Swedish authorities probe Oracle Cerner health record rollout

Oracle's electronic health records system is under scrutiny by multiple Swedish authorities after a $190 million rollout in the Västra Götaland region (VGR) encountered significant issues.

Following local media reports, the regional government in western Sweden confirmed several problems involving the Cerner Millennium software have been reported in a number of health settings earlier this month.

Since some of these incidents involve personal data VGR has registered an initial report with IMY, Sweden's data protection authority.

The case involved missing or lost words in health records, rather than a security breach or data being stolen, the regional government spokesperson said and added the incidents are "either linked to unforeseen technical problems with the start of operations and/or that routines for handling [data] have not been sufficiently implemented."

A spokesperson said on November 12, the software went live in one hospital - Södra Älvsborgs sjukhus in Borås – as well as several health centers, including physiotherapy units. This initial deployment represented a small proportion of the healthcare system in the region.

Cerner Millennium, a globally used electronic health records system, became part of Oracle in June 2022 following its $28.3 billion acquisition of Cerner Corporation, a long-established healthcare software provider.

The software was chosen by the VGR in October 2018 following a procurement process. Since then, the region's health service has made extensive preparations focused on adapting the software to the requirements of Swedish healthcare and making the necessary preparations in the receiving organizations, the spokesperson said.

The total budget for the project is about 2.1 billion Swedish Kronor ($190 million) for the preparations, implementation, and use of Millennium for several years ahead, according to the agreement between the regional government of Västra Götaland and Oracle's Swedish subsidiary.

Sweden's Medical Products Agency (MPA) has confirmed to The Register that it has started an investigation into the concerns raised following the Millennium implementation, bringing forward a planned assessment of the use of the software.

"What we have now done is to bring forward the planned supervision. However, it is not a specific suspicion of shortcomings that lies behind this, but the reason is partly the questions the MPA has received in relation to the implementation of the system, and partly the reports that have occurred in the media. These have led us to consider that it is appropriate to start a review," a spokesperson said.

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Sweden's Health and Social Care inspectorate (IVO) said it had not begun an investigation, but had received several reports and information concerning the implementation. "We are currently assessing everything we have to determine whether we will open a supervision. All information that IVO receives is read and assessed and can be used as the basis for possible future inspections."

The Parliamentary Ombudsmen has also received complaints regarding the Cerner Millennium system.

Oracle has been offered the opportunity to comment.

However, the Swedish implementation is not the only one that has attracted criticism.

In April 2023, the US Department of Veterans Affairs shut down a $10 billion Oracle Cerner Millennium project indefinitely following repeated problems with the rollout of electronic health records, some of which were linked to instances of patient harm.

In the UK, a coroner's report into a death at a hospital in northern England has said patients are at risk unless concerns about the implementation of a new Oracle Cerner patient administration system are addressed.

Oracle later responded to the February report, saying it deeply regretted and was saddened to learn of the various medical omissions that ultimately caused the death. However, it said there was no suggestion that the software was at fault. “Oracle Health has not identified any evidence to suggest that the death of the deceased was preventable by reason of any alleged defect in its software,” it said. ®