April 23, 2011 Leave a comment
According to the website FierceMobileIT.com, the FDA has enacted new rules for mobile medical devices used by healthcare providers. These devices will be classified as Medical Device Data Systems (MDDS) and will mostly be considered, for regulatory approval purposes, as Class I (low risk) medical devices.
Lynette Luna reports:
The rule requires IT companies to register health care hardware and software that transfer, store, convert or display health care data. According to the FDA, these Class 1 devices don’t include devices that will be used for active patient monitoring.
The following devices will fall under this FDA classification:
- Medical billing systems
- Work flow software
- Communications protocols
- Wireless modems
- Laptops and tablets (such as the iPad)
Devices not covered by this ruling, according to the report, include those used for active monitoring of patients.
Like other Class I medical device vendors, MDDS vendors “list their products and detail publicly any potential adverse effects of their products. And health care providers must report any deaths or serious injuries MDDS devices may have contributed to or caused.”
“This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems,” Dr. Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health, said in a statement. “This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers, but continue to assure that data stored, transferred or displayed on these systems remain reliable.”