Aitrics has rejected claims that its product is being used in violation of government regulations, saying there is no basis for the allegations in the relevant government notice, regulatory approvals or court rulings.
According to the company on Thursday, allegations recently emerged that VitalCare, its flagship product, violated government guidelines by omitting some blood test results from the data entered into the system. The Ministry of Health and Welfare is reportedly conducting on-site inspections at some medical institutions using VitalCare.
VitalCare is an artificial intelligence (AI) medical solution that analyzes electronic medical record (EMR) data from hospitalized patients to predict the risk of acute deterioration and sepsis among general ward patients, as well as acute deterioration among intensive care unit patients.
The system uses 19 types of patient information: six vital signs, including systolic and diastolic blood pressure, pulse rate, respiratory rate and body temperature; 11 blood test results, including bilirubin, lactate, pH, sodium, potassium, creatinine, hematocrit, white blood cell count, bicarbonate, platelet count and C-reactive protein; a consciousness score based on the Glasgow Coma Scale (GCS); and the patient's age.
Critics have claimed that Aitrics uses the system without actually measuring some of the 19 required parameters, in violation of government guidelines.
In response, Aitrics said the guidelines define the technology's usage as analyzing patient age, six vital signs, 11 hematological test results and consciousness scores collected from EMRs and other sources to provide a risk score between zero and 100.
"This means collecting and analyzing information available in EMRs. The wording does not require every item to be physically measured," the company said.
Aitrics added that VitalCare always inputs and analyzes all 19 data points, filling in values that have not been measured using methods approved by the Ministry of Food and Drug Safety (MFDS), such as the most recent measurement or the midpoint of the normal range.
"The claim that the system is used while omitting some test results is not true," the company said.
In two civil lawsuits filed against Aitrics over the same issue, lower courts dismissed both claims. In April, the Osan Branch of the Suwon District Court ruled that government guidelines do not require all 19 data points to be "actually measured," adding that the hospital had used the technology in compliance with the prescribed procedures.
The Ulsan District Court also dismissed a claim on similar grounds.
The Health Insurance Review and Assessment Service reportedly responded to verification requests and objections concerning the patient involved in the lawsuits, saying the medical fees qualified as non-covered medical expenses under applicable regulations. Both cases are currently under appeal.
Aitrics said its regulatory approval specifies that blood tests should, in principle, be prescribed for diagnosing and treating patients' conditions.
"Drawing blood from every hospitalized patient solely to calculate predictive scores would subject patients to unnecessary tests and additional costs," the company said.
It added that the MFDS had confirmed the approved usage through three separate responses and that it was cooperating fully with the ongoing investigation and new health technology assessment.
"VitalCare is being used exactly as approved by the MFDS, and courts have also ruled that its use complies with government guidelines," a company official said. "We will clarify the facts so that a technology developed to protect patient safety is not rejected in the field because of inaccurate claims."
in THEBIO
