CCHIT Comments on Interim Final Rule for EHR Certification Criteria

CCHIT has published their comments made on the Interim Final Rule (45 CFR Part 170, RIN 0991-AB58), published in the Federal Register of Jan 13, 2010, “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology.” Or as I like to call it, the EHR Certification criteria.

Here’s 3 paragraphs that kind of describe CCHIT’s broad feedback on the EHR Certification criteria:

Before offering detailed suggestions, the Commission wishes to highlight three overarching concerns with the IFR as written:

• Scope. While “Complete EHR”sounds like a desirable certification, the package of requirements in the IFR may not match the needs and expectations of doctors and hospitals, nor the realities of the marketplace, for EHRs. By including two functions of an administrative/billing system in the scope of EHR certification, ONC may exclude one third or more of the offerings in the current EHR marketplace, while suddenly forcing hundreds of billing products to undergo unnecessary certifications. In other areas, the scope falls short of being complete: for example, an EHR that does not offer competent electronic management of progress notes would be unusable and medico-legally unsound, and an EHR that fails to prominently display patient advance directives in an emergency could compromise patients’ rights at their time of greatest vulnerability.
• Interoperability. The Commission and its expert volunteer panels believe that certain criteria and standards in the IFR represent a step backwards in progress toward EHR interoperability. For example, well-defined standards for receiving electronic laboratory results in the doctor’s office and for exchanging clinical summaries had already been recognized by the Federal government and widely supported by industry – as evidenced by the certification of over 80 EHR products to those standards in 2008. Yet under the IFR, that standard for receiving laboratory results, and the specific implementation guidance for exchanging clinical data, have been dropped. Where one standard was previously recognized for clinical data exchange, the IFR offers two different, incompatible standards. Conversely, other interoperability criteria in the IFR, such as the requirement that EHRs be capable of transmitting biosurveillance data to public health authorities, could immediately increase EHR cost and complexity while benefits remain years away because public health authorities lack standards-compliant infrastructure and systems for receiving that data.
• Functionality. Some of the IFR criteria define required functionalities of an EHR too microscopically, adding unnecessary complexity and creating barriers to innovation. Other criteria are too vague to be reliably verified in a testing process, creating a risk that the expectations of providers, payers, and the public regarding the performance, safety, and benefits of Certified EHRs will not be met. A particular concern surrounds the reporting of quality measures, with the IFR calling for standards and measures that are yet to be defined or that require significant revision to make them computable from EHR-based data.

I’ll be interested to hear people’s comments about CCHIT’s feedback on the HHS EHR Certification Criteria.