“Digital Operation Room Assistant” DORA was designed to prevent technical errors in increasingly complex operation rooms. A clever design solved a dilemma that prevented DORA from being used effectively. DORA increases patient safety and makes it easier to learn from medical errors. However, the video recordings DORA makes in the operation room could also potentially be used in criminal proceedings, and this is a hurdle to acceptance by medical professionals. Through a clever design in the data storage feature, DORA can contribute to improved care without the legal risks. This project made that possible by researching the legislation on video recording of medical procedures.

The research team looked into which specific recordings could be used by DORA and made an inventory of existing legislation on video recording in a medical setting. This included a review of privacy and medical responsibility. The project outcome was a description of the legislation governing the use of DORA, as well as a recommendation on guidelines for developing registration systems that can filter out sensitive information. This is an important step in the further development of recording technology used in medical settings. A pivotal question was what information the “black box” for the operation room should and should not contain. On the one hand, certain information had to be left out to avoid legal abuse and on the other hand, data that could lead to improved patient safety had to be registered, of course.

Dilemma

DORA was designed to improve patient safety in increasingly high-tech operation rooms, and thus improve the quality of health care. DORA alerts medical staff if there are pending technical issues so that they can make timely adjustments and it also enables medical professionals to learn better from things that go wrong. DORA is an important innovation for society, as some figures suggest that medical errors in the Netherlands result in around 1,000 to 2,000 deaths a year.

DORA, however, raised a dilemma. It was feared that under privacy legislation some of the footage recorded by DORA might have to be included in the patient’s file. This footage might then be used in criminal proceedings in the event of medical errors. That was a hurdle for acceptance by medical professionals, which is essential for rapid implementation of the system.

Video in the OR: lessons learned

Existing legislation on video recording in the OR is highly complex. Consequently, the guidelines used in practice were based on (incorrect) assumptions or an inadequate interpretation of the legislative basis. An important conclusion is that what constitutes correct application of the current legislation depends on whether or not personal data are processed.

In an article in the Dutch Journal of Medicine, Nederlands Tijdschrift voor Geneeskunde, researchers summarised the specific lessons learned from the project. These include:

• In legal terms, storing video footage constitutes the processing of personal data. This means that there are a number of requirements, under privacy legislation, on how the video footage should be processed.
• Legally, there are three different ways to use video footage:
  1. as an essential component in the treatment, such as with endoscopy;
  2. to promote the quality of the procedure; and
  3. in peer review or education.
  Which party authorisation for registration should be requested from and how is different for each of these use options.

• It is advisable to record video footage of critical moments in operations in the patient file. This also applies to chance findings or complications should this be desirable, from the perspective of proper care provision, for the patient’s treatment.

There was a lot of interest in the results from various professional groups. The researchers’ report was included in the ongoing discussions of the “Directive on Minimal Invasive Surgery” working group, for example, and in this way the report contributed to the guidelines formulated by the profession at the request of the Health Inspectorate. In 2013, a pilot was carried out with DORA at the Reinier de Graaf Hospital in Delft, where she is now used as a permanent “team member” in the operation rooms.

digital operating room, privacy, medical mistakes, video registration, video registration, hospitals, legal risks, patient safety, operating room equipment, medical liability, patient record

Official project title: