ehr onc final certification - Department of Health Care Services

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Response. We have considered the public comments received on this matter and we are convinced that it is prudent to remove the adopted standards, SOAP and REST. We did not intend for the significant potential conflicts identified by commenters to occur as a result of our adoption of SOAP and REST. We have determined that it would be more appropriate and reasonable for us not to require at the present time specific transport standards as a condition of certification. We hope that this will reduce some of the burden on Complete EHR and EHR Module developers and provide greater opportunities for innovation. With that said, we plan to carefully watch the impact of this decision and its affect on interoperability. We encourage Complete EHR and EHR Module developers to utilize transport standards that will help the industry coalesce around common methods for electronic health information exchange, and we plan to examine this decision in future rulemakings. 3. Certification Criteria and Associated Standards and Implementation Specifications We have organized our discussion of the final certification criteria according to the order in which they are currently specified at 45 CFR 170 subpart C. We note that the final regulatory citations will have changed for many certification criteria and encourage the public to review, in full, the final regulatory text specified in subpart C of part 170 in the regulation text of this final rule. We begin with the certification criteria at 45 CFR 170.302 (general certification criteria for Complete EHRs and EHR Modules), move on to 45 CFR 170.304 (specific certification criteria for Complete EHRs and EHR Modules designed for an ambulatory setting) and end with 45 CFR 170.306 (specific certification criteria for Complete EHRs or EHR Modules designed for an inpatient Page 44 of 228
setting). We also include, where appropriate, a discussion of the adopted standard(s) and implementation specifications associated with each certification criterion. For each final certification criterion, we start with an overview of the final version and then discuss and respond to public comments. a. General Certification for Complete EHRs or EHR Modules - §170.302 §170.302(a) - Drug-drug, drug-allergy, drug-formulary checks Meaningful Use Stage 1 Objective Implement drugdrug and drugallergy interaction checks Meaningful Use Stage 1 Objective Implement drugformulary checks Meaningful Use Stage 1 Measure The EP/eligible hospital/CAH has enabled this functionality for the entire EHR reporting period Meaningful Use Stage 1 Measure The EP/eligible hospital/CAH has enabled this functionality and has access to at least one internal or external drug formulary for the entire EHR reporting period Page 45 of 228 Certification Criterion Interim Final Rule Text: (1)Alerts. Automatically and electronically generate and indicate in real-time, alerts at the point of care for drug-drug and drug-allergy contraindications based on medication list, medication allergy list, age, and computerized provider order entry (CPOE). (3)Customization. Provide certain users with administrator rights to deactivate, modify, and add rules for drug-drug and drug-allergy checking. (4)Alert statistics. Automatically and electronically track, record, and generate reports on the number of alerts responded to by a user. Final Rule Text: §170.302(a) (1) Notifications. Automatically and electronically generate and indicate in real-time, notifications at the point of care for drug-drug and drug-allergy contraindications based on medication list, medication allergy list, and computerized provider order entry (CPOE). (2) Adjustments. Provide certain users with the ability to adjust notifications provided for drug-drug and drug-allergy interaction checks. Certification Criterion Interim Final Rule Text: (2)Formulary checks. Enable a user to electronically check if drugs are in a formulary or preferred drug list in accordance with the standard specified in §170.205(b). Final Rule Text: §170.302(b) Drug-formulary checks. Enable a user to electronically check if drugs are in a formulary or preferred drug list.
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 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: already existing regulatory require
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
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
Page 111 and 112:
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
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
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Send reminders to patients per pati
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specified data elements and CMS’s
Page 141 and 142:
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
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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
Page 157 and 158:
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
Page 165 and 166:
§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
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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
Page 183 and 184:
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
Page 189 and 190:
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
Page 195 and 196:
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
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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).
Page 225 and 226:
(d) Electronic copy of health infor
Page 227 and 228:
specifications) specified in §170.
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