A Malvern medical-device maker has agreed to pay $44.88 million to settle accusations that it sent U.S. military members’ and veterans’ heart monitoring records to be analyzed in India, after falsely certifying that it wouldn’t let that information out of the United States.
Although U.S. law requires that this work be done in this country, tests at BioTelemetry’s CardioNet division were sent for review from 2013 to 2018 to 450 technicians in India, many of whom were not qualified to do the work, even if it had been legally exported, the U.S. Attorney’s office in Philadelphia said Tuesday.
Unidentified whistleblowers at CardioNet tipped off the government to CardioNet’s deception. The whistleblowers will be able to claim part of the civil settlement as compensation for taking the risk of reporting the company’s illegal practices, the prosecutor’s office said.
According to the company’s owner, Philips, a European equipment maker that bought the company in 2020 for $2.4 billion, “CardioNet and BioTelemetry deny the allegations, and the settlement agreement does not represent an admission of liability,” said Steve Klink, head of Philips’ global press office.
“Philips has agreed to the settlement agreement to resolve this legacy complaint,” he added, noting that the company had already set aside money for the settlement.
The investigation was conducted by special agents of the Department of Health and Human Services, the Defense Criminal Investigative Services, and the Justice...
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