April 27, 2024

And, it’s not a tiny company with very limited resources, either…

He can’t talk to us because Apple fires employees who talk with the press without permission, but also because the company must walk a fine line in the medical arena. Right now, the U.S. Food and Drug Administration seems set on regulating the software that runs on the iPad, not the device itself, but if the FDA were to decide that Apple is marketing the iPad for regulated medical uses, it could unleash a regulatory nightmare on the company.

Apple has to carefully watch what it says when it talks about the iPad in medicine, says Bradley Thompson, a partner with the law firm Epstein Becker Green and an expert on FDA regulations. As long as they promote it as a general-use computing device, Apple should be fine. But “if they were promoting it for specific medical device uses,” he says, “they would cross a line.”

via Apple’s Secret Plan to Steal Your Doctor’s Heart | Wired Enterprise | Wired.com.

For those who wonder why many of us are against the regulate-everything environment…