Health information exchanges (HIEs) and clinically integrated networks (CINs) have faced significant challenges in their mission to promote interoperability throughout the continuum of care—from a lack of common standards to a general reluctance to participate in multiple data-sharing agreements. The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program proposed rule aims to address these challenges. Additionally, the proposed rule intends to provide patients with easy access to their medical record and foster innovation within the health IT space.
Despite the adoption of certified EHR technology (CEHRT) by nearly 90% of providers, interoperability has lagged considerably, with less than 50% of all nonfederal acute care hospitals reporting the ability to electronically send, receive, query, and integrate patient health information and less than 25% consistently using information received electronically from providers or outside sources while treating patients. These suboptimal metrics highlight the significant challenges HIEs and CINs encounter when attempting to promote interoperability and the need for regulatory action to guide and incentivize interoperability across the healthcare industry.
Below are five
challenges that the proposed rule will address and the implications of each.
Challenge One: Workflows Supporting Interoperability Are Cumbersome
It can be difficult to integrate information received by query or via other electronic routes (e.g., direct message) into the EHR and ultimately the workflow. Issues such as patient matching, source verification, and inbox monitoring complicate workflows further. Organizations must perform these additional steps to ensure the correct records are being added to the correct chart to avoid patient harm and prevent duplicate medical records. Further, many of these workflows do not support real-time or near-real-time data sharing, significantly reducing the clinical utility of the information and its ability to positively affect patient care.
Implication: The proposed rule would address workflow inefficiencies by requiring the use of open APIs using HL7 FHIR standards to allow health information to be accessed, exchanged, and used without “special effort.” The use of APIs would enable secure and seamless access to patients’ health information. The workflow burden will also be alleviated by requiring health IT to support the export of the entirety of a patient’s health information at any time, without subsequent developer assistance, to an electronic, computable format with information on its structure and syntax.
Challenge Two: Health Information Is Often Inaccessible
The information captured by the Common Clinical Data Set (CCDS) yields limited clinical utility, with the most beneficial information usually trapped in clinical notes and inaccessible to the receiving provider or organization. The CCDS issue is of particular relevance to CINs, which are tasked with aggregating data from multiple sources.
Implication:The proposed rule would remove certification criteria elements that are nearly universally present from the ONC 2015 Edition Certification Criteria to make way for more advanced, updated certification requirements. The rule would also replace the CCDS with the United States Core Data for Interoperability initiative, expanding upon the CCDS by introducing new data classes and fields, including clinical notes.
Challenge Three: External Health Information Is of Poor Quality
The lack of standards for how hospitals collect, record, structure, and export health information has created several issues that hinder interoperability. External records are frequently received in formats clinicians do not find useful (e.g., C-CDA). Such formats amalgamate many disparate data points and make certain information difficult to find.
Implication:The proposed rule’s push toward HL7 FHIR–based APIs through the new certification criterion will enable providers to search for specific data elements rather than receive a C-CDA or another file format that must be reconciled, increasing accessibility and decreasing provider burden. Additionally, the previously mentioned export criteria should ease the burden of integrating different file formats by requiring that a file’s format, including structure and syntax, be included with the data.
Challenge Four: Provider Contact Information Is Often Missing
Health systems and participants in HIEs often do not have access to an accurate local provider directory, making the process of electronically sending health information to other providers burdensome or impossible.
Implication: Under the proposed rule, providers’ digital contact information would be added to provider entries in the National Plan and Provider Enumeration System, enabling it to serve as a national directory for provider information that can be integrated into CEHRT to ease the burden of finding contact information.
Challenge Five: Providers Are Reluctant to Participate and Commit
Bringing community partners to the table and establishing effective data-sharing agreements is a current challenge that is complicated by technology limitations. Healthcare organizations often find that focusing on developing their interoperability architecture to increase data exchange between affiliated provider locations—particularly as organizations merge and incorporate new facilities—is more beneficial than engaging with regional HIEs and community partners. In addition, some organizations are simply reluctant to share information with other entities, leading to isolated data-sharing alliances.
Implication: The new information-blocking provisions in the proposed rule would require healthcare providers and health information networks to respond to all requests for health information from authorized sources or risk being reported for information blocking. While the penalty for healthcare providers has not yet been proposed, civil monetary penalties (up to $1 million per violation) are in place within the proposed rule for the other regulated actors (e.g., health IT vendors, payers), and providers can expect similar penalties.
The final rule has not yet been published, but concrete objectives are being pushed within the proposed regulation that should survive future edits. Information blocking will no longer be tolerated, and civil monetary penalties are likely to be adopted for health systems, providers, and health IT developers. APIs with HL7 FHIR standards are a core component of the ONC’s approach to interoperability, which is aimed at making data more easily accessible to patients, providers, payers, and developers.
To prepare your organization for these changes, take the following next steps:
- Assess which interoperability issues your organization is experiencing.
- Evaluate your organization’s processes for obtaining and sending health information from or to external sources.