There are currently no regulations in place to protect patients from errors.

There is always tension between the desire to provide a product quickly and the need for quality review to maximize safety. HIT does not receive any of the oversight afforded other medical devices.

For example, currently, there are no regulatory requirements to evaluate HIT system safety. Many policy makers believe that the risks of HIT are minor and have fought against oversight. The FDA has and continues to promote a hands-off approach.

In February of 2011 the FDA issued a final rule that provides a “less burdensome path” to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

Medical Device Data Systems are defined as off the shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use. Examples include: devices that store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed.

The new Medical Device Data Systems Rule changes these devices from a Class III (or high risk) devices requiring premarket approval or accessories to an existing medical device or Class I.