American Medical News (amednews.com) recently reported on statements made in February by FDA officials regarding regulation of medical software.
Here is an excerpt from the story:
Sen. Charles Grassley (R, Iowa) … sent a letter on Feb. 24 to Health and Human Services Secretary Kathleen Sebelius asking what her agency intended to do to ensure the safety of EMRs…
The next day, an FDA director [Jeffrey Shuren, MD, director of the FDA Center for Devices and Radiological Health] stated flatly: “Under the Federal Food, Drug and Cosmetic Act, HIT software is a medical device.”
…he reported that his agency had received 260 reports over the past two years of health IT-related malfunctions causing 44 injuries and six deaths.
In the story, the reporter queries various experts in medical regulation and goes on to quote Dr. Shuren who proposed various scenarios:
…most of which would involve tracking problems after a device or software has hit the market. For example, there could be a database of adverse effects, or a registration list of devices. Another option might be a requirement that developers adhere to the FDA’s Quality Systems Regulation, a list of specific guidelines manufacturers must follow.
Clearly, the rapid proliferation of medical software on mobile devices is raising the interest of not just physicians but also regulators. Hopefully, regulations will remain flexible enough to keep up with the rapid changes in usage and capabilities of mobile devices.
