There has been considerable interest for years in the digitalization of healthcare to make it more accessible and affordable with better outcomes for more people. The ongoing pandemic has created a new sense of urgency. A key part of digitalizing healthcare is ensuring that holistic information about patients is accessible at the right time and place to facilitate diagnosis and treatment.
Importantly, this includes ensuring patients have meaningful access to their own data. This is enshrined in for the U.S. market by the final rule in the Trump Administration’s MyHealthEData initiative and its “promise to put patients first, giving them access to their health information when they need it most and in a way they can best use it”.
In our online era, access to information online on-demand sounds simple, but in fact has proved an immense stumbling block. To quote from CMS.com, a U.S. federal website funded by U.S. Centers for Medicare & Medicaid Services, “the lack of seamless data exchange in healthcare has historically detracted from patient care, leading to poor health outcomes, and higher costs”.
The essential step to digitally transforming healthcare is enabling “different information systems, devices and applications (systems) to access, exchange, integrate and cooperatively use data in a coordinated manner,” according to the Healthcare Information and Management Systems Society (HIMSS), the member association committed to transforming the global health ecosystem.
The critical component to enabling that exchange of data on demand is application programming interfaces or APIs. They are the backbone of the internet, seamlessly connecting different software, applications and devices in a secure, controlled, pragmatic and standardized way – if they are implemented consistently (see Section 2). The idea is to make linking disparate data sources together ‘plug and play’ like building blocks.
APIs are used in many industries and are foundational to the success of the world’s largest and most valuable – note all digital-native – companies, including Alphabet (Google’s parent company), Amazon, Apple and Meta (formerly Facebook). Yet standard or open APIs have not been widely implemented across the healthcare ecosystem.
The U.S. federal government recognized the importance of APIs within the healthcare ecosystem and has taken steps to embed their use, most recently the ONC published the long-anticipated Trusted Exchange Framework and the Common Agreement (TEFCA) – developed by the Sequoia Project – on 18 January.
The Fast Healthcare Interoperability Resources (FHIR®) is a Health Level Seven (HL7) standard for exchanging healthcare information electronically and is used to standardize APIs. It is central to the success of the U.S. digital health initiative, becoming an optional part of electronic health information (EHI) in 2023 and a mandatory part in 2024.
Introduction – U.S. policy supports adoption of standardized APIs
The U.S. federal government understood the importance of standardized APIs and has pursued a policy that increasingly mandates their inclusion in the health ecosystem. In 2014, the U.S. Health IT Policy and the Health IT Standards committees endorsed recommendations for more public (open) APIs. In 2015, the Office of the National Coordinator for Health Information Technology (ONC) required the use of APIs in certified electronic health record systems (EHRs).
In turn, the Centers for Medicare & Medicaid Services (CMS), required health care providers to use products certified as meeting those requirements or else receive reduced payment from federal government. In the same year, the ONC also required certified EHRs to make a subset of data, called the Common Clinical Data Set (CCDS) available to patients via a portal or API, although not necessarily a standard one, at no cost to patients.
The CCDS contains essential health information, such as medication lists and vital signs, as identified by the federal government.
The initial goal was to specify the use of two profiles from the Fast Healthcare Interoperability Resources (FHIR®), an HL7 standard for exchanging healthcare information electronically.
The ONC in 2020, expanded the dataset available to patients and renamed it the United States Core Data for Interoperability (USCDI). This set of information contains all data in the CCDS and adds additional important information like clinical notes and expanded patient demographics.
The 2020 regulation required the use of the Fast Healthcare Interoperability Resources (FHIR®), an HL7 standard for exchanging healthcare information electronically, and expanded the dataset that must be available for exchange via APIs.
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