ehr onc final certification - Department of Health Care Services

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couple of these commenters specifically recommended using implementation specifications that would identify message types necessary for transmissions to immunization registries. Commenters also suggested using the CDC’s implementation guides, and explicitly recommended that we adopt the CDC public health information network (PHIN) implementation guide version 2.2 associated with HL7 2.3.1 for the transmission of immunization information and the CDC implementation guide as well as the implementation guide associated with HL7 2.5.1. Response. In the Interim Final Rule, we expressed our interest in receiving public comment on whether there were additional implementation specifications that we should adopt. We also noted that we would consider adopting implementation specifications for any or all of the standards adopted in the Interim Final Rule. After further consideration of commenters’ recommendations and consultation with the CDC, we agree with these commenters and believe that adopting implementation specifications for the transmission of immunization information would benefit EHR technology developers and users. Moreover, given commenters’ general requests for greater specificity and our stated goal of greater interoperability, we believe that it would be appropriate to adopt the following implementation specifications for the submission of immunization data. For HL7 2.3.1 we have adopted the “Implementation Guide for Immunization Data Transactions using Version 2.3.1 of the Health Level Seven (HL7) Standard Protocol, Implementation Guide Version 2.2.” We are aware that this implementation specification has been successfully adopted numerous times in various contexts since its publication four years ago and do not believe that it will be burdensome for Complete EHR and EHR Module developers to implement these specifications. For HL7 2.5.1, we have adopted the “Implementation Page 94 of 228
Guide for Immunization Messaging Release 1.0.” This implementation specification represents the collaborative effort of the American Immunization Registry Association (AIRA) and the CDC. We have also consulted with CDC, and the CDC confirms the appropriateness and supports the usage of these implementation specifications in this context. We encourage migration to this newer implementation specification and believe that it will likely advance interoperability across the country and improve query capabilities. Comment. A commenter recommended that we clarify that the certification criterion should be limited to verifying the ability of the system to record, retrieve, and transmit immunization information. Response. The purpose of testing and certifying a Complete EHR or EHR Module to this certification criterion is to verify that it can perform the capabilities included in the certification criterion. Comment. A couple of commenters strongly supported the transmission of immunization data to state and local immunization registries but requested that the data requirements be expanded to include the transmission of information regarding diseases such as cystic fibrosis to pediatric registries. Response. Presently, we do not believe that it is necessary or appropriate to expand this certification criterion in this manner. We emphasize, though, that this should not preclude eligible professionals or eligible hospitals from using Certified EHR Technology to submit other types of information as medically appropriate and if the recipient of the information is capable of receiving the data. Page 95 of 228
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DEPARTMENT OF HEALTH AND HUMAN SERV
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HHS Department of Health and Human
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5. Definition of Qualified EHR 6. D
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technology. Section 3004(b)(1) of t
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esolve identified technical challen
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Some commenters appear to have misi
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efficiencies and desired quality im
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codes must be used “inside” an
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not necessarily have applied to our
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3. Definition of Implementation Spe
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program established by the National
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criteria adopted by the Secretary a
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Comment. In the context of the defi
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y the certification criteria for a
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commenters asked whether we meant t
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adopted by the Secretary. The secon
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Response. We would like to make cle
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Response. In the Interim Final Rule
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could be a health care professional
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standard for certain purposes. In s
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e voluntary and would not be requir
Page 43 and 44: already existing regulatory require
Page 45 and 46: setting). We also include, where ap
Page 47 and 48: clarification on why the number of
Page 49 and 50: more clearly specify this capabilit
Page 51 and 52: Response. While we do not require t
Page 53 and 54: that check, the functionality show
Page 55 and 56: Response. The comments are correct
Page 57 and 58: enable the user to electronically r
Page 59 and 60: longitudinal care, or whether the E
Page 61 and 62: EHR and EHR Module developers to pr
Page 63 and 64: suggestions for different age range
Page 65 and 66: Record smoking status for patients
Page 67 and 68: 23) during the EHR reporting period
Page 69 and 70: laboratory test results are receive
Page 71 and 72: commenters reasoned that because a
Page 73 and 74: laboratory test results to be elect
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Page 77 and 78: months). We believe that these revi
Page 79 and 80: that the PQRI 2009 Registry XML spe
Page 81 and 82: To better align this certification
Page 83 and 84: the capability specified by the cer
Page 85 and 86: vendors were unwilling or unable to
Page 87 and 88: the concerns expressed by some comm
Page 89 and 90: Page 89 of 228 electronically compa
Page 91 and 92: (1) The standard (and applicable im
Page 93: for the purposes of demonstrating c
Page 97 and 98: Response. We clarify for commenters
Page 99 and 100: serve as a limiting factor, however
Page 101 and 102: Page 101 of 228 Unchanged Comment.
Page 103 and 104: Comment. One commenter suggested th
Page 105 and 106: Response. We appreciate the thought
Page 107 and 108: Complete EHRs or EHR Modules design
Page 109 and 110: Response. We disagree. As stated ab
Page 111 and 112: Response. As discussed above, we ha
Page 113 and 114: SHA-1 and other secure hash algorit
Page 115 and 116: misinterpreted our example and stat
Page 117 and 118: Other commenters also expressed con
Page 119 and 120: eferenced in FIPS 140-2 Annex A, wh
Page 121 and 122: of the most secure encryption algor
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Page 125 and 126: Use CPOE for medication orders dire
Page 127 and 128: equire EHRs to build custom interfa
Page 129 and 130: esult, we do not believe that this
Page 131 and 132: was needed before RxNorm could be a
Page 133 and 134: • MDDB - Medi-Span Master Drug Da
Page 135 and 136: Response. We do not believe that it
Page 137 and 138: Send reminders to patients per pati
Page 139 and 140: specified data elements and CMS’s
Page 141 and 142: what would qualify as a "response."
Page 143 and 144: Comment. A commenter recommended th
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in accordance with one of the adopt
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Comments. Many commenters suggested
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flexibility in this certification c
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productive, confusing, time-consumi
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include in this initial set. Accord
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to the HITSP C32 implementation spe
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Response. Again, we do not believe
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e achieved without these and recomm
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electronically record, store, retri
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EHRs and EHR Modules designed for a
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§170.205(a)(2)(iii); and (v) The s
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Response. We disagree, as doing so
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Dental Terminology as a condition o
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However, we do not preclude Complet
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ability of CCD and CCR to support t
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ability to receive these reports. M
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commenters acknowledged and express
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a meaningful use objective they wou
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CMS and ONC had worked together to
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The eligible professional or eligib
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EHR technology with the needs of us
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The RFA requires agencies to analyz
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values seemed low and that the gap
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commenter provided), our assumption
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absolute low we estimated for a per
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number of previously CCHIT-certifie
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for Certification Low High Page 197
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Finally, the third type of cost we
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2012 15% $10.10 $30.80 $20.45 3-Yea
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The RFA requires agencies to analyz
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The Office of Management and Budget
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The standards and implementation sp
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The Secretary adopts the following
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any edition other than that specifi
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(e) Regenstrief Institute, Inc., LO
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4. Revise subpart C to read as foll
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smoker; current some day smoker; fo
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(2) Generate audit log. Enable a us
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(3) Medication allergy list; (4) De
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§170.205(a)(1) or §170.205(a)(2).
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(d) Electronic copy of health infor
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specifications) specified in §170.
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