Most would agree that the aspirational goal─the ideal─for healthcare is an open and secure ecosystem where individual patients can access their data effortlessly through smart apps, and clinicians can access additional information from external systems efficiently and seamlessly.
In fact, the Office of the National Coordinator (ONC) for Health IT and Centers for Medicare and Medicaid Services (CMS) have published rules designed for increased patient access to their own Information and guarantee a standard of interoperability across systems.
One of the foundational elements of these rules is standards adoption using secure application programming interfaces (APIs).
The leading standard for the exchange of health information, Fast Healthcare Interoperability Resources (FHIR), rises to the challenges of interoperability and the necessity of meeting demand for smart applications in healthcare.
HL7 and FHIR APIs
FHIR has become one of the most popular new standards in healthcare today. It holds great promise for the development of smart applications that deliver value-added health information exchange.
In the early 2010, the Health Level Seven (HL7) international standards organization recognized the need for interoperability was growing: data siloes had to be broken down and access to information enabled in real time.
One challenge of interoperability is that different organizations have independent upgrade and install cycles that run at their own pace. The value of these systems comes when they are connected at a critical mass, allowing ease of integration to emerge.
HL7 v2 enables consistency where there had been proprietary variation. It’s now the mainstay of back-end communications, allowing interfaces to "talk" the world over.
The exchange of information and creation of a longitudinal electronic health record (EHR) presents challenges as it often includes data from traditional and emerging sources, as well as data sourced from disparate systems. Seamless exchange would require a modern standard that could bring together a cohesive representation of patient data across the healthcare IT domain, and so FHIR was born.
Twenty years on, we have different needs, and this is where FHIR comes in. FHIR allows a much wider array of technologies and approaches. HL7 is very much a system-to-system integration mechanism, whereas FHIR embraces a modern API approach that enables real-time, stateless connectivity that is simple for developers to connect to consumer apps. Given the market requirement for FHIR 4.0.1, there will be a dramatic increase in the number of systems enabled in this regard and there will be much faster adoption of FHIR relative to HL7 V2.
In the near future patients will have on-demand access to their information and life without access to the use of healthcare apps will seem a distant memory.
Technical Considerations In Preparation for 21st Century Cures Act Final Rule
The March 2020 release of the 21st Century Cures Act final rule lays out a series of mandates around interoperability standards for healthcare payers and providers. At its heart, the final rule promotes patient access to their electronic health information, but the wider benefits will support provider needs, advance innovation, and address the industry-wide proliferation of information blocking practices.
Organizations must proactively prepare and assess technical considerations linked to the implementation of the Final Rule.
The first thing payers and providers must do is to make sure their data "house" is in order. Data aggregation is the first step in the process. Bring together all data sources both traditional (clinical data, medical device data, labs data, claims data, etc.), and non-traditional sources (social determinants of health, such as income and education data, and lifestyle data) and then begin normalizing, standardizing, parsing (natural language processing), routing, mapping, sequencing, and categorizing-all key to successful data aggregation.
The next thing is to make sure an API gateway is in place. This gateway must allow organizations to operationalize access to information en masse and must handle rate limiting issues, which are both crucial to ensure systems don’t get swamped. The gateway enables information to flow appropriately to through the connecting API- for example to an app on a cell phone.
Connecting the API to the App
The point of the ONC rule is to put the power in the hands of the patient, and this is the interesting part: how does a patient get access to their data?
In order for a patient to access their health Information in their EHR, a patient needs to be a user with credentials, such as username and password. To get those, you have to have worked with the organization and gained access.
So, let’s take a case where there is a patient portal in place. During a hospital visit the patient might have been invited to access a patient portal or a primary care provider could have facilitated this access.
Apple has enabled its patient-facing app HealthKit to gain access to medical records via a user selecting their institution and then authenticating their user credentials to access their data. This approach will likely become more common, but will leverage the newer FHIR 4.0.1 capability.
Liberation of Health Information
Another consideration is that of privacy. The interesting thing is the way in which when the data leaves the clinical system, HIPAA no longer applies, but other privacy laws will. This is similar to the way in which a patient handles a paper record. Once it’s in the patient’s charge, they become responsible for how it’s handled, with the clear complication of the app developer in the mix. Ultimately, this comes down to liberating health information ─ the balance between ease of access, ease of use, and privacy. This could be quite an interesting prospect for health information exchanges (HIEs), where they could come to handle some of these activities on the behalf of varying participating organizations.
Much as we have seen rapid progress in consumer choice and ease of access across a wide variety of industries, such as banking, transportation and communication, modern interoperability will enable similar step change for healthcare. With information being readily accessible, health consumers will have the opportunity─ if not the power─ to understand and advocate for better outcomes, be they related to cost or choice of treatment. In healthcare this is unprecedented and will no doubt enable a revolutionary advancement. Today's approach will quickly seem as archaic as visiting the bank to check one's account balances.
Is It Just about FHIR APIs?
Part of the Interoperability and Patient Access requirement is a modification of the CMS rule for condition of participation (for Medicare and Medicaid hospitals). This is more orientated around transmission of admit, discharge, and transfer (ADT) messages, which is very much in the wheelhouse of the HL7 V2 messaging. When patients are admitted to a hospital, the electronic medical record can generate HL7 messages for connected systems. These messages contain patient demographic information as well as details of the admission event. From this, a connected HIE, for example, would then aggregate the information for the purposes of clinicians beyond the facility admitting the patient. This information is useful for care coordination purposes as it can provide insight of patient discharges to those in the primary care segment.
Electronic notifications are necessary when a patient presents at or is discharged from the emergency department to their primary care provider, post-acute care service providers, or those that the patient has an established care relationship with. If the hospital can’t identify care providers then they aren’t required to send a notification.
Many HIEs are deployed with notification capabilities and are enabled to handle this, and so these organizations, if participants, are potentially most of the way there.
These developments will result in a sea change in the way in which consumers interact with those providing healthcare and, in turn, the opportunity for greater interoperability between providers and HIEs alike. With wide market adoption of a normative release of FHIR, we can expect to see rapid consumerization of health and new innovations that are universally applicable, regardless of vendor or provider.
Chris Lucas (firstname.lastname@example.org) is the vice president of clinical portal and Amadeus at Orion Health.