The data from surgical “black boxes” would revive liability concerns that previously arose from patients recording childbirth and the practice of surgeons giving patients a video of their procedure to take home, legal experts say.
Risk managers and malpractice defense attorneys raised the alarm about birth videos years ago, and they had similar concerns when laparoscopy was fairly new and surgeons realized they had video of the procedure that they could give to patients afterward. In both cases, the worry was that those videotapes could be produced as evidence in a malpractice case and a lay jury might be unduly swayed by images they didn’t fully understand. Those concerns led to many hospitals banning both practices.
“I can see the analogy to any kind of video recording, like when a hospital allows a simple video recording of surgery,” says Melissa Goldman, JD, an attorney with the Florida Health Law Center in Davie. “Depending on how the hospital sets up its policies and procedures, those are discoverable, and it can be a problem in malpractice. Generally, you don’t want those videotapes used in a surgery malpractice case because there are so many team members involved and there is a higher incidence of malpractice than in other forms of care.”
Goldman says she can’t imagine why data from a black box would be any different. She notes that data collected during robotic surgery has been used in subsequent malpractice cases.
The hospital’s best strategy would be to identify the purpose of the black box data clearly by emphasizing that it is being collected solely for the purpose of peer review and quality improvement, Goldman suggests. It also is possible to identify only the surgeon but not the patient in the data, she says. A destruction policy such as the one in use at St. Michael’s in Toronto also is extremely important, she says. Some states already require that video recordings become part of the patient record, while federal law is silent on the issue.
“There’s no need to keep the data for years unless your state considers it part of the medical record,” Goldman says. “You also will have to consider the physical storage requirements, keeping the physical data under lock and key, and encrypting all the digital information to keep it safe under HIPAA.”
Address patient consent
Patient consent also will be an issue. The CMS requires patient consent for video recording, and The Joint Commission requires notice to patients, Goldman notes. Permission also might be needed from staff members who will be recorded by the black box.
Risk managers will have to balance the potential benefits of a black box with the potential damage that could come if the data is used in a malpractice case, says Katie Norris, formerly a compliance officer with a medical device manufacturer and now a director with Berkeley Research Group in Houston, TX.
“There is always the potential that creating a true documented bird’s-eye view of the procedure from start to finish does open the procedure to some risk,” Norris says. “But patient safety is a priority, so this technology should not be shied away from. Rather, the answer is something that strikes a middle ground, where facilities are managing the use of the technology and creating structure around how the information is going to be collected and used internally.”
The information gathered with a black box could be misused in court, says Max Gaujean, JD, a malpractice attorney and founding member in the White Plains, NY, office of the Brown, Gruttadaro, Gaujean & Prato law firm. Even if the video and data show an error during surgery, that error is not always going to be the cause of the adverse event, he notes. But the jury can make that leap, and at a minimum, you have shown the jury members something else that went wrong, which diminishes their confidence in the defendants.
While agreeing about the risks, Nicholas D. Jurkowitz, JD, partner with Fenton Law Group in Los Angeles, which represents hospitals, says the black box also could be a useful tool for the defense. Particularly in a case that typically would come down to battling expert witnesses, black box data could prove definitively that the defendants did not do what the plaintiff’s witness suggests.
Another potential benefit for the hospital is that black box data might show, early on, exactly where it stands with a malpractice case.
“Hospitals want to know where they stand, how likely it is that they’re at fault, how hard it will be to prove that, so that they can decide what kind of stance to take with the lawsuit,” Jurkowitz explains. “There could be a benefit to knowing that right away and possibly settling the case sooner than you might have without that information.”
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Melissa Goldman, JD, Florida Health Law Center, Davie, FL. Email: [email protected].
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Max Gaujean, JD, Brown, Gruttadaro, Gaujean & Prato, White Plains, NY. Email: [email protected].
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Nicholas D. Jurkowitz, JD, Partner, Fenton Law Group, Los Angeles. Telephone: (310) 444-5244. Email: [email protected].
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Katie Norris, Director, Berkeley Research Group, Houston, TX. Telephone: (202) 753-5835. Email: [email protected].
