ehr onc final certification - Department of Health Care Services

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Complete EHRs and EHR Modules and the testing and certification of such Complete EHRs and EHR Modules.” In §§170.200 and 170.300, we further specify that “[t]he standards and implementation specifications adopted in this part apply with respect to Complete EHRs and EHR Modules” and that “[t]he certification criteria adopted in this subpart apply to the testing and certification of Complete EHRs and EHR Modules.” The purpose of this final rule, therefore, is to adopt standards, implementation specifications, and certification criteria to test and certify that a Complete EHR or EHR Module provides certain capabilities, and where applicable, to require that those capabilities be implemented in accordance with adopted standards and implementation specifications. The adopted standards, implementation specifications, and certification criteria were not intended to impose independent requirements on the entities using Certified EHR Technology. Unlike certain other regulatory requirements to which eligible professionals or eligible hospitals may be subject, it is not within the intended scope of this final rule to specify the requirements for entities using Certified EHR Technology. We understand the commenters’ point though that an adopted standard and implementation specification could apply equally to electronic transactions between legal entities as well as to transmissions within an entity. This final rule, however, is not intended to specify the conditions under which adopted standards and implementation specifications must be used, only that a Complete EHR or EHR Module, in order to be certified, must include specified capabilities that are implemented in accordance with those standards, implementation specifications, and certification criteria. We anticipate that other regulations, as well as the clinical and business needs of HIT users, anticipated Page 12 of 228
efficiencies and desired quality improvements, and technical, architectural, and enterprise limitations will determine when entities will utilize the capabilities required of Certified EHR Technology. Additionally, we would note that Complete EHRs and EHR Modules will, in many cases, be tested and certified independent of the environment within which they will be implemented. Consequently, specifying when an entity that implements Certified EHR Technology must utilize a particular capability in its operating environment exceeds the scope of this rule. To further demonstrate this point, Certified EHR Technology implemented by an eligible professional will need to possess the capability to generate an electronic prescription according to one of the standards we have adopted. To specify the contexts in which an electronic prescription (generated according to the adopted standard) must be transmitted would go beyond the scope of certification. Moreover, it would raise a more serious and practical consideration. Attempting to specify when entities must utilize the capabilities of Certified EHR Technology would add an unnecessary level of complexity to this rule and create the potential for conflicts with other regulations promulgated by the HHS. For instance, HHS has already promulgated at least two sets of regulations identifying when health care providers need to use specific standards and the contexts in which those standards must be used. Under the HIPAA Transactions and Code Sets Standards regulations, HHS specifies at 45 CFR 162.923(a) that “[e]xcept as otherwise provided in this part, if a covered entity conducts with another covered entity (or within the same covered entity), using electronic media, a transaction for which the Secretary has adopted a standard under this part, the covered entity must conduct the transaction as a standard transaction.” (Emphasis added.) Consequently, in the HIPAA context, Page 13 of 228
Page 1 and 2: DEPARTMENT OF HEALTH AND HUMAN SERV
Page 3 and 4: HHS Department of Health and Human
Page 5 and 6: 5. Definition of Qualified EHR 6. D
Page 7 and 8: technology. Section 3004(b)(1) of t
Page 9 and 10: esolve identified technical challen
Page 11: Some commenters appear to have misi
Page 15 and 16: codes must be used “inside” an
Page 17 and 18: not necessarily have applied to our
Page 19 and 20: 3. Definition of Implementation Spe
Page 21 and 22: program established by the National
Page 23 and 24: criteria adopted by the Secretary a
Page 25 and 26: Comment. In the context of the defi
Page 27 and 28: y the certification criteria for a
Page 29 and 30: commenters asked whether we meant t
Page 31 and 32: adopted by the Secretary. The secon
Page 33 and 34: Response. We would like to make cle
Page 35 and 36: Response. In the Interim Final Rule
Page 37 and 38: could be a health care professional
Page 39 and 40: standard for certain purposes. In s
Page 41 and 42: 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
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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
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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
Page 89 and 90:
Page 89 of 228 electronically compa
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(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 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
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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
Page 117 and 118:
Other commenters also expressed con
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eferenced in FIPS 140-2 Annex A, wh
Page 121 and 122:
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
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• MDDB - Medi-Span Master Drug Da
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Response. We do not believe that it
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Send reminders to patients per pati
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specified data elements and CMS’s
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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
Page 167 and 168:
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
Page 187 and 188:
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
Page 193 and 194:
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
Page 199 and 200:
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
Page 207 and 208:
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
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
Page 227 and 228:
specifications) specified in §170.
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ehr onc final certification - Department of Health Care Services

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