ehr onc final certification - Department of Health Care Services

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disability communities on accessibility and usability and how HIT will impact members of this community. The commenters requested that we clarify the applicability of accessibility standards and that we add technological non-discrimination as a goal to guide future standards work. Response. We appreciate the thorough and thoughtful comments provided related to accessibility. We believe that HIT has the potential to provide all persons with more efficient access to their health information. In that regard, we solicited public comment on the issue of accessibility and certification to garner more information about available standards and to begin a path forward that included these standards as part of the overall standards adoption process. We reiterate what we discussed in the interim final rule when we provided the context for our solicitation of public comment on accessibility. “Nothing required by this interim final rule should be construed as affecting existing legal requirements under other Federal laws. While the capabilities provided by Certified EHR Technology may assist in the compliance with certain legal requirements, they do not in any way remove or alter those requirements….As another example, in providing patients with access to their online health information, it is important to note that the accessibility requirements of the Americans with Disabilities Act of 1990 and Section 504 of the Rehabilitation Act of 1973 still apply to entities covered by these Federal civil rights laws. Additionally, Title VI of the Civil Rights Act of 1964 and its implementing regulations protect persons from unlawful discrimination on the basis of race, color and national origin. Under Title VI and its implementing regulations, recipients of Federal financial assistance must take reasonable steps to ensure meaningful access to their programs, services, and activities by eligible limited English proficient persons.” While we have not yet adopted specific accessibility standards as a condition of certification, we believe that the adoption of such standards in a future rulemaking would prove beneficial, to enable all persons (including health care providers with disabilities) to have equitable access to EHR technology and the electronic information it generates. In the interim, we encourage Complete EHR and EHR Module developers to design their Page 184 of 228
EHR technology with the needs of users of assistive technology in mind, and remind eligible professionals and eligible hospitals who seek to adopt Certified EHR Technology to review and comply with applicable legal obligations regarding accessibility. Among the ways of designing certain capabilities with accessibility in mind, we would encourage Complete EHR and EHR Module developers to consider implementing, for example, the WCAG 2.0 8 when providing web-oriented content so that it is more accessible to persons with disabilities. We expect the HIT Standards Committee to identify accessibility- oriented standards 9 when it issues recommendations regarding the standards that the Secretary should adopt in future years. Comments. Several commenters made recommendations related to standards that we could adopt to support future stages of meaningful use. Other commenters expressed concerns related to the “candidate Stage 2 standards” that we referenced in the Interim Final Rule. Finally, commenters requested that Certified EHR Technology include specific capabilities that had no relationship to meaningful use. Response. We have reviewed these comments and appreciate the forethought provided by commenters. Given that these suggestions were not germane to the policies associated with the Interim Final Rule we have not considered them for the purposes of promulgating this final rule. F. Comments Beyond the Scope of this Final Rule 8 http://www.w3.org/TR/WCAG20/ 9 As previously mentioned, there are several accessibility standards for electronic and information technology currently in use. For example, Section 508 of the Rehabilitation Act requires Federal agencies to ensure that electronic and information technology that they develop, procure, maintain, or use is accessible to persons with disabilities and authorizes the Architectural and Transportation Barriers Compliance Board (Access Board) to promulgate standards setting forth the technical and functional performance criteria necessary to implement the requirements of Section 508. Information regarding the Electronic and Information Technology Standards can be found on the Access Board’s website at http://www.access-board.gov/508.htm. Page 185 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
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misinterpreted our example and stat
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Other commenters also expressed con
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eferenced in FIPS 140-2 Annex A, wh
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of the most secure encryption algor
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the disclosure was made (recipient)
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Use CPOE for medication orders dire
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equire EHRs to build custom interfa
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esult, we do not believe that this
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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 and 166: §170.205(a)(2)(iii); and (v) The s
Page 167 and 168: Response. We disagree, as doing so
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: The eligible professional or eligib
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
Page 217 and 218: smoker; current some day smoker; fo
Page 219 and 220: (2) Generate audit log. Enable a us
Page 221 and 222: (3) Medication allergy list; (4) De
Page 223 and 224: §170.205(a)(1) or §170.205(a)(2).
Page 225 and 226: (d) Electronic copy of health infor
Page 227 and 228: specifications) specified in §170.
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