With the release of the 21st Century Cures Act Interoperability Rules, the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS) have introduced measurable progress that reduces the existing segmentation in EHR systems. This segmentation had previously limited the ability for patients to access their information and act as informed consumers in their healthcare decisions.
HIMSS defines interoperability as the “ability of different information systems, devices and applications to access, exchange, integrate and cooperatively use data in a coordinated manner.” Data sharing has always been important for healthcare providers, payers and patients as a way to more rapidly and accurately communicate knowledge among stakeholders. Interoperability supports the sharing of existing knowledge across a heterogeneous set of stakeholders, avoiding duplication of efforts and containing costs. The ONC and CMS rules are a quantum leap forward for the nation that provide a transformative foundation.
Below are five ways that your organization can leverage and embrace interoperability as a result of these two momentous regulations that promote and accelerate data sharing.
These rules harmonize the data format used to exchange data with certified electronic health IT products. The CMS rule requires any payer that they administer through Medicare Advantage, Medicaid Fee for Service, Medicaid Managed Care, CHIP Managed Care entities, and qualified health plans sold on the federal marketplace to make specific data available to the patient.
ONC’s rule mandates the use of the Fast Healthcare Interoperability Resources (FHIR) R4 standard for transmitting health data. This rule addresses information blocking, the use of application program interfaces (APIs), and processes for the required use of software systems that support the U.S. Core Data for Interoperability (USCDI), ONC’s standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.
Prior rules had specified the data elements that needed to be accessible with health IT systems. However, they did not constrain how those data elements should be accessed nor their exact form. With the ONC and CMS rules, EHR systems have a well-understood and market-supplier-neutral standardized platform. This allows developers of such products to access a much wider market of both patients and clinical providers without being limited by the choice of a provider's other systems.
As a technical foundation to the ONC and CMS rules, there are requirements that clinical data elements be made available via the standard as profiled by the USCDI U.S. Core Implementation Guide. FHIR is an international standard created by the Health Level Seven International (HL7) standards development organization. It was created to define how clinical data elements should be represented in an interoperable format and to provide API support for the electronic exchange of data. Healthcare standards and market supplier communities have embraced the standard because of its numerous positive attributes: simplicity, scalability, existing implementation libraries, open source, and a strong foundation based on web standards.
With FHIR providing clarity around formatting of data and APIs for the exchange of data, stakeholders now have agreed-upon interfaces to monitor evolving system capabilities over time. This can provide better situational awareness of the availability of different data sources that can provide authorized access to health data via the standard.
While FHIR has the potential to unlock our health information, short-term expectations should be tempered on the current capabilities of the standard provided by products that still need to catch up with the pace of the standard and these two regulations.
Taken together, the ONC and CMS rules increase the ability of individuals to access their health information by making specific data available via standards-based APIs. Patients and clinicians will now have more access and control of their data to make informed decisions about their care and outcomes, as well as the associated cost of that care.
A provision in the rules require that federally regulated payers implement a FHIR-based patient access API to allow patients access to claims, encounters and certain clinical information directly from their preferred device, from third-party applications that they choose. Organizations should consider new services and capabilities to facilitate data access and control so that patients can analyze their data to make informed decisions about their care.
Inferno is a free open-source testing tool that ensures the commercial EHR market supplier community conforms to the details of the FHIR standard as defined in the ONC rule. Inferno also provides ONC, Health and Human Services, and hospital purchasers with visibility of capabilities in commercial products that address information blocking and the use of APIs on the part of patients and other third-party marker suppliers.
Making the software source code of Inferno via a free open-source license provides a high degree of auditability of the quality of the testing code and provides flexibility for commercial market suppliers who are free to download, test and remediate issues with their products privately and before pursuing formal certification.
As FHIR continues to increase its adoption and impact, HL7 has created an accelerator program to convene discussions with stakeholders interested in particular use cases. Work group participants spanning healthcare technologists, policy leaders, payers and clinicians openly discuss, prioritize and vet the data they need to define parameters to support use case-specific data exchange needs via the standard.
Going forward, it is expected that numerous new accelerators will continue to be developed to address the needs of specific use cases. All of the HL7 accelerators provide entry points for new community members to engage with the respective community aligned with each specific use case.
The ONC and CMS rules are steppingstones that allow for higher-level regulations and processes to be introduced to build upon the liberated data now accessible to patients and healthcare providers. There are numerous ongoing considerations of how to build upon this increased access, with particular attention on the increasingly influential role that patients will have as an informed consumer, supported by a growing number of tools and services.
Clinical decision support (CDS) systems can inform clinicians and patients on evidence-based pathways to guide actions and decision-making around their care and alert them to deviations in the clinical standard of care. CDS supports the processes for enhancing health-related decisions and actions with pertinent, organized clinical knowledge and patient information to improve healthcare outcomes and healthcare delivery. The keystone to creating effective CDS is the clinical data inputs associated with patients.
The ONC and CMS rules provide a bridge to accelerate the creation of CDS artifacts to support a shared conversation of decision-making considerations between healthcare providers and their patients. An example of a forward-leaning capability in this space is the Agency for Healthcare Research and Quality-led CDS Connect project and work group community that is creating processes and tools to take evidence-based care, translate and codify information into an interoperable health IT standard, and promote a collaborative model of CDS development.
As the nation addresses the COVID-19 pandemic, telehealth has seen a sharp increase in adoption to allow for healthcare providers to safely perform initial consultations and determine the correct engagement for potentially sick patients. Telehealth continues to be an emerging domain to more effectively allow healthcare providers to scale their support to larger numbers of geographically distributed patients.
Artificial intelligence and deep learning to develop new processes to improve outcomes without direct patient input rely heavily on ever-increasing amounts of data. Consideration around regulations detailing the use of data for the purposes of AI and deep learning will likely leverage and build upon the ONC and CMS rules.
The views and opinions expressed in this content or by commenters are those of the author and do not necessarily reflect the official policy or position of HIMSS or its affiliates.
No matter where you are in the world, you can be part of what’s next for health. View digital resources, a content showcase and social media highlights on the HIMSS Global Health Conference Digital Experience page.