Key Developments Driving the Need for Patient Access to HIEs
Expansion of HIEs into HDUs
While HIEs have classically provided services to providers, health data utilities “support multi-stakeholder needs across care and service settings by functioning as a health data resource for treatment, care coordination, quality improvement, and community and public health purposes (Maryland Health Care Commission, 2023).” This wider range of participants increases the need for patients’ participation in granting access to their health information.
The 21st Century Cures Act
The Cures Act, passed in 2016, tasked the Secretary of Health and Human Services to “use existing authorities to encourage partnerships between health information exchange organizations and networks and health care providers, health plans, and other appropriate entities with the goal of offering patients access to their electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated automatically (U.S. Congress, 2016).
FHIR – Fast Healthcare Interoperability Resources:
“is a next generation standards framework created by HL7. FHIR combines the best features of HL7's v2, HL7 v3 and CDA product lines while leveraging the latest web standards and applying a tight focus on implementability. FHIR solutions are built from a set of modular components called ‘Resources’. These resources can easily be assembled into working systems that solve real-world clinical and administrative problems at a fraction of the price of existing alternatives (HL7, 2023).”
FHIR specifies both the method of transmission for health data, based on RESTful APIs, and the formats of the data to be transmitted. FHIR permits transmission of much more granular health data (the previous standards were based on transmitting documents). Moreover, HL7 is developing standards for FHIR-compatible “problem-oriented” records to improve the organization and clinical utility of EHRs (see below). While the FHIR standards are still very much a work in progress, the standard for transmitting documents (in the previous HL7 formats) is ready for use. FHIR APIs are currently required for EHR certification. As FHIR resources are further developed, they will permit more precise transmission of health data, consistent with the HDU concept and with finer levels of patient permission for data sharing.
Problem-Oriented Health Records (POHRs)
If lifetime longitudinal records are to serve as a “single source of truth” (Wikipedia, 2023) for all users of an individual’s record (including the individuals themselves), an organizing standard to compile and structure these records is needed. POHRs can fill this need. The POHR’s most familiar elements are problem lists and “SOAP notes” (the latter being a standard for writing clinical notes). The POHR’s core organizing principle is that most record elements (e.g., clinical notes, care plans, orders, test results, specialists’ reports) should be linked to the problems on the problem list to which they relate. In this way the problem list becomes a table of contents to the record, and each record entry is placed in its clinical context. This organizational scheme greatly improves health records in their clinical functionality, communication and coordination among team members, and value for research. Moreover, problem-orientation evolved over decades to include "knowledge coupling" tools for improving clinician inputs to the record. Yet, the concept of problem-orientation has never been widely understood and rigorously implemented. Accordingly, an HL7 EHR Work Group has undertaken a project to develop a POHR functional profile (FHIR-compatible), intended to be a standard for both current provider EHRs and lifetime longitudinal records, consistent with the HDU concept (HL7, 2021).
Clinical trials are moving to multi-location trials in order to gain statistical validity, especially for previously underrepresented groups. Simplified patient selection and enrollment is key to the success of expanded trial participation and clinical trial cost reduction. While research applications with HIE participation have been limited in the past, FHIR APIs at HIEs with complete longitudinal records hold the potential to simplify clinical trial patient onboarding and other processes, especially if those records are problem-oriented.
Patient, Caregiver and Provider Desires
The Sequoia Project’s Consumer Voices Workgroup (Sequoia Project, 2023) identified three priorities among patients and caregivers:
“Having all my Electronic Health Information (EHI) in one place”,
“Sharing my EHI with other healthcare providers” including “Sharing images with providers who didn’t take or order the images”,
“Using my EHI to manage my own health”
Similarly, from the provider perspective, Dr. Ilana Yurkiewicz states “fragmentation [of patient records] is the single greatest problem underlying American healthcare” (Ilana Yurkiewicz, 2023)
The French “My Health Space”
The French began attempting to create secure longitudinal health records for individuals in 2004, the same year President George W. Bush set a goal of providing all Americans that wanted one a secure longitudinal health record within 10 years. While in 2023, no Americans have such records, as of late 2022, all residents eligible for French health care have such a record unless they have opted out. In addition to a sharable health record, My Health Space (Ministère de la Santé et de la Prévention, 2023) provides a secure mail account for individual-to-provider messaging, an “agenda” to manage appointments, including recommended preventive care, and finally, access to a set of applications reviewed and approved by a committee of the major stakeholders in healthcare IT. One of these stakeholders is ASOS, the umbrella organization of patient advocacy groups, equivalent to our National Health Council. The approval of patient apps provides a check on their privacy capabilities. The first twelve applications with access to the sharable health record are currently under test (Agence Du Numérique En Santé, 2022). Under the current US guidelines, there is no such check – current regulations require providers with a FHIR API to allow access to any third-party application that a patient designates as an agent.
Proposed Revisions to the Information Blocking Rule
As noted in a recent article by Don Rucker, (Rucker, 2023) the current proposed revisions to the ONC Information Blocking Rule (Health and Human Services Department, 2023) may endanger the development and use of FHIR APIs and the associated applications. The proposed rule would allow providers to claim “interoperability” for purposes of meeting CMS requirements for bonuses by participation in the Qualified Health Information Network (QHIN) system currently being implemented. This system is based on the HL7 document standards. While there is a FHIR roadmap associated with this system, there are few details in the roadmap and the likely result of cutting out the FHIR API requirement from the Information Blocking rule is a delay in implementing FHIR. Furthermore, a large percentage of users may choose a QHIN because they already participate with one of the QHIN candidates. This provision is likely to make it much harder to recruit participants to an HIE, since there will be no additional interoperability credit provided for HIE participation. An additional concern for HIEs is security. HRBA has pointed out the security perils of the QHIN approach and the improved security of the Health Record Bank architectural model (Health Record Banking Alliance, 2023).
We have been studying the issues involved with HIEs adding patient access to their capabilities for several years and would like to share our conclusions.
HIEs are a logical place for the creation and maintenance of a Cures Act patient record.
HIEs have already consolidated much provider information within their geographic area for patients. This greatly reduces the effort to build a complete record. HIEs may have processed the collected data to remove duplicate information, while retaining the original records with their provenance.
Patient involvement will be required to create a complete record
Patient involvement will be required to complete the access to all of a patient’s providers, since some may not be within the bounds of a state or regional HIE. Patients can target these additional providers for the HIE, based on their personal or their health plan records.
Patient involvement will be required to make full use of a complete record
HIEs, with patient access, can simplify patient participation in community exchange and other SDOH support activities and assist in incorporating identified health plan data. Patients can participate in clinical trials and other research activities more easily by authorizing access to information required for such trials and by indicating their willingness to participate.
A FHIR API and onboarded FHIR applications can minimize the administrative burden of patient access for HIEs
An HIE FHIR interface for patient access would allow HIEs/HDBs to take advantage of trusted FHIR-based patient-centered applications to minimize the administrative burden on HIEs of patient access. For patients that wish to participate with SDOH support and with research, the interface can provide a simple method to authorize access to their information.
HIEs/HDUs can be a key element in the transition from a longitudinal, record to a problem-oriented health record based on the developing FHIR standards
HIEs, as holders of the definitive patient record, could play a key role in the development of a FHIR ecosystem. All users – patients, providers, researchers, public health, community support activities and patient advocacy groups – would benefit from a comprehensive, longitudinal health record, with the patient in control of access to the record.
Agence Du Numérique En Santé. (2022, July 11). Mon espace santé : le catalogue de services est désormais disponible ! Retrieved from E-Santé: https://esante.gouv.fr/actualites/mon-espace-sante-le-catalogue-de-services-est-desormais-disponible
Health and Human Services Department. (2023, April 18). Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. Retrieved from Federal Register: https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and
Health Record Banking Alliance. (2023, January 25). HRBA Response to OSTP RFI on Clinical Research Infrastructure and Clinical Trials. Retrieved from healthbanking.org: https://www.healthbanking.org/uploads/9/6/9/4/9694117/ostp_rfi1_clin_res_infra_emerg_clin_trials_20230125.pdf
HL7. (2021, August 13). Problem Oriented Health Record (POHR) 2. Retrieved from Confluence: https://confluence.hl7.org/display/EHR/Problem+Oriented+Health+Record+%28POHR%29+2
HL7. (2023, March 26). Introducing HL7 FHIR. Retrieved from HL7 FHIR Release 5: https://www.hl7.org/fhir/summary.html
Ilana Yurkiewicz, M. (2023). Fragmented - A Doctor's Quest to Piece Together American Health Care. New York, NY: W. W. Norton & Company.
Maryland Health Care Commission. (2023, May 31). Health Data Utility. Retrieved from Maryland Health Care Commission: https://mhcc.maryland.gov/mhcc/Pages/hit/hit_hdu/hit_hdu.aspx#:~:text=Chapter%20296%20(House%20Bill%201127,of%20data%20between%20public%20health
Ministère de la Santé et de la Prévention. (2023, September 4). Mon espace santé. Retrieved from Mon espace santé: https://gnius.esante.gouv.fr/en/regulations/regulation-profiles/mon-espace-sante
Rucker, D. (2023, August 7). OPINION: WILL TEFCA RULE-MAKING STOP PATIENT DIGITAL ACCESS? Retrieved from Healthleaders: https://www.healthleadersmedia.com/technology/opinion-will-tefca-rule-making-stop-patient-digital-access
The Sequoia Project. (2023, July 1). Consumer Voices Workgroup. Retrieved from sequoiaproject.org: https://sequoiaproject.org/wp-content/uploads/2023/08/Consumer-Voices-Workgroup_ReportofFindings_FINAL_2.pdf
U.S. Congress. (2016, December 13). H.R.34 - 21st Century Cures Act. Retrieved from CONGRESS.GOV: https://www.congress.gov/bill/114th-congress/house-bill/34/text
Wikipedia. (2023, August 20). Single Source of Truth. Retrieved from Wikipedia: https://en.wikipedia.org/wiki/Single_source_of_truth