ehr onc final certification - Department of Health Care Services

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definition of author is consistent with our expectation. While we believe that in most cases a user will be a health care professional performing an action using Certified EHR Technology, it is also possible that a device or another software process or program could perform any one of these actions. We do not intend to preclude Complete EHR and EHR Module developers from including these and other types of specific features. Comment. One commenter stated that the audit alert criterion exceeds reasonable expectations for Certified EHR Technology to provide automatic alerts, and recommended that the audit criteria focus on record access rather than electronic alerts. Several commenters suggested that alerts are not well defined and should be removed from the criteria. Several commenters expressed concern that the audit alerting criterion goes beyond what is required by HITECH and HIPAA and exceeds the current capabilities of products in the market, and recommends that the alerting criterion be eliminated from the final rule. Some commenters recommended against the adoption of certification criterion that requires EHR systems to create an unlimited and open-ended series of rules to produce user-defined alerts, and suggested that we should clearly define which actions should be recorded and what alerts should be defined and provided in an audit log. Several commenters stated that the use of the phrase “based on user-defined events” in the criterion could be easily misinterpreted or misunderstood to extend beyond “entity-defined” events to include individual patient preferences. Some of the commenters that expressed concerns also contended that it would be difficult to test and certify this portion of the certification criterion. Response. Again, we appreciate the thoroughness of the commenters’ suggestions. With respect to alerts based on user-defined events, we had intended for Page 106 of 228
Complete EHRs or EHR Modules designed to provide this capability to be capable of being configured by a specific user of Certified EHR Technology or based on organizational policy to generate alerts when certain actions (defined in the standard) had taken place. For example, a user-defined event could be when a patient’s health information is accessed outside of normal business hours. In this case, it was our expectation that Certified EHR Technology would alert a specific user of the Certified EHR Technology or the organization’s information security staff. We understand the point that commenters raise, however, about the potential for misinterpretation of this certification criterion and the consequent potential burden. Our overall intent for the third paragraph of this certification criterion was to ensure that Certified EHR Technology provided the capability for eligible professionals and eligible hospitals to gain access to a specified portion, or a complete representation, of the Certified EHR Technology’s audit log. We believe that this capability is essential for eligible professionals and eligible hospitals for risk analysis and other purposes. Therefore, in concert with the feedback commenters provided on the second paragraph, we analyzed whether combining the third paragraph with the second paragraph into a single paragraph would express a clearer requirement. Accordingly, we have merged the two paragraphs and have adopted in the final rule a requirement that we believe more clearly expresses our intent for this certification criterion. We also note for clarification that the phrase “any of the elements specified by 170.210(b)” would also include, for example, “date” or that information has been “deleted.” Finally, we believe that it is important for our privacy and security certification criteria to remain consistent with the HIPAA Security Rule to the degree that Certified Page 107 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
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clarification on why the number of
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more clearly specify this capabilit
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Response. While we do not require t
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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 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: Response. We appreciate the thought
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
Page 149 and 150: flexibility in this certification c
Page 151 and 152: productive, confusing, time-consumi
Page 153 and 154: include in this initial set. Accord
Page 155 and 156: 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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ehr onc final certification - Department of Health Care Services

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