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March 11 -- The Office of the Secretary of Health and Human Services invites public comment by May 10, 2021 regarding its proposed study of Access, Exchange and Use of Social Determinants of Health Data in Clinical Notes.  
The 21st Century Cures Act (Cures Act) requires the Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC) to improve the interoperability of health information. ONC's Cures Act final rule also identifies important data elements that should be made electronically available and exchanged through the use of health information technology (IT). The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. ONC will follow a predictable, transparent, and collaborative process to expand the USCDI.  
A growing body of research highlights the importance of social determinants of health (SDOH) – the conditions in which people live, learn, work, and play – in access to care and health outcomes. However, data reflecting SDOH remains much more limited across healthcare. There is a growing recognition that by capturing and accessing SDOH data during the course of care, providers can more easily address non-clinical factors, such as food, housing, and transportation insecurities, which can have a profound impact on a person's overall health. Therefore, it is important to identify SDOH data elements for potential inclusion in the USCDI in the future.
In a 2018 report, researchers conducted interviews with six electronic health records (EHRs) vendors with large market shares in both ambulatory and inpatient settings. Vendors described a number of places where SDOH data could be documented or found. These include EHR specific data sets or forms, problem tables, free-text fields located in various places (e.g., social history section, clinical notes and assessments section, details section of structured screening tools), the demographic section of the patient’s health record, and the patient portal. Researchers also found that in a clinical encounter, the person collecting and entering SDOH data into the EHR varies based on the available resources of the clinical setting, time allocated for the visit, availability of kiosks at check-in, and the sensitivity of the data to be captured. Variation in how SDOH data is collected and captured in a clinical setting makes it difficult to ensure that the information can be exchanged in a standardized way and ultimately used by health care providers.

Additionally, patients might not be willing to share SDOH data with their health care providers. There are a number of sensitivities surrounding SDOH data. Patients may not feel comfortable sharing sensitive matters such as intimate partner violence, homelessness, or child abuse directly with their health care provider. There are also a number of concerns regarding what the information will be used for and whether the information could lead to future discrimination. Additionally, patients may feel comfortable sharing information with a provider that they have established a relationship with but would be concerned about the information being shared with a different provider.

The federal government has made significant investments to accelerate the development and use of health IT to exchange clinical data. As a result, today, nearly all hospitals and 8 in 10 office-based physicians have a certified EHR. Adoption and use of health IT has led to an increase in health information exchange. However, with the emergence of new technologies and growing number of entities such as social service providers that could benefit from use of these technologies, it is critical to measure how to advance the access and use of SDOH data and to take into account both providers’ and patients’ perspectives.
The purpose of the information collection is for ONC is to obtain data from health care providers and patients through qualitative research (focus groups) and analysis to understand:
(1) To what extent do health care providers document and use SDOH information to treat a patient or offer referral services;  
(2) How do health care providers leverage open text fields, specifically clinical notes and assessments sections of an EHR, to document SDOH data;
(3) Challenges clinicians experience when using SDOH data, including data captured in open text fields;
(4) The types of SDOH data that individuals (both providers and patients) want collected, shared and used;
(5) Methods individuals (both providers and patients) currently use or would like to use in the future to collect, share and use SDOH data, including smartphone apps or improvements to patient portals; and
(6) Barriers individuals (both providers and patients) perceive with the exchange of SDOH data, including privacy and security issues as well as secondary uses of the data.

Through qualitative data collection, this project will collect information from health care providers (including behavioral health providers) and patients/caregivers to inform ONC’s work on SDOH data collection and exchange. Specifically, it will inform:
• The creation of tools and resources, such as updates to the Health IT Playbook, to assist health care providers with documenting and acting upon SDOH data; and
• Identifying SDOH data elements that both health care providers and patients agree are important to capture and exchange for future data standardization efforts, such as USCDI expansion.

Ultimately, ONC is seeking to understand how patients and health care providers understand social determinants of health, how these data are currently documented in the electronic health record, and how they are used in care.
Draft SDOH data study technical documentation: https://www.dropbox.com/sh/q7s3ejlsluxt78y/AAAkXVUHQVEUnqANC_wXj0Tsa?dl=0
USCDI website: https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi  
FR notice inviting public comment: https://www.federalregister.gov/documents/2021/03/11/2021-05041/agency-information-collection-request-60-day-public-comment-request
Point of contact: Carmelita Marshall, Data Analysis Branch, Office of Technology, Office of the National Coordinator for Health Information Technology carmelita.marshall@hhs.gov 202.691.2062

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