Patient medical records are rapidly evolving due to increasingly sophisticated electronic health record systems. The impact on litigation involving medical records is still being explored and continues to evolve. In this segment of a four-part series, we will discuss the history of electronic health records and their unique capabilities.
When it comes to litigation involving health or injury-related claims, medical records are a critical component to “telling the story” of the plaintiff and the patient care, either verifying or disproving (among other factors) the alleged injuries sustained and/or the treatment received. Thus, proper management of the health information and medical records (collection, organization, storage, analysis, etc.) is critical in order to bring about resolution to the litigation at issue.
Historically, medical records have been maintained in paper format, or in more “static” digital format. When legal action involving medical claims would arise, copying and preserving a patient’s records was fairly straightforward: the provider would simply copy, fax, or email the patient’s chart, then restrict access to the original file for preservation purposes. However, with the ever-increasing adoption of electronic health record (EHR) systems, the format of the medical record has morphed into an entirely different animal.
Although EHR systems have existed for over 30 years, fewer than 10% of hospitals as of 2006 had a fully integrated system.₁ According to a CDC report, by 2009, the EHR adoption rate had risen to 48.3%. As of 2014, more than 80% of hospitals in the U.S. have adopted some type of EHR system (note, however, that the type of EHR data and mix varies significantly).₂ The impetus behind this unprecedented growth was primarily based on two things, which occurred almost simultaneously: significant changes to the Federal Rules of Civil Procedure, and the adoption of the Health Information Technology for Economic and Clinical Health Act.₃
EHRs are, in the simplest form, digital (computerized) versions of patients’ paper charts.₄ However, their capabilities and possibilities extend far beyond that. The focus of EHRs is primarily on the concept of real-time, patient-centered records, which can make information available instantly, “whenever and wherever it is needed.”₅ The goal of EHRs is to bring together all information regarding a patient’s health into one place.₆ EHRs can:
- Contain real-time information about a patient’s medical history, diagnoses, medications, immunization dates, allergies, radiology images, lab and test results, and billing records;
- Offer access to evidence-based tools that providers can use in making decisions about a patient’s care;
- Automate and streamline providers’ workflow, including computer-assisted documentation and diagnosis support;
- Provide alerts such as improper drug dosages, adverse drug interactions and drug allergies;
- Increase organization and accuracy of patient information; and
- Support key market changes in payer requirements and consumer expectations.₇
A key feature of EHRs is that they can be created, managed and consulted by authorized providers and staff across multiple health care organizations.₈ A single EHR can bring together information from current and past doctors, emergency facilities, school and workplace clinics, pharmacies, laboratories and medical imaging facilities.
Unique Capabilities of EHRs
Perhaps one of the fundamental differences between paper and electronic health records is the addition of audit trails and metadata to the patient record. In order to comply with the Privacy and Security Rules set forth in the Health Insurance Portability and Accountability Act (HIPAA), covered entities are required to use “audit controls” and to “implement procedures to regularly review records of information system activity, such as audit logs, access reports and security tracking reports.”₉ The result of such audit controls is metadata: the information about the access and use of a patient’s records, as well as the use and operation of the actual computer device maintaining or transmitting the records.
Metadata and audit trails are not generally considered a part of the formal “medical record.”₁₀ However, in more and more cases, the metadata is proving to be invaluable in litigation involving medical claims. When the date, time, entry or source of a record entry is in dispute, metadata can give the “who, what, when and where” story of the record.₁₁ Furthermore, metadata can provide clarity as to whether a record has been altered in any way, or deleted altogether.₁₂
Another unique aspect of EHRs is the inclusion of automated workflows and computer-assisted documentation. Where the traditional charting practice may have involved handwritten notes entered into a patient’s file, EHRs typically involve a series of menus and mouse clicks. Users will select from drop-down lists and checkboxes, and computer-generated documentation is automatically populated into the appropriate sections of the record. Moreover, as data is entered, algorithm-based alerts and warnings may pop up on the user’s screen, denoting potential adverse drug interactions or patient allergies that may affect treatment.
Lastly, many EHR systems utilize Clinical Decision Support applications, which analyze data entered into the system to help healthcare providers make actual clinical decisions at the point of care.₁₃ For example, an EHR system with diagnostic decision support functionality may use a series of questions and menus to obtain patient data, then use complex algorithms to propose a set of appropriate diagnoses.₁₄ The provider would use the output to make an informed decision about which potential diagnosis(es) may be relevant, or order further tests to narrow down the list of potential options.₁₅ Particularly sophisticated systems may even mine through patient data and stored clinical research to make predictions about future illnesses or events.₁₆
Part II of this series will discuss the impact EHRs have on litigation.
Part III of this series will discuss several case studies involving EHRs.
Part IV of this series will discuss what's next for EHRs in litigation.
1. Detley Smaltz & Eta Berner, The Executive’s Guide to Electronic Health Records 3 (2007).
2. The Analysis Group, Inc., Big Data in Health Care, The National Law Review (Sept. 17, 2014), http://www.natlawreview.com/article/big-data-health-care.
3. Matthew P. Keris, A View from the Trenches: Discovery Issues with Electronic Medical Records, Risk Rx, special Edition on the Electronic Health Record, University of Florida, Vol. 8, No. 1 (January – March, 2011).
4. Office of the National Coordinator for Health Information Technology, What Is an Electronic Health Record (EHR)?, http://www.healthit.gov/providers-professionals/faqs/what-electronic-health-record-ehr (last updated Mar. 16, 2013).
5. Office of the National Coordinator for Health Information Technology, Benefits of Electronic Health Records (EHRs), http://www.healthit.gov/providers-professionals/benefits-electronic-health-records-ehrs (last updated Mar. 11, 2015); see also S.A. Levingston, Opportunities in Physician Electronic Health Records: A Road Map for Vendors, Bloomberg Government (2012).
7. Office of the National Coordinator for Health Information Technology, What Are the Advantages of Electronic Health Records?, http://www.healthit.gov/providers-professionals/faqs/what-are-advantages-electronic-health-records (last updated Sept. 4, 2014).
9. James G. Meyer et al., Electronic Medical Records: Metadata as Evidence in Litigation, 101 Ill. B.J. 8 (2013).
11. AHIMA, Rules for Handling and Maintaining Metadata in the EHR, J. of AHIMA (May 2013), http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_050177.hcsp?dDocName=bok1_050177.
13. Eta Berner, Clinical Decision Support System: Theory and Practice, 2nd Ed. (2007).
14. Chris Dimick, EHRs Prove a Difficult Witness in Court, J. of AHIMA (Sept. 2010), http://journal.ahima.org/2010/09/24/ehrs-difficult-witness-in-court/.
15. Eta Berner, Clinical Decision Support System: Theory and Practice, 2nd Ed. (2007), supra.
16. Matthew P. Keris, A View from the Trenches: Discovery Issues with Electronic Medical Records, supra.