§ 170.315 2015 Edition health IT certification criteria.

The Secretary adopts the following certification criteria for health IT. Health IT must be able to electronically perform the following capabilities in accordance with all applicable standards and implementation specifications adopted in this part:

(a) Clinical—(1) Computerized provider order entry—medications. (i) Enable a user to record, change, and access medication orders.

(ii) Optional. Include a “reason for order” field.

(2) Computerized provider order entry—laboratory. (i) Enable a user to record, change, and access laboratory orders.

(ii) Optional. Include a “reason for order” field.

(3) Computerized provider order entry—diagnostic imaging. (i) Enable a user to record, change, and access diagnostic imaging orders.

(ii) Optional. Include a “reason for order” field.

(4) Drug-drug, drug-allergy interaction checks for CPOE—(i) Interventions. Before a medication order is completed and acted upon during computerized provider order entry (CPOE), interventions must automatically indicate to a user drug-drug and drug-allergy contraindications based on a patient's medication list and medication allergy list.

(ii) Adjustments. (A) Enable the severity level of interventions provided for drug-drug interaction checks to be adjusted.

(B) Limit the ability to adjust severity levels in at least one of these two ways:

(1) To a specific set of identified users.

(2) As a system administrative function.

(5)Demographics. (i) Enable a user to record, change, and access patient demographic data including race, ethnicity, preferred language, sex, sexual orientation, gender identity, and date of birth.

(A) Race and ethnicity. (1) Enable each one of a patient's races to be recorded in accordance with, at a minimum, the standard specified in § 170.207(f)(2) and whether a patient declines to specify race.

(2) Enable each one of a patient's ethnicities to be recorded in accordance with, at a minimum, the standard specified in § 170.207(f)(2) and whether a patient declines to specify ethnicity.

(3) Aggregate each one of the patient's races and ethnicities recorded in accordance with paragraphs (a)(5)(i)(A)(1) and (2) of this section to the categories in the standard specified in § 170.207(f)(1).

(B) Preferred language. Enable preferred language to be recorded in accordance with the standard specified in § 170.207(g)(2) and whether a patient declines to specify a preferred language.

(C) Sex. Enable sex to be recorded in accordance with the standard specified in § 170.207(n)(1).

(D) Sexual orientation. Enable sexual orientation to be recorded in accordance with the standard specified in § 170.207(o)(1) and whether a patient declines to specify sexual orientation.

(E) Gender identity. Enable gender identity to be recorded in accordance with the standard specified in § 170.207(o)(2) and whether a patient declines to specify gender identity.

(ii) Inpatient setting only. Enable a user to record, change, and access the preliminary cause of death and date of death in the event of mortality.

(6)–(8) [Reserved]

(9) Clinical decision support (CDS)—(i) CDS intervention interaction. Interventions provided to a user must occur when a user is interacting with technology.

(ii) CDS configuration. (A) Enable interventions and reference resources specified in paragraphs (a)(9)(iii) and (iv) of this section to be configured by a limited set of identified users (e.g., system administrator) based on a user's role.

(B) Enable interventions:

(1) Based on the following data:

(i) Problem list;

(ii) Medication list;

(iii) Allergy and intolerance list;

(iv) At least one demographic specified in paragraph (a)(5)(i) of this section;

(v) Laboratory tests; and

(vi) Vital signs.

(2) When a patient's medications, allergies and intolerance, and problems are incorporated from a transition of care/referral summary received and pursuant to paragraph (b)(2)(iii)(D) of this section.

(iii) Evidence-based decision support interventions. Enable a limited set of identified users to select (i.e., activate) electronic CDS interventions (in addition to drug-drug and drug-allergy contraindication checking) based on each one and at least one combination of the data referenced in paragraphs (a)(9)(ii)(B)(1)(i) through (vi) of this section.

(iv) Linked referential CDS. (A) Identify for a user diagnostic and therapeutic reference information in accordance at least one of the following standards and implementation specifications:

(1) The standard and implementation specifications specified in § 170.204(b)(3).

(2) The standard and implementation specifications specified in § 170.204(b)(4).

(B) For paragraph (a)(9)(iv)(A) of this section, technology must be able to identify for a user diagnostic or therapeutic reference information based on each one and at least one combination of the data referenced in paragraphs (a)(9)(ii)(B)(1)(i), (ii), and (iv) of this section.

(v) Source attributes. Enable a user to review the attributes as indicated for all CDS resources:

(A) For evidence-based decision support interventions under paragraph (a)(9)(iii) of this section:

(1) Bibliographic citation of the intervention (clinical research/guideline);

(2) Developer of the intervention (translation from clinical research/guideline);

(3) Funding source of the intervention development technical implementation; and

(4) Release and, if applicable, revision date(s) of the intervention or reference source.

(B) For linked referential CDS in paragraph (a)(9)(iv) of this section and drug-drug, drug-allergy interaction checks in paragraph (a)(4) of this section, the developer of the intervention, and where clinically indicated, the bibliographic citation of the intervention (clinical research/guideline).

(10) Drug-formulary and preferred drug list checks. The requirements specified in one of the following paragraphs (that is, paragraphs (a)(10)(i) and (a)(10)(ii) of this section) must be met to satisfy this certification criterion:

(i) Drug formulary checks. Automatically check whether a drug formulary exists for a given patient and medication.

(ii) Preferred drug list checks. Automatically check whether a preferred drug list exists for a given patient and medication.

(11) [Reserved]

(12) Family health history. Enable a user to record, change, and access a patient's family health history in accordance with the familial concepts or expressions included in, at a minimum, the version of the standard in § 170.207(a)(4).

(13) Patient-specific education resources. (i) Identify patient-specific education resources based on data included in the patient's problem list and medication list in accordance with at least one of the following standards and implementation specifications:

(A) The standard and implementation specifications specified in § 170.204(b)(3).

(B) The standard and implementation specifications specified in § 170.204(b)(4).

(ii) Optional. Request that patient-specific education resources be identified in accordance with the standard in § 170.207(g)(2).

(14) Implantable device list. (i) Record Unique Device Identifiers associated with a patient's Implantable Devices.

(ii) Parse the following identifiers from a Unique Device Identifier:

(A) Device Identifier; and

(B) The following identifiers that compose the Production Identifier:

(1) The lot or batch within which a device was manufactured;

(2) The serial number of a specific device;

(3) The expiration date of a specific device;

(4) The date a specific device was manufactured; and

(5) For an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c).

(iii) Obtain and associate with each Unique Device Identifier:

(A) A description of the implantable device referenced by at least one of the following:

(1) The “GMDN PT Name” attribute associated with the Device Identifier in the Global Unique Device Identification Database.

(2) The “SNOMED CT® Description” mapped to the attribute referenced in in paragraph (a)(14)(iii)(A)(1) of this section.

(B) The following Global Unique Device Identification Database attributes:

(1) “Brand Name”;

(2) “Version or Model”;

(3) “Company Name”;

(4) “What MRI safety information does the labeling contain?”; and

(5) “Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437).”

(iv) Display to a user an implantable device list consisting of:

(A) The active Unique Device Identifiers recorded for the patient;

(B) For each active Unique Device Identifier recorded for a patient, the description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section; and

(C) A method to access all Unique Device Identifiers recorded for a patient.

(v) For each Unique Device Identifier recorded for a patient, enable a user to access:

(A) The Unique Device Identifier;

(B) The description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section;

(C) The identifiers associated with the Unique Device Identifier, as specified by paragraph (a)(14)(ii) of this section; and

(D) The attributes associated with the Unique Device Identifier, as specified by paragraph (a)(14)(iii)(B) of this section.

(vi) Enable a user to change the status of a Unique Device Identifier recorded for a patient.

(15) Social, psychological, and behavioral data. Enable a user to record, change, and access the following patient social, psychological, and behavioral data:

(i) Financial resource strain. Enable financial resource strain to be recorded in accordance with the standard specified in § 170.207(p)(1) and whether a patient declines to specify financial resource strain.

(ii) Education. Enable education to be recorded in accordance with the standard specified in § 170.207(p)(2) and whether a patient declines to specify education.

(iii) Stress. Enable stress to be recorded in accordance with the standard specified in § 170.207(p)(3) and whether a patient declines to specify stress.

(iv) Depression. Enable depression to be recorded in accordance with the standard specified in § 170.207(p)(4) and whether a patient declines to specify depression.

(v) Physical activity. Enable physical activity to be recorded in accordance with the standard specified in § 170.207(p)(5) and whether a patient declines to specify physical activity.

(vi) Alcohol use. Enable alcohol use to be recorded in accordance with the standard specified in § 170.207(p)(6) and whether a patient declines to specify alcohol use.

(vii) Social connection and isolation. Enable social connection and isolation to be recorded in accordance the standard specified in § 170.207(p)(7) and whether a patient declines to specify social connection and isolation.

(viii) Exposure to violence (intimate partner violence). Enable exposure to violence (intimate partner violence) to be recorded in accordance with the standard specified in § 170.207(p)(8) and whether a patient declines to specify exposure to violence (intimate partner violence).

(b) Care coordination—(1) Transitions of care—(i) Send and receive via edge protocol. (A) Send transition of care/referral summaries through a method that conforms to the standard specified in § 170.202(d) and that leads to such summaries being processed by a service that has implemented the standard specified in § 170.202(a)(2); and

(B) Receive transition of care/referral summaries through a method that conforms to the standard specified in § 170.202(d) from a service that has implemented the standard specified in § 170.202(a)(2).

(C) XDM processing. Receive and make available the contents of a XDM package formatted in accordance with the standard adopted in § 170.205(p)(1) when the technology is also being certified using an SMTP-based edge protocol.

(ii) Validate and display—(A) Validate C–CDA conformance—system performance. Demonstrate the ability to detect valid and invalid transition of care/referral summaries received and formatted in accordance with the standards specified in § 170.205(a)(3), (4), and (5) for the Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary document templates. This includes the ability to:

(1) Parse each of the document types.

(2) Detect errors in corresponding “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in § 170.205(a)(3), (4), and (5).

(3) Identify valid document-templates and process the data elements required in the corresponding section-templates and entry-templates from the standards adopted in § 170.205(a)(3), (4), and (5).

(4) Correctly interpret empty sections and null combinations.

(5) Record errors encountered and allow a user through at least one of the following ways to:

(i) Be notified of the errors produced.

(ii) Review the errors produced.

(B) Display. Display in human readable format the data included in transition of care/referral summaries received and formatted according to the standards specified in § 170.205(a)(3), (4), and (5).

(C) Display section views. Allow for the individual display of each section (and the accompanying document header information) that is included in a transition of care/referral summary received and formatted in accordance with the standards adopted in § 170.205(a)(3), (4), and (5) in a manner that enables the user to: