ehr onc final certification - Department of Health Care Services

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seeking and will enable Complete EHR and EHR Module developers to focus their efforts on a more specific implementation of the HL7 2.5.1 standard. We do not believe that a suitable implementation specification for HL7 2.3.1 exists for the purpose of public health surveillance and reporting. Comments. Multiple commenters stated concerns that the Federal government and state governments, as well as other public health agencies, do not have the capability to receive information electronically in a standardized format. One commenter stated that while they supported using the HL7 standards, some agencies are only able to accept public health submissions if they have an HL7-based feed. Several commenters suggested that the public health reporting requirement be delayed until a single, national standard exists. One commenter stated that requiring EHRs to “electronically record, retrieve, and transmit syndrome-based public health surveillance information to public health agencies” is a worthwhile future goal, but they strongly questioned the likelihood that it could be accomplished within the 2011-2012 timeframe. The commenter also noted that the certification criterion did not specify which agencies (local, state, Federal) are included, and that most of those agencies are not prepared to receive biosurveillance data electronically in the format specified. The commenter concluded that it would be difficult for any EHR to prove compliance with the certification criterion as written and recommended the following alternative: “Electronically record, retrieve, and be capable of producing an electronic message containing syndrome-based public health surveillance information in accordance with one of the standards specified in §170.205(g).” Response. We recognize that some public health agencies do not yet have the capability of electronically receiving information. We do not believe that this should Page 98 of 228
serve as a limiting factor, however, or preclude Certified EHR Technology from having the capability to transmit information in a standard format. Comment. One commenter commented that if a public health agency is unable to accept the data, separate reports could be filed with the public health agency to ensure compliance with the standards. Response. The commenter’s point is unclear, as is its proposal. We therefore reiterate that Certified EHR Technology must be capable of transmitting health information in accordance with the standards adopted by the Secretary, regardless of whether a specific public health agency can accept or receive the information. Comment. One commenter suggested that if current interfaces comply with public health surveillance data using older versions of HL7, the organizations should be allowed to keep these versions and not be required to upgrade to a newer version. Response. We permit a Complete EHR or EHR Module to be tested and certified to either HL7 2.3.1 or HL7 2.5.1. No other versions will be considered compliant with the adopted standards or certification criterion. Comment. One commenter recommended that we specify acceptable testing methods. The commenter also recommended that the testing methods should include an evaluation of HL7 conformance, completeness, and accuracy of test messages sent to a state public health agency with a demonstrated capability for electronic laboratory reporting. Response. We do not specify the testing methods applicable to the certification criterion, because that information is outside the scope of this final rule. Page 99 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
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already existing regulatory require
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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
Page 75 and 76: or outreach Generate patient lists.
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 and 94: for the purposes of demonstrating c
Page 95 and 96: Guide for Immunization Messaging Re
Page 97: Response. We clarify for commenters
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
Page 123 and 124: the disclosure was made (recipient)
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
Page 145 and 146: in accordance with one of the adopt
Page 147 and 148: 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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