Clarifications:
- In order to certify to this criterion, a Health IT Module must be certified to all eight domains in paragraphs (a)(15)(i)-(viii). These eight domains together provide a comprehensive picture of the patient that can facilitate care management and coordination. [see also 80 FR 62631]
- We provide the following OID to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
- LOINC® OID: 2.16.840.1.113883.6.1 [see also 80 FR 62612]
- Health IT Modules can present for certification to a more recent version of LOINC® than outlined in regulation per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]
- In addition to the privacy and security requirements for this criterion, ONC recommends that institutions develop and maintain policies for the collection and dissemination of the social, psychological, and behavioral data consistent with applicable federal and state laws. [see also 80 FR 62631, 89 FR 1224]
- This criterion does not require that users capture social, psychological, and behavioral data beyond the specified types of data listed in the criterion and only in accordance with the specified standards.
- Certified Health IT Modules must allow all actions to be performed at the questionnaire level. Actions include enabling a user to record, change, and access the patient social, psychological, and behavioral data outlined in this certification criterion.
- A Certified Health IT Module is required to enable a user to record whether the patient declined to specify (i.e., respond/provide) the requested information at the third paragraph level. Paragraphs (a)(15)(i) through (viii) are at the third paragraph level. Therefore, as an example, a Health IT Module is required to enable a user to record whether a patient declined to provide information regarding depression (§ 170.315(a)(15)(iv)) for the purposes of testing and certification. Specification of patient actions in terms of compliance with the standard (i.e., whether the patient declined to respond to a question in a questionnaire) is beyond the scope of testing and certification but may also jeopardize the validity of the questionnaire.
- The criterion requires Certified Health IT Modules to be capable of capturing specific LOINC® codes associated with the identified domain questions and answers. Specific questionnaires, tools, or other documents were not adopted as part of this criterion. Accordingly, they are not within the scope of certification.
- ONC acknowledges that the LOINC® codes adopted for the physical activity domain questions are attributed to the Substance Abuse and Mental Health Services Administration (SAMHSA). Several health IT developers wishing to develop the capabilities outlined in this criterion have commented that these questions differ slightly from the questions that comprise the Kaiser Permanente-developed Exercise Vital Sign (EVS) instrument. ONC acknowledges these differences exist. ONC also acknowledges that the EVS has been recommended as a screening tool by the American College of Sports Medicine’s Exercise is Medicine initiative and received the highest available rating by the Institute of Medicine (IOM) as an available standard and for its usefulness and feasibility (see also “Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2” report: Records Phase 2 Report, page 212). Further, in the 2015 Edition proposed rule, ONC expressed a desire to align with the IOM “Phase 2” report (80 FR 16826). LOINC® codes are currently in development by the standards developing organization (Regenstrief Institute) for the EVS questions. When they become available, ONC will provide certification to those LOINC® codes in lieu of the current question LOINC® codes for the physical activity domain. In the interim, health IT developers may choose to proceed with the testing and certification of their Health IT Modules that supports the EVS instrument by demonstrating that the health IT can capture the appropriate EVS questions and associate them with the adopted answer LOINC® codes for the physical activity domain. Health IT developers will be responsible for updating their health IT within six months of the publishing of the LOINC® codes for the EVS questions. After expiration of this time period and during surveillance, a health IT product would be found non-conforming if it could not produce the proper LOINC® codes for the EVS questions. Health IT Modules already certified to this criterion will not be required to retest or recertify to the new LOINC® codes aligned with EVS. Health IT developers may also continue to choose to test and certify to the adopted LOINC® codes for “SAMHSA” questions in lieu of the EVS questions.
