ehr onc final certification - Department of Health Care Services

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professional or eligible hospital who adopts Certified EHR Technology to use this capability. We disagree that requiring Certified EHR Technology be capable of encryption would hinder adoption. To the contrary, we believe that Certified EHR Technology capable of encrypting electronic health information will be desired, especially in light of the new breach notification requirements established by the HITECH Act and the Breach Notification for Unsecured Protected Health Information Interim Final Rule. We also take this opportunity to make a technical correction to this certification criterion. We inadvertently combined both encryption capabilities under the same paragraph and per our reaffirmed interpretation expressed in the Temporary Certification Program, we believe that the scope of one certification criterion starts at the first paragraph level and includes all subparagraphs. As a result, we view these as two distinct capabilities and have created a separate certification criterion for each. Comments. One commenter stated that the security requirements, particularly for encryption, are lower than the security standards it already meets. This commenter consequently believes that our adoption of this standard would require it to reduce the security of its products. Another commenter stated that encryption technology should not be integrated into an EHR product, but should instead be implemented through other means as part of the system on which an EHR may be installed. Response. We believe that Certified EHR Technology must be capable of performing encryption. Because of the flexibility in the adopted standard, however, how encryption is technically implemented is up to the Complete EHR or EHR Module developer to determine within the parameters of Annex A of FIPS 140-2. Given the changes we have made to the general encryption standard, we believe that the full range Page 120 of 228
of the most secure encryption algorithms are available for Complete EHR and EHR Module developers to implement. Comments. A few commenters stated that the term “user-defined preferences” in the certification criteria was too vague and allowed too much latitude for divergent interpretations of the requirement. Other commenters noted that users do not always get to define such preferences as they would conflict with overarching organizational policies. Response. We intended the phrase, “according to user-defined preferences” in the Interim Final Rule, to mean that users would have the ability to elect when they wanted encryption to occur, for example, at log-off. We recognize that organizational policies, software as service models and other architectures in which Certified EHR Technology may be implemented, could lead to encryption being instituted in significantly different ways and, as a result, we have removed the reference to “user-defined preferences.” §170.302(v) - Accounting of disclosures 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 121 of 228 Certification Criterion Interim Final Rule Text: Record disclosures made for treatment, payment, and health care operations in accordance with the standard specified in §170.210(e). Final Rule Text: §170.302(w) Certification criterion made optional, while the text of this certification criterion remains unchanged Comments. Many commenters asserted that the certification criterion and accompanying standard for accounting of disclosures for treatment, payment, and health care operations (as these terms are defined at 45 CFR 164.501) would be a resource
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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
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longitudinal care, or whether the E
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EHR and EHR Module developers to pr
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suggestions for different age range
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Record smoking status for patients
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23) during the EHR reporting period
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Page 71 and 72: commenters reasoned that because a
Page 73 and 74: laboratory test results to be elect
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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
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: eferenced in FIPS 140-2 Annex A, wh
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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
Page 161 and 162: electronically record, store, retri
Page 163 and 164: 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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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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