ehr onc final certification - Department of Health Care Services

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specify that electronic media such as thumb drives or CDs must be used. An eligible hospital will be able to determine, consistent with its security posture, if certain electronic media is permissible and if so, what types. It will also be able to determine the means and location through which an electronic copy may be provided, e.g., at the records management department or office. As the commenter suggested, a patient portal would be an acceptable mechanism to provide an electronic copy. Comment. A commenter stated the certification criterion for eligible hospitals should be limited to information or tests performed during the course of a patient visit or hospital stay and include only summary information of diagnostic test results or of information that is clinically significant and discovered during the encounter or admission. Other commenters requested that we clarify the reference to procedures. The commenters asked that the regulations specify whether the EHR technology must enable the user to create an electronic copy of procedures associated with the most recent hospitalization, or any historical procedures, or the procedures that the patient should follow-up to do after discharge. Response. At a minimum, Certified EHR Technology must be capable of generating an electronic copy of health information that includes the elements specified by the certification criterion in an electronic copy. We do not specify the time period for which the electronic copy must cover as a condition of certification. Comment. A commenter requested that we consider eliminating the reference to standards in this certification criterion for Stage 1 and focusing on human readable formats. Page 166 of 228
Response. We disagree, as doing so would run counter to our long term goals and would not help build the foundation necessary for more comprehensive capabilities to be added in the future. Comments. A few commenters noted that neither the CCD nor CCR contain an applicable section for discharge summary. One commenter recommended that because the provision of an electronic copy of discharge instructions was required by another certification criterion, that discharge instructions should be removed as an element in this electronic copy. Response. We reviewed commenters’ concerns and agree that there is no applicable section for a discharge summary. Therefore, we have revised this certification criterion to reflect that while the other data elements can be conveyed using the patient summary record standards (CCR or CCD), we are not requiring the use of any standards for the discharge summary section. In order to support the meaningful use objective and measure, however, we note that we do expect Certified EHR Technology to be capable of providing a electronic copy of a discharge summary like a patient summary record, in human readable format and on electronic media or through some other electronic means. Other electronic means could include, for example, the discharge summary represented as a CCD plus the "Hospital Course" CDA section or provided as a PDF. We have revised the certification criterion accordingly. We note that our responses to the following comments also apply to other certification criteria that reference procedures. Comments. A commenter requested clarification as to what we meant by "procedures" for hospitals, because coding for medical procedures typically occurs after Page 167 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
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Response. The comments are correct
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enable the user to electronically r
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longitudinal care, or whether the E
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EHR and EHR Module developers to pr
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suggestions for different age range
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Record smoking status for patients
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23) during the EHR reporting period
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laboratory test results are receive
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commenters reasoned that because a
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laboratory test results to be elect
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or outreach Generate patient lists.
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months). We believe that these revi
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that the PQRI 2009 Registry XML spe
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To better align this certification
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the capability specified by the cer
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vendors were unwilling or unable to
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the concerns expressed by some comm
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Page 89 of 228 electronically compa
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(1) The standard (and applicable im
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for the purposes of demonstrating c
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Guide for Immunization Messaging Re
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Response. We clarify for commenters
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serve as a limiting factor, however
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Page 101 of 228 Unchanged Comment.
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Comment. One commenter suggested th
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Response. We appreciate the thought
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Complete EHRs or EHR Modules design
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Response. We disagree. As stated ab
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Response. As discussed above, we ha
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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
Page 157 and 158: Response. Again, we do not believe
Page 159 and 160: e achieved without these and recomm
Page 161 and 162: electronically record, store, retri
Page 163 and 164: EHRs and EHR Modules designed for a
Page 165: §170.205(a)(2)(iii); and (v) The s
Page 169 and 170: Dental Terminology as a condition o
Page 171 and 172: However, we do not preclude Complet
Page 173 and 174: ability of CCD and CCR to support t
Page 175 and 176: ability to receive these reports. M
Page 177 and 178: commenters acknowledged and express
Page 179 and 180: a meaningful use objective they wou
Page 181 and 182: CMS and ONC had worked together to
Page 183 and 184: The eligible professional or eligib
Page 185 and 186: EHR technology with the needs of us
Page 187 and 188: The RFA requires agencies to analyz
Page 189 and 190: values seemed low and that the gap
Page 191 and 192: commenter provided), our assumption
Page 193 and 194: absolute low we estimated for a per
Page 195 and 196: number of previously CCHIT-certifie
Page 197 and 198: for Certification Low High Page 197
Page 199 and 200: Finally, the third type of cost we
Page 201 and 202: 2012 15% $10.10 $30.80 $20.45 3-Yea
Page 203 and 204: The RFA requires agencies to analyz
Page 205 and 206: The Office of Management and Budget
Page 207 and 208: The standards and implementation sp
Page 209 and 210: The Secretary adopts the following
Page 211 and 212: any edition other than that specifi
Page 213 and 214: (e) Regenstrief Institute, Inc., LO
Page 215 and 216: 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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