SYDNEY — Letters have been mailed to 277 patients in Cape Breton informing them of a privacy breach involving their medical records.
John Malcom, CEO of the Cape Breton District Health Authority, says inappropriate access to the records happened during a research study into the effectiveness of a new type of drug treatment for diabetes.
Researchers were given names, addresses and results from two specific lab tests before physicians involved in the study asked patients for their consent to participate, he said Wednesday.
He said the project was immediately stopped after the breach was discovered in mid-April.
Malcom said health officials are confident the information was not shared beyond the researchers, who were conducting a multi-site international study for Janssen Inc.
“We were quite satisfied that because we had retrieved all of the information, and because we were dealing with reputable researchers who assured us that they hadn’t made any copies and they’d returned everything, that there wasn’t an ongoing serious issue of confidentiality,” said Malcom.
Malcom said the breach was discovered as the district was dealing with a significant outbreak of C. difficile, and it also took time to verify the addresses of the patients involved.
He said the intention was to send letters to patients in June but the recent postal strike prevented that from happening.
“It’s a rather complex issue . . . so you actually do need something in your hand to understand what exactly happened and what steps we took, so sending it by mail appeared to us the best way to do it,” he said.
He said the incident revealed research protocols need to be more widely shared among district officials, and any further release of information would not be allowed without multiple checks on consent.
There will be no disciplinary action.
“It was our mistake as a district, we acknowledge that, but it wasn’t one individual’s mistake,” said Malcom.
Article source: http://www.thechronicleherald.ca/Front/1253243.html