Wednesday, October 10, 2007

Premature Certification: Ready, Fire, Aim?

It may be harmful to certify prematurely what is not yet clearly understood.

It may be wasteful to deliver too many "top down" recommendations without being absolutely sure the certification body has both an understanding of and an appreciation for the complexity of issues and a respect for the professional societies, organizations, and other bodies who have been exploring (often for decades) issues underlying certification requirements.

The Certification Commission for Health Information Technology was developed in response to the HHS health information technology road map first released on July 21, 2004. The report described "private sector certification of health information technology products." The authors argued:
EHRs and even specific components such as decision support software are unique among clinical tools in that they do not need to meet minimal standards to be used to deliver care. To increase uptake of EHRs and reduce the risk of product implementation failure, the federal government is exploring ways to work with the private sector to develop minimal product standards for EHR functionality, interoperability, and security. A private sector ambulatory EHR certification task force is determining the feasibility of certification of EHR products based on functionality, security, and interoperability.
Phase one of the process was to focus on market institutions to foster adoption and did mention the relationship of EHR to health information exchange. The report stated:
Many of the agents and entities that are necessary for the health care industry to realize better value do not exist and must be developed and made operational before widespread change can occur. Certification organizations, group purchasing entities, and low-cost implementation support organizations are examples of market institutions that do not exist at this time, but which are necessary to support clinicians as they procure and use information technology. Likewise, although there are a variety of regional health information organizations, there is no consistent institution that can provide a platform through which financial investment or other support can be channeled to clinicians.
What began as a very clear and directed effort to reassure wary clinicians that health information technologies would meet clinical needs and could be acquired with minimal technical and financial risk has, arguably, devolved into a morass of overlapping and complex groups with great competence, sincere intention, and strong, balanced management.

Three years after the release of Secretary Thompson's report, much work needs to be done on fundamental issues widely perceived to be critical to progress. Examples include the ability to efficiently and securely deliver laboratory and prescription drug information to qualified providers at the point of care and need. Although there are early promising results, one wonders if the momentum on these critical areas has been stalled because of the barrage of meetings, use cases, demonstrations that do not release data, and an ever-changing set "priorities."

No one can question the talent and energy dedicated to - or the importance of - each and every one of these activities (how can you argue with drawing more attention to child health?), but increasingly, one gets the feeling of a technology debate landscape that is 10 miles broad and 1 inch deep. It is increasingly hard even to follow this work much less understand the priorities. It is increasingly difficult to see if the facts are even agreed upon. (The health information exchange discussion, for example, claims there are between 120 and 200 exchanges that - allegedly in the public interest - must be "certified"). This writer isn't sure there are a dozen functioning exchanges and questions whether or not certification is premature.

Here's a list of the working groups and their description

Ambulatory
The Ambulatory EHR Work Group develops criteria and test scripts for certifying electronic health record (EHR) products used in physician offices - large and small - where most Americans get their care.

Inpatient
Tasked with prioritizing and developing criteria and testing for Inpatient EHRs, the Inpatient EHR Work Group monitors the current need for health IT technology used in acute, hospital-based care.

Network
Interoperable EHRs require a structure for sharing information—a secure network. With the guidance of the Expert Panels, the Network Work Group is tasked with initiating the development of criteria and tests for these emerging health information exchanges.

Foundation
A core set of requirements underlie all EHR products and networks. The Foundation Work Group works with all other Certification Work Groups and Expert Panels, to propose the criteria and tests that belong to that core set.

Interoperability
Ensuring that EHR products and networks can share data compatibly is one of the primary goals of certification—and the public and private heath IT communities. The Interoperability Expert Panel works with all CCHIT Work Groups to recommend criteria and testing that ensures data portability.

Security
Charged with advising on the security requirements for CCHIT Certified EHRs and networks, the Security Expert Panel remains up-to-date on security standards and best practices to recommend criteria and testing for all EHRs and their networks.

Child Health
The care of children spans physician specialty practices and care settings. It's the role of the Child Health Expert Panel to ensure that EHR products and networks address the health IT requirements of caring for this special population by developing criteria and test scripts to be added to other certification categories as an option for certification.

Cardiovascular Medicine
The Cardiovascular Expert Panel has been tasked with recommending optional criteria and test scripts to other certification categories to address the unique needs of office-based cardiovascular physicians and practices with a goal of improving health IT adoption in that specialty medicine group.

Emergency Department
For this newly created certification category for a special care setting, the Emergency Department Work Group is charged with initiating the development of criteria and test scripts to certify EHR products used to support the treatment of Emergency Department patients.

Privacy & Compliance
To ensure patient confidentiality and regulatory concerns are addressed, the Privacy & Compliance Expert Panel is charged with recommending criteria and test scripts to all Work Groups for certification of EHRs and networks.

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