Wednesday, February 15, 2012

EMR Driving Sales of Handhelds

The best way to have a busy and fairly mobile healthcare provider comply with EMR meaningful use requirements is to get her a handheld device for data entry. It's not occurring in every hospital, but it is notable trend in the most wired hospitals. As reported in CMIO (citing Kalorama Information's conclusions), the fastest growth in handhelds in healthcare has been in the administrative side, the type of handhelds used to perform data entry and look at patient records during visits. Though there are a number of factors, we think data entry for EMR is a significant one.

The handheld device market’s more than 10 percent growth since 2007 to $11 billion in 2011.

Kalorama Information's report on this topic can be obtained at our website. t The report includes revenue breakouts by type of device and applications.

Monday, February 13, 2012

FDA Moves Quickly On Illegal Handheld X-Rays

The spread of handheld devices in healthcare is not without its hiccups, as evidenced by the recent crackdown by the FDA on online sales of handheld X-ray units which do not comply with regulations. The units, shipped from outside the United States to U.S. dentists and vets, were not compliant with effectiveness standards of the FDA and may expose a patient to more radiation than the FDA permits (no patient was harmed according to the agency). X-ray units cleared by the FDA bear a permanent certification label/tag, a warning label, and an identification (ID) label/tag on the unit. This was not present in the questioned devices, which were noticed by the Washington State Department of Health and brought to the attention of the FDA.

"Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health.

There are several handheld x-ray systems that do comply with FDA regulations; one is the Aribex NOMAD

The spread of handheld devices will create different regulatory responses which Kalorama Information has monitored. Last year the agency hinted it would regulate new handheld apps as very low-level (Class I) designation. That kind of flexibility would be needed for the market for medical handheld and corresponding apps to grow. However, when the device can do harm or influence a diagnosis, the agency is likely to be more aggressive. Kalorama Information has detailed the markets for handhelds and x-rays in two recent reports:

Handhelds in healthcare:

X-Ray Markets: