On January 2, Health Level Seven debuted the new version of its interoperability specification. Many CIOs and technologists in healthcare have been awaiting the fourth iteration of the Fast Healthcare Interoperability Resources standard – FHIR 4, for short – because future changes now will be backward compatible.

“Applications that implement the normative parts of R4 no longer risk being non-conformant to the standard,” said FHIR Product Director Grahame Grieve on the FHIR blog.

Grieve also said that, in addition to the base platform, several key pieces of FHIR also now are normative, including the RESTful API, the XML and JSON formats, the terminology layer, the conformance framework and its Patient and Observation resources.

How can FHIR 4 help health IT interoperability?

Micky Tripathi, president and CEO of the Massachusetts eHealth Collaborative and co-chair of the HL7 Advisory Council, told Healthcare IT News that no single technical standard is going to solve the problem of health IT interoperability, FHIR included.

“That said, FHIR is a modern interoperability standard that is more flexible and more functional than the standards in current use in healthcare today,” he explained. “It is bi-directional, read or write; flexible to different levels of granularity, individual data elements or whole documents; and, it supports pluggable apps, like one might download from the Apple App Store or Google Play.”

FHIR is a relatively new standard but it has gotten tremendous early uptake. FHIR R4 is important because it is the first version that has some components reaching the point of being a normative, which means that the specification is considered ready for use and stable and all future FHIR versions will be required to be backward compatible with the normative R4 components.

That makes it less risky to implement if one is a software developer, which hopefully will spur even more technology vendors to embrace it, Tripathi said.

FHIR is an essential component to health information exchange and interoperability in modern health IT, said Dr. Blackford Middleton, chief informatics and innovation officer at Apervita and a member of the HL7 Advisory Council.

“FHIR 4 builds upon the rich legacy of FHIR DSTU2 and FHIR STU3 and has the primary added advantage of facilitating backward compatibility of the FHIR 4 standard going forward,” he said. “It is a balloted and passed standard that will now move as a normative standard to ANSI. This removes a significant potential headache for developers and should warrant its widespread use.”

So easy, even kids can do it

The FHIR standard brings healthcare interoperability to the present using off-the-shelf programming APIs that kids are learning in school today, said Dr. Shafiq Rab, board chair of the College of Healthcare Information Management Executives and senior vice president and CIO at Rush University Medical Center.

“Gone are the days of extensive training for traditional HL7; and standing up an interface takes hours rather than days,” Rab said.

In general, FHIR provides health IT vendors with a standard to work against as they build tools to help physicians to gain point-of-care access to patient information, said Dan Gainer, chief technology officer at Medicomp Systems.

"It is a balloted and passed standard that will now move as a normative standard to ANSI. This removes a significant potential headache for developers and should warrant its widespread use."

Dr. Blackford Middleton, Apervita and HL7

“Though we have had other standards in the past, FHIR is a particularly big deal because it provides a much simpler set of APIs, and getting up and running with the FHIR API is easier and quicker for vendors,” he explained. “Having a standard mechanism such as FHIR 4 is critical for interoperability and for giving clinicians access to patient information, regardless of where the data originated.”

Clinical documentation architecture, or CDA, also is a standard, but it is so general that everyone has implemented it a bit differently, he added. Where CDA is more of a means to fetch data to show a user, FHIR 4 provides a more rigid structure and gives a simple mechanism for retrieving computable data that vendors can write software against, he said.

Business concerns driving decisions on data sharing

Dave Shaver, CTO and founder of Corepoint Health and a board member of HL7, said there have always been business concerns when it comes to sharing health data, and that FHIR 4 can help here.

“Business concerns drive all interoperability discussions with difficult, complex answers to a simple question: With whom shall we share data and why?” Shaver noted. “In the 1990s and 2000s, the boogieman of ‘data blocking’ was the HIT vendors, who were seen by some as having a competitive advantage by not sharing data.”

The oft-reported scheme was that a vendor that locked away the data would not face competition from rivals trying to participate in the clinical workflows. More recently, as the market now expects care coordination to occur across facilities, the boogieman has moved to the providers themselves, Shaver said.

“From a strictly business perspective, many facilities are unexcited about sharing patient data with a competing facility across town without a legal mandate to do so,” he said. “No interoperability standard by itself – including FHIR – can solve the business drivers for healthcare reimbursement, value-based care approaches such as ACOs, and doing what is right for patient care.”

The hope with FHIR is that by reducing the technology barriers, specifying a better data model and adding new workflow options, the business decision regarding “to share or not to share” can be made based on an assumption that interoperability is possible and thus is a business choice to do so without other limitations, Shaver said.

FHIR 4 components, new and improved

There are a variety of components to FHIR 4, and experts say they are all of more or less equal importance. Some are new to FHIR, some are refined.

“The addition of imaging resources, financial resources and decision support resources opens the door for more precise data analytics and precision medicine, further the pushing of normative approach for the underlying layer of the API will allow easier and more standardized adoption of FHIR,” said Rab of CHIME.

FHIR 4 promotes health information exchange and interoperability across the healthcare continuum – EHRs, research and even patient clinical information access from their providers, said Middleton of Apervita.

“Apple uses a FHIR API to get my data onto my iPhone from my healthcare providers,” he explained. “The notion of backward compatibility of this standard means that developers can be much more assured that the code they write won’t be tossed when a new FHIR version comes out and their apps should continue to work.”

While FHIR 4 added a number of new components, from Medicomp Systems’ perspective, none are any more important than others, said Gainer.

“We are trying to provide the entire clinical picture of the patient, so the more data we can retrieve the better,” he said. “More important to us is the stability that FHIR 4 offers. If I write a particular program, it’s really helpful to know that the data structure won’t change with the next version, and I won’t have to rework things with a different data model.”

Stability makes it easier for vendors to justify investing resources against a particular API, which will be a big boost for interoperability as a whole, Gainer said. Having a true, stable standard across the board will help spur wider participation and grow the interoperability ecosystem, he added.

Shaver, of Corepoint Health, said that some of FHIR’s resources now have reached a stage of maturity and are now considered “normative” which means the data model is considered stable and has been locked, subjecting it to compatibility rules moving forward.

“In addition, FHIR’s RESTful API approach, JSON encoding, and other technical aspects are unlikely to change substantially, giving FHIR implementers confidence that their development work will not be wasted,” he added.

The challenges facing FHIR 4

FHIR 4 certainly sounds like the fix to many interoperability challenges. But it faces some hurdles on the way to widespread adoption.

Middleton, of Apervita, explained for instance that's a wide variety of standards in use – in varying stages of maturity – to support healthcare information exchange and interoperability, which is a $78 billion opportunity in this country at least, according to the Center for IT Leadership.

"Business concerns drive all interoperability discussions with difficult, complex answers to a simple question: With whom shall we share data and why?"

Dave Shaver, Corepoint Health and HL7

“FHIR APIs need to evolve in concert with the evolution and roll out of the USCDI – the US Core Data Set for Interoperability, and the rich prescriptions for U.S. healthcare in the 21st Century Cures Act,” he said.

“Beyond the interoperability of healthcare data, however, we need to increase our attention similarly on the interoperability of shareable computable biomedical knowledge artifacts – only then can we hope to assure we have not only the right patient data but also the right best practice knowledge available to the patient and provider at the time of each and every clinical decision," Middleton added.

Tripathi, chair of the HL7 Advisory Council, reaffirmed that no technical standard can solve interoperability because the main barriers to interoperability are not technological, they are related to business and culture, and FHIR won’t solve those things.

“Thus, the challenges facing FHIR are the same ones that face existing technical standards – up until recently there has not been enough business incentive and physician desire to create demand for interoperability,” he said.

“Added to that are the barriers that face any new standard – change will come incrementally over time, not overnight, because the older standards though inferior have the advantage that they are in use today and the cost of ‘ripping and replacing’ them is not worth the added benefit.”

Growing demand for interoperability

Demand for interoperability has grown dramatically in recent years owing to the success of Meaningful Use at fostering widespread adoption of EHR systems, changes in business models such as accountable care, a growing sense among the new generation of physicians that information sharing should be a standard of care, and finally, growing expectations among patients that their information should be as conveniently shared as it is in other walks of life, Tripathi explained.

Recent statutory and regulatory changes, such as the 21st Century Cures Act, put wind in the sails of those trends, he said.

“FHIR’s emergence and rapidly rising maturity thus come at the perfect time because it offers tools to provide better interoperability experiences just at the moment that physicians are now demanding it,” said Tripathi. “Equally exciting is that FHIR is opening up new avenues of interoperability, such as exchange with patients through apps, and with organizations in other parts of the healthcare value chain such as health insurers, life insurers and life sciences companies.”

The biggest challenge in general is not with FHIR 4 but with the lack of two-way communication between apps and EHRs, said Medicomp's Gainer.

“Many EHR vendors are implementing FHIR and developing APIs, but for the most part, the EHRs provide read-only access to their system,” he contended. “In other words, the apps can request data from the EHR and present the information to the user, but few EHRs can allow users to take action within the app and have that activity sent back into the EHR.”

While technologically it’s doable, this step is more challenging and introduces concerns about accepting data that originates outside of the EHR, he added. It’s a big ask for vendors, but that’s what vendors need to make interoperability actually happen, he said.

Keeping the standard standard

Rab of the College of Healthcare Information Management Executives added that keeping FHIR standard is another challenge the standard faces.

“There are already several profiles of FHIR and keeping it interoperable is a main focus of the groups working on it,” he said. “There are several reasons for different flavors, but we need to work toward a universal standard to avoid the in-operability we see today.”

And finally, over-hyped expectations are another challenge FHIR 4 faces, and they are pervasive for two reasons, said Shaver of Corepoint Health.

“First, we are early in the implementation cycle, and second, there are deep, pent-up demands to urgently solve a wide range of interoperability concerns,” he explained. “FHIR’s ability to query source-of-truth systems in real time and its improved data model reducing friction for data exchange makes sugarplums dance in the minds of most stakeholders.”

The reality will be more difficult. Even allowing that FHIR is a dramatically better and transformational approach to interoperability, he said, no single standard will be a panacea for interoperability.

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com