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The passage of the HITECH Act and the 2011 launch of the Medicare and Medicaid EHR Incentive Programs (now known as the Medicare Promoting Interoperability Program and commonly referred to as Meaningful Use) were pivotal events in health information technology (IT). They began the historic, nationwide effort to rapidly convert our health care delivery system from paper to electronic health records (EHRs). Through large public and private financial investments, as well as enormous “sweat equity” from provider organizations and technology developers, more than 90 percent of hospitals and physician practices now use EHR systems.
This dramatic change in what is arguably the most complex and fragmented sector of our economy is a mammoth achievement. However, EHR adoption was but a first step to delivering on the promises of a modern, digital health care system. Process change often lags technology change, and the health care industry and intertwined regulations remain deeply imbued with workflows and mindsets born of a paper-based world. Although we haven’t yet wrung paper (and faxes!) completely out of health care, it’s now time to firmly focus on a 21st century health care system freed from paper’s constraints. Health system reform should be reconceived on the premise of electronic data that can securely, appropriately, and easily flow wherever and whenever needed to improve health care quality, safety, efficiency, affordability, and equity.
This year will be a transformative year. Policy and technical infrastructure needed for information sharing at a nationwide scale will become a reality. This year providers, patients, payers, public health practitioners, technology developers, researchers, and other stakeholders will take the decade-long investment in health information technology to the next level.
Our potential to innovate and use information to deliver value in health care has never been greater. Key provisions of the 21st Century Cures Act (Cures Act), passed in 2016 with overwhelming bipartisan support, will be implemented this year and will be critical factors in dramatically enhancing clinical interoperability. These include:
- Continued implementation and enforcement of the information blocking regulations will make information sharing practices (that is, practices that do not interfere with access, exchange, and use of electronic health information [EHI]) a priority across the industry ( 114-255, Sect. 4004, 130 Stat. 1176).
- Application programming interface (API) standardization will establish a foundation of secure, standardized API capabilities to make information sharing easier with certified EHR systems (45 C.F.R. Sect. 170.315(g)(10)).
- Trusted Exchange Framework and Common Agreement (TEFCA) will create a nationwide policy and infrastructure backbone to ease information sharing across networks of EHRs and other health IT systems ( 114-255, Sect. 4003, 130 Stat. 1165 (2016)).
Taken together, these policies will improve innovation in health care delivery, public health, and medical research. Rather than trying to determine or predict where the industry is headed, the Office of the National Coordinator for Health Information Technology’s (ONC’s) goal is to establish and sustain basic principles and building blocks for an open health IT ecosystem that continues to expand the boundaries of what’s possible for the improvement of health care.
Information Blocking Rule
The Health Insurance Portability and Accountability Act (HIPAA) has been the federal policy foundation for information sharing since 1996, defining how HIPAA-regulated health care entities are both permitted to share information with other entities and obligated to make information available to patients. The Cures Act and the Cures Act Final Rule released by the ONC include information blocking provisions that complement HIPAA in several ways, including by:
- Covering a generally broader group of health care entities, including providers not regulated by HIPAA, certified health IT developers, and health information networks/exchanges (importantly, the Cures Act did not expressly name payers, but some may fall into one of the other aforementioned categories) (45 C.F.R. Sect. 171.102).
- Directing (rather than just permitting) information sharing with authorized entities by setting up penalties (42 U.S.C. Sect. 300jj-52(b)(2)) for actors that engage in information blocking practices (45 C.F.R. Sect. 171.102 and 171.103; see also 42 U.S.C. Sect. 300jj-52(a)).
- Advancing information sharing with patients and other entities to be more responsive to their needs and enabled by modern electronic systems.
At the ONC, we don’t think about “information blocking” so much as we think about “information sharing” because the information blocking penalties established by the Cures Act demonstrate Congress’ commitment to information sharing that “allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law.” Calling for sharing of “all electronically accessible health information” is somewhat of a paradigm shift for interoperability, which has mostly focused on the exchange of standardized, structured data over non-standardized, unstructured records such as notes and transcriptions. This approach generally made sense when unstructured records were too unwieldy to extract, process, store, and analyze. However, advances in analytics, algorithms, machine learning, and natural language processing, coupled with the availability of commodity computing power and storage capacity, now offer opportunities to derive rich insights from unstructured records, and it no longer makes sense to exclude them from basic expectations for information sharing.
Enabling access to “all” electronically accessible health information is complex because EHR systems typically contain a wide mix of structured and unstructured data in a diverse range of formats that vary across vendor platforms and provider settings. To ease compliance with these new requirements, the Cures Act Final Rule allows an incremental approach, which starts with what is already easily shareable today, and gives more time for actors to develop and implement policies, processes, and technology for sharing more unstructured and non-standardized data.
On May 1, 2020, the ONC published the Cures Act Final Rule in the Federal Register and, on April 5, 2021, the information blocking provisions of the rule went into effect requiring that all covered actors engage in information sharing or be subject to penalties (Pub. L. No. 114-255, Sect. 4004, 130 Stat. 1176 (2016)). Through October 5, 2022, the definition of EHI is limited to the data elements represented in United States Core Data for Interoperability V1 (USCDI V1), an ONC standard that many providers and vendors already support today, as it is a requirement for numerous Centers for Medicare and Medicaid Services payment models and the ONC Health IT Certification Program. It is also the core payload for many health information networks.
However, starting on October 6, 2022, all actors—providers, certified health IT developers, and health information networks—will be expected to share all EHI, not just the data elements represented in USCDI V1 (45 C.F.R. Sect. 171.102; 45 C.F.R. Sect. 171.103). In recognition of the fact that EHI beyond such data elements is typically non-standardized, heterogenous, and often not easily shareable, the rule allows some flexibility in how an actor can make EHI available in a variety of industry-standard formats and even, as a last resort, in a “machine-readable” format (45 C.F.R. Sect. 171.301).
Expanding the aperture of interoperability to include as much electronic information as possible will provide richer information to inform patient care and reduce the burden on patients of having to manually gather and lug reams of paper records from provider to provider. It will also open new horizons for modernization across the entire health care continuum.
FHIR API Certification
While the Cures Act Final Rule creates the regulatory framework for information blocking, the rule also takes significant steps to make it easier for developers of certified health IT to exchange information by reducing variation in business practices and technical approaches related to exchange. There are two important deadlines in 2022 that will require such developers to ensure a level playing field for information sharing and enable access to information through application programming interfaces (APIs) “without special effort” as called for in the Cures Act.
On April 1, 2022, health IT developers certified to any of the API certification criteria will be required to attest to compliance with certain practices for access to APIs as part of the Conditions and Maintenance of Certification of the Cures Act Final Rule (45 C.F.R. Sect. 170.406). These practices cover areas that enhance competition such as pricing, contracting, and non-discrimination vis-à-vis competitors. In short, the Cures Act Final Rule helps to ensure that certain business terms of certified technology developers are not barriers that prevent providers from using certified APIs however they want and with whomever they want (45 C.F.R. Sect. 170.404).
Establishing such requirements sets the stage for the rollout of standard APIs across the industry later in the year. HL7® Fast Healthcare Interoperability Resources (FHIR®) is a rapidly maturing interoperability standard based on modern internet technology approaches. ONC certification has required the deployment of APIs since 2015 but did not require the use of FHIR APIs due to the immaturity of the standard at the time. This had the desired effect of spurring rapid growth in the availability of APIs, allowing us to now focus on ironing out variations in different underlying API standards that undercut scalability across EHR platforms.
Thanks to considerable effort by technology developers and the HL7® community, FHIR is now ready for prime time, and health IT developers seeking certification to application programming interface criteria are now required to provide a standard FHIR API to all organizations that deploy the developer’s certified API technology by December 31, 2022 (45 C.F.R. Sect. 170.404(b)(3); 45 C.F.R. Sect. 170.404(c)). This will create a climate of innovation by allowing technology developers to build to a common, industrywide specification. Open APIs and apps are what make it easy to check your bank account or order meal delivery right from a mobile app regardless of which type of device you use. We want patients and providers to have that same flexibility and ease of use with medical records regardless of which technology platform they use. The business and technical advances that the Cures Act Final Rule brings to reality this year will firmly establish APIs and apps as core drivers of enhanced access, functionality, and user experience in health care interoperability.
The Trusted Exchange Framework And Common Agreement (TEFCA)
The establishment of a unified nationwide clinical interoperability network has been part of the ONC’s vision since our founding in 2004. Our goal is for interoperability networks that ensure that medical records flow securely and reliably behind the scenes in the same way that back-end bank systems make sure that your financial information is always accurate and up to date.
The health care industry has made considerable progress advancing exchange networks, and numerous networks operate today at the national and state/regional levels, conducting millions of secure medical record transactions per day among providers for treatment purposes. However, progress has slowed in recent years because getting to higher levels of exchange entails tackling business issues that market competitors find difficult to agree on and/or complex legal and regulatory issues that are hard to cut through without federal government facilitation.
Recognizing this dynamic, the Cures Act called on the ONC to “develop or support a trusted exchange framework, including a common agreement [TEFCA] among health information networks nationally” (Cures Act, Pub. L. No. 114-255, Sect. 4003(b), 130 Stat. 1165 (2016)). Partnering with The Sequoia Project, TEFCA was launched on January 18, 2022, establishing a common legal agreement and technical standards for networks to more easily connect with each other. The key goals for TEFCA are to: accelerate the tremendous progress already made by the market and establish a universal floor of nationwide interoperability based on uniform exchange contracts, open-industry technical standards, and transparent rules of the road; create the policy and technical infrastructure for organizations to securely exchange information to support patient care and generate health care value; and enable individuals to efficiently access their health care information from wherever it is. TEFCA will also play an important role in greatly expanding the scalability of FHIR APIs for business-to-business and business-to-consumer uses.
Enforcing The Cures Act Rule
ONC is responsible for defining the policies related to information blocking and establishing a complaint process, and the HHS Office of Inspector General (OIG) is responsible for investigating complaints and assessing any necessary penalties on certified health IT developers or health information networks/exchanges. In March 2022, the OIG is expected to release its final rule to begin enforcement of the ONC’s information blocking policies.
2022 And Beyond
The industry has made substantial progress in information sharing in a relatively brief period. That said, in this highly fragmented system, progress is not uniform and is affected by different priorities across industry actors. The Cures Act helps bring needed consistency across the industry by encouraging providers, developers of certified health IT, and health information networks/exchanges to move information sharing up the priority list from a “may” to a “must.” This is a significant change in thinking and thus requires deliberate changes to current organizational information-sharing policies and processes. However, it’s important to not lose sight of the fact that any compliance burden on you is also a burden on others to share information with you.
It has been said that technological progress compounds over time; we overestimate what technology can achieve in the short term and underestimate what it will achieve in the longer term, often because adjacent possibilities grow exponentially and are hard to predict. The past decade was focused on laying a foundation for the use of EHRs. In 2022, the vision of the Cures Act will become a reality and allow us to start to reap the full potential of what a truly digital health care system can do to improve the lives of patients.