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LONDON, Ont. — Health regulators worldwide are concerned about a wave of medical smartphone apps and say some of them may place patients at risk.

More than 97,000 health apps were available earlier this year, according to one estimate, and their number is growing explosively.

Regulators are meeting to discuss how to safeguard citizens from medical claims that may be unfounded.

Health Canada has joined its counterparts from the U.S., Brazil, Japan, Australia, China, the European Union and the World Health Organization to seek a co-ordinated way to keep pace with a technology some call mhealth — "m" for mobile.

The Canadian regulator also is looking out for apps that claim to be a substitute for traditional medical devices but that haven’t gone through the testing required to be used in Canada.

"Adding a disclaimer to say that it is not intended as a medical device does not exempt it from the requirements of the Medical Devices Regulations," Health Canada wrote in response to questions from QMI Agency.

The concerns are well founded, says a former investigator with the U.S. Food and Drug Administration (FDA), Christopher Rush, who runs a consulting firm that helps companies navigate rules south of the border.

A patient who relied on unfounded marketing claims by an mhealth app could be hurt or even killed, he said.

"It could be fatal. The FDA is really going to have to take a hard stance," said Rush, president of Texas-based FDA Quality and Regulatory Consultants.

Concerns have been raised over some of the claims made by apps, including one that touted itself as a way to measure your blood pressure using only your phone.

"No cuff or any additional accessory is required," Aura Labs claimed in its marketing for Instant Blood Pressure.

It also claimed that its app was connected to Johns Hopkins University in Baltimore — a claim the school quickly stamped out.

"Upon learning of the app’s claims, Johns Hopkins’ legal counsel contacted the developer and sent a letter insisting he cease and desist with any use of the Johns Hopkins name," a school spokesperson wrote.

Aura Labs has since removed the claim but still markets its app as a replacement to the traditional blood pressure cuff — a claim qualified only if a prospective buyer clicks for more information in the iTunes store.

Aura Labs did not reply to a request for comment Wednesday.

jonathan.sher@sunmedia.ca

Twitter: @JSHERatLFPress