Medical Device Daily

VIENNA — A pioneer of electronic health records (EHRs), Mark Leavitt, MD, is chairman of the Certification Commission for Healthcare Information Technology (CCHIT; Chicago), an organization charged with validating the interoperability of patient record systems and medical devices that connect with those systems.

After practicing internal medicine for 10 years, in 1985 Leavitt founded and for 15 years led MedicaLogic (Portland, Oregon), an early developer of ambulatory EHR systems. GE Healthcare (Waukesha, Wisconsin) acquired MedicaLogic in 2002 and Leavitt served as GE’s vice president of clinical initiatives.

CCHIT was founded in October 2005, with a three-year contract of $7.5 million from the U.S. Department of Health and Human Services, and charged with developing certification criteria and inspection processes for EHRs and the networks through which they interoperate.

During a panel session at last week’s World of Health IT congress here, Leavitt said that after two years at the helm of CCHIT, he has learned that “certification is a powerful lever to move a market, but also that it is a lever made of wood that will break if you yank on it too hard.

“Look at what happened with e-prescribing systems,” he said. “It took quite a few years to resolve the problems, but now it is a key requirement for any system.”

Among other lessons learned, CCHIT includes with its published criteria a roadmap that looks two years ahead in order “to signal the industry about criteria that will become important,” Leavitt said.

He also said CCHIT is moving away from self-attestation as a stage in the evaluation process. Instead the certification organization relies increasingly on a juried product demonstration in parallel with technical testing that requires 100% compliance with established criteria.

Leavitt spoke with Medical Device Daily in Vienna.

• Will CCHIT be certifying personal health care devices?

“We are not so much interested in the hardware, but rather the data at the intersection with health records. If it is dead-end device, like a heart rate monitor on a running treadmill, then this is outside of our camp.

“But if the device designers expect medical professionals to look at the personal data, then it needs to be in the right format and efficient for that professional, so here it enters into our camp. Physicians are not interested in receiving raw data from a personal device — for example, from a continuous glucose monitor four times per day. But the doctor does want to see trend data, maximums and minims and the analysis. Here we will need standards and security, including especially identification, so here the device has entered the area of certification.

“When you start to send that data over a pipeline, again we are not as interested in the hardware of that exchange. I don’t believe we will ever get into the box at home nor the links to download. For example, if it is wireless transmission, this is the area for the Continua Alliance (Portland, Oregon) and their certification efforts.

“An interesting area for us will be serious monitoring devices that will be used for clinical research. It is still at a very early stage and we do not yet have a work group here, but these devices are going to be generating validated data and I know it will become important.”

• Is the personal health record (PHR) important?

“Well, Google and Microsoft think it is, and those are some pretty big players.

“Right now Intel, Cisco and Wal-Mart are creating a PHR for their employees, called Dossia, that will be a PHR as well as a portal for health information.

“We expect to move our certification into this area for security and identity and especially interoperability.

“Where we will touch this area, again, is where it moves to professional standards to connect personal health records to the professional system.

“One method may be browser-based. A second model could be through an aggregator program, a medical version of Quicken, the software for personal finances. We have become comfortable with personal finance software, so can we expect to see similar proposals for personal medical software?

“With this model, the software is a proprietary system that both sends and receives data about the patient. It goes out on the web, or to designated devices, and collects information. It treats that information, perhaps with some analytics and sends it out, perhaps to doctors or care professionals. Now it becomes important for certification.”

• Can there be a global certification standard?

“If there can be, it will not be anytime soon. The reason is there are so many different models of medical practice around the world, along with health financing and information systems, that conform to local requirements.

“It would be a foolish exercise to say one-size-fits-all. It is against the reality of what exists, and for good reasons. Still, a convergence at some level will certainly take place at some point. But it is very hard to predict when.”

Also at the World of Health IT meeting, Royal Philips Electronics (Amsterdam, the Netherlands) rolled out a tablet for medical staff to make the headaches of data tracking in intensive care wards a little less intensive.

A clipboard-sized tablet computer, the CliniScape Mobile Clinical Assistant is a tablet-PC is a 10.4” pen-touch screen with a digital camera that is loaded with RFID and wireless transmission features.

The pass-around electronic patient monitor, to be available in 1Q08, is medical-grade, with wipeable surfaces and combat-hardened with ready-to-be-dropped construction defined by Intel’s (Santa Clara, California) Digital Health Group with input from nurses and physicians.

A semi-sealed device with a single USB slot behind a protective cover, the CliniScape Mobile can be clean with disinfectant to reduce the spread of infection.

Weighing 3.5 pounds, the lightweight portable runs on an Intel Core Solo Processor with a 60 gigabyte hard drive and displays with a XGA touch-screen with digitizer. A barcode reader is an add-on option.

A hand grip helps reduce fatigue when held flat for extended periods and can be docked at a station with a built-in battery charger, 3 USB ports and one Ethernet jack.