Medical errors, caregiver stress: How to Avoid the Pitfalls of Digitalization
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 University Regional Hospital
While the “Ma santé 2022” plan aims to make the shared medical record andthe Digital Health Space two pillars of future digital transformations in the healthcare sector, it is important to learn from the challenges 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?
EMR systems are cross-functional software solutions designed to capture, store, and transmit data related to patient care processes. They typically include modules for prescribing medications and administering care (by nurses). Unlike custom-developed solutions, these software systems are generally “off-the-shelf,” meaning they are developed and marketed by a specialized vendor, rather than tailored to a 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 designed to encourage the widespread adoption of EHRs were based on numerous promises, such as the traceability of patient care information and reduced data entry time through the use of a single software system (thanks to a unified database that complements or replaces the various specialized software systems used by different medical specialties).
In theory, the EHR was appealing and should have rendered “paper” patient records obsolete. Unfortunately, the software supporting the EHR was designed and implemented based on the model of enterprise resource planning (ERP) systems—namely, a standardized view of care processes—which clashed with the diverse reality of local contexts and different medical specialties.
When software has unintended consequences
The adverse effects of EHRs have been documented in the literature for many years. As early as 2005, a study highlighted an unexpected increase in patient mortality following the implementation of medication prescribing software. Subsequently, numerous studies have revealed the negative consequences of implementing and using prescribing software, and later, electronic health records.
A recent article titled “Identifying electronic health record usability and safety challenges in pediatric settings” shows, for example, that 36% of EHR-related safety reports are attributable to a lack ofusability of this software. In other words, in real-world settings, the usability of this software has proven to be lacking, resulting in harm to the patient in 18.8% of cases.
Design issues compounded by technical problems
This lack of usability results in healthcare professionals spending more time on documentation. They are spending an increasing amount of time entering, verifying, or reviewing EHR data. Furthermore, these non-intuitive software systems require additional training and, above all, adaptation. Indeed, these standard software systems must be configured to align with the existing processes and departments in each hospital and clinical department.
In addition to these usability issues, more technical problems persist, hindering the work of healthcare professionals: technical failures (including outages that have disrupted patient care; data loss; recurring bugs; long response times; and security vulnerabilities that have led to several recent attacks, including the one that paralyzed the UK’s healthcare system in 2017).
Thus, more than 20 years after the first studies and the accumulation of evidence and knowledge regarding the problems caused by electronic health records, the media continue to regularly report on usability issues that contribute to physician stress and medical errors.
In France, there is a lack of data
What is the situation in France? There are few French studies on the use of EHRs. One notable example is Frédéric Kletz’s study, conducted across some fifty institutions, which aimed to assess the benefits of the EHR for healthcare professionals. It offers a mixed assessment of the electronic health record. A very recent doctoral dissertation also documents and analyzes the impact of the EHR in a French hospital.
In the absence of scientific studies and assessments, as well as public and open databases on incidents related to ICDs, various news articles report problems similar to those identified in the international literature for some time now.
While our country’s delay in documenting these issues prevents us from drawing definitive conclusions, it is reasonable to assume that the existing problems are the same as those faced by our neighbors. However, the lack of data collection on issues related to the use of EHRs (unlike the data available for medications and medical equipment) prevents us from capitalizing on these experiences to improve and ensure the reliability of information technology use in healthcare, and to enhance design processes.
Nevertheless, various studies have identified best practices for improving the functionality, usability, and adoption of PPE, which should be taken into account.
Solutions that are rarely implemented
On the software provider side, technical evaluation and certification can be based on international standards (such as ISO standards for information security— ISO 27000 —or information service quality— ISO 20000), agile development that takes user-specific needs into account (ISO 9241-210 standard), and certification ofthe usability of medical devices. However, these standards are not mandatory. The French National Authority for Health (HAS) offers voluntary certification for prescription support software and, by extension, EHRs that include prescription support. Other recommendations address best practices related to the development of healthcare software and mobile applications.
For healthcare organizations, adapting care processes—coupled with the fine-tuning of EHRs—requires in-house expertise, 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 outlined in the “Ma Santé 2022” plan .”
However, whether they involve software developers or healthcare organizations, these best practices require time, human resources, and additional expenses—which are not always considered a priority. One solution could be to foster collaboration between healthcare facilities, software developers, and researchers in computer science and the humanities and social sciences (ergonomics, management science, sociology, etc.).
France should also establish a public database for reporting incidents related to EHRs and other healthcare software that can be used for research purposes. Admittedly, under the national system for reporting IT incidents in healthcare organizations established in 2017, 140 incidents had been recorded one year later. However, no information has been released regarding the nature and scope of these incidents. Information on incidents related to healthcare software should be more transparent to facilitate 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 intended to collect reports on PHRs (it focuses solely on medical devices, from which U.S. PHRs are excluded), it contains a wealth of valuable information onusability issues, implementation challenges, and instances of misuse and errors in the use of electronic health records.
Moving from recommendations to mandatory certifications
The European Court of Justice recently ruled that “software whose functions include the analysis of patient-specific data—in particular to identify contraindications, drug interactions, and excessive dosages—constitutes, with respect to that function, a medical device.”
This ruling clarifies that prescription support and prescription verification features for medications are medical devices, and therefore so are EHRs that incorporate these features. As such, this software must meet numerous requirements—including certainusability requirements—to be certified, receive the CE mark, and be placed on the market. However, these requirements are not easy to meet for functions as complex as prescribing.
Furthermore, these certifications are expensive and time-consuming. Implementing them therefore risks favoring large companies at the expense of startups. To address this issue, we could consider earmarking public funds to cover these costs, since the ultimate goal is to build secure healthcare services for patients. In any case, standards and certifications must be mandated by the regulator. Could we imagine, in the aviation or nuclear sectors, software being left entirely to the discretion of the stakeholders?
Roxana Ologeanu-Taddei, Associate Professor with the authority 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
This article is republished from The Conversation under a Creative Commons license. Readthe original article.