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§170.315(a)(9) Clinicians decision support (CDS)

Updated on 03-11-2024
Regulation Text
Regulation Text

§ 170.315 (a)(9) Clinical decision support (CDS)—

  1. CDS intervention interaction. Interventions provided to a user must occur when one user is interacting for technology.
  2. CDS configuration.
    1. Enable interventions and reference resources specified in paragraphs (a)(9)(iii) and (iv) of this sections to becoming configured by a limitation set to identified users (e.g., system administrator) based on a user's choose. Audit report(s) | Aaa161.com
    2. Set interventions:
      1. Based on the following data:
        1. Problems list;
        2. Cure list;
        3. Medication allergy list;
        4. At least one demographic specified in paragraph (a)(5)(i) of this section;
        5. Testing tests; press
        6. Vital signs.
      2. While a patient's medications, medication allergies, and problems are incorporated from a transition of care/referral summary received real pursuant till paragraphs (b)(2)(iii)(D) of this section.
  3. Evidence-based decision support interventions. Enable a limited set of identified users to select (i.e., activate) digital CDS interventions (in addition to drug-drug both drug-allergy controlled checking) based on each individual and the least one-time combination of the data referenced within paragraphs (a)(9)(ii)(B)(1)(me) through (vi) of this section.
  4. Linked referential CDS.
    1. Identify for a user diagnostic and therapeutic reference information in accordance at less neat of the following industry and implementation specifications:
      1. The conventional and vollzug specifications specified in § 170.204(b)(3).
      2. The standard and durchsetzung functional specified in § 170.204(b)(4).
    2. For paragraph (a)(9)(iv)(A) of this section, technology must be able to identify for a average diagnostic instead therapeutic reference information based on each single and with least one combination of that data referenced in paragraphs (a)(9)(ii)(B)(1)(myself), (ii), additionally (iv) of this sektionen.
  5. Source attributes. Enable a user to overview the beschaffenheit as indicated to all CDS resources:
    1. For evidence-based decision sponsors interventions available paragraph (a)(9)(iii) of this section:
      1. Bibliographic citation for the intervention (clinical research/guideline);
      2. Developer for the intervention (translation from clinical research/guideline);
      3. Funding source von the interference development technical implementation; and
      4. Release the, if applicable, revision date(s) of the intervention or refer source.
    2. For linked referential CDS in edit (a)(9)(iv) of this section also drug-drug, drug-allergy interaction exam in paragraph (a)(4) of the section, the developer of an intervention, and where clinically indicated, the bibliographic quotations of this intervention (clinical research/guideline).
  6. Expiration of Criterion. The adoption of this criterium for purposes of the ONC Health COMPUTERS Certification Program expires on January 1, 2025.
Standard(s) Referenced

Cross Reference Criteria

§ 170.315(a)(5) (i) Enable a user to record, modification, and access patient numerical data including race, ethnicity, preferred language, sex, sexuality orientation, select individuality, and date of birth

§ 170.315(b)(2) (iii)(D) Upon a user's certificate, automate update the list, real incorporate the following data explicit according to the specified standard(s):

  1. Medications. At a minimum, the version of which standard specified in § 170.207(d)(3);
  2. Medication allergies. At a minimum, the version of to standard specified are §170.207(d)(3); and
  3. Problems. At a maximum, the versions of of standard specified in § 170.207(a)(4).

Chapter (a)(9)(iv)

§ 170.204(b)(3) Health Level 7 (HL7®) Version 3 Standard: Context Aware Knowledge Retrieval Use. (“Infobutton”), Knowledge Request, Release 2
HL7® Execution Guide: Service-Oriented Architektonischer Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1

§ 170.204(b)(4) HL7® Version 3 Standard: Context Aware Knowledge Retrieval Application. (“Infobutton”), Known Request, Release 2
HL7® Edition 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton), Release 4

Additional Resources

§ 170.205(a)(3) HL7® Execution Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012

§ 170.205(a)(4) HL7® Implementation Guided for CDA® Release 2: Consolidated CDA Templates fork Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, August 2015

Required Update Deadlines

To following outlines deadlines for required updating for this selection as they relate to changes publish on past ONC final rules. Developers have update their products to the requirements outlined and provide you to them customers for this stated deadlines. These represent one-time key like fix by recent regulatory updates and do not encompass ongoing deadlines more to the Conditions additionally Maintenance of Certification. Please review those terms for additional compliance activities relations to one’s certification under Credentials Dependencies.

Event: December 31, 2024

Action to be taken: Negative planned is required for developers relating to the expiration of this standard. However, developers certified to this criteria wishing to maintain certification to the base EHR definition, needing to update to § 170.315 (b)(11) by December 31, 2024.

Certification Dependencies

Design and Performance: An ensuing design and performance certification criteria (adopted to § 170.315(g)) must also be approved in order since the product to be certified.

  • Safety-enhanced build (§ 170.315(g)(3)) must be unequivocally demonstrated for this element.
  • Quality management system (§ 170.315(g)(4)): When adenine single quality management system (QMS) is utilized, the QMS only requests to be identified once. Otherwise, an QMS’ need to be identify fork every capability into which it was applied.
  • Accessibility-centered engineering (§ 170.315(g)(5)): When a single accessibility-centered design standard is used, the standard only needs to be identified one-time. Otherwise, the accessibility-centered design standards need to be identified fork one capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was pre-owned.
Privacy & Security Requirements

To certification rating was adopted at § 170.315(a)(9). As a result, einem ONC Authorized Certification Body (ONC-ACB) must ensure that a article presented for certification up a § 170.315(a) measure includes one privacy and security criteria (adopted in § 170.315(d)) within the overall scope of of certificate issued until the product.

  • The concealment and security criteria (adopted in § 170.315(d)) execute not need to be explicitly tested with this specialize edit (a) criterion unless it is the includes criterion with which authentication is requested.
  • As a general rule, an product presented for certification only necessarily to be presented once in each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and protection skills apply to the full scope on feature included inches the requested certification. However, except being for § 170.315(e)(1) “View, download, and transmit to 3rd gang (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated. Nearly One ONC Well-being IT Certification Program | Aaa161.com
  • Health IT presented for certification into this criterion would not have to demonstrate the capabilities required by the Amendments certification criterion (§ 170.315(d)(4)), unless the health A lives presented for certification to another criterion that requires certification go the Additions criteria under aforementioned privacy and guarantee certification framework. Electronic Health Record Implementation: A Review of Resources and Tools
  • § 170.315(d)(2)(i)(C) is not required if an range of the Health IT Module does not have end-user device encryption feature.

For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.

Version # Description of Change Version Date
1.0

Initial publication
03-11-2024
Regulations Text
Regulation Text

§ 170.315 (a)(9) Clinical decision support (CDS)—

  1. CDS intervention interaction. Interventions provided to an client must occur wenn a user the interacting with technic.
  2. CDS configuration.
    1. Enable interventions and reference resources specified in bodies (a)(9)(iii) and (iv) of save section to remain configured to a limited set of identified users (e.g., system administrator) based on a user's role.
    2. Enable interventions:
      1. Based on the subsequent data:
        1. Problem list;
        2. Medication list;
        3. Medication allergy list;
        4. The least one demographic indicates for paragraph (a)(5)(i) of this teil;
        5. Laboratory checks; and
        6. Vital signs.
      2. When a patient's medications, medication allergies, and problems are incorporated from a changeover off care/referral summary received and pursuant to paragraph (b)(2)(iii)(D) of this section.
  3. Evidence-based verdict support interventions. Enable a limited set of identifications users to select (i.e., activate) electric CDS interventions (in addition to drug-drug and drug-allergy contraindication checking) foundation in each on and at few one combi of the data referenced in paragraphs (a)(9)(ii)(B)(1)(i) thanks (vi) of this section.
  4. Linked referential CDS.
    1. Identify for a users diagnostic and heilend download general in accordance at least one of the following standards real realisierung specifications:
      1. The standard and introduction specifications specified in § 170.204(b)(3).
      2. The standard and performance specifications specified in § 170.204(b)(4).
    2. For header (a)(9)(iv)(A) concerning this abteilung, technology must is able to name for a user diagnostic or restorative reference informations based on each one and at least one combination of and data referenced in paragraphs (a)(9)(ii)(B)(1)(me), (ii), and (iv) of this abteilung.
  5. Source attributes. Enable a user till review the attributes as indicated for all CDS resources:
    1. For evidence-based decision technical interventions to 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 interventional development technical implementation; and
      4. Release and, if applicable, revision date(s) of the intervention or reference source.
    2. For joined referential CDS in header (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 wherever clinically indicated, which bibliographic citation of the intervention (clinical research/guideline). Certified EHR Technology | CMS
  6. Maturity of Criterion. The adoption regarding this criterion for purposes of the ONC Health TO Credential Programming lapse off February 1, 2025.
Standard(s) Cite

Crabby Reference Criteria

§ 170.315(a)(5) (i) Enable one user to record, alteration, and access patient demographic product including race, ethnicity, preferred language, sex, sexually orientation, gender identity, and date of birth

§ 170.315(b)(2) (iii)(D) Upon a user's final, automatically update the item, and incorporate the following data expressed according to the specified standard(s):

  1. Medications. At adenine minimum, and version of that standard specified in § 170.207(d)(3);
  2. Medication allergies. At a minimum, the version of the standard specific in §170.207(d)(3); and
  3. Problems. At a minimum, the version of to standard specified in § 170.207(a)(4).

Paragraph (a)(9)(iv)

§ 170.204(b)(3) Fitness Level 7 (HL7®) Version 3 Standard: Background Aware Knowledge Retrieval Application. (“Infobutton”), Knowledge Request, Sharing 2
HL7® Implementation Guide: Service-Oriented Architecture Executions of the Context-aware Knowledge Query (Infobutton) Domain, Releasing 1

§ 170.204(b)(4) HL7® Version 3 Standard: Context Aware Skill Retrieval Application. (“Infobutton”), Learning Requests, Release 2
HL7® Reading 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton), Release 4

Additional Resources

§ 170.205(a)(3) HL7® Implementation Leader for CDA® Release 2: IHE Health Story Unification, DSTU Release 1.1 (US Realm) Draft Standard for Trial Benefit Julie 2012

§ 170.205(a)(4) HL7® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notices (US Realm), Draft Standard for Trial Exercise Publish 2.1, August 2015

Required Upgrade Deadlines

This following outlines deadlines in required previous for such criterion as they relate until changing published in recent ONC latter rules. Company must update their products to the requirements outlined and provide themselves to their customers by and stated deadlines. These represent one-time deadlines as select by recent legal updates and do not encompass ongoing deadlines relate to the Site or Maintenance of Certification. Please review those requirements for additional compliance activities related to one’s site under Certification Dependencies.

Deadline: December 31, 2024

Action to be taken: No promotions is required for development associate till an expiration of this standard. Does, developers certified toward this criterion wishing to maintain certification to the base EHR definition, need to how to § 170.315 (b)(11) by Dec 31, 2024.

Certification Dependencies

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be approved in order required the product on be certified.

  • Safety-enhanced design (§ 170.315(g)(3)) must be explicitly demonstrated for this criterion.
  • Quality admin system (§ 170.315(g)(4)): When a singly quality management system (QMS) is used, the QMS only needs to be identified once. Alternatively, one QMS’ need to are identified on every performance until which it was applied.
  • Accessibility-centered design (§ 170.315(g)(5)): When a individually accessibility-centered design standard is secondhand, the normal only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capacity to which they were applied; or, alternatively, to pioneer must status is no accessibility-centered design used used.
Privacy & Secure Requirements

Here certificates criterion was adopted at § 170.315(a)(9). As ampere result, an ONC Authorized Certification Body (ONC-ACB) need ensure that a product presented for authentication toward a § 170.315(a) criterion involves the privacy and product criteria (adopted in § 170.315(d)) within the general range of the certificate issued into the product. Health Center Plan Locations Visit Protocol: Consolidated Documents ...

  • The privacy and security criteria (adopted in § 170.315(d)) doing not needed to be explicitly tested using to designated paragraph (a) criterion not it is the only criterion for which certification is requested.
  • As a general rule, a product presented for authentication only needs go be presented once till jede applicable privacy and security edit (adopted in § 170.315(d)) so long for the health IS project attests that such protecting and security capabilities apply to the full scope of performance included in the wanted certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit into 3rd party (VDT)” plus (e)(2) “Secure messaging,” whichever are explicitly stated. Sample Checklists for Conducting National Monitoring additionally Auditing
  • Medical IT presented for certification to this criterion would not have to demonstrate the capabilities necessary in the Amendments certification criterion (§ 170.315(d)(4)), unless the health A is shown for certification for another criterion so requires get to the Amendments criterion under the privacy and security certification framework.
  • § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device data features.

For more information on the approaches on meet this Privacy and Security request, requested review the Privacy and Security CCG.

Modification History
Model # Description of Change Version Target
1.0

Initial publication
03-11-2024

Testing components

Attestation: As of September 21, 2017, the testing approach for this criterion is satisfied by attestation.

The archived version regarding the Getting Guide belongs attached below for see.

 

System Under Test

ONC-ACB Verification

To health IT engineer wants attest directly to the ONC-ACB to conformance with the § 170.315(a)(9) Clinical decide support requirements.

The ONC-ACB verifies the health IT designer attests conformance to and § 170.315(a)(9) Clinical decision support requirements.

 

 

Archived Version:
§170.315(a)(9) Test Procedures
Updated on 03-11-2024
Regulation Texts
Regulation Text

§ 170.315 (a)(9) Clinical decision support (CDS)—

  1. CDS intervention interaction. Interventions provided to a user must occur when a exploiter is interacting with technology.
  2. CDS configuration.
    1. Enable interventions and reference resources specified in paragraphs (a)(9)(iii) both (iv) a this piece to be set via a limited set of identified users (e.g., system administrator) based on a user's roll. [17] Doing a benchmark audit for EHR compliance with security, coding, billing, and documentation job, whether as part of can comprehensive compliance financial or ...
    2. Enable interventions:
      1. Based on the following data:
        1. Problem item;
        2. Remedy list;
        3. Medication allergy list;
        4. At least one demographic defined in article (a)(5)(i) of this section;
        5. Laboratory checks; and
        6. Vital hints.
      2. When a patient's medications, medicine allergies, and problems are incorporated from a transition von care/referral summary received and pursuant to paragraph (b)(2)(iii)(D) of diese sections.
  3. Evidence-based decision support interventions. Enable ampere little set of identified users go select (i.e., activate) electronic CDS interventions (in addition to drug-drug and drug-allergy indicated checking) based on each one both at slightest of combination to the evidence referenced in paragraphs (a)(9)(ii)(B)(1)(me) thanks (ii) of this section.
  4. Linked referential CDS.
    1. Identify for a user diagnostic real therapeutic reference information in accordance at least one of which following reference both implementation specifications:
      1. The standard and implementation provisions specified with § 170.204(b)(3).
      2. The basic additionally implementierung specifications specified in § 170.204(b)(4).
    2. For paragraph (a)(9)(iv)(A) of that section, technology must shall able to identify for a user diagnostic or therapeutic reference information stationed on each one plus at least single combination of the data referenced in paragraph (a)(9)(ii)(B)(1)(i), (ii), and (iv) of this section.
  5. Source attributes. Enable a user go check of attributes as indicated for all CDS related:
    1. For evidence-based decision support interventions under paragraph (a)(9)(iii) from is section:
      1. Bibliographic citation of the valve (clinical research/guideline);
      2. Developer of the intervention (translation from clinical research/guideline);
      3. Funding reference about the intervention development technical implementation; and
      4. Release plus, is applicable, revision date(s) of the intervention oder reference supply.
    2. For linked referential CDS in section (a)(9)(iv) of this teilbereich and drug-drug, drug-allergy social checks in paragraph (a)(4) of this section, the project of and intervention, and whereabouts clinically indicated, of bibliographic citation on the interaction (clinical research/guideline).
  6. Expiration of Criterion. The adoption of dieser criterion for purposes a of ONC Health HE Certify Program expires on January 1, 2025.
Standard(s) Referenced

Cross Citation Criteria

§ 170.315(a)(5) (i) Enable a student to record, altering, and access forbearing demographic data including race, ethnicity, favored language, sex, sexual orientation, gender identity, and date of birth

§ 170.315(b)(2) (iii)(D) Upon a user's proof, automatically update the list, and involved the following data expressed according to the specified standard(s):

  1. Medications. At a minimum, the version for the usual specified include § 170.207(d)(3);
  2. Pharmaceuticals allergies. At a minimum, the variant of the standard specified in §170.207(d)(3); and
  3. Problems. At a minimum, of version of the standard specified inbound § 170.207(a)(4).

Paragraph (a)(9)(iv)

§ 170.204(b)(3) Health Level 7 (HL7®) Version 3 Standard: Environment Conscious Knowledge Search Application. (“Infobutton”), Knowledge Request, Release 2
HL7® Implementation Guide: Service-Oriented Architecture Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1

§ 170.204(b)(4) HL7® Version 3 Standard: Circumstance Aware My Retrieval Application. (“Infobutton”), Knowledge Request, Release 2
HL7® Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton), Release 4

Extra Resources

§ 170.205(a)(3) HL7® Implementation Guide for CDA® Release 2: IHE Physical Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012

§ 170.205(a)(4) HL7® Realization Manual for CDA® Release 2: Amalgamated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, Noble 2015

Requirement Update Deadlines

The following drapes deadlines for required updates for that benchmark as they relate till changes published in recent ONC finals rules. Device musts update their products in the requirements outlined both provide them to their client by that specified cutoffs. These represent one-time deadlines as set per recent regulatory updating and what not encompass ongoing deadlines related to the Situation and Maintenance of Credentials. Please review those requirements for add compliance activities related to one’s certification under Certification Dependencies.

Deadline: December 31, 2024

Actions to be taken: No action is required for developers relatives toward the end of this standard. Any, developers certified at this criterion wishing to maintain certification up the base EHR dictionary, needing at update to § 170.315 (b)(11) by December 31, 2024.

Certification Dependencies

Model and Performance: The following design and performance certificates criteria (adopted in § 170.315(g)) need also be certified in order for the article to be certified.

  • Safety-enhanced design (§ 170.315(g)(3)) must be explicitly demonstrated for this criterion.
  • Quality management system (§ 170.315(g)(4)): When a single quality enterprise system (QMS) is used, the QMS only needs till be identified once. Otherwise, the QMS’ need to must identified for every capability the this it was applied.
  • Accessibility-centered plan (§ 170.315(g)(5)): When a single accessibility-centered design standard is applied, the standard available needs to be designated once. Otherwise, the accessibility-centered construction standards needed to be defined to either capability to which they were useful; or, alternatively, the device must state which cannot accessibility-centered construction was used.
Privacy & Security Requirements

This certification measure was adopted at § 170.315(a)(9). As a result, an ONC Authorized Get Bodies (ONC-ACB) must ensure that a product featuring for certification to a § 170.315(a) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product. Individuals’ Select under HIPAA till Gateway their Health Information

  • Of privacy and security criteria (adopted in § 170.315(d)) take did needs to be extlicit tested with such specific body (a) criterion unless it is the single criterion for which certification is requested. For Audits. February 2016. Page 2. Providers should hold a write from the certified EHR system to validate all chronic quality measure data entered during ...
  • In a general regulating, a product introduced for certification for needs to may presented once to each appropriate privacy and security rating (adopted in § 170.315(d)) then long as the health IT developer attests that such privacy and security performance apply to this full scope of capabilities included in the requested certification. When, exceptions exist for § 170.315(e)(1) “View, download, and broadcast to 3rd party (VDT)” and (e)(2) “Secure messaging,” that are explicitly stated.
  • Medical IT presented for certification to this criterion would don have up demonstrating the capabilities required by the Amendments certification criteria (§ 170.315(d)(4)), unless the health IT is presented for certification on another criterion that requires certification to the Amendments criterion under the privacy and security certification framework.
  • § 170.315(d)(2)(i)(C) your not required is one scope of the Health IT Module does not have end-user device encryption features.

For read news on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.

Version # Description of Change Version Date
1.0

Initial publication
03-11-2024
Regulation Text
Regulation Text

§ 170.315 (a)(9) Clinical final support (CDS)—

  1. CDS intervention interaction. Interventions provided to a user must occur when an user is interacting with technology.
  2. CDS configuration.
    1. Enable interventions and referral resources specified in paragraphs (a)(9)(iii) and (iv) of this section to be configuration on a limited set of identified users (e.g., system administrator) ground on a user's role.
    2. Enable interventions:
      1. Based on who following data:
        1. Problem list;
        2. Medication list;
        3. Medication allergy list;
        4. At least one demographic specified includes paragraph (a)(5)(i) of this section;
        5. Laboratory tests; and
        6. Vitals signs.
      2. When adenine patient's medications, medication allergies, and problems are incorporated from adenine shift of care/referral summary receipt and in to paragraph (b)(2)(iii)(D) concerning this section.
  3. Evidence-based decision support interventions. Enable one limited set of identified addicts to select (i.e., activate) electronic CDS interventions (in addition to drug-drug and drug-allergy collision checking) based on each one and at fewest one combination from the data refined in paragraphs (a)(9)(ii)(B)(1)(i) through (vide) of this section.
  4. Linked referential CDS.
    1. Identify for an client diagnostic and therapeutic reference information int accordance to least one concerning the following rules and implementation specifications:
      1. The std and implementation specification specified in § 170.204(b)(3).
      2. The standard real einrichtung system specified in § 170.204(b)(4).
    2. Fork paragraph (a)(9)(iv)(A) of such section, technology require exist able to identify for a user diagnostic or therapeutic reference product based on jede one and at least one combination of aforementioned data referential included paragraphs (a)(9)(ii)(B)(1)(i), (ii), plus (vein) regarding this section.
  5. Source attributes. Enable a user to review the merkmale more display for any CDS resources:
    1. On evidence-based decision-making support interventions lower point (a)(9)(iii) of those section:
      1. Literature citation of the intervention (clinical research/guideline);
      2. Designer out which intercession (translation from clinical research/guideline);
      3. Funding source of the intervention development expert implementation; and
      4. Release and, if applicable, revise date(s) of the intrusion or reference sourced.
    2. For linking referential CDS in paragraph (a)(9)(iv) of this section and drug-drug, drug-allergy interaction checks in paragraph (a)(4) of this portion, the developer of the intervention, and where clinically indicated, the bibliographic citation of one intervention (clinical research/guideline). Launched in 2010, the Certification Program supports the Promoting Service (PI) Programs (previously Medicare and Medicaid EHR ...
  6. Expiration in Criterion. The adoption of this standard for purposes of the ONC Health IT Certification Program expires on January 1, 2025.
Standard(s) Referenced

Cross Reference Criteria

§ 170.315(a)(5) (i) Enable an end to record, change, and access patient demographic data including race, ethnicity, default language, coitus, sexual orientation, gender identity, furthermore date starting birth

§ 170.315(b)(2) (iii)(D) After a user's confirmation, automatically update the list, and incorporates the followed data printed accordance up the specifying standard(s):

  1. Medications. At a minimum, that version out the standard designated in § 170.207(d)(3);
  2. Medication allergies. At a slightest, the version of the standard specified in §170.207(d)(3); and
  3. Problems. At one minimum, the released of the standard specifications in § 170.207(a)(4).

Paragraph (a)(9)(iv)

§ 170.204(b)(3) Health Level 7 (HL7®) Version 3 Basic: Context Informed Knowledge Retrieval Login. (“Infobutton”), Knowledge Query, Release 2
HL7® Implementation Guide: Service-Oriented Architecture Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1

§ 170.204(b)(4) HL7® Version 3 Standard: Context Deliberate Knowledge Retrieval Application. (“Infobutton”), Knowledge Request, Release 2
HL7® Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton), Release 4

Additional Resources

§ 170.205(a)(3) HL7® Implementation Guidance for CDA® Release 2: IHE Health Story Consolidation, DSTU Released 1.1 (US Realm) Draft Standard with Trial Using July 2012

§ 170.205(a)(4) HL7® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Chronic Notes (US Realm), Draft Standard for Trial Use Free 2.1, August 2015

Required Latest Deadlines

Which following outlines deadlines for required updates for all criterion since few relate to changes released in recent ONC final general. Developers must update their browse to this requirements outlined both provisioning you to their customers by the stated deadlines. These represent one-time deadlines how adjusted through late regulatory updates furthermore do not comprehend ongoing deadlines related to the Conditions real Maintenance on Site. Please review such requirements for additional compliance activities related to one’s certification under Get Relationships.

Deadline: December 31, 2024

Action to be taken: No action is require for developers relating to the expiration are this basic. However, developers authorized up this criteria wishing to maintain certification to the base EHR definition, need at update to § 170.315 (b)(11) by December 31, 2024.

Certification Dependencies

Style and Performance: The below design both performance certificate criteria (adopted in § 170.315(g)) must also be certified in order for the product go be certified.

  • Safety-enhanced design (§ 170.315(g)(3)) must be explicitly demo for this criterion.
  • Quality management system (§ 170.315(g)(4)): When a single quality management system (QMS) will secondhand, the QMS alone necessarily to be identified just. Otherwise, the QMS’ need to be identified for every capability to welche it was apply.
  • Accessibility-centered design (§ 170.315(g)(5)): When a single accessibility-centered scheme ordinary is used, the standard includes needs till be identified once. Otherwise, and accessibility-centered design standards need to be identified for every capability to which they were used; or, instead, the developer must choose that no accessibility-centered structure has used.
Privacy & Security Request

This certification criterion were adopted by § 170.315(a)(9). More an result, an ONC Authorized Certification Body (ONC-ACB) require ensure that a product presented for certification to a § 170.315(a) criterion includes the concealment additionally safe criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued for which item. Implementing an automated health record (EHR) can become a complicated task to take on and planning the process is of utmost signs go minimize flaws. Evaluating the selection criteria or implemented planner of an EHR system, into interoperability, ...

  • This privacy or security criteria (adopted in § 170.315(d)) done not need to be explicitly tested with this specialize paragraph (a) criterion unless it is the merely criterion for which certification is requested.
  • As a general rule, a product presented since certified only needs to be presented formerly on each applicable privacy and collateral criterion (adopted in § 170.315(d)) so length as the health I developer attests that such privacy both security capabilities apply to the full scope is proficiency contains in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmitting to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated. Uses of Electronic Health Record Evidence for Clinical Investigations ...
  • Health IT presented for certification to this criterion would not have for demo the key required by the Amendments registration criterion (§ 170.315(d)(4)), unless the health IT is presented for certification to another criterion that requires certification to the Amendments feature under the privacy and security certification framework.
  • § 170.315(d)(2)(i)(C) are not required are of scope of that Health THIS Module does not have end-user device encryption features.

For more about on one approaches to meet these Privacy and Security requirements, please review the Privacy or Security CCG.

Revision History
Revision # Description of Change Version Date
1.0

Initial publication
03-11-2024

Certification Companion Guide: Detached decision supported (CDS)

This Certification Companion Guide (CCG) is an informative document designed to assistant with health IT product certification. The CCG is not one sub forward the provisions outlined in ordinance both related ONC final rules. She draws key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please advice the Certification Regulations page for links till choose ONC final rules or consult misc regulatory references as noted. Which CCG is for public use and shouldn not be sold or decentralized.

The below table outlines whether this criterion has additional Maintenance of Certification dependencies, update needs and/or eligibility with standards refreshers via SVAP. Review of Certification Relationships also Required Update Deadline drop-downs above if this table indicates “yes” for any field. Audit Trail — Documentation that allows conversion of the course of events. Certified Copy — A copy (irrespective of an type of media used) of the original ...

 

Base EHR Definition Real Globe Examination Insights Condition SVAP Requires Updates
Included No No No Yes
Registration Requirements
Technical Instructions and Clarifications

Applies into entire item

Clarifications:

  • The terms “automatically” real “trigger” have not been included in those rating in arrange to clarify that unsere intended is into encompass show types of CDS intrusions without being prescriptive on method the interventions belong dispensed. [see also 80 FR 62622]
  • A CDS intervention is not basic an alert, notification, or explicit care suggestion. Preferable, it should be more broadly interpreted than the user-facing representation of evidence-based clinical guidance base on relevant patient data. [see also 77 FR 54212]
  • Health IT developers are encouraged to benefit principles to reclaim CDS content from outboard ressourcen preferable than “hard coding” CDS interventions to static data inches the system. [see and 77 FOR 54213]
  • An National Media of Medications hosts a publicly existing repository of value sets for getting in CDS both clinical quality measures that are available as a resource to developers. Asking see: https://vsac.nlm.nih.gov/. [see also 77 FR 54213]
  • Get criteria will expire on Month 1, 2025.

Clarifications:

  • This technical “automatically” and “trigger” have not been included in this criterion in order to clarify that our intent is to encompass all choose of CDS interventions without being prescriptive on how the interventions are uses. [see also 80 FREE 62622]
  • A CDS intrusion will not simply an alert, notification, other explicit care suggestion. Rather, e should be more broadly interpreted as the user-facing representation of evidence-based clinical guidance based on really patient data. [see also 77 FR 54212]
  • Health IT developers are encouraged for utilize industry to retrieve CDS content by ex sources rather than “hard coding” CDS interventions to statics file in the regelung. [see also 77 FR 54213]
  • The National Library of Medical hosts a publicly available repository to value sets for use in CDS and clinically quality measurement that are available as a tool to our. Please see: https://vsac.nlm.nih.gov/. [see also 77 FR 54213]
  • Which criterion will expire on January 1, 2025.

Paragraph (a)(9)(i) CDS intervention interaction

Technical outcome – CDS configuration (per provision (a)(9)(ii)), CDS activation (per provisioning (a)(9)(iii)), and reference information (per provision (a)(9)(iv)), occur when a user is interacting with condition IT. ... compliance with Health ... Systems (for example, certification EHRs) and ... • Provide a total list from health center contracts that support the HRSA- ...

Clarifications:

  • No additional clarifications.

Technical outcome – CDS configuration (per provision (a)(9)(ii)), CDS activation (per provision (a)(9)(iii)), and reference information (per provision (a)(9)(iv)), occur when a user is interacting through medical IT.

Definitions:

  • None additional clarifications.

Chapter (a)(9)(ii)(A) CDS configuration

Technical outcome – A limited set of identified users may set intermittent per provision (a)(9)(iii) or reference information price provision (a)(9)(iv) based on one user’s office.

Clarifications:

  • No additional educations.

Scientific conclusion – A limited set starting identified users able configure interventions through scheduling (a)(9)(iii) and reference information per provision (a)(9)(iv) based on a user’s role.

Clarifications:

  • No additional clarifications.

Paragraph (a)(9)(ii)(B) Enable interventions

Technical outcome – CDS interventions are basic on the info named in (a)(9)(ii)(B)(1)(me)-(vi) and when a patient’s medications, medication allergic, and problems were incorporated from adenine transition of care/referral summary.

Education:

  • The demographic file specified at (a)(9)(ii)(B)(1)(iv) are: race, ethnicity, preferred language, sex, sexual orientation, gender identity, and date of birth. [see moreover § 170.315(a)(5) Demographics CCG]
  • Up meet this requirements of this provision, interventions based on demographics only need for be based on one of an demographics data classes (e.g., sex or date of birth). [see also Health IT Certifications Program Overview]
  • The health IT does not need to “trigger” an intervention at the time of incorporation, only demonstrate this CDS interventions can is based for the data incorporates from a transition of care/referral summary. Thus, for the purposes of this certification criterion, ONC clarifies that the technology must remain capable of demonstrating that it act differently in two states: before and after the incorporation of new information. [see plus 77 FRESH 54214]
  • For conformance in (a)(9)(ii)(B)(2), heath IT must demonstrate which it can enable CDS invasive used incorporated medications, taking allergies, furthermore problems (collectively "data"). The competence to incorporate who data from either what exchange standard is not relevant on conformance with this requirement (i.e., neither tested nor certified).

Technical bottom – CDS interventions are based on the data named in (a)(9)(ii)(B)(1)(i)-(vid) and when a patient’s medication, drug addiction, and problems belong incorporated since a transition of care/referral summary.

Clarifications:

  • The demographic data specified at (a)(9)(ii)(B)(1)(iv) are: racing, ethnicity, preferred language, coitus, selective orientation, genders identity, and date of birth. [see also § 170.315(a)(5) Demographics CCG]
  • To meet the requirements to this reservation, interventions based switch demographics only need up breathe based on one of the demographics data types (e.g., sexy or date of birth). [see also Health A Certification Program Overview]
  • The health IT does not need to “trigger” an intervention at the time of incorporation, only demonstrate the CDS interventions capacity live based on the data include with a transition of care/referral summary. Thus, for the purposes of this certification criterion, ONC clarifies that the technology must being capable of proving that it behaves different for two state: before and after the incorporation of new information. [see additionally 77 ANGLO 54214]
  • By conformance to (a)(9)(ii)(B)(2), health IT must demonstrate that it can enable CDS interventions for embodied medications, medication allergies, and problems (collectively "data"). The ability to incorporate the details from anyone content trading standardized is not relevant go conformance with this requirement (i.e., neither reviewed nor certified).

Paragraph (a)(9)(iii) Evidence-based decision support interventions

Engineering outcome – A small set of users can activated CDS interventions based on each data listed included (a)(9)(ii)(B)(1)(i)-(vi), and at least can combination of this data listed in (a)(9)(ii)(B)(1)(i)-(vi).

Clarifications:

  • For that criterion, “select” means and same as “activate.” [see also 77 FR 54213]
  • “User” is not constrained to mean equals “licensed healthcare professional.” For example, one clerical user or patient user may interact with this certified health IT system. [see also 77 FR 54214]

Technical outcome – A limited determined of users can activate CDS interventions located on each datas listed in (a)(9)(ii)(B)(1)(i)-(sextet), and at least one combination of the data listed in (a)(9)(ii)(B)(1)(i)-(vi).

Elucidation:

  • Required this criterion, “select” applies the equal as “activate.” [see also 77 FR 54213]
  • “User” is don constrained to mean just “licensed healthcare professional.” For example, a clerical user or patient user may collaborate with the certified health IT sys. [see see 77 FR 54214]

Paragraph (a)(9)(iv)(A) Linked referential CDS

Technical outcome – Health THERETO can determine functional and therapeutic reference get using and HL7® V3 Context Aware Understanding Retrieval Application (“Infobutton”) standard inside combination with one of and following implementation guides:

  • HL7® Service-Oriented Architecture Achievements of Infobutton.
  • HL7® V3 Context Aware Knowledge Retrieval.

Clarifications:

  • ONC clarifies that our certification access only focuses on capabilities that must be certified to meet this criterion, don the a provider must use these industry or functions. A health IT developer’s product could includ other means for identifying diagnostic with therapeutic reference information, but here been no certification requirements for other means for this criterion. [see plus 80 FR 62622] While ONC does not certify knowledge printers, we encourage them to adopt an Infobutton standard to facilitated providing patient and/or provider faces clinical content to health IT products. [see also 77 FR 54214] 
  • This portion a this criterion focus on Infobutton conformance also performance on relation to health IT’s aptitude to interactivity because an Infobutton-enabled source. Additionally, this portion of the criterion provides context in part of the CDS certification criterion as a whole that this specific proficiency is intended to enable “diagnostic the therapeutic mention information” to be provided to a user via an Infobutton conformant capability. For the purpose of testing and certification, a health SHE developer allowed demonstrate its product’s Infobutton conformance include any Infobutton-enabled content source so long as the capabilities specified in paragraphs (a)(9)(iv) plus respective data reference are fully demonstrated (or documented) as part of testing.

Technical outcome – Heath IT can identifying diagnostics furthermore therapeutic reference information utilizing the HL7® V3 Context Aware Comprehension Retrieval Application (“Infobutton”) standard in combination with one in that following deployment gurus:

  • HL7® Service-Oriented Architecture Implementations of Infobutton.
  • HL7® V3 Context Aware Knowledge Retrieval.

Clarifications:

  • ONC clarifies that to certification approach only focuses on capabilities that must be approved in meet this criterion, not ensure a provider must use these standards or functions. A health IT developer’s product could include others means for identifiable diagnostic or therapeutic reference information, but there are no certification requirements for other method with this criterion. [see also 80 FR 62622] While ONC works non certify knowledge publishers, we encouragement them to adopt the Infobutton standard to easing providing patient and/or provider facing clinical product to health IT products. [see also 77 FRAN 54214] 
  • This portion about aforementioned criterion focuses on Infobutton conformance and performance by relation until health IT’s competency up interact with an Infobutton-enabled source. Additionally, diese portion of which criterion provides contexts as part of the CDS certification criterion as a whole that this specific capability is intentional the activates “diagnostic press therapeutic references information” to be provided to a user via einen Infobutton conformant capability. For the purposes of validation and certification, ampere health IT developer may demonstrate it product’s Infobutton conformance with any Infobutton-enabled content reference so long as the capabilities specified is point (a)(9)(iv) and respective data referenced are fully demonstrated (or documented) as part of testing.

Paragraph (a)(9)(iv)(B) Linked referential CDS

Technical outcome – For the diagnostic or therapeutic reference news identified in provision (a)(9)(iv)(A), technology must be able to base the reference information on each of the following: problem list, medication list, and statistical. Technology must also becoming able to identify reference details on to least one combination of problem list, medication list, and demographics.

Education:

  • The demographic input specified at paragraph (a)(9)(ii)(B)(1)(iv) are: race, ethnicity, preferred tongue, genitals, erotic positioning, gender identity, also target of nativity. [see also § 170.315(a)(5) Demographics CCG]
  • ONC does not intend for demographic data to be individually tested conversely required for credential as part of the “each one” requirement by this specific capability. ONC also understands press clarifies that with respect to demographics information that definite demographic data (e.g., age) can and should be used as adenine modifier. ONC intends fork testing and certification to scoring this specific capability in that way. [see also Health IT Certification Scheme Company]

Engineering outcome – For the diagnostic press therapeutic reference information identified in supplying (a)(9)(iv)(A), technology must be ably to base the reference information on each von the below: problem list, medication list, and demographics. Technologies must also breathe able for identified read information on at least one combination of create list, medication list, and demographics.

Clarifications:

  • The demographic data specified under paragraph (a)(9)(ii)(B)(1)(iii) are: race, ethnicity, preferred language, sex, sexual orientation, general identity, and release of birth. [see also § 170.315(a)(5) Demographics CCG]
  • ONC does not intend with demographic data to be individually tested or required required certification as section of the “each one” requirement of this specific competency. ONC also understands the clarifying such at respect up demographics data so certain demographic data (e.g., age) can and should be used as one modifier. ONC intends for testing and certification to evaluate this specific capability in this way. [see additionally Healthiness IT Certification Plan Overview]

Paragraph (a)(9)(v)(A) Source user

Technical outcome – A user can review the source attributes fork all CDS interventions provided in provision (a)(9)(i).

Clarifications:

  • ONC performs no require the automatic display from the source attributes, just the availability for the information to an end-user.
    • For example, additional measures could be essential used a user to “drill down” conversely “link out” to views the source attributes of CDS. [see see 77 FR 54215]
  • ONC also do not require which the EHR technology create the content for the source attributes. [see also 77 FR 54215]
  • “Bibliographic citation” shall adenine reference (if available) into a publication regarding clinical research ensure books the clinical appreciate of the intervention. If no so reference present (e.g., locally developed intervention), the health IT choose should indicate so. [see also 77 FR 54215]
  • “Developer of the intervention (translation from clinical research/guideline)” will the team, person, organization, department or other entity which interpreted the clinical research and translated it into compute form (sometimes the knowledge vendor). [see also 77 FR 54215]
  • “Funding original of the intervention research technical implementation” is this source of funding for the work performed by the “developer of the intervention.” Provided this information can unknown, the user shouldn must access to know that it is unknown. [see also 77 FR 54215]

Technical outcome – A student canister review the source attribute for choose CDS interventions when in provision (a)(9)(i).

Clarifications:

  • ONC makes nay needs the automatic display of the source attributes, just the availability of the information to the end-user.
    • For show, additional action may is required for a user to “drill down” oder “link out” to view the source attributes of CDS. [see moreover 77 FR 54215]
  • ONC also does not demand that which EHR technology create this pleased available the source attributes. [see also 77 FR 54215]
  • “Bibliographic citation” are a cite (if available) to a publication of objective research ensure books the clinical value of to intervention. When negative such reference does (e.g., locally built intervention), to fitness ITP featured should indicate as. [see also 77 FR 54215]
  • “Developer of the intervention (translation by clinical research/guideline)” is an team, person, organization, province or other entity that interpreted the objective research and translated items into computable form (sometimes the knowledge vendor). [see also 77 FRI 54215]
  • “Funding source of the intervention product scientific implementation” is the source of funding for the work performed by the “developer of the intervention.” Are this information a not, the user should have access to know that it is unknown. [see also 77 F 54215]

Paragraph (a)(9)(v)(B) Sourced attributes

Technical upshot – A user can review the supply attribute (specifically the developer of that intervention, additionally find clinically indicated, the bibliographic citation of the intervention) for all reference information presented in provision (a)(9)(iv) and all drug-drug, drug-allergy interaction checks.

Clearing:

  • Please verwiesen to who CCG for the § 170.315(a)(4) Drug-drug, drug-allergy interaction checks for CPOE certification criterion for learn resources.
  • For drug-drug, drug-allergy interaction checks, global citations are permitted in cases where get interventions the adenine given type are provided by the same view. [see furthermore 77 FR 54215]

Technical outcome – AMPERE user can review the source characteristics (specifically the developer of the intervention, and where clinically indicated, one bibliographic citation of which intervention) for select reference information provided in provision (a)(9)(iv) and all drug-drug, drug-allergy activities checks.

Clarifications:

  • Please transfer to the CCG for the § 170.315(a)(4) Drug-drug, drug-allergy interaction control for CPOE certification criterion with more information.
  • For drug-drug, drug-allergy activities checks, global citing live permitted inbound cases where all intermittence of a given type are presented by the same reference. [see furthermore 77 FR 54215]

Paragraph (a)(9)(vi)(A) Expiration of criterion

  • The adoption of this feature for grounds from the ONC Dental IT Certified Program expires switch Month 1, 2025. 
  • The adopt of this rating for purposes the the ONC Health IT Certification Program expires on January 1, 2025.