HIPAA Compliance Plan
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§170.306 Specific certification criteria for Complete EHRs or EHR Modules designed for an inpatient setting.

The Secretary adopts the following certification criteria for Complete EHRs or EHR Modules designed to be used in an inpatient setting. Complete EHRs or EHR Modules must include the capability to perform the following functions electronically and in accordance with all applicable standards and implementation specifications adopted in this part:

(a) Computerized provider order entry. Enable a user to electronically record, store, retrieve, and manage, at a minimum, the following order types:

(1) Medications;

(2) Laboratory;

(3) Radiology/imaging;

(4) Blood bank;

(5) Physical therapy;

(6) Occupational therapy;

(7) Respiratory therapy;

(8) Rehabilitation therapy;

(9) Dialysis;

(10) Provider consults; and

(11) Discharge and transfer.

(b) Record demographics. Enable a user to electronically record, modify, and retrieve patient demographic data including preferred language, insurance type, gender, race, ethnicity, date of birth, and date and cause of death in the event of mortality.

(c) Clinical decision support.

(1) Implement rules. Implement automated, electronic clinical decision support rules (in addition to drug-drug and drug-allergy contraindication checking) according to a high priority hospital condition that use demographic data, specific patient diagnoses, conditions, diagnostic test results and/or patient medication list.

(2) Alerts. Automatically and electronically generate and indicate in real-time, alerts and care suggestions based upon clinical decision support rules and evidence grade.

(3) Alert statistics. Automatically and electronically track, record, and generate reports on the number of alerts responded to by a user.

(d) Electronic copy of health information. Enable a user to create an electronic copy of a patient’s clinical information, including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations, procedures, and discharge summary in:

(1) Human readable format; and

(2) On electronic media or through some other electronic means in accordance with:

(i) One of the standards specified in §170.205(a)(1);

(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a minimum, the version of the standard specified in §170.205(a)(2)(i)(B);

(iii) One of the standards specified in §170.205(a)(2)(ii);

(iv) At a minimum, the version of the standard specified in §170.205(a)(2)(iii); and

(v) The standard specified in §170.205(a)(2)(iv).

(e) Electronic copy of discharge information. Enable a user to create an electronic copy of the discharge instructions and procedures for a patient, in human readable format, at the time of discharge on electronic media or through some other electronic means.

(f) Exchange clinical information and summary record.

(1) Electronically receive and display. Electronically receive a patient’s summary record from other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations, procedures, and discharge summary in accordance with §170.205(a) and upon receipt of a patient summary record formatted in an alternate standard specified in §170.205(a)(1), display it in human readable format.

(2) Electronically transmit. Enable a user to electronically transmit a patient’s summary record to other providers and organizations including, at a minimum, diagnostic results, problem list, medication list, medication allergy list, immunizations, procedures, and discharge summary in accordance with:

(i) One of the standards specified in §170.205(a)(1);

(ii) The standard specified in §170.205(a)(2)(i)(A), or, at a minimum, the version of the standard specified in §170.205(a)(2)(i)(B);

(iii) One of the standards specified in §170.205(a)(2)(ii);

(iv) At a minimum, the version of the standard specified in §170.205(a)(2)(iii); and

(v) The standard specified in §170.205(a)(2)(iv).

(g) Reportable lab results. Electronically record, retrieve, and transmit reportable clinical lab results to public health agencies in accordance with the standard specified in §170.205(f)(1) and, at a minimum, the version of the standard specified in §170.205(f)(2).

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