Author: Smile Digital Health | Published: April 20, 2022
The COVID-19 pandemic is far from over, yet with vaccination programs well underway and an end to rising infections in sight, we now have the opportunity to assess whether there was adequate access to vital health information by those in charge of the pandemic response. Specifically, were those providing care, those creating guidelines, and those doing research able to obtain the data they needed to inform their decisions? This information is important for our understanding of what could be done to improve the response to the next global health event. It is also important to explore the ways that improvements in the availability of data can be made to meet the goals of the 21st Century Cures Act, as well as whether the time and effort will be worth it for healthcare systems that are already under budgetary constraints.
Cures Act
The 21st Century Cures Act is a driving force for digital transformation in healthcare. Signed into law in December 2016, its purpose is to ensure that medical advances and innovations reach patients faster and more efficiently. The ONC’s Cures Act Final Rule supports “seamless and secure access, exchange, and use of electronic health information”. At a practical level, this can only occur when the data structure supports interoperability and information blocking is eliminated so that legitimate parties can access the digitized records they require. Beginning April 2021, the Cures Act requires that clinical notes must be made available free of charge to patients. With this in mind, what we glean from our experience with COVID-19 can make this a robust transition with the flexibility to serve as yet unidentified future needs.
A Common Language
At the base of any data-sharing initiative is the common requirement for patients, caregivers, public health officials, and researchers to have access to health data in real-time. During the COVID-19 pandemic, this need has highlighted the importance of open data standards for the exchange of digitized healthcare information at each level of the pandemic response, in combination with APIs (Application Programming Interface) to serve as an intermediary between the data and the users. In particular, the COVID-19 pandemic has demonstrated the benefits of the HL7 FHIR (Fast Healthcare Interoperability Resources) specification when data sharing is essential—as it soon will be under provisions of the Cures Act. Essentially, FHIR fills the need for all involved parties to have data that speaks a common language.
FHIR
FHIR makes it possible for different systems to “speak” to one another when exchanging data by coordinating the data flow at seven levels. This integrity in the data structure is essential if users are to access the data they need and have trust in that data:
- Physical: Connects the entity to the transmission media
- Data Link: Provides error control between adjacent nodes
- Network: Routes the information in the network
- Transport: Provides end-to-end communication control
- Session: Handles problems that are not communication issues
- Presentation: Converts the information
- Application: Provides different services to the applications
APIs
Once the health data is digitized and aligned with FHIR, there is still the job of interfacing with the data before it is used by a specific API. SMART on FHIR standardizes the process through which calls to the data are made. It allows healthcare organizations to focus on the user experience for their staff and patients rather than the mechanism for communication with the data.
Time & Money
Time. Money. Those are two resources in short supply in healthcare systems - especially during the COVID-19 pandemic. Yet, a recent report from the Pew Trusts underscores the importance of FHIR and APIs despite the time and money involved in the initial creation of the system. The report states, “Hospitals and labs might argue that they are stretched too thin by high caseloads and test volumes to be able to improve their digital record systems now. But sharing information in rapid seamless electronic means is critical to the country’s public health response, and health care facilities and labs can update their existing record systems with minimal time and expense.” It’s also evident that those healthcare systems and localities with the ability to aggregate patient data were better able to use that data in planning a science-driven response.
All-or-Nothing
Given the need to meet the Cures Act requirements, the growing use of portals to provide patients access to their records, and the steady stream of apps for consumers to track every aspect of their health, the growing need and demand for interoperability is undeniable. The Pew Trusts report also addresses the concerns of healthcare systems that lack the resources to go all-in at one time. The report points out that it need not be an all-or-nothing process. In fact, “... [M]any [hospitals and labs] have already deployed technology that allows facilities to send their test results to one system and then automatically route them to the correct public health department. To address the concern that modernizing technology to improve information sharing is too burdensome during the pandemic, the requirement could be limited to COVID-19 reporting for the duration of the public health emergency. This would allow healthcare providers—who have been wary of penalties for information blocking—to focus resources on upgrades needed to support pandemic response.” It’s entirely possible that some of the work is already underway between departments in the healthcare system.
In Action
One useful step to committing to FHIR is the ability to see what benefits it would bring to a specific organization. The HAPI FHIR Pandemic Rapid Response Toolkit: Customizable, Open Source Apps for Clinicians, Developers, and Public Health Authorities is a resource addressing the need and ability of international caregivers to identify and agree upon the data that is required for a coordinated response. Since those requirements will begin at the patient level, this exercise presents an opportunity to create systems that benefit all participants in the healthcare system. It was evident early on with COVID-19, that a coordinated response at the local, state, national, and international levels was required. With a specification standard like FHIR, health systems would input data once at the patient level, with the individual’s identification appropriately masked, but available at all other levels. By leveraging open data standards, like FHIR, along with other complementary technologies like APIs, the requirement of the Cures Act can be implemented to meet the needs of individual patients while improving the quality of public health responses to future large-scale events.
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