In a blog posted to the Health Affairs Forefront section (formerly the Health Affairs Blog), National Coordinator for Health IT Micky Tripathi, Ph.D., on Tuesday, Feb. 22, shared some extended perspectives on the objectives he sees for the Office of the National Coordinator for Health IT (ONC) this year, and how he hopes that leaders in the field will cooperate with ONC and with one another, to bring about needed change going forward.
In his article, entitled “Delivering On The Promise Of Health Information Technology In 2022,” Tripathi focused on four areas: the information-blocking regulations announced nearly two years ago now; standardization of APIs (application programming interfaces), as APIs evolve forward; the full rollout of TEFCA, the Trusted Exchange Framework and Common Agreement; and, as he put it, “2022 and Beyond.”
With regard to the first three items, Tripathi wrote, early on in his “Forefront” article, described those three as his top priorities right now:
1. 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).
2. 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)).
3. 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)).
Per those top three priority items, Tripathi wrote that, “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.”
Further, Tripathi wrote, “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:
Ø 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).
Ø 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)).
Ø Advancing information sharing with patients and other entities to be more responsive to their needs and enabled by modern electronic systems.”
Importantly, Tripathi chose to clarify some things by writing that, “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.”
Tripathi also clarified another issue, noting that “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.”
When it came to API development, Tripathi reinforced the requirement that goes into effect on April 1 that will require health IT developers certified to any API certification criteria to attest to compliance with requirements under the Cures Act Final Rule, which lays out specifics. For developers. Per those requirements, he wrote, “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).” Indeed, he said, “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,” and, what’s more, “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.”
Meanwhile, with regard to TEFCA, Tripathi wrote that “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.” Per TEFCA, he used the article to emphasize that “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.”
Meanwhile, with regard to the CURES Act, Tripathi wrote that “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.”
What about the near future? Tripathi concluded his article by emphasizing that “The industry has made substantial progress in information sharing in a relatively brief period,” but also noting that “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.’” He recognized that that entails “a significant change in thinking,” and requires “deliberate changes to current organizational information-sharing policies and processes.” Still, he believes that, while “The past decade was focused on laying a foundation for the use of EHRs.” Looking forward, he concluded, “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.”
