AHA Recommends Changes to EHR Standards, Implementation

Adding its voice to the EHR standards debate, the American Hospital Association asked for changes to proposed EHR standards, implementation, and certification.

The AHA sent its recommendations and comments regarding the interim final rule specifying the initial set of standards, implementation specifications, and certification criteria for EHR technology to the National Coordinator for Health IT in a March 15 letter.

The AHA made recommendations in five areas:

On EHR certification for meaningful use

The AHA believes:

• There needs to be "a clear distinction between the responsibilities of healthcare providers and the responsibilities of vendors of health IT products," as certification is intended to support providers, not impose an additional burden.


• Realistic timelines are necessary. AHA recommends one year between certification criteria finalization and vendor system certification, and an additional two years after certified products become available before providers must implement and/or use them to meet meaningful use criteria.


• The ONC should support CMS in creating a grandfathering provision for already-installed EHRs that permits providers to meet meaningful use criteria.

On implementation issues

The AHA offered the following commentary:

• While the interim final rule's definitions of EHR technologies in the interim final rule provide a solid framework for discussing certification, they don't take into account the complexity of EHR systems deployed in hospitals. Clarification is needed regarding which elements of an EHR system need certification and verifying that certain common practices will not necessitate additional or separate certifications.


• The AHA recommends that ONC specifically state the following: A hospital only needs to attest that its EHR system includes elements certified against the meaningful use objectives it must meet; a hospital's EHR system may also include auxiliary components and feeder systems that the hospital will use to meet meaningful use objectives, but do require separate certification; hospitals may install interfaces and programs to connect or complete EHR modules and related systems, but they do not require certification; hospitals may modify or customize certified EHR technology without needing additional certifications; and hospitals "will not be held responsible for having certified EHR modules for functionalities that no vendors support."


• The AHA believes there should be no requirement to conduct separate, on-site certifications for all best-of-breed systems or those composed of a base system with add-on components.


• The AHA encourages ONC and CMS to provide clear guidance establishing minimum requirements for hospitals to demonstrate an EHR is certified, and that those requirements be subject to notice and comment. AHA believes requiring hospitals to attest to their certification status is a legal compliance burden that could "result in significant penalties if hospitals and enforcement agencies have differing understandings of the specific requirements."

On EHR certification criteria modifications

The AHA recommends the ONC do the following:

• Take all necessary regulatory steps (e.g., publishing a final rule or even a second interim final rule) as soon as possible because EHR vendors and stakeholders require lead time to bring certifiable products to the market.


• For measures included in the meaningful use final rule requiring a number or percentage as a response, include certification criteria for the generation of the health IT functionality measures. In addition, certification of EHR products should require only generation of the associated measure.
• Include certification criteria for any new objectives in CMS' EHR incentive program final rule.


• Remove the electronic claims submission and electronic verification of insurance eligibility certification criteria

On certification criteria and standards

The AHA recommends:

• Changing the medication reconciliation certification criteria to avoid potential safety concerns. AHA suggests that the criteria should state, "Display simultaneously two or more medication lists and provide tools for the clinician to perform medication reconciliation that will result in a single list."


• Adopting Health Level Seven Clinical Document Architecture Release 2 Level 2 Continuity of Care Document (HL7 CDA CCD) as the sole standard for patient summary records.


• Certifying vendors based on their systems' ability "to accurately and reliably collect and report" on quality measures once they are ready for automated reporting.


• Delaying quality reporting until at least 2012 because of the lack of "appropriate e-specifications for hospital quality measures"


• Deferring adoption of the public agency reporting standard until there is one viable national standard

On privacy and security

The AHA recommended that:

• The rule specify that for EHRs seeking certification, privacy and security certification criteria are "addressable" the same way that certain HIPAA security rule specifications are "addressable."


• There be a delay in the accounting of disclosures criteria and standards until the HHS Secretary issues an updated rule. This will help ensure that the technical specifications match the obligations that the forthcoming rule puts in place.


• Revisions should be made to ensure that EHR technology is capable of providing electronic access and copies of health information for patients.


• The ONC should clarify that the interim final rule's standards for encryption and hashing do not involve any additional requirements for HIPAA covered entities beyond those that the security rule already requires.


• The audit alerting criterion be eliminated because it "goes beyond" HIPAA and HITECH requirements and exceeds the current capabilities of products on the market.