ehr onc final certification - Department of Health Care Services

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ecommended that the definition of Qualified EHR be clarified with one commenter suggesting that the definition should follow the definition of EHR as it relates to health care providers. Response. We appreciate these comments and recognize that the existence of multiple terms that include the word “EHR” can be confusing. However, we believe that Congress intended for HHS to apply the definition of a Qualified EHR found in section 3000 of the PHSA to this regulation for specific reasons that cannot be overlooked. As a result, we have decided not to adopt the recommendation to follow the definition of the term EHR that is found in Subtitle D of the HITECH Act. We discuss additional responses to comments on the definition of Qualified EHR below. Comments. A few commenters requested that we expand the definition of Qualified EHR to include a variety of additional functionality and that a Qualified EHR be able to comply with business or legal requirements. These comments requested that we add required elements for an EHR to constitute a Qualified EHR, including that the EHR: have a record-keeping capability for legal purposes; include certain requirements for usability; enable health care providers to perform several other actions not specified in the definition; and that certain elements of patient demographic information be specified. Response. We understand the rationale behind these commenters’ suggestions, but we do not believe that it is necessary to add more prerequisite capabilities to the definition of Qualified EHR. We believe Congress defined Qualified EHR to include a minimum level of capabilities. Furthermore, to meet the definition of Certified EHR Technology, a Qualified EHR must be certified in accordance with a certification Page 20 of 228
program established by the National Coordinator. As a result, we believe that any additional capabilities a Qualified EHR would need to possess to allow an eligible professional or eligible hospital to be in a position to qualify for incentive payments under the Medicare and Medicaid EHR incentive programs will be more appropriately addressed through the Secretary’s adoption of additional standards, implementation specifications, and certification criteria. Comments. Some commenters requested that we clarify some of the terms in the definition of Qualified EHR such as “capture,” “query,” “other sources,” and “relevant to health care quality” with respect to how they related to Certified EHR Technology. Another commenter expressly stated that if we only intended to repeat the statutory definition of Qualified EHR without modification, we should at least clarify the meaning of demographic information. Response. We do not believe that additional clarity is needed or desirable for such terms because the meanings are context specific. The intended meanings of these terms will depend significantly on the contexts in which the terms are used and the associated capabilities of the Certified EHR Technology. The terms’ meanings may also be affected by any standards and implementation specifications that are associated with those capabilities and adopted. In certain circumstances, for instance, the meaning of the phrase “other sources” as used in the definition of Qualified EHR will depend on the specific context in which electronic health information is being integrated or exchanged, and perhaps on whether the source is external to or internal within the Complete EHR or the EHR Module. Similarly, the meanings of the terms or phrases “capture,” “query,” “relevant to health care quality” and “demographic” information may vary according the Page 21 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: 3. Definition of Implementation Spe
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
Page 69 and 70: laboratory test results are receive
Page 71 and 72:
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
Page 101 and 102:
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
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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
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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
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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
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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
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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
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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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