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Introduction

Health Information Technology (Health IT) plays a large role in the diagnostic process. Health IT includes electronic medical records (EHRs), clinical decision support, patient engagement tools, computerized provider order entry, laboratory and medical imaging information systems, health information exchanges and medical devices.1  The information Health IT captures directly affects workflows and decision making in the diagnostic process both positively and negatively.1 This article discusses the design of Health IT, the interoperability of patient health information, Health IT patient safety issues, and how Health IT has the possibility to aid in the measurement of diagnostic errors.1

Health IT Design

            Health IT needs to be designed in a way to enhance the diagnostic process. When Health IT is poorly designed or poorly implemented, it can impede the diagnostic process and become a burden for healthcare professionals.  The key attributes of safe Health IT from the Institute of Medicine (IOM)/ National Academies of Science (NAS) are:

  1. “Easy retrieval of accurate, timely and reliable native and important data
  2. A system the user wants to interact with
  3. Simple and intuitive data displays
  4. Easy navigation
  5. Evidence at the point of care to aid in decision making
  6. Enhancements to workflow, automating mundane tasks, and streamlining work, never increasing physical or cognitive workload
  7. Easy to transfer information to and from other organizations and clinicians (interoperability)
  8. No unanticipated downtimes.”1

The design of Health IT should promote interprofessional teamwork in the diagnostic process. Most EHRs have helped to enhance communication, redefine team roles and improve delegation.

The Office of the National Coordinator for Health Information Technology (ONC), Health IT vendors, and Health IT users should collaborate to ensure Health IT supports health care professionals and patients in the diagnostic process. It is also important to share best practices and make continuous improvements to the design, implementation and use of Health IT.

Interoperability of Health IT and Safety of Health IT

Another need for ensuring safe patient care with the use of EHRs is for interoperability, or seamless flow and use of data and information exchanged between computer systems.  There are two major types of interoperability:  syntactic interoperability and semantic interoperability.1 Syntactic interoperability involves the communication of data from point a to point b.  However, semantic interoperability involves not only the communication of data between multiple information systems, but the understanding of the meaning of the data by the computer, which is much more challenging to achieve.

Health professionals need access to the right data at the right time and in the right format for clinical decision making and providing safe patient care2,3.  As a result, NAS recommended in 2015 that, “ONC should require health IT vendors to meet standards for interoperability among different health IT systems to support effective, efficient, and structured flow of patient information across care settings to facilitate the diagnostic process by 2018.”1

In early 2020, much progress has been made towards that goal.  ONC’s incentive program and vendor certification criteria have resulted in hospitals (including hospital-based laboratories) and physicians using certified EHRs, which utilize a variety of messaging, coding and other standards to exchange and report data.  Not all laboratories today are utilizing the same messaging and coding standards (such as LOINC) as many laboratories weren’t incentivized and required to meet interoperability standards, leading to inoperability of laboratory data when the receiving EHR is unable to process results in an automated fashion.  Lack of coding or structured data can lead to manual processes and review, which may delay availability of laboratory data when needed by physicians.2,3,4

In addition to financial barriers, “information blocking,” may occur when a health system or physician refuses to share medical data with a competitor.  It may also occur when a health IT vendor does not provide functionality for health data to be shared with facilities using competitor EHRs.

ONC and Centers for Medicare and Medicaid (CMS) have taken note and issued a proposed rule in 2019 to penalize those engaged in information blocking and provide additional regulations aimed to overcome many of these barriers to advance interoperability.  At the time of this publication, the anticipated final rule had not yet been published.  The push towards interoperability must be balanced with patient safety in mind.  Exchanging more information faster on a syntactic level without semantic interoperability introduces risk.

Risks in patient care can result in harm, or worse, to patients, whether a result of human error or judgment or health IT design and use issues.  Although the true number of near misses, harm and death attributed to healthcare IT is unknown, hampered by many vendor contracts that prohibit end users from sharing such concerns,4 ONC is attempting to classify such actions as information blocking to promote transparency of these patient safety risks.  The American Medical Informatics Association (AMIA) has also published a report on recommendations for those to consider when entering into or updating their vendor contracts.  Subsequently, the NAS supports transparency in sharing experiences with health IT vendor implementations and not prohibit information related to patient safety.  They further recommend open exchange of user experiences which may negatively impact the diagnostic process.  Additionally, the NAS recommends Health and Human Services (HHS) to require health IT vendor products to be evaluated with regard to negative impacts of the diagnostic process.

Some are reporting quite a few errors, functionality challenges, and the like with EHRs, so much so that media coverage has expanded in the area.5,6,7  A Pew survey highlights EHR usability patient safety concerns,2 while other reports outline communication issues leading to patient safety issues.3, 4, 6, 7  Yet another study highlighted over 18,000 EHR safety issues over an eleven year period ending in 2018.4  What is really needed is a central registry of any and all IT-related issues that can be documented and shared centrally, with the goal of improving vendor interoperability and preventing patient harm. Although such a “safety center” is mentioned by NAS,1 a central repository of health IT patient safety issues has yet to exist.

Diagnostic Technologies: mHealth, Wearable Technologies, and Telemedicine

Additional diagnostic technologies such as mHealth (mobile health)/wearable technology and telemedicine/telehealth create opportunities to improve and aid in the diagnostic process. Telemedicine and telehealth use electronic communication to exchange medical information from one site to another to improve patients’ health status. Also known as remote healthcare services, this includes “two-way video, email, smart phones, wireless tools and other forms of telecommunication technology”.1 Telemedicine usually takes place between a clinician and patient who is in a different location and/or between two clinicians for consultations. Telemedicine can reduce cost and increase access to care in comparison to traditional methods of retrieving healthcare services. Telemedicine has the ability to reach patients in remote areas, provide access to specialist services such as radiology, pathology, dermatology, cardiology, neurology, etc., and provide access to interpretive services. Challenges to telehealth include the possible absence of the patient-clinician relationship and limiting providers’ ability to perform comprehensive physical exams, plus certain health conditions cannot be diagnosed through telemedicine. Technology can also fail or have transmission errors. It is important that telemedicine is used appropriately to best benefit the patient.

Wearable technologies and mHealth applications are available to clinicians and patients. They have the ability to assist clinicians by providing drug reference guides, medical calculators, clinical practice guidelines, textbooks, literature search portals and other decision support aids. mHealth applications have the ability to gather diagnostic data or assist patients in coordinating their care by keeping track of medical conditions, diagnostic tests and treatments. mHealth can also provide education opportunities and aid in the diagnostic process though the ability to pull up radiology images on a tablet. Smartphones could be used with specialized attachments to make laboratory-based diagnostics more accessible, such as electrocardiograms. Wearables provide the ability to track patients’ lifestyles through activity, diet, glucose readings, heart rate and more, and to upload the data through the internet for a clinician to see. Challenges with mHealth and wearables include variability in mobile applications and there are concerns about the accuracy, privacy, and safety of these applications. There is also a lack of data to support and identify best practices for mHealth and wearable technology and the integration with EHRs for patient monitoring. Health literacy is also a concern along with the evolving regulatory framework for mHealth.

Conclusion

In short, information systems such as EHRs are a major tool in the diagnostic process which need functionality coupled with usability to adequately communicate information about a patient’s diagnostic process at the right time, place, and format to avoid patient safety issues.  The NAS makes several recommendations to improve overall processes and patient care.  While a number have been implemented, leading to transparency and improved functionality in some EHR aspects, others have been much slower to realize their benefits in protecting patients from harm.  Improvement in health IT in providing safer patient care is an ongoing process.

Resources:

  1. The National Academies of Sciences, Engineering, and Medicine. (2015). Improving Diagnosis in Health Care. National Academies Press, 1-472.
  2. Kent, J. (2017, December 21). Pew: EHR Usability Concerns May Still Impact Patient Safety. Retrieved from Health IT Analytics: https://healthitanalytics.com/news/pew-ehr-usability-concerns-may-still-impact-patient-safety
  3. Bresnick, J. (2016, February 1). EHRs Contribute to Patient Safety Risks, Communication Errors. Retrieved from Health IT Analytics: https://healthitanalytics.com/news/ehrs-contribute-to-patient-safety-risks-communication-errors
  4. Schulte, F., & Fry, E. (2019, March 18). Death by 1,000 Clicks: Where Electronic Health Records Went Wrong. Retrieved from Kaiser Health News: https://khn.org/news/death-by-a-thousand-clicks/
  5. Tran, P. (2020, January 17). Relaunching the Fight Against Medical Errors. Retrieved from The Hill: https://thehill.com/opinion/healthcare/478868-relaunching-the-fight-against-medical-errors
  6. Lyons, M. (2019, December 19). The Joint Commission Issues Quick Safety Advisory on Reducing Diagnostic Errors. Retrieved from The Joint Commission: https://www.jointcommission.org/resources/news-and-multimedia/news/2019/12/the-joint-commission-issues-quick-safety-advisory-on-reducing-diagnostic-errors/
  7. Aroditis, A. (2019, December 6). The Patient Safety Risks of EHR Errors. Retrieved from Health IT Outcomes: https://www.healthitoutcomes.com/doc/the-patient-safety-risks-of-ehr-errors-0001

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