Medical errors, caregiver stress: how to avoid the pitfalls of computerization
Numerous studies have highlighted the poor ergonomics of electronic health records (EHRs), which lead to medical errors as well as stress and work overload among physicians.
Roxana Ologeanu-Taddei, University of Montpellier and Romaric Marcilly, Lille Regional University Hospital Center
While the "Ma santé 2022" plan aims to make shared medical records andthe Digital Health Space two pillars of future digital transformations in the healthcare sector, it is important to learn from the problems posed by these older information technologies so as not to repeat the same mistakes.
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Telemedicine, e-health: why is there resistance?
What are electronic health records?
EHRs are cross-functional software programs used to capture, store, and transmit data related to patient care processes. They generally include modules for medical prescriptions and care administration (by nurses). Unlike custom-developed solutions, this software is usually "off-the-shelf," meaning that it is developed and marketed by a specialized publisher, rather than developed for each specific context or project.
Launched in 2011 by the Directorate General for Healthcare Provision, the French Digital Hospital program aimed to modernize hospital information systems. Policies encouraging the widespread adoption of EHRs were based on a number of promises, such as the traceability of healthcare information and reduced data entry time in a single software program (thanks to a single database, complementing or replacing the various business software programs or those for each medical specialty).
In theory, EHR was appealing and should have relegated paper patient records to the status of antiques. Unfortunately, EHR support software was designed and implemented based on the model of integrated management software packages, i.e., a standardized vision of healthcare processes, which clashed with the diverse reality of local contexts and different specialties.
When software has undesirable effects
The adverse effects of EHRs have been known in the literature for many years. As early as 2005, a study highlighted the unexpected increase in patient mortality following the implementation of medication prescription software. Subsequently, numerous studies have revealed the negative consequences of the implementation and use of prescription software, followed by electronic health records.
A recent article entitled "Identifying electronic health record usability and safety challenges in pediatric settings" shows, for example, that 36% of safety reports related to EHRs are attributable to a lack ofusability of this software. In other words, in a work situation, the ergonomics of this software proved to be flawed, resulting in harm to the patient in 18.8% of cases.
Design issues coupled with technical problems
This lack of usability leads to an increase in the time spent on documentation by healthcare professionals. They are spending more and more time entering, checking, or consulting EHR data. What's more, these unintuitive software programs require additional training and, above all, adaptation. These standard software programs must be configured according to the processes and services existing in each hospital and each clinical department.
In addition to these usability issues, more technical problems persist, hindering the work of professionals: technical failures (breakdowns that can even prevent patient care; data loss; repeated bugs; long response times; security breaches that have led to several recent attacks, including the one that paralyzed the British healthcare system in 2017.
Thus, more than 20 years after the first studies and the accumulation of evidence and knowledge on the problems caused by electronic patient records, the media continue to regularly report on the difficulties of use contributing to stress among physicians and medical errors.
In France, there is a lack of data.
What about France? There are few French studies on the use of PGD. One example is Frédéric Kletz's study, conducted in around 50 establishments, which aimed to assess the benefits of EHRs for healthcare professionals. It paints a mixed picture of electronic health records. A very recent doctoral thesis also documents and analyzes the consequences of EHRs in a French hospital.
In the absence of scientific studies and assessments, as well as public and open databases on incidents related to DPI, various press articles report problems similar to those identified in the international literature for a long time.
Although our country's delay in documenting these dysfunctions means that no definitive conclusions can be drawn, it is reasonable to assume that the problems are the same as those experienced by our neighbors. However, the lack of information gathering on problems with the use of IPR (whereas such information exists for drugs and medical equipment) prevents us from capitalizing on these experiences to improve and make the use of health information technologies more reliable, and to improve design processes.
However, various studies have proposed best practices for improving the functioning, ergonomics, and use of EPDs, which should be used as a source of inspiration.
Solutions that are rarely applied
On the publisher side, technical evaluation and certification can be based on international standards (e.g., ISO standards for IT security— ISO 27000 —or information service quality— ISO 20000), agile development that takes user-specific requirements into account (ISO 9241-210 standard), and certification ofthe usability of medical devices. However, these standards are not mandatory. The Haute Autorité de Santé (French National Authority for Health) offers optional certification for prescription assistance software and, by extension, EHRs that include prescription assistance. Other recommendations focus on best practices related to the development of healthcare software and mobile applications.
On the healthcare organization side, adapting care processes, coupled with fine-tuning EHR settings, requires internal skills within organizations, change management support, and training for healthcare professionals. The first Digital Health Council also highlightedthe importance of supporting stakeholders in order to achieve the digital transformations in healthcare set out in the "Ma Santé 2022" plan ."
But whether they concern software publishers or healthcare organizations, these best practices require time, human resources, and additional expenditure, which are not always considered a priority. One solution could be to encourage collaboration between healthcare institutions, software publishers, and researchers in computer science and the humanities and social sciences (ergonomics, management sciences, sociology, etc.).
France should also establish a public database of incidents related to IPR and other healthcare software that can be used for research purposes. Admittedly, under the national system for reporting IT incidents in healthcare organizations set up in 2017, 140 incidents were recorded one year later. However, no communication has been made about the nature and scope of these incidents. Information on incidents related to healthcare software should be more transparent in order to promote improvements in both the software and the care processes in which it is used.
In the United States, even though the MAUDE database is not supposed to receive reports on EHRs (it only covers medical devices, excluding US EHRs), it is full of valuable information onusability and implementation issues, as well as misuse and errors in the use of electronic health records.
Moving from recommendations to mandatory certifications
The European Court of Justice recently recognized that "software whose functions include the processing of patient-specific data for the purpose, in particular, of detecting contraindications, drug interactions, and excessive dosages, constitutes, in respect of that function, a medical device."
This ruling clarifies that prescription assistance and prescription verification features are medical devices, and therefore so are EHRs that incorporate these features. As such, this software must meet numerous requirements, including certain ergonomic (usability) requirements, in order to be certified, receive the CE mark, and be placed on the market. However, these requirements are not easy to meet for features as complex as prescription.
Furthermore, these certifications are expensive and time-consuming. Their implementation therefore risks favoring large companies at the expense of start-ups. To overcome this problem, public funding could be earmarked to cover these costs, since the ultimate goal is to build secure healthcare services for patients. In any case, standards and certifications must be imposed by the regulator. Could we imagine, in the aeronautics or nuclear sectors, software being left to the sole discretion of the players involved?
Roxana Ologeanu-Taddei, Senior Lecturer authorized to supervise research in Information Systems Management, Polytech Montpellier, University of Montpellier, University of Montpellier and Romaric Marcilly, Research Project Manager, Lille Regional University Hospital Center
This article is republished from The Conversation under a Creative Commons license. Readthe original article.