ehr onc final certification - Department of Health Care Services

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Response. We have adopted certification criteria to ensure that Certified EHR Technology includes certain capabilities, in this case that Certified EHR Technology be capable of permitting authorized users to access electronic health information during an emergency. The criterion is not intended to specify what constitutes an emergency or who would be authorized to access electronic health information in an emergency. In a medical emergency, those determinations would be made under specific factual circumstances and in accordance with applicable state and federal laws, organizational policies and procedures, and the relevant standard of care. With respect to emergency access, we note that HHS stated in the HIPAA Security Final Rule (68 FR 8355): We believe that emergency access is a necessary part of access controls and, therefore, is properly a required implementation specification of the ‘‘Access controls’’ standard. Access controls will still be necessary under emergency conditions, although they may be very different from those used in normal operational circumstances. For example, in a situation when normal environmental systems, including electrical power, have been severely damaged or rendered inoperative due to a natural or manmade disaster, procedures should be established beforehand to provide guidance on possible ways to gain access to needed electronic protected health information. We believe that this certification criterion is consistent with the HIPAA Security Rule. Some commenters appeared to interpret our reference to “emergency” in “emergency access” as solely constituting a clinical or life threatening emergency related to a patient for which access would be required. We believe that emergency could encompass that scenario, as well as a broader range of possibilities, including normal patient care when timely access to electronic health information becomes critical. Therefore, we have not sought to limit the development of emergency access capabilities for Certified EHR Technology to a particular scenario. Page 102 of 228
Comment. One commenter suggested that we require automated notification of user activity to system administrators when emergency access is invoked. Response. We appreciate this suggestion. However, at the present time, we do not believe that this requirement should be a condition of certification because a person or entity’s organizational policies and procedures may ensure timely notification of appropriate personnel. §170.302(q) - Automatic log-off 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 103 of 228 Certification Criterion Interim Final Rule Text: Automatic log-off. Terminate an electronic session after a predetermined time of inactivity. Final Rule Text: §170.302(q) Unchanged Comments. One commenter supported this requirement. Another commenter concurred with the purpose of the certification criterion, but noted that it may be difficult in some circumstances for eligible professionals or eligible hospitals to implement this capability if the Certified EHR Technology is offered as a service and multiple individuals are using the Certified EHR Technology at the same time. Response. We appreciate the commenters’ support for the adoption of this certification criterion. We believe that automatic logoff capabilities are commonplace and that this certification criterion can be met by any Complete EHR or EHR Module developer. We are aware that many web services today logoff customers after a period of inactivity and do not believe this requirement is unduly burdensome for any Complete EHR or EHR Module developer. §170.302(r) - Audit log
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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
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: Page 101 of 228 Unchanged Comment.
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
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
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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
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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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