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CHIME's comments were delivered in a September 21 letter to Department of Health and Human Services' secretary Kathleen Sebelius, in which the organization chided HHS over plans to include metadata standards in Meaningful Use Stage 2, and expressed doubt that healthcare stakeholders are fully onboard with the decision to use the HL7 CDA R2 header to support metadata standards.
"We do not believe enough progress has been made, or evidence gathered, to support the technologies and strategies needed to include metadata standards as part of Meaningful Use Stage 2," wrote Richard Correll, CHIME president and CEO, and Lynn Vogel, CHIME board chairman.
Regarding metadata standards that would be appropriate for electronic health information exchange, the recently published advanced notice of proposed rulemaking (ANPRM) focuses on three categories: 1) patient identity, which includes data elements about a patient, 2) provenance, which consists of data elements about the source of the clinical data, and 3) privacy, which includes data elements about the type(s) and sensitivity of clinical data.
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Furthermore, the government's Health IT Standards Committee has recommended the use of the HL7 CDA R2's XML, which they believe is the best format for describing generic clinical documents to support the implementation of metadata standards.
Sharon Canner, CHIME's senior director of advocacy, said she wants to see a broader number of pilot projects and proofs of concept--to be followed by proofs of scalability around metadata standards. Furthermore, Canner said she's seen some troubling signs that initial efforts to adopt other standards that once held great promise were not implemented.
"A great example is the CMS [Center for Medicare and Medicaid Services'] effort with respect to PQRI 2009 Registry XML, which pertains to the submission of clinical quality measures to CMS. CMS has acknowledged that the standard they were using (and consequently made all the vendors use and hospitals implement) will not work moving forward," Canner told InformationWeek Healthcare.
She said CMS has proposed a pilot program to figure out standards that will work, and hospitals can simply "attest" to the clinical quality measures (as they did for the first payment year) in subsequent payment years. In this example, however, the inadequate standard does not cause much harm or waste many resources, but that might not be the case with metadata standards.
"If similar problems occur with metadata, the ramifications will be much more severe. The workflow issues are of much graver concern with metadata than with clinical quality measure reporting; for example, if ONC [Office of the National Coordinator] ends up having to change those standards at Stage 3 there will be much bigger problems. This is when they'd be in danger of "falling behind," Canner said.
CHIME's letter, which is in response to HHS' proposed rules on metadata standards to support nationwide electronic health information exchange, comes at a time when the ONC is spearheading two initiatives--Query Health and Data Segmentation--which will advance the use of metadata in clinical information systems. However, these initiatives are early in the development stage.
While CHIME commended ONC's efforts on query health, data segmentation, and other initiatives within the Standards & Interoperability (S&I) framework, the organization is urging more action to verify the range of possible standards and develop an implementation process.
"Additionally, ONC should engage hospitals, vendors, and health information organizations to determine feasibility for future Meaningful Use certification. However, we do not foresee this scenario happening before Meaningful Use Stage 3," Correll and Vogel wrote.
They continued: "If ONC is confident robust metadata standards currently exist, CHIME would like to offer its services and assist in establishing implementation guidelines to ensure that protocols can scale across the provider community."