ehr onc final certification - Department of Health Care Services

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(4) Public Health Information Network HL7 Version 2.5 Message Structure (5) [Reserved] Specification for National Condition Reporting Final Version 1.0, including Errata and Clarifications, National Notification Message Structural Specification, 8/18/2007, August 18, 2007, IBR approved for §170.205. (h) Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, Maryland 21244; Telephone (410) 786-3000 (1) CMS PQRI 2009 Registry XML Specifications, IBR approved for §170.205. (2) 2009 Physician Quality Reporting Initiative Measure Specifications Manual for Claims and Registry, Version 3.0, December 8, 2008 IBR approved for §170.205. (i) National Institute of Standards and Technology, Information Technology Laboratory, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899–8930, http://csrc.nist.gov/groups/STM/cmvp/standards.html (1) Annex A: Approved Security Functions for FIPS PUB 140-2, Security (2) [Reserved] Requirements for Cryptographic Modules, Draft, January 27, 2010, IBR approved for §170.210. (j) American National Standards Institute, Health Information Technology Standards Panel (HITSP) Secretariat, 25 West 43rd Street – Fourth Floor, New York, NY 10036, http://www.hitsp.org (1) HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component, HITSP/C32, July 8, 2009, Version 2.5, IBR approved for §170.205. Page 214 of 228
4. Revise subpart C to read as follows: Subpart C—Certification Criteria for Health Information Technology Sec. 170.300 Applicability. 170.302 General certification criteria for Complete EHRs or EHR Modules. 170.304 Specific certification criteria for Complete EHRs or EHR Modules designed for an ambulatory setting. 170.306 Specific certification criteria for Complete EHRs or EHR Modules designed for an inpatient setting. §170.300 Applicability. (a) The certification criteria adopted in this subpart apply to the testing and certification of Complete EHRs and EHR Modules. (b) When a certification criterion refers to two or more standards as alternatives, use of at least one of the alternative standards will be considered compliant. (c) Complete EHRs and EHR Modules are not required to be compliant with certification criteria that are designated as optional. §170.302 General certification criteria for Complete EHRs or EHR Modules. The Secretary adopts the following general certification criteria for Complete EHRs or EHR Modules. Complete EHRs or EHR Modules must include the capability to perform the following functions electronically, unless designated as optional, and in accordance with all applicable standards and implementation specifications adopted in this part: (a) Drug-drug, drug-allergy interaction checks. (1) Notifications. Automatically and electronically generate and indicate in real-time, notifications at the point of care for drug-drug and drug-allergy contraindications based on medication list, medication allergy list, and computerized provider order entry (CPOE). Page 215 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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Record smoking status for patients
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23) during the EHR reporting period
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laboratory test results are receive
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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
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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
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
Page 169 and 170: Dental Terminology as a condition o
Page 171 and 172: However, we do not preclude Complet
Page 173 and 174: ability of CCD and CCR to support t
Page 175 and 176: ability to receive these reports. M
Page 177 and 178: commenters acknowledged and express
Page 179 and 180: a meaningful use objective they wou
Page 181 and 182: CMS and ONC had worked together to
Page 183 and 184: The eligible professional or eligib
Page 185 and 186: EHR technology with the needs of us
Page 187 and 188: The RFA requires agencies to analyz
Page 189 and 190: values seemed low and that the gap
Page 191 and 192: commenter provided), our assumption
Page 193 and 194: absolute low we estimated for a per
Page 195 and 196: number of previously CCHIT-certifie
Page 197 and 198: for Certification Low High Page 197
Page 199 and 200: Finally, the third type of cost we
Page 201 and 202: 2012 15% $10.10 $30.80 $20.45 3-Yea
Page 203 and 204: The RFA requires agencies to analyz
Page 205 and 206: The Office of Management and Budget
Page 207 and 208: The standards and implementation sp
Page 209 and 210: The Secretary adopts the following
Page 211 and 212: any edition other than that specifi
Page 213: (e) Regenstrief Institute, Inc., LO
Page 217 and 218: smoker; current some day smoker; fo
Page 219 and 220: (2) Generate audit log. Enable a us
Page 221 and 222: (3) Medication allergy list; (4) De
Page 223 and 224: §170.205(a)(1) or §170.205(a)(2).
Page 225 and 226: (d) Electronic copy of health infor
Page 227 and 228: specifications) specified in §170.
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