Medical errors, caregiver stress: how to avoid the pitfalls of lʼinformatisation

Numerous studies have highlighted the poor ergonomics of computerized patient records (CPRs), which lead to medical errors as well as stress and work overload for doctors.

Roxana Ologeanu-Taddei, University of Montpellier and Romaric Marcilly, Lille Regional University Hospital

While the "Ma santé 2022" plan calls for the shared medical record and theDigital Health Space to be two pillars of future digital transformations in the healthcare sector, it's important to learn from the problems posed by these older information technologies so as not to repeat the same mistakes.

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What are electronic patient records?

CIOs are cross-functional software applications used to capture, store and transmit data related to patient care processes. Typically, they integrate modules for medical prescription and care administration (by nurses). Unlike customized solutions, these are generally "off-the-shelf", i.e. they are developed and marketed by a specialized publisher, and not developed for each specific context or project.

Launched in 2011 by the Direction Générale de l'Offre de Soins, the French Hôpital Numérique program aimed to modernize hospital information systems. Policies to encourage the widespread use of CIOs were based on multiple promises, such as traceability of care information or reduced data entry time in a single software package (thanks to a single database, complementing or replacing the various business software packages or for each medical specialty).

In theory, the CIO was attractive, and should have relegated "paper" patient records to the status of antiques. Unfortunately, the software used to support the DPI was designed and implemented on the model of enterprise resource planning (ERP), i.e. a standardized vision of care processes that clashed with the diverse realities of local contexts and different specialties.

When software has undesirable effects

The adverse effects of PGDs 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 drug prescription software. Subsequently, numerous studies have revealed the negative consequences of implementing and using prescribing software, and then computerized patient 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 an IPR are attributable to a lack ofusability of the software. In other words, the software's ergonomics proved deficient in working situations, resulting in patient harm in 18.8% of cases.

Design problems coupled with technical problems

This lack of usability leads to an increase in documentation time for healthcare professionals. They spend more and more time entering, verifying or consulting CIO data. What's more, this unintuitive software requires additional training and, above all, adaptation. This is because standard software has to be parameterized according to the processes and services existing in each hospital and clinical department.

In addition to these usability issues, more technical problems persist, hampering the work of professionals: technical failures(breakdowns to the point of blocking patient care; data loss; repeated bugs; long response times; security flaws at the root of several recent attacks, including the one that paralyzed the British healthcare system in 2017.

So, more than 20 years after the first studies and the accumulation of evidence and knowledge on the problems caused by computerized patient records, the media continue to regularly report on the difficulties of use contributing to physician stress and medical errors.

In France, there is a lack of data

What is the situation in France? French studies on the use of PGDs are few and far between. One example is Frédéric Kletz's study, carried out on some fifty establishments, which aimed to assess the benefits of the DPI for healthcare professionals. The results were mixed. A very recent doctoral thesis also documents and analyzes the consequences of IPR in a French hospital.

In the absence of scientific studies and evaluations, as well as public and open databases on IPR-related incidents, we find that various press articles report similar problems) to those identified by the international literature long ago.

Although our country's delay in documenting these malfunctions means that no definitive conclusions can be drawn, it is safe to assume that the problems that exist are the same as those encountered by our neighbors. However, the lack of data collection on IPR usage problems (as is the case for drugs and medical equipment) prevents us from capitalizing on these experiences to improve and make more reliable the use of information technologies in healthcare, and to improve design processes.

A number of studies have nonetheless suggested best practices for improving the operation, ergonomics and use of IPRs, which should be emulated.

Solutions rarely applied

For software publishers, evaluation and technical certification can be based on international standards (e.g. ISO standards for IT security - ISO 27000 - or quality of information service - ISO 20000), agile mode development taking into account user specificities(ISO standard 9241-210) and certification of medical deviceusability. However, these standards are not mandatory. The Haute Autorité de Santé is proposing optional certification for prescribing assistance software and, by extension, for PGDs incorporating prescribing assistance. Other recommendations relate to good practice in the development of healthcare software and mobile applications.

As far as healthcare organizations are concerned, adapting care processes, coupled with fine-tuning CIO settings, requires in-house skills in organizations, support for change and training for healthcare professionals. Indeed, the first Conseil du numérique en santé highlighted theimportance of supporting players 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 priorities. One solution could be to encourage collaboration between healthcare establishments, software publishers and researchers in IT and the human and social sciences (ergonomics, management sciences, sociology, etc.).

France should also set up a public database for reporting incidents involving CIOs and other healthcare software that can be used for research purposes. Admittedly, as part of the national system for reporting IT incidents in healthcare organizations set up in 2017, 140 incidents were listed a year later. However, there has been no communication on the nature and scope of these incidents. Information on healthcare software incidents should be more transparent to encourage improvements to both the software and the care processes in which the use of this software fits.

In the U.S., even though the MAUDE database is not supposed to receive incidents involving CIOs (it only covers medical devices, from which U.S. CIOs are excluded), it is packed with valuable information onusability and implementation problems, as well as misuse and errors in the use of computerized patient records.

From recommendations to mandatory certification

The European Court of Justice recently recognized that "software, one of whose functionalities enables the use of patient-specific data, in particular for the purposes of detecting contraindications, drug interactions and excessive dosages, constitutes, as far as this functionality is concerned, a medical device".

This ruling makes it clear that prescription assistance and prescription verification functionalities are medical devices, and therefore also PGDs that integrate these functionalities. As such, such software must meet a number of requirements, including ergonomics(usability), in order to be certified, receive CE marking and be placed on the market. However, these requirements are not easy to meet for functions as complex as prescribing.

What's more, these certifications are expensive and time-consuming. There is therefore a risk that they will favor large companies to the detriment of start-ups. To alleviate this problem, public funding could be earmarked to cover these costs, since the ultimate aim is to build secure healthcare services for patients. In any case, standards and certification must be imposed by the regulator. Can we imagine software in the aeronautics or nuclear sectors being left to the sole whim of the players involved?

Roxana Ologeanu-Taddei, Senior Lecturer in Information Systems Management, Polytech Montpellier, University of Montpellier, University of Montpellier and Romaric Marcilly, Project Manager Research, Lille Regional University Hospital

This article is republished from The Conversation under a Creative Commons license. Read theoriginal article.