Federal EHR Activity

FEDERAL EHR ACTIVITY

There's so much federal activity related to healthcare IT right now, observers almost need a scorecard. And the overall level continues to build as the Bush administration attempts to improve healthcare efficiency, effectiveness and safety through automation and interconnectivity inducements. In a telephonic media briefing on Oct. 6, Mark Leavitt, M.D., Ph.D., medical director for the Healthcare Information and Management Systems Society (HIMSS) and chair of the Certification Commission for Health Information Technology (CCHIT), described healthcare's IT sector as an "immature marketplace," one that is confused, where purchasers can't tell what they're obtaining, and populated by unsophisticated and IT-inexperienced buyers. But it is one of the few areas in which progress is the goal of all parties, factions and interest groups on Capitol Hill.

Goals facilitate progress
In August, the U.S. Department of Health & Human Services (HHS) formalized the organization, functions and delegation of authority for its Office of the National Coordinator for Health Information Technology (ONC), led by David Brailer, M.D., Ph.D. The office is leading a public-private effort to develop a national healthcare IT infrastructure.

The three goals of standards harmonization, interoperability, and electronic health record (EHR) product certification are preeminent in the ONC's overall efforts and will serve as building blocks for a national healthcare information network (NHIN), says Karen Bell, M.D., interim director of the Office of Health IT Adoption within the ONC. "To move forward with involving physicians and developing a national framework, there clearly needs to be a number of steps," she explains, and the three goals will guide those steps.

Autumn contracts
On Oct. 6, HHS announced that it had awarded three contracts totaling $17.5 million to "public-private groups that will accelerate the adoption of health IT and the secure portability of health information across the U.S." Each of the contracts, which resulted from governmental requests for proposal (RFP), has a specific focus.

• The $3.3 million standards harmonization contract was awarded to the American National Standards Institute (ANSI), Washington, D.C. ANSI is charged with convening the Health Information Technology Standards Panel to develop a process for nationwide "interoperability among healthcare software applications, particularly EHRs," according to the ONC.
• The $2.7 million compliance certification contract to develop an EMR/EHR certification process went to CCHIT, Chicago, a private, nonprofit industrywide vendor alliance. CCHIT was required to submit recommendations for ambulatory care criteria in December 2005 and will submit inpatient criteria in 2006.
• The $11.5 million privacy and security contract, aimed at addressing compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy and security provisions and with state-based laws in those areas, went to the Health Information Security and Privacy Collaboration (HISPC). HISPC is a new partnership consisting of a multidisciplinary team of industry experts and representatives of the National Governors Association, Washington, D.C. The collaborative will work with about 40 state and territorial governments to address variations in business policies and state laws that may interfere with health information exchange. RTI International, Research Triangle Park, N.C., a private, nonprofit corporation, will oversee HISPC's work.

In late November, HHS awarded four more contracts, totaling $18.6 million, to four consortia consisting of technology developers and healthcare providers. Leaders of the four consortia are Accenture, New York; Computer Sciences Corp., Birmingham, Ala.; IBM Corp., Armonk, N.Y.; and Northrop Grumman, Los Angeles. (For the complete membership of each consortium, go to www.hhs.gov/news/press/2005pres/20051110.html.)

Each group will develop an architecture and a prototype network for secure information sharing among hospitals, laboratories, pharmacies and physicians. They will test the networks for patient identification, user authentication and other security protections and will examine the feasibility of large-scale deployment. The contracts resulted from RFPs announced by HHS in June 2005.

CCHIT charter looms large
CCHIT is sponsored by HIMSS, the American Health Information Management Association (AHIMA) and the National Alliance for Health Information Technology, all based in Chicago. AHIMA, the national organization for health information management professionals, provides staff support and physical hosting.

Through CCHIT, the three sponsoring organizations are helping advance the work of EHR certification and interoperability. Among CCHIT's goals, according to its Web site, are reducing the risk of EHR investment for providers; directing investments toward products that can improve care quality, safety and efficiency; protecting health information privacy by ensuring adequate security in EHR products and network infrastructure; ensuring EHR interoperability with the NHIN architecture; and facilitating incentives for provider adoption of EHRs.

According to an Oct. 6 press release, CCHIT has already made "significant progress toward certification readiness, publishing and accepting public comment on the first two versions of its work related to ambulatory EHR functionality, interoperability, security and reliability, and the certification process." Pilot testing of the final version of the ambulatory EHR criteria and process is expected to be complete and the first round of product certification available in March 2006.

AHIMA CEO Linda Kloss says she's very pleased with CCHIT's progress so far. "The certification commission was fortunate to have been formed 14 months before the start of this contract," Kloss says. "Therefore, we had well-qualified volunteers and contractors working on this with all deliberate speed and with really just a strong, strong commitment to seeing this effort move forward."

At press time, CCHIT was just about to review the first set of criteria for ambulatory EHR certification. And, adds Kloss, "We're really ready to go to pilot-test on this first round of EHRs around the first of the year and then go to market with the first set of performance criteria in the spring. So we're moving very quickly."

Vendor support
The healthcare IT vendor community is, overall, highly supportive and involved in the process, though concerns remain over potential pitfalls. Charlene Underwood is director of government and industry affairs for Malvern, Pa.-based Siemens and chair of HIMSS EHRVA [Electronic Health Record Vendor Association], a trade association of EHR vendors that operates as a unit within HIMSS. "At this point, EHRVA is generally positive about the process and where things are," she says. "We were formed around the anticipation that there would be certification."

The real question, Underwood says, is whether certification will be an onerous burden for vendors. Clearly, HIMSS-EHRVA is striving to prevent that outcome. Not only has it carefully evaluated every segment of work product, it has made sure that individual association members are affiliates of each of the four workgroups--functionality, interoperability, security and reliability--as well as participants in the certification process itself.

Those members have already participated in two full cycles of all four workgroups, Underwood notes. Her major concerns, she says, are that the ultimate process not prove to be unnecessarily costly, time-consuming or cumbersome, but that it ensure for healthcare IT provider organizations that the federally certified products have the requisite functionality, interoperability and so forth. HIMSS-EHRVA leadership wants to make sure the final model for the certification process is closer in aspect to the streamlined recent model of pharmaceutical approval coming out of the Food and Drug Administration than to the complex and cumbersome model United Laboratories follows for certifying electrical devices, she says.

AHIMA's Kloss understands Underwood's viewpoint, saying "I think that's a shared concern." Kloss adds that CCHIT represents all the major constituencies involved in the process--vendors, providers, payers, purchasers and, now, even consumers, health services researchers and the government. "They all share a goal to move this approach forward," Kloss says. She is confident that the certification process will end up being workable for all involved in reaching the goal of adoption.

Development of federal certification, facilitation of regional health information networks, evolution of the NHIN and other aspects of the federal push for healthcare IT innovation are works in progress, everyone agrees. But the first phases are seeing forward movement. How many hurdles are encountered and how they are managed remains to be seen.

Mark Hagland is a contributing writer based in Chicago.