ehr onc final certification - Department of Health Care Services
ehr onc final certification - Department of Health Care Services ehr onc final certification - Department of Health Care Services
Response. At the present time, we believe that the definition of Certified EHR Technology already includes some of the flexibility these commenters request. We permit, for example, a Complete EHR designed for an ambulatory setting and a Complete EHR designed for an inpatient setting both to meet the definition of Certified EHR Technology, even though each is compliant with a slightly different set of applicable certification criteria. In that regard, we believe we have integrated a balanced and appropriate amount of flexibility into the definition of Certified EHR Technology, which will also allow us to make additional refinements over time. We believe that it is possible based on industry need for us to specify in a future rulemaking sets of applicable certification criteria for Complete EHRs and EHR Modules designed for particular clinical settings. 9. Definition of Human Readable Format Comments. A number of commenters across several certification criteria requested that we clarify the meaning of “human readable format.” These commenters questioned what human readable format meant when it was used in the certification criteria and offered examples of what they thought would constitute human readable format such as, style sheets and PDFs. A couple of commenters suggested that human readable format should consider patients’ linguistic needs. A commenter requested we discuss the compliance requirements associated with the Americans with Disabilities Act and the relevant sections of the Rehabilitation Act of 1973 to ensure human readable format was meant to include an obligation to provide people with disabilities alternative formats such as large print or Braille. Page 34 of 228
Response. In the Interim Final Rule, we discussed the meaning of human readable format and provided examples of what we believe would constitute human readable format. We reiterate that discussion below. We believe that in order to recognize the enormous potential of HIT, greater standardization in future years is necessary. In that regard, we recognize that more advanced interoperability requires health information to be represented by specific vocabularies and code sets that can be interpreted by EHR technology as well as converted and presented in a readable format to the users of such technology. At the present time we recognize that implementing certain vocabularies and code sets in EHR technology is a difficult, technical undertaking. For that reason, we have not adopted specific vocabularies and code sets for a number of the exchange purposes … We have, however, as a transitional step, adopted certification criteria that require Certified EHR Technology to be capable of presenting health information received in human readable format. By human readable format, we mean a format that enables a human to read and easily comprehend the information presented to them regardless of the method of presentation (e.g., computer screen, handheld device, electronic document). This would likely require information in coded or machine readable format to be converted to, for example, its narrative English language description. In an effort to further the transition to, and prevalence of, more specific vocabularies and code sets, we are interested in public comment regarding industry readiness if we were to adopt certification criteria requiring the use of additional vocabularies and code sets in parallel with meaningful use Stage 2. Such certification criteria could include not only that Certified EHR Technology be capable of presenting information in human readable format but also that it be capable of automatically incorporating certain vocabulary or code sets (i.e., machine readable information). The term human readable format is used in two contexts, when coded health information should be displayed to an eligible professional or (to a health care professional within) an eligible hospital using Certified EHR Technology and in the circumstances where Certified EHR Technology must be capable of generating an electronic copy of health information for individuals. Each context may dictate a different human readable format. For example, the use of a style sheet may be appropriate for both health care professionals that are interacting with Certified EHR Technology as well as individuals who receive an electronic copy of their health Page 35 of 228
- Page 1 and 2: DEPARTMENT OF HEALTH AND HUMAN SERV
- Page 3 and 4: HHS Department of Health and Human
- Page 5 and 6: 5. Definition of Qualified EHR 6. D
- Page 7 and 8: technology. Section 3004(b)(1) of t
- Page 9 and 10: esolve identified technical challen
- Page 11 and 12: Some commenters appear to have misi
- Page 13 and 14: efficiencies and desired quality im
- Page 15 and 16: codes must be used “inside” an
- Page 17 and 18: not necessarily have applied to our
- Page 19 and 20: 3. Definition of Implementation Spe
- Page 21 and 22: program established by the National
- Page 23 and 24: criteria adopted by the Secretary a
- Page 25 and 26: Comment. In the context of the defi
- Page 27 and 28: y the certification criteria for a
- Page 29 and 30: commenters asked whether we meant t
- Page 31 and 32: adopted by the Secretary. The secon
- Page 33: Response. We would like to make cle
- Page 37 and 38: could be a health care professional
- Page 39 and 40: standard for certain purposes. In s
- Page 41 and 42: e voluntary and would not be requir
- Page 43 and 44: already existing regulatory require
- Page 45 and 46: setting). We also include, where ap
- Page 47 and 48: clarification on why the number of
- Page 49 and 50: 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
Response. In the Interim Final Rule, we discussed the meaning <strong>of</strong> human<br />
readable format and provided examples <strong>of</strong> what we believe would constitute human<br />
readable format. We reiterate that discussion below.<br />
We believe that in order to recognize the enormous potential <strong>of</strong> HIT, greater<br />
standardization in future years is necessary. In that regard, we recognize that<br />
more advanced interoperability requires health information to be represented by<br />
specific vocabularies and code sets that can be interpreted by EHR technology as<br />
well as converted and presented in a readable format to the users <strong>of</strong> such<br />
technology. At the present time we recognize that implementing certain<br />
vocabularies and code sets in EHR technology is a difficult, technical<br />
undertaking. For that reason, we have not adopted specific vocabularies and code<br />
sets for a number <strong>of</strong> the exchange purposes … We have, however, as a<br />
transitional step, adopted <strong>certification</strong> criteria that require Certified EHR<br />
Technology to be capable <strong>of</strong> presenting health information received in human<br />
readable format. By human readable format, we mean a format that enables a<br />
human to read and easily comprehend the information presented to them<br />
regardless <strong>of</strong> the method <strong>of</strong> presentation (e.g., computer screen, handheld device,<br />
electronic document). This would likely require information in coded or machine<br />
readable format to be converted to, for example, its narrative English language<br />
description. In an effort to further the transition to, and prevalence <strong>of</strong>, more<br />
specific vocabularies and code sets, we are interested in public comment<br />
regarding industry readiness if we were to adopt <strong>certification</strong> criteria requiring the<br />
use <strong>of</strong> additional vocabularies and code sets in parallel with meaningful use Stage<br />
2. Such <strong>certification</strong> criteria could include not only that Certified EHR<br />
Technology be capable <strong>of</strong> presenting information in human readable format but<br />
also that it be capable <strong>of</strong> automatically incorporating certain vocabulary or code<br />
sets (i.e., machine readable information).<br />
The term human readable format is used in two contexts, when coded health<br />
information should be displayed to an eligible pr<strong>of</strong>essional or (to a health care<br />
pr<strong>of</strong>essional within) an eligible hospital using Certified EHR Technology and in the<br />
circumstances where Certified EHR Technology must be capable <strong>of</strong> generating an<br />
electronic copy <strong>of</strong> health information for individuals. Each context may dictate a<br />
different human readable format. For example, the use <strong>of</strong> a style sheet may be<br />
appropriate for both health care pr<strong>of</strong>essionals that are interacting with Certified EHR<br />
Technology as well as individuals who receive an electronic copy <strong>of</strong> their health<br />
Page 35 <strong>of</strong> 228
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