Regulation FAQs

Do the 2011 Edition and 2014 Edition certification criteria pertaining to electronic prescribing, which reference certain content exchange standards (e.g., NCPDP SCRIPT 10.6), require that a Complete EHR or EHR Module be capable of electronically exchanging information with only external recipients (i.e., recipients that are not part of that legal entity) according to the appropriate standard (and implementation specifications) or do they apply more broadly?

The 2011 Edition and 2014 Edition certification criteria pertaining to electronic prescribing refer to the capability of electronically exchanging information only with external recipients. The certification criteria adopted at (45 CFR 170.304(b) and 170.314(b)(3)) for electronic prescribing reference content exchange and vocabulary standards that were adopted for the purpose of enabling a user of Certified EHR Technology to electronically “exchange” certain health information with different… more

Could an interface that transmits lab results in HL7 message format between a hospital laboratory system and a physician’s EHR (presuming that the transmissions were occurring between two different legal entities) satisfy the certification criteria related to the exchange of key clinical information in 45 CFR 170.304(i) and 45 CFR 170.306(f)? If not, please specify the required data types and exchange characteristics that must be part of the required clinical information exchange.

As implied in the question, for certification a Complete EHR or an EHR Module must have the capability to electronically receive and display, and transmit certain key clinical information in accordance with one of two separate certification criteria (45 CFR 170.304(i) or 45 CFR 170.306(f)), depending on the setting for which the EHR technology is designed (ambulatory or inpatient, respectively). Generally speaking, these certification criteria require two types of information exchange… more

For the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, is an eligible professional or eligible hospital limited to demonstrating meaningful use in the exact way that EHR technology was tested and certified? For example, if a Complete EHR has been tested and certified using a specific workflow, is an eligible professional or eligible hospital required to use that specific workflow when it demonstrates meaningful use? Similarly, if the EHR technology was tested and certified with certain clinical decision support rules, are those the only clinical decision support rules an eligible health care provider is permitted to use when demonstrating meaningful use?

This FAQ has been jointly posted by ONC as FAQ24 and by CMS as FAQ 10473. In most cases, an eligible professional or eligible hospital is not limited to demonstrating meaningful use to the exact way in which the Complete EHR or EHR Module was tested and certified. As long as an eligible professional or eligible hospital uses the certified Complete EHR or certified EHR Module's… more

For an eligible professional using EHR technology certified to the 2011 Edition, can the definition of Certified EHR Technology be met by combining EHR technology certified for an inpatient setting with EHR technology certified for an ambulatory setting?

Yes. For all of the certification criteria that apply to Complete EHRs or EHR Modules designed for use in an ambulatory setting for which there is an equivalent or more comprehensive certification criterion that applies to Complete EHRs or EHR Modules designed for use in an inpatient setting, the EP may include the EHR technology tested and certified to the inpatient certification criteria as part of the EHR technology the EP possesses. For example, the “electronic copy of the health… more

Will ONC immediately enforce the new provisions in the Principles of Proper Conduct for ONC-ACBs (45 C.F.R. § 170.523) that require ONC-ACBs to report test results hyperlinks to ONC as well as ensure that EHR technology developers follow “price transparency” requirements?

No.

Reporting of Test Results Hyperlinks to ONC

In the September 4, 2012 standards and certification criteria final rule (77 FR 54163), section 170.523(f) was revised to require an ONC-ACB to provide ONC a hyperlink that enables the public to access the test results used by the ONC-ACB to certify each Complete EHR and EHR Module.

We will only enforce this provision against ONC-ACBs for certifications that are issued:

  1. After ONC specifies that the CHPL is… more
The 2014 Edition preferred language standard (45 CFR 170.207(g)) requires EHR technology to be capable of representing a patient’s preferred language in accordance with ISO 639-2 “limited” by ISO 639-1. What does “limited” or “constrained” by ISO-639-1 mean? Additionally, in some instances, there are ISO 639-2 languages that have both a (B) bibliographic code and (T) terminology code. In these instances, what code must be used?

“Limited” or “constrained” by ISO 639-1 means that the languages in ISO 639-2 that an EHR technology must be capable of representing are limited or constrained to those languages that have a corresponding alpha-2 code in ISO 639-1. EHR technology must be capable of representing these languages in the alpha-3 codes of ISO 639-2 for the purposes of certification. In instances where both a bibliographic code and terminology code are present for a required ISO 639-2 language, EHR technology is… more

Are ONC-ACBs required to certify 2014 Edition Complete EHRs to both of the mandatory certification criteria at 45 CFR 170.314(g)(1) and (g)(2)? Similarly, if EHR technology presented for certification as an EHR Module has been tested to satisfy a combination of the capabilities specified in 45 CFR 170.314(g)(1) or (g)(2),what certification criterion must an ONC-ACB indicate as the one to which the EHR technology is certified when the ONC-ACB submits its weekly certification data to ONC?

Complete EHRs

EHR technology issued a 2014 Edition Complete EHR certification must be certified to § 170.314(g)(2) (“automated measure calculation”) as it is a mandatory certification criterion consistent with the 2014 Edition Complete EHR definition requiring certification to all mandatory certification criteria for a particular setting (ambulatory or inpatient). While § 170.314(g)(1) (“automated numerator recording”) is also designated as a mandatory certification criterion, a 2014… more

How many clinical quality measures (CQMs) must EHR technology be certified to in order to be issued a 2014 Edition Complete EHR certification?

A 2014 Edition Complete EHR is defined as EHR technology that meets the Base EHR definition and has been developed to meet, at a minimum, all mandatory 2014 Edition EHR certification criteria for either an ambulatory setting or inpatient setting. The Base EHR definition specifies how many CQMs EHR technology must be certified to for the inpatient and ambulatory setting and, thus, how many CQMs EHR technology must be certified to in order to be issued a 2014 Edition Complete EHR certification… more

What certification approaches would satisfy the 2014 Edition transitions of care certification criteria adopted at 45 CFR 170.314(b)(1) and (b)(2) as well as permit an eligible provider to have EHR technology that meets the Certified EHR Technology (CEHRT) definition? Please emphasize how the adopted transport standards fit in.

In general, EHR technology developers can take the three approaches outlined in the table below to meet the transitions of care certification criteria and their included transport standard(s). EHR technology certified according to any one of these three approaches could then be used by eligible providers to meet the CEHRT definition.

As additional context, it is important to keep in mind the “scope of a certification criterion” in the 2014 Edition EHR certification criteria (see 77… more

The XDR/XDM for Direct Messaging v1.0 adopted at 45 CFR 170.202(b) specifies that the value of three attributes (i.e., DocumentEntry.uniqueId, SubmissionSet.sourceId, and SubmissionSet.uniqueId) should be a UUID URN (Universally Unique Identifier Uniform Resource Name). This part of the XDR/XDM specification appears to be inconsistent with how both Integrating the Healthcare Enterprise (IHE)1 and eHealth Exchange2 specifications represent those same attributes (i.e., in the form of OIDs). Shouldn't these attributes all be represented the same way to be consistent across all three sets of specifications?

Yes, there should be consistency across these specifications. Thus, for these three attributes, EHR technology developers implementing the XDR/XDM for Direct Messaging specification should use UUID URNs formatted as OIDs. We expect testing to this specification to reflect this clarification.

  1. http://www.ihe.net/technical_framework/upload/ihe_iti_tf_rev7-0_vol3_ft_2010-08-10.pdf [PDF - 1 MB]
  2. http://www.healthit.gov/policy-researchers-implementers/nationwide-health-… more
CMS allows EPs, eligible hospitals, and CAHs flexibility in the ways they can calculate certain percentage-based meaningful use measures for attestation. As an EHR technology developer seeking certification to the 2014 Edition “automated measure calculation” certification criterion (45 CFR 170.314(g)(2)), must the EHR technology I present for certification be able to support every possible method of calculation that an EP, eligible hospital, or CAH could choose for a percentage-based measure?

For the 2014 Edition “automated measure calculation” certification criterion, we explained in the final rule that “for MU objectives which CMS has provided flexibility in its final rule for EPs, EHs, and CAHs to pursue alternative approaches to measuring a numerator and denominator, the EHR technology must be able to support all CMS-acceptable approaches in order to meet this certification criterion” (77 FR 54244 – 54245). This FAQ clarifies that statement in order to provide EHR technology… more

Certain data found in paragraphs 45 CFR 170.314 (e)(2)(iii)(A) and (B), appear duplicative in the listing of the required data for the EHR technology clinical summary certification criterion. For that data and also for “immunizations” as part of the clinical summary certification criterion, how will these be tested and certified where vocabulary standards have been adopted?

In subparagraphs 45 CFR 170.314 (e)(2)(iii)(A) and (B), we list the minimum data EHR technology must permit a user to select when creating a clinical summary. However, upon further analysis, we have identified inadvertent redundancies between subparagraphs (A) and (B) that we now seek to clarify. As identified in the table below, certain data specified in subparagraph (B)are duplicative or are generally redundant of those listed in subparagraph (A) as part of the Common MU Data Set. For… more

Will the demonstration/use of vital signs and/or medication allergies data be individually required for testing and certification of the linked referential clinical decision support (CDS) capability specified in the certification criterion adopted at 45 CFR 170.314(a)(8)?

The specific capability for linked referential CDS is found at 45 CFR 170.314 (a)(8)(ii)(A), which states:

“(A) EHR technology must be able to:

(1) Electronically identify for a user diagnostic and therapeutic reference information; or

(2) Electronically identify for a user diagnostic and therapeutic reference information in accordance with the standard specified at § 170.204(b) and the implementation specifications at § 170.204 (b)(1) or (2).

and, further 45… more

Are “coded entries” required for data referenced by 2014 Edition EHR certification criteria that specify the use of the Consolidated CDA standard even when the standard allows for narrative?

Yes, in all instances where we have adopted a vocabulary standard in § 170.207 the accompanying Consolidated CDA section-template implemented must be done so using the section-template with required structured data, coded entries required. Additionally, where a section-template with coded entries required is unavailable, we expect that testing and certification will still assess that data for which a vocabulary standard is adopted is represented in an appropriate coded entry structure within… more

Are ONC-Authorized Certification Bodies (ONC-ACBs) required to perform gap certification under the ONC HIT Certification Program?

No. We stated in the Permanent Certification Program final rule (76 FR 1291) that gap certification would be an option for ONC-ACBs and that it would be left to the discretion of each ONC-ACB as to whether to offer gap certification. We emphasize, however, that if an ONC-ACB decides to offer gap certification, it must conduct gap certification according to regulatory requirements and should be aware of ONC guidance under the ONC HIT Certification Program. ONC-ACBs should also offer gap… more

In the 2014 Edition Standards and Certification Criteria Final Rule, ONC clarified that the two new SNOMED CT codes for smoking status “light tobacco smoker” and “heavy tobacco smoker” meant, respectively, fewer than 10 cigarettes per day and greater than 10 cigarettes per day. To which code should exactly 10 cigarettes per day be attributed?

The “heavy tobacco smoker” code.

How will compliance to the ONC Applicability Statement for Secure Health Transport standard adopted at 45 CFR 170.202(a), and included in such certification criteria as “Transitions of Care” (45 CFR 170.314(b)(1) and (2)) be tested and certified with respect to header protection specified in RFC 5751 section 3.1 (more commonly referred to as “message wrapping”)?

The ONC Applicability Statement for Secure Health Transport standard1 adopted at 45 CFR 170.202(a) requires that Security/Trust Agents “(STAs)”2 support S/MIME v3.2 as specified by RFC 5751… more

The clinical decision support and patient list creation certification criteria (45 CFR 170.314(a)(8) and 45 CFR 170.314(a)(14), respectively) require EHR technology to perform capabilities based on "demographics" data. To meet these two certification criteria, does EHR technology presented for certification need to demonstrate the capability to use more than one of the demographics data categories listed in the “Demographics” certification criterion adopted at 45 CFR 170.314(a)(3)?

"No." To meet the requirements of 45 CFR 170.314(a)(8) (Clinical decision support) and 45 CFR 170.314(a)(14) (Patient list creation), EHR technology must demonstrate its capability to utilize at least one of the more specific data categories included in the "Demographics" certification criterion (45 CFR 170.314(a)(3)) (e.g., sex or date of birth).

Would an EHR technology that allows manual entry of problem, medication, or laboratory test data into an education search tool be able to satisfy the “other-than-Infobutton1 -enabled” capability required by the “patient-specific education resources” certification criterion at 45 CFR 170.314(a)(15)(ii)?2
  1. For both capabilities within the certification criterion (170.314(a)(15)(i) and (ii)), we interpret there to be 3 specific conditions that need to be satisfied:
  2. EHR technology must be able to "electronically identify" education resources;
  3. The education resources must be "patient-specific;" and
  4. The education resources must be based on data included in the patient's problem list, medication list, and laboratory tests.

While the alternative method… more

Can Surescripts’ version of the e-prescribing standard, NCPDP SCRIPT 8.1, called “SCRIPT 8.1E” be used to satisfy the 2011 Edition EHR certification criterion for electronic prescribing (45 CFR 170.304(b))?

Yes. While NCPDP SCRIPT 8.1 is the specific version of the SCRIPT standard ONC incorporated by reference in its final rule for the 2011 Edition EHR certification criteria, it is our understanding that an EHR technology implemented to follow “SCRIPT 8.1E” would be compliant with the general NCPDP SCRIPT 8.1 standard for non-controlled substances, since SCRIPT 8.1E supports the electronic prescribing of both non-controlled and controlled substances.

Additionally, we note that CMS… more

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