SDOH Clinical Care
3.0.0-ballot - STU 3 Ballot

SDOH Clinical Care - Downloaded Version 3.0.0-ballot See the Directory of published versions

## Specifications for Personal Characteristics

Page standards status: Informative

### Background

Collection of personal characteristics data (e.g., Race and Ethnicity (R/E), gender identity, sexual orientation, recorded sex and gender, and personal pronouns) is important to achieving the goal of health equity. For example, the Cross-Industry Coalition Health Equity Pledge to Address Disparities, and the proposed NCQA race/ethnicity stratification approach "Episode 9", from June 22, 2021, Future of HEDIS presentation (see slides 15-25) both include a focus on the collection of Race & Ethnicity (R/E) data.

However, there are standards-based challenges for collection and exchange of personal characteristics data. For example, some state insurance policies may require payers and/or providers to include R/E data in reporting and some states may require capturing the source (i.e., performer) and collection method for R/E data (e.g., the Oregon Health Authority, Office of Equity and Inclusion Division 70, Race, Ethnicity, Language and Disability Demographic Data Collection Standards has rules and policy related to collection of R/E data.)

In general, personal characteristics data is sensitive personal information with significant privacy and security considerations. Laws vary on the extent to which this data can be disclosed. Before exchanging personal characteristics data, regulatory and policy considerations related to consent and exchange of this data should be understood. Guidance as to the necessary privacy, security, and consent requirements related to the exchange of this data is beyond the scope of this implementation guide. Implementers should understand and abide by their local requirements.

### Specifications

This Implementation Guide (IG) has defined specifications for the exchange of personal characteristics data.

For example, the R/E specifications are defined to meet the reporting requirements of a number of states. As an example, specific organizations require that the source and collection method of R/E data must be reported. Depending on the source and collection method, it is possible for an individual to have more than one observation about a specific personal characteristic (e.g., more than one race and/or more than one ethnicity expressed for an individual).

The current race extension and ethnicity extension for the US Core Patient profile allow specification of multiple coded values, but do not allow multiple occurrences of either extension or the capture of source and collection method.

Since personal characteristics (e.g., R/E) are more consistent with an observation than demographic data, we have modeled the specifications as profiles on the base Observation resource.

There are seven personal characteristic Observation profiles included in this IG:

1. Personal Characteristic (Abstract)
2. Race
3. Ethnicity
4. Gender Identity
5. Recorded Sex and Gender
6. Sexual Orientation
7. Personal Pronouns

#### Value Sets for Personal Characteristics

Value sets for the personal characteristics profiles are based on existing value sets (e.g., US Core, Gender Harmony Project, VSAC, USCDI, etc.).

The personal characteristic profiles adhere to the following consistent structure with respect to handling null flavors:

- Race and Ethnicity – These profiles allow more than one `Observation.component.value` in order to allow race or ethnicity to be expressed with high-level codes, and/or more detailed level codes, and/or as a string. Null values (e.g., unknown, asked-declined, etc.) apply to all assertions about race or ethnicity regardless of granularity. For this reason, null values cannot be captured as part of individual components and are instead captured as a single element using `Observation.dataAbsentReason`. As a consequence, the value sets for `Observation.component.value` have been modified to exclude null value concepts. Thus, for R/E, the value sets for `Observation.component.value` are the same as those defined in the US Core Patient extensions with the exception that null flavors are represented using `Observation.dataAbsentReason`.

- Sexual Orientation, Gender Identity, Recorded Sex and Gender, Personal Pronouns - These profiles allow only one `Observation.value`. Therefore, null value concepts are allowed in the value set for `Observation.value`.

The value set for `Observation.method` may also change as feedback is solicited and/or according to policy (e.g., at the organizational, state, or federal level). For further detail on method, see Recommendations for Collection and Reporting of Personal Characteristics.

#### Guidance for Personal Characteristics of a Related Person or Practitioner

The personal characteristic observations can be used to document not only personal characteristics of the patient but also of other actors (i.e., a practitioner or a related person such as a caretaker) who interact with the patient. Collection and use of personal characteristics data for a practitioner or related person should be treated with the same safeguards as for the patient.

#### Guidance for Personal Characteristics (e.g., R/E) that are also included as extensions on US Core Patient

If there are one or more race observations, each with one or more races expressed, and the referenced US Core Patient uses the race extension to express one or more races, then the US Core Patient race value(s) SHALL match the race value(s) of at least one of the race observations.

If there are one or more ethnicity observations, and the referenced US Core Patient uses the ethnicity extension, then the US Core Patient ethnicity SHALL match the ethnicity of at least one of the ethnicity observations.

Similar guidance may be required as additional personal characteristic extensions are added to US Core Patient.

### Recommendations for Collection and Reporting of Personal Characteristics

The value set for method as well as the allowed references for performer may change as feedback is solicited and/or according to policy (e.g., at the organizational, state, or federal level).

With respect to the values for method, the general recommendation is that personal characteristics should be determined by attestation of the subject. In the event that the subject is a minor or incapable of attesting, there may be situations where a related person may report on their behalf, and this might be captured as “reported-by-related-person”. Additionally, “reported-by-related-person” may apply when an individual is a subscriber to an insurance plan and supplies the plan with information (e.g., recorded sex) of other members/related persons included on the policy. However, when a competent adult is relaying their information to a “related-person”, who is merely filling out a form or sharing that information on their behalf, the general recommendation of this implementation guide is to use “self-reported” as opposed to “reported-by-related-person”.

R/E Example:

Since 1997, self-reported collection of R/E in a two question format has been the standard of the Office of Management and Budget (OMB) (Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity).

Currently, federal policy allows visual observation of R/E in some situations but prohibits it in others (e.g., USDA Food and Nutrition Service policy Collection of Race and Ethnicity Data by Visual Observation). Although the IG value set provides “observed” as a collection method for the R/E profiles, there are concerns over the lack of reliability of “visual observation” of R/E. Therefore, the general recommendation is that R/E should be determined by attestation of the subject (or a related person in the event the subject is a minor or incapable of attesting) and the use of visual observation (i.e., “observed”) to determine R/E is generally discouraged. If future federal law or regulation completely prohibits visual observation of R/E, “observed” will be removed from the IG value set.

In situations where an individual (e.g., a parent, guardian, caregiver, etc.) has legal authority on behalf of a subject, the complexity of whether R/E is “self-reported” versus “observed” versus “reported by related person” may need to be determined by policy at the local, state or federal level (e.g., Department of Education pg. 59268, Section II C- Identification of Racial and Ethnic Categories and Missing Data).

#### Guidance for use of Provenance with Race and Ethnicity Personal Characteristics

There is a possibility that either or both the US Core Patient profile and Personal Characteristics observation profiles for race and ethnicity may have provenance associated with them. Since the Provenance resource only points to the resource instance that it is supporting (target), there is no way to determine which elements (if any) have been changed. We suggest that provenance should be used in conjunction with this IG to determine one of the following:

- the author organization responsible for the information, and
- the transmitter (e.g. provider, payer, etc.) that provided the information.

Additional guidance is provided in the US Core 3.1.1 Basic Provenance Guidance.