ehr onc final certification - Department of Health Care Services

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way that signified that a Complete EHR would be able to provide all of the capabilities a health care provider desired or deemed necessary, or that the entity’s EHR could only include the capabilities for which the Secretary has adopted certification criteria. Nor did we define Complete EHR according to a particular functional model, because doing so would have been inconsistent with the regulatory purpose of the definition. In light of public comment and to further clarify the regulatory purpose of the definition of Complete EHR as well as make clear that a Complete EHR should not be misinterpreted to mean EHR technology that is any more comprehensive than the certification criteria to which it was tested and certified, we have added the phrase “at a minimum” to the definition. The final definition of Complete EHR will therefore read “EHR technology that has been developed to meet, at a minimum, all applicable certification criteria adopted by the Secretary.” As a related point, we would also note that an eligible professional or eligible hospital would need to use a capability that is included among the adopted certification criteria to meet the associated meaningful use objective or measure. The eligible professional or eligible hospital therefore could not attempt to use a capability that is superfluous to certification to demonstrate the meaningful use of “Certified EHR Technology.” We understand that the Medicare and Medicaid EHR Incentive Programs final rule discusses this issue more fully in several places, and we defer to those discussions concerning the requirements for achieving meaningful use of Certified EHR Technology. Page 24 of 228
Comment. In the context of the definition of Complete EHR, one commenter asked for clarification regarding how many certification criteria a Complete EHR must be developed to meet. Response. For the purposes of meeting the definition of Complete EHR, EHR technology designed for an ambulatory setting (to be used by eligible professionals) must be certified to all of the certification criteria adopted at 45 CFR 170.302 and 45 CFR 170.304, and EHR technology designed for an inpatient setting (to be used by eligible hospitals) must be certified to all of the certification criteria adopted at 45 CFR 170.302 and 45 CFR 170.306. 7. Definition of EHR Module Comments. Numerous commenters strongly supported our inclusion of a modular approach to meet the definition of Certified EHR Technology. Many of these commenters saw this approach as a way to spur greater innovation in the HIT marketplace, provide more choices for health care providers, and generally broaden the appeal of HIT and expedite its adoption. Some commenters noted, however, that they believed the definition needed further clarification with respect to what would constitute an EHR Module. In most cases, these commenters provided examples of technologies that they believed should meet the definition of EHR Module and they sought confirmation that these technologies would meet the definition. Included among these technologies were radiology information systems (RIS), picture archiving and communication systems (PACS), PHRs, speech recognition software, electrocardiogram systems, remote patient monitoring (RPM) devices, and other electronic devices including non-health care devices. Page 25 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 and 12: Some commenters appear to have misi
Page 13 and 14: efficiencies and desired quality im
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: criteria adopted by the Secretary a
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
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
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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
Page 111 and 112:
Response. As discussed above, we ha
Page 113 and 114:
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
Page 131 and 132:
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."
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Comment. A commenter recommended th
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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
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
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
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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
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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
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
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
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The Secretary adopts the following
Page 211 and 212:
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
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
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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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