ehr onc final certification - Department of Health Care Services

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adopted in the Interim Final Rule as part of the integrity certification criterion that specified that Certified EHR Technology must be capable of detecting alterations to audit logs. We encourage the HIT Standards Committee to consider additional capabilities that could be specified related to audit logs. Comment. One commenter recommended that the IHE Audit Trail and Node Authentication (ATNA) Integration Profile be used, but that its use be constrained to the electronic transactions among organizations, rather than electronic transmissions within an organization. Response. We decided to defer our adoption of the ATNA standard because it can be configured in multiple ways and we did not believe that it would be appropriate at this time to require a specific implementation as a condition of certification. Our deferral does not preclude Complete EHR and EHR Module developers from using the standard, however. Comment. One commenter requested clarification between “read” audits and “write” audits, and how each is to be used. The commenter suggested that not requiring the capability of “read” audits will significantly reduce the ability of auditors to identify and investigate inappropriate use of health information when records are accessed but not manipulated. The commenter noted that auditing all read operations for all data elements within an EHR is infeasible. The commenter further suggested that “read” operations should be audited only when certain demographic health information needed to identify a patient (e.g., name, record number, date of birth, address) is presented to or can be known by the user. Page 110 of 228
Response. As discussed above, we have adopted in the standard the action of “accessed” which would encompass the action of “read.” At the present time, we only identify certain data elements in the adopted standard that must be recorded and believe that this specificity will help reduce any potential burden associated with recording the action of “accessed.” §170.302(s) - Integrity Meaningful Use Stage 1 Objective Protect electronic health information created or maintained by the certified EHR technology through the implementation of appropriate technical capabilities Meaningful Use Stage 1 Measure Conduct or review a security risk analysis per 45 CFR 164.308 (a)(1) and implement security updates as necessary and correct identified security deficiencies as part of its risk management process Page 111 of 228 Certification Criterion Interim Final Rule Text: (1)In transit. Verify that electronic health information has not been altered in transit in accordance with the standard specified in §170.210(c). (2) Detection. Detect the alteration and deletion of electronic health information and audit logs, in accordance with the standard specified in §170.210(c). Final Rule Text: §170.302(s) (1) Create a message digest in accordance with the standard specified in 170.210(c). (2) Verify in accordance with the standard specified in 170.210(c) upon receipt of electronically exchanged health information that such information has not been altered. (3) Detection. Detect the alteration of audit logs. Comments. Several commenters requested a definition of “in transit.” Other commenters suggested that hashing of messages in transit be limited to circumstances of transmission over public networks only. These commenters suggested that messages transmitted over private networks be exempt from complying with this standard. One commenter suggested that in addition to message hashing, digital signatures should be required on messages in transit. Another commenter stated that requiring hashing of messages in transit is overly burdensome. One commenter requested that we clarify whether we intended §170.302(s)(1) to require that the receiver of a message always verify messages received rather than simply demonstrate the capability to use hashing.
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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
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: Response. We disagree. As stated ab
Page 113 and 114: SHA-1 and other secure hash algorit
Page 115 and 116: misinterpreted our example and stat
Page 117 and 118: Other commenters also expressed con
Page 119 and 120: eferenced in FIPS 140-2 Annex A, wh
Page 121 and 122: of the most secure encryption algor
Page 123 and 124: the disclosure was made (recipient)
Page 125 and 126: Use CPOE for medication orders dire
Page 127 and 128: equire EHRs to build custom interfa
Page 129 and 130: 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
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
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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
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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).
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(d) Electronic copy of health infor
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specifications) specified in §170.
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