ehr onc final certification - Department of Health Care Services

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technology through the implementation of appropriate technical capabilities security updates as necessary and correct identified security deficiencies as part of its risk management process information when exchanged in accordance with the standard specified in §170.210(a)(2). Final Rule Text: §170.302(u) General encryption. Encrypt and decrypt electronic health information in accordance with the standard specified in §170.210(a)(1), unless the Secretary determines that the use of such algorithm would pose a significant security risk for Certified EHR Technology. §170.302(v) Encryption when exchanging electronic health information. Encrypt and decrypt electronic health information when exchanged in accordance with the standard specified in §170.210(a)(2). Comments. A number of commenters stated that transmissions of health information over leased or private network lines should not be subject to the encryption of data in transit requirement. Response. Certified EHR Technology must include the capability to encrypt and decrypt information regardless of the transmission method used. This certification criterion and related standard do not specify the circumstances under which encryption and decryption must be performed; they simply require the capability. If an eligible professional or eligible hospital determines that encryption is an appropriate and necessary safeguard, we believe that Certified EHR Technology should provide the capability to implement encryption. Overall, we want to ensure that Certified EHR Technology is capable of assisting eligible professionals and eligible hospitals to implement more secure technical solutions if they determine, based on their risk analysis, that technical safeguards such as encryption are reasonable and appropriate, or required. Comment. One commenter requested further clarification of the phrase “encrypted and integrity protected link.” Several commenters recommended that Transport Layer Security (TLS) ought to be specifically named as a required protocol. Page 116 of 228
Other commenters also expressed concern that unless TLS is explicitly named, all example protocols would be required to be supported. Response. The example list of protocols that would meet the certification criterion is not intended to be exhaustive or suggest that Complete EHRs or EHR Modules must be capable of using all of the listed protocols to be certified. The example list of protocols in the Interim Final Rule was included solely for illustrative purposes. We have, however, consistent with the way we have restructured the regulatory text for some standards (to better associate them with the adopted certification criterion that reference them), modified this standard to simply express that the standard is any encrypted and integrity protected link. Comments. Several commenters suggested replacing the functional description of the encryption standard with a specific reference to FIPS 140-2. These commenters also noted that HHS had included such a reference in an update to its guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable that was included in the Breach Notification for Unsecured Protected Health Information Interim Final Rule, published on August 24, 2009 (74 FR 42740), and further, requested that we make our standard consistent with this guidance. Some commenters explicitly recommended that AES be specified as the encryption algorithm standard. Response. We have considered these commenters’ points and have decided to revise our adopted standard to be more flexible regarding the encryption algorithms we permit EHR Technology to implement to be certified. We have also sought to clarify how our adopted standard relates to the guidance included in the breach notification Page 117 of 228
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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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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
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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: misinterpreted our example and stat
Page 119 and 120: eferenced in FIPS 140-2 Annex A, wh
Page 121 and 122: of the most secure encryption algor
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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
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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
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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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