. It’s a good idea though to ask for the user manuals when you’re doing this process and you want to make sure that you’re clear about asking for the complete revision history.
2. Review EMR Records Produced
Identify Examples of Withheld Records or Apparent Manipulation
Filters beyond the patient used such as user id or department
Lack of production of records from the beginning of the notable time period until the date the EMR report was generated
Audit trail lacks details of the revision history
Production of the data in a non-usable format
So I talked about the review of the records produced and typically, we’re trying to identify examples of withheld records or other things that we can find or prove that are deficient from the production. Audit trails that lack the definition of what was being changed are an example, the production of data in a non-usable format, going onsite to have it exported. So it’s not produced in a crazy, out-of-order duplicative format is often helpful.
3. Request Supplemental Production of Deficient Records
Ask for what you want specifically before filing a motion.
Request the complete revision history showing the life cycle of the patient’s EMR.
The supplemental request for the production of deficient records is likely to not bear fruit but is necessary to show you tried to work things out before seeking judicial intervention.
So when we’re asking for the records that we’re missing, we want to be specific on that and ideally pose that directly to opposing counsel in an email. So that it’s documented and that way, if you’re hearing a motion, you can show the judge that you’ve already tried to be specific about what you were asking for. It should always include the revision history. That phrase is so important. Usually, that’s missing from productions. And it’s often, the case that even though you ask for things correctly, they still aren’t produced as requested. So, having that clear documentation of asking for it in email is important.
4. Review Supplement Production of Records Received
Immediately review the supplemental production upon receipt.
Check to see if the request that was made was answered correctly.
To the extent that production remains unresponsive, communicate that to opposing counsel before filing your motion.
So when the supplemental production comes in, we want to typically look at that quickly, try to see if they’ve complied or failed to address certain sections. If they failed to disclose their filters or they filtered things differently than requested, you want to create a paper trail and send a follow-up email asking for that, and then if they don’t comply, that’s going to help you with your motion to compel when appearing in front of the judge.
5. Affidavit in Support of Motion to Compel Onsite Direct Inspection
Detailed foundation for the request
Reference prior requests and data produced
Communicate the deficiencies in the produced EMR
Establish examples where the revision history showing changes is important
Establish that the reported dates are not necessarily the original entry time and that modification history can be obtained by directly examining the EMR system
So the affidavit that we’re generating is typically outlining these deficiencies. It might be sharing exhibits that include the emails that you sent asking for the data. We want to make sure that we’ve detailed the foundation for the request, pointing out examples of what was asked for what was produced, how that was deficient? Giving examples where the revision history showing changes is important. Specifically, the lack of when the records were actually created or last updated, who updated them, when? That information is very important and it’s often not in the initial round of production of EMR.
6. File Motion To Compel Onsite Inspection Of EMR
A federal U.S. District Court ordered a hospital to provide such direct access to a patient plaintiff in a medical malpractice case. (Borum v. Smith, W.D. Ky. No. 4:17-cv-17, 2017 U.S. Dist. LEXIS 109249 (July 14, 2017)
The court’s decision lays out the arguments made by the hospital opposing the onsite inspection.
So, finally the motion to compel the onsite inspection of EMR, there’s a useful case out of Kentucky, Western District of Kentucky, the Borum versus Smith case. I think on our website, if you search at enigmaforensics.com for Borum, B-O-R-U-M, there’s a hyperlink to this case and it’s a federal case that lays out the arguments establishing and overcoming objections made by a hospital resisting an onsite inspection. So this can be very useful to lay the groundwork for arguing your motion to compel.
7. Court Testimony in Support of Motion to Compel Onsite Inspection
Having your EMR expert at this hearing is important
Overcome objections
Establish protocol for examination
Allow recording of the HIS software as it relates to the patient
Allow for the reproduction of previously produced EMR to verify filter settings and obtain the data in a delimited format
Ensure that all versions of notes including inactive and historical versions are included in the production of EMR
When that motion to compel hearing is held having someone like myself there to be able to answer questions of the judge, overcome objections, help to establish protocols for the exam to ensure that it’s effective and not a waste of everyone’s time is important. Recording of the HIS software should be allowable. An agreement to redact or call out anything that might’ve been captured that doesn’t relate to the patient is something that I see there’s no issue to but the ability to document and the record is critical. Ideally, during this onsite, you want to be able to reproduce what they produced previously so that you can confirm whether or not they had filters applied to it. If their earlier production of EMR only includes active records and no historical records, producing it in a more complete manner will help you to demonstrate to the court that the hospital was holding back important records that were your patient’s or your client’s records, that they have a right to. So again, making sure that inactive historical versions are included in the production of EMR is very important.
8. Onsite Inspection – Capture of Patient’s EMR
Inspection can occur using Zoom or other remote desktop tools
An in-person inspection can be advantageous
Your EMR expert should be able to direct the health care provider’s IT admin to perform any query or other activity that relates to the patient
Data can be saved to external media for later examination
Your EMR expert should be allowed to capture photos or video from the live system
So inspection onsite during the pandemic, a lot of things have shifted to Zoom or WebEx, that can certainly happen. An onsite inspection does have advantages and I usually recommend the onsite where possible. Now that vaccines are widely available, the concerns over going onsite should be much less. During this inspection, I always recommend that the healthcare providers, IT person with admin rights actually be the person that’s typing at the keyboard and moving the mouse but at the direction of the requesting party. That helps protect from any potential harm to the hospital information system and really shuttle out for full observation of the EMR as it exists within the system.
Typically, data is exported to external media and at the conclusion of that, the data is shared with a producing party, in requesting party subject to the right for either party to deem data confidential or redact, which typically, the confidentiality requirements, hospitals are already following that for the most part. So really, as long as the data is restricted to the patient, there really shouldn’t be much reason to hold back data that belongs to a patient as long as it’s just that patient’s data. That data will be examined after the onsite when there’s time to analyze it.
9. Review Records Captured Onsite
Limited time for onsite inspection and collection of data
Consider delaying review if a settlement offer is likely
EMR expert compares initial productions vs. onsite data collected
Identify examples of manipulated records or previously withheld records
Consider disclosing some of these smoking guns before proceeding with a written report by an EMR expert
So after the onsite, that’s when there’s more time to look at the data to analyze it, to compare it. If there’s an expectation that smoking guns were captured during the onsite, sometimes a plaintiff expert might want to just hold off for a week or two if they think that a settlement’s likely so that the costs aren’t incurred. To discuss the comparison of initial productions versus what was collected on-site, trying to identify examples of manipulated records or previously withheld records can be important in understanding what happened with the case.
So whether or not you write a formalized report or just disclose some of the smoking guns, that’s a decision that plaintiff counsel often considers. Defense counsel often needs to consult with their insurance carrier and have someone like me help tell them what the situation is so that they can decide, does the case have merit or should you proceed to trial and not make a settlement?
10. Write Final Report
Detail examples of previously withheld information
Detail examples of fabrication or manipulation of information
Clarify what happened with the EMR
So the final report that gets written up again, details, examples of previously withheld information. Examples of fabrication or manipulation of information and trying to clarify, in human words, a storyline of what took place.
11. Expert Witness Deposed
Survive Daubert challenge
Avoid mistakes
Establish a foundation for the admissibility of electronic evidence
Clarify any opinions expressed in the affidavit(s) or report(s)
So, when the deposition phase occurs, it’s important that your expert be able to survive a Daubert challenge. You don’t want to have all the work tossed out because the collection of data was not done properly or not performed by someone that has appropriate experience. It’s important to try to avoid mistakes, which sometimes typos happen and whatnot but trying to minimize mistakes typically requires giving your expert time to review and proof their report. Having other peer review processes performed and engaging with your expert to make sure that everything is clear and understandable. And ultimately, you’re trying to establish a foundation to admit important information that relates to EMR so that you can clarify what events took place and having your expert be able to explain that to a judge is really important.
12. Trial Testimony with Prep
Select an expert that is skilled at presenting technically complex information to non-technical audiences.
Verify that your expert has court testimony experience.
Ensure your expert has time to review materials before trial.
Most cases never make it to trial and settle earlier where the EMR speaks for itself.
So one of the things you want to look for when you’re picking an expert, you want to look for identifying an experienced expert that has testified on cases before and is capable of taking technically complex information and presenting it in an easy-to-understand manner. And that isn’t always easy for many geniuses out there that understand a lot of complex information. You want to make sure again, that your expert has time to refresh and review the materials before trial. Experts that are busy are going to be in many different cases and shifting between one med mail case matter in another involving EMR takes some time to shift.
So, I like to try to work on a case solidly for a period of time, get it up to a report, finish that and then come back to a case at the next checkpoint so that I can focus and not be split between two similar but different cases. As I said before, most cases never make it to trial because ultimately, the electronic medical records, if obtained and produced in their entirety with the date and time that they were entered, modified, and whatnot, that data will typically speak for itself. So, whether you’re defending a case or pursuing one, getting an understanding of events that took place, it’s highly critical.
13. Case Settles or Case Dropped
In our experience, in cases where EMR has been withheld or manipulated, settlement agreements are usually reached.
Establishing that the medical record doesn’t support allegations of abuse can result in a case being dropped.
Settlement offers increase when you are able to prove that the health care provider purposely withheld information.
Proving willful fabrication or manipulation of the EMR can help win the highest settlement.
So when we find examples of manipulation of information, settlement agreements are usually reached because if a hospital took a case to trial and it was proven that they manipulated the records, they would face far more litigation from other plaintiffs as a result of that. In some cases, some of the outcomes might not be to have a cash settlement, it might be for a parent to regain custody of their child because there were inappropriate allegations of harm that aren’t substantiated by the electronic medical record. If you can prove that a healthcare provider purposely withheld information, it’s really helpful to get a settlement or a favorable outcome if you’re on the plaintiff’s side. And again, as I said, what I’ve seen is the highest settlement offers usually come if you prove the willful fabrication or manipulation of EMR.
I had a case back in, I think it was around 2004 involving a heart catheterization operation that went wrong, and days after the operation, the patient was discharged and then passed away. It’s an unfortunate circumstance that left a family with one less parent. In that case, so years after the accident, the surgeon produced a CD disk that contained the video clips documenting the surgery. But what happened when I examined the CD, I was able to establish that the CD had been created a month previously. The CDs have headers that show the date and time that they’re created by a specific computer.
Furthermore, I looked at the video clips, there were DICOM video files. DICOM is digital imaging and communication of medicine and these video files had embedded metadata that showed the sequence number and the date and time and length of the clip. Well, what had happened is I think it was clip six, seven, and eight were deleted nine, 10, and 11 were renumbered to be six, seven, and eight. So there were three video clips that were removed and then the renaming of the files effectively made it look like the deleted clips never existed. Well, in doing forensics on that, I was able to establish what had happened and then during my deposition, I testified to that. At the end of it, the attorney for the hospital asked me, do you have any proof that the hospital had anything to do with this? Keep in mind, the surgeon was the one who produced the CD years after the operation.
Oh, my reply to the attorney for the hospital was if, given the opportunity to examine the hospital’s equipment, I could determine whether or not the CD that was produced was generated by their equipment and my deposition ended. Quickly after that, they asked for my business cards and then the maximum settlement of the insurance coverage from both the surgeon and the hospital, that offer was made in the case of, so it was a favorable outcome.
One other thing too, in many cases that have caps on liability, if the plaintiff is able to prove willful manipulation, in some states, those caps go away. So, if you’re defending a hospital in one of these cases, having someone like myself help you determine if the EMR shows willful manipulation or fabrication. That can be very important because exposure to the hospital could be much greater than in the case where things simply, you know, mistakes happen and unfortunately, mistakes happen and good people suffer harm as a result of disease, surgeries, and whatnot. But in situations where bad things happen and then individuals in a healthcare organization take efforts to fabricate the record, to make it look other than what events really took place, that can be very risky for a healthcare provider. And knowing that early on in a case is really important that hospitals know that and other health care providers. So in those situations, I’ve had a lot of experience digging in and answering those questions quickly before the plaintiff gets their answers. I’ve also helped the plaintiff get the answers to those questions and reached satisfactory settlements.
Watch other videos making up this 4 part series, Unlocking the EMR Audit Trail.
Join us on Friday, June 25 from noon – 1:00 pm. Please register on Eventbrite at:
https://electronicmedicalrecords.eventbrite.com
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.
Enigma Forensics, Inc. was founded by Lee Neubecker, CISSP, an established Computer Forensics Expert for over 20 years and the President / CEO of Enigma Forensics. Mr. Neubecker has been ranked as one of the top global experts in cybersecurity and computer forensics by Who’s Who Legal for many years running.
Please join us this week, on Friday, June 25th at Noon to 1 PM CST for a complimentary Zoom webinar learn more about:
Neubecker demystifies Electronic Medical Records (EMR) by revealing how EMR can be fabricated, filtered, incomplete or misleading.
Neubecker will walk through the typical stages involved with litigating medical malpractice cases as they relate to EMR.
Neubecker will discuss some of the typical problems and concerns with tendered EMR audit trails and patient charts as produced during discovery.
You will learn how to request and compel discovery to obtain the complete patient EMR audit trails and EMR revision history.
Most of all, you will learn how to detect records that may have been electronically manipulated.
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.
Enigma Forensics are experts in collecting and understanding electronic medical records or the EMR audit trail. Check out this blog to view our list of EMR Discovery Questions.
Electronic Medical Records (EMR) can be tricky! In most cases, during eDiscovery, you get what you ask for and only what you ask for! Every Discovery request involving a healthcare provider has unique aspects that need to be considered.
Enigma Forensics is an established Computer Forensic Expert Witness firm that has been involved in many medical malpractice cases and specializes in interpreting electronic medical records (EMR) audit trail or audit logs. Our staff has extensive experience with numerous EMR applications and can assist you with navigating through the challenges of EMR Audit Trails and/or Audit Logs. Electronic Medical Record a.k.a., EMR audit trail or log is the answer to who knew what when, in essence, it tells the story about what took place during the treatment of that patient.
The following is a list of important questions to file for the demand for eDiscovery for Electronic Medical Records, in a medical malpractice case.
Provide the name of all medical software applications utilized to store [Patient Name]’s Electronic Medical Records (EMR).
For each medical software application that contains [Patient Name]’s EMR, please provide the specific version of the software as well as the name of the company that produces the software during the relevant time period beginning on [beginning date] through the present date.
For each medical software application that contains [Patient Name]’s EMR, please indicate if any of the specified software applications were migrated off to a new platform and what the current status is of [Patient Name]’s EMR on the original system.
For each medical software application that contains [Patient Name]’s EMR, please provide the application administrators that have full access to the stored data and audit trails.
For each medical software application that contains [Patient Name]’s EMR, please provide all user and administrator manuals for each of the medical software applications.
For each application that contains [Health Care Provider Name]’s EMR, please provide the current retention settings for the audit trail for all patient’s EMR. Are the privacy log retention settings sent to a secondary audit log (e.g., Fair Warning)? Is the secondary audit log retention configurable within the systems and/or applications?
For each application that contains [Health Care Provider Name]’s EMR, please provide the earliest date that [Patient Name]’s EMR appears in the application’s audit trail.
Please provide the complete EMR audit trail for [Patient Name] detailing any health care provider’s access, review, modification, printing, faxing, or deletion activities in a comma-delimited format with any and all corresponding native files that may relate to the Electronic Medical Record for [Patient Name] as required by the Health Insurance Portability and Accountability Act § 164.312(a)(1). Such an audit trail should include the original values and new values for any alteration of the EMR and shall indicate the user making the change and the date and time of the change.
Please provide the data dictionary for each software application containing [Patient Name]’s EMR. Such dictionary shall include the username key that maps the real names of individuals to their unique user login account IDs for each medical software application containing any EMR for [Patient Name] as required by the Health Insurance Portability and Accountability Act § 164.312(a)(2)(i). Additionally, any lab test, codes, or other short-form identifiers included in [Patient Name]’s EMR Chart or EMR audit trail should be provided as part of the data dictionary production.
Please provide any and all original voice transcription recordings that were made by [Health Care Provider Name], or any other staff that related to [Patient Name].
Please provide any other native electronic files or emails that relate to [Patient Name] in the native format with an index containing the original unmodified metadata for each of the native files or emails produced.
Please provide any DICOM files that were captured as part of [Patient Name]’s treatment by [Health Care Provider].
Please provide electronic records of any outbound faxes and/or other methods of communication that were utilized by [Health Care Provider Name] to [EMR Recipient], in its native form with a corresponding comma file listing containing all available metadata in a delimited format with the corresponding file path to the native file produced for each record.
Please provide the name and title of the person most knowledgeable for the [Health Care Provider Name]’s software/auditing and compliance system.
What customizations and settings were active at the time when the plaintiff was admitted into the hospital? What privacy-related logging is in place for each such system and/or application? Are privacy log retention settings in place for each such system and/or audit log?
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”).[1] For example, the HITECH Act (American Recovery and Reinvestment Act of 2009[2]) 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.[3]
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)[4] 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.”[5]
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.”[6]
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.”[7] 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)[8]
Volatile[9] 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.[10]
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.”[11] 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.[12]
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[13] and a Security Rule[14]. 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,[15] tampering, or destruction[16].
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.[17]
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.[18]
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”.[19] 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.”[20]
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”[21] and to “implement procedures to regularly review records of information system activity, such as audit logs, access reports and security tracking reports.”[22] 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.[23]
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.[24] 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.[25]
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.”[26] Rule 214, “Discovery of Documents, Objects, and Tangible Things,” specifically requires production of “all retrievable information in computer storage in printed form.”[27]
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.”[28] 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.[29]
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.[30] 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,”[31] admissible as “duplicates”[32] or when offered “in the form of a chart, summary, or calculation.”[33]
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).
CONCLUSION
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.
Notes
[1] 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
[2] 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”).
[3] 77 Ill. Admin. Code § 250.1510(b)(2).
[4] Public Law 104-191, 110 Stat. 1396 (1996).
[5] 45 C.F.R. §160.103.
[6] Id. (Note that PHI may also consist of paper records and oral communications).
[7] storage media
[8] 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.
[9] http://en.wikipedia.org/wiki/Volatile_storage
[10] Id.
[11] 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).
[12] http://www.mhimss.org/about-us (last visited February 25, 2013).
[13] 45 CFR §164.500, Subpart E, Privacy of Individually Identifiable Health Information. (The Privacy Rule applies to both paper and electronic medical records.)
[14] 45 CFR §164.302, Subpart C, Security Standards for Protection of Electronic Protected Health Information.
[15] 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.”
[16] 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.”
[17] See generally, 45 CFR §§ 164.506, 164.508, 164.510, 164.512.
[27] 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.”
[28] Illinois Rule of Evidence 801(a).
[29] See generally, The Sedona Conference Commentary on ESI Evidence & Admissibility 10 (2008).
[30] Illinois Rule of Evidence 803(6) “Records of Regularly Conducted Activity.”
[31] Illinois Rule of Evidence 1001.
[32] Illinois Rule of Evidence 1003.
[33] 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
