Oct 21 -- The Department of Health and Human Services (HHS), Office of the Secretary, Office of the National Coordinator for Health Information Technology (ONC) invites comments to OMB regarding the proposed new collection: Access, Exchange and Use of Social Determinants of Health Data in Clinical Notes.
The Department of Health and Human Services (HHS), Office of the Secretary, Office of the National Coordinator for Health Information Technology (ONC), promotes the access, exchange, and use of electronic health information to improve health care. There are ongoing efforts to determine what types of information should be recorded in patients' electronic medical records and how that information can be utilized to improve health and healthcare. Data reflecting Social Determinants of Health (SDOH)—the conditions in which people live, learn, work, and play—is limited across healthcare yet is vital to collect and understand for both individual care and public health. 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.
The 21st Century Cures Act (Cures Act) requires HHS and ONC to improve the interoperability of health information. ONC's Cures Act final rule identifies important data elements that should be made electronically available and exchanged through the use of health information technology (IT).
In support of these efforts, ONC seeks to better understand patients' and health care providers' knowledge of SDOH, how SDOH data are currently documented in the electronic health record and how this information is used in patient care. Additionally, ONC seeks to understand challenges experienced and preferences for SDOH data collection, sharing and utilization from both the provider and patient perspectives.
A series of 20 focus groups, a mix of asynchronous (discussion board) and synchronous (live), will be conducted among groups of healthcare professionals (10 groups) and patients/care partners (10 groups), representing various backgrounds, demographics, and healthcare professions, to learn more about their experiences and thoughts relating to the capture and utilization of SDOH data. A prescreening questionnaire will be sent to 1,500 individuals and 200 of those 1,500 people will be chosen to participate in the focus groups. Each individual will participate in one 90-minute focus group.
The 10 clinician/healthcare professional groups will include those practicing in the following care settings: primary care, specialty care, pediatrics, emergency medicine, case management, mental health care, safety net/rural underserved settings. The 10 patient/caregiver groups will include the following: Black/African American individuals, Spanish-speakers, E-patients, parent/guardian caregivers, individuals with disabilities or multiple chronic conditions, those age 65+, rural residents, members of the LGBTQ+ community.
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.
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:
• To what extent do health care providers document and use SDOH information to treat a patient or offer referral services;
• How do health care providers leverage open text fields, specifically clinical notes and assessments sections of an EHR, to document SDOH data;
• Challenges clinicians experience when using SDOH data, including data captured in open text fields;
• The types of SDOH data that individuals (both providers and patients) want collected, shared and used;
• 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
• 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.
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.
ONC has contracted with OpenNotes/Beth Israel Lahey Health (BILH) on this study. OpenNotes/BILH will use a subcontractor to conduct the data collection associated with this study. OpenNotes/BILH’s subcontractor, MedPanel, will be responsible for participant recruitment, focus group facilitation, and disseminating data to OpenNotes/BILH. The project contract period is from September 30, 2020 until September 30, 2022. The focus groups will take place January-March 2022. Results will be analyzed starting in April 2022. A final report will be submitted to ONC by September 30, 2022. OpenNotes/BILH will work with ONC to determine the timing and method of dissemination of the final report.
Currently, there is a government-wide effort to address health equity. The ONC goals include supporting the collection and use of SDOH data to improve care delivery and patients’ outcomes and reduce health disparities. If this collection is not conducted, ONC will not have sufficient information to fully inform its efforts to standardize documentation and encourage the use of SDOH data in a way that helps to achieve these goals. This information will help inform the development of tools necessary to assist providers with documenting sensitive SDOH data in the clinical notes section of the EHR. This information will also help to inform ONC’s data standardization efforts. Data standardization ensures that electronic health information is collected in a uniform way across providers and organizations. Such uniformity will allow for greater data interoperability and utilization – both key elements in coordinated, equitable care. Currently, SDOH data is collected in non-standard ways across health care systems and there is minimal uniformity. This project will greatly inform that work.
ONC submission to OMB:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202103-0955-002 Click on IC List for data collection instruments, View Supporting Statement for technical documentation. Use this site to submit comments.
FR notice inviting public comment:
https://www.federalregister.gov/documents/2021/10/21/2021-22946/agency-generic-information-collection-request-30-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
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at
https://www.aeaweb.org/content/file?id=5806