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Electronic Medical Records

(ONC-AA), and multiple ONC authorized certifi ca- tion bodies (ONC-ACBs). These permanent evaluators would certify products based in part on the independent testing results. Don’t worry about that though; EHR/ EMR developers will just be adding the overhead costs into the prices of the EMR products they develop and tax dollars will be funding the increase in size of these federal agencies. Not a good idea? Apparently several organizations are also concerned about this approach. The American Hospital Association recently issued the following statement to the ONC:

ing of what the process is meant to accomplish, what it will entail, and how the results of surveillance efforts will be used. “We request, therefore, that ONC conduct and make available to the public a thorough study on the purpose, scope and process for surveillance of certifi ed EHRs. The study should involve consultation with all relevant stake- holders and include, among other things, a clear discus- sion of the expected benefi ts of surveillance; a summary of alternative approaches to surveillance; a discussion and estimate of the expected impact on stakeholders, including providers whose facilities are chosen for the surveillance process; examples of how surveillance has been conducted in related areas, such as NIST’s program to validate cryptographic modules for conformance to Federal Information Processing Standard Publication (FIPS) 140-2; a comparison of the surveillance process to other forms of accreditation in healthcare, such as required accreditations for healthcare providers to comply with Medicare conditions of participation; and a discussion of how the results of surveillance might be used by the federal government, by vendors and by purchasers of systems.

Figure 6 – Copyright 2010 by MSP. All rights reserved.

“While we understand that the temporary process is meant to provide an expedited process to ensure certifi ed products are available on the market as soon as possible, the two-stage approach for certifi cation will prolong the current instability in the health IT marketplace, which ONC should take steps to limit. In the near term, the market will be negatively affected by queues for certi- fi cation; rapid growth in demand for vendors’ products; limited vendor capacity to support installations; and health IT workforce shortages. Linking the two certifi - cation programs and building confi dence in the value of certifi cation under the process will provide a measure of assurance for those buying and selling certifi ed products.” (Source: AHA Web site)

Indeed, one of the widest reaching new proposals from Medicare and Medicaid (CMS), in its notice of proposed rule making, or NPRM, was for the ONC- ACBs to conduct surveillance of certifi ed EHRs after they have been tested, certifi ed and installed. That means that CMS is not content with testing of EMRs/EHRs alone, but wants them to be tested after they are in use in the hospital setting. Even the FDA does not require that for drugs, but apparently this regulatory expansion is needed for EMR systems. But on what basis? Again, the AHA commented:

“Surveillance of installed, certifi ed products is … a new concept in health IT that, as the NPRM notes, raises many questions. It is diffi cult for stakeholders to answer those questions, however, without a better understand-

22 July 2010

“In considering the process for surveillance from the provider perspective, relevant questions include: Will surveillance only involve interactions with the vendor, or will the ONC-ACBs also involve providers with installed systems? If providers with installed systems are involved, how will the ONC-ACB choose them? What notice will be required? If surveillance is conducted at a particular provider site, what activities will take place? Will the ONC-ACB need access to a provider’s information sys- tems? If so, how will HIPAA privacy requirements be met? Will a business associate agreement be required? Will the ONC-ACB introduce new data to a provider’s system to conduct tests? If so, what assurances will the provider have the ONC-ACB will not negatively impact its system? How will costs incurred by the provider be reimbursed? A thorough study will, no doubt, bring to light ad- ditional questions.” (Source: AHA Web site)

Our conclusions

How long will it take to sort all of this new bureau- cracy out and what will that cost? If MU defi nition clarifi cation is any barometer (now in its 15th month and counting), then CCHIT certifi cation should be sorted out sometime in 2011. But, October 1, 2010 is the date for the fi rst year’s MU self-certifi cations under the ARRA legislation, with reimbursement to begin in January, 2011. If MU isn’t clarifi ed until July 2010 (something that is by no means certain) how much time will EMR developers have to bring their EMRs into compliance with October 1, 2010 MU standards? To be fair, EMR developers have been given a guidance document of what


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