Wayne Kubick

In the world of regulated research, we’re conditioned to do things the same way, over and over again, to conform with SOPs. With respect to clinical studies, patients are anonymous “subjects,” and we’re enslaved to the case report file (CRF), designing studies to collect a set of data entered into EDC systems and moved along a complex, often recursive chain through data management, analysis, and interpretation. It’s not easy to exercise creativity in trials, because we can be punished severely if we stray from the tried-and-true path.

	Historically, all this made sense, since medical records were generally in paper folders, stored in massive mechanical file systems. To make the data usable, we relied on coordinators to copy the data into the CRFs, recognizing the need to scrutinize every data point because of the likelihood of transcription or omission errors.

	Even when electronic medical records (EMRs) became available at sites, there wasn’t much of a change to the transcription process. In some cases, researchers learned to tap into an electronic health record (EHR) system for source data verification, and risk-based monitoring tempered the monitoring burden somewhat. But in research, it still all started and ended with the CRF. And it generally seemed easier to just copy the data into EDC, rather than confront the complex challenges of trying to load it in electronically from EHR systems. 

	But while research labors on, the world of digital healthcare has been transformed. The U.S. 21st Century Cures Act established a requirement for certified EHRs to allow patients to access their data “without special effort” and “without the requirement for vendor-specific interfaces” by 2019. This requirement has become realistically attainable with HL7

	As Don Rucker, National Coordinator for Health IT, noted in a Health Information Technology (ONC) blog, “Open and accessible APIs (application programming interfaces) have transformed many industries. We think they can transform healthcare as well.” A more recent ONC blog from Steve Posnack has shown how healthcare is already poised to capitalize on the era of APIs. In his recent celebrated 

article, Atul Gawande has identified targeted apps built on APIs as a critical tool to lessen the EHR burden on clinicians, by allowing medical staff to “pick and choose the apps according to their needs.”  And if this is happening in healthcare, why can’t this be the case for subjects, investigators, and research professionals? The SMART on FHIR (Fast Healthcare Interoperability Resources) app store provides a tangible glimpse into what apps built on FHIR APIs could also do for research. 

	But while HL7 FHIR has made this possible, it still requires a committed effort to make it happen. Within the healthcare industry, the Argonaut Project paved a path for engaging multiple stakeholders (providers, IT vendors, and consultants) to work together on a common implementation guide for using patient-focused APIs. This approach has been repeated by the Da Vinci project, involving a similar collaboration of participants plus payers to use clinical data to support value-based care. Da Vinci has also taken a lead in implementing the FHIR Bulk Data capability to use APIs to access data for entire populations of patients-a use case that could be adapted to improve pharmacovigilance and other research use cases as well. 

	One significant example of how APIs can help to partner with patients is the NIH 

 Research Program, formerly the Precision Medicine Initiative, which seeks to engage one million patients who will voluntarily share their health and genomic data with research. The 

technology platform is built upon SMART-on-FHIR APIs-an approach that could also reinvent the conduct of clinical studies. The Apple Health Records app is already bringing digital health data to the masses, and FDA’s recently announced MyStudies app builds on Apple and FHIR to support the use of real-world evidence.

	FHIR forefather Grahame Grieve refers to it as “the web, for healthcare.” The world of clinical research now stands before a doorway paralleling the advent of the Worldwide Web more than 25 years ago. 

 is Chief Technology Officer at Health Level Seven International.

Articles

The availability of FHIR-based APIs enabling patients to access and use their healthcare data for multiple purposes has opened a door to an entirely new world of opportunities for partnering with patients on clinical studies.

Patients as Partners in the API Era

	You may have noticed that many conferences lately have been offering “Innovation Theaters,” “Innovation Showcases” or “Innovation Corners” that reserve presentation slots for many familiar technology and service companies to “showcase (their) products and services” in a special area on the exhibit floor. The primary entry criterion appears to be being first in line to pay an extra fee-there didn’t seem to be any obligation to prove actual innovation value. I believe I heard one presentation at a recent conference was actually touting “paperless” as an innovation.

	Of course, it doesn’t take much detective work to find claims of innovation. It’s difficult to imagine anyone being in this business who wants to label themselves “same old, same old” instead. Indeed, many technology and service providers use “innovation” as just another technological buzzword

, a kissing cousin, if you will, to “Big Data” or “Cloud Computing.” 

	Sometimes it seems as if jumping on a bandwagon (especially a fast-moving one) is all it takes to be innovative. But if everyone’s doing these things (or at least saying they are) can any of them really be all that innovative?

	“Innovation” is defined by Merriam-Webster.com as: 

“The introduction of something new” or “a new idea, method, or device.” 

	So fine, it’s new. But doesn’t it matter if it’s new to me (such as my shiny new smartphone, which is already a generation old to others), new to you (which depends on how much you knew previously) or, above all, new to a historically conservative industry that desperately needs to embrace dramatic change across the board in order to remain viable?

	And if newness is all that matters, I guess every teenager posting today’s selfie can claim to be innovative, too. 

	Which brings me to another, more rigorous definition offered by author Scott Berkun who has railed against misuse of the term for years: “Innovation is significant positive change. This is a high bar, and it should be. To call every little change you make in your work an innovation belittles the possible scale of progress.  It’s hubris.” 

	Today there’s plenty of talk about innovation in medical research. We have efforts to push for more funding for the precision medicine initiative, Congress moving forward with the 21st Century Cures Act, and FDA interacting seemingly everywhere toward the advancement of regulatory science. 

	But which technology and service providers in the clinical research ecosystem are really offering unique, new solutions that are truly innovative so as to impart significant positive change? 

	On the other hand, there’s plenty of support for the Luddite position. According to the findings of a PA Consulting Group innovation survey, 46% of senior executives describe their innovation activity as a “costly failure.” If Mr. Peabody were a pharmaceutical or 

biotechnology executive, he might say, “Sherman, set the Wayback machine back to yesteryear-and leave it there.”

	How can we reimagine research using our new capabilities to apply real-world evidence, patient engagement and collaborative technologies while retaining the proven gold standard of a more efficient randomized controlled clinical trial? 

	Can’t we find ways to use all of our ideas, tools, capabilities and experience to generate some meaningful disruption and actually make some positive great leaps forward?   

	So what truly innovative ideas in clinical research products or services have you seen recently? And do they meet Scott Berkun’s high bar? Let’s keep the dialogue going.

 is Chief Technology Officer, Health Level Seven International

With the term "innovation" a buzzword du jour these days, the important quest for industry is to reimagine R&D using its new capabilities to apply real-world evidence, patient engagement, and collaborative technologies.

Searching for Innovation in Research

	Now that the era of digital health is upon us in the U.S. and other countries, it’s time for a fresh look at how we collect research data. What if we could make a great leap forward by completely changing our approach through electronic health record (EHR) eSource? Would we dare to try?

	“Source” is the initial recording of data for a clinical study.  When the original recording is on digital media rather than paper, it’s “eSource.” Clinical trials have used eSource for years in ECG readings, lab results, and other measurements.  The FDA eSource Guidance describes different ways to transmit eSource data (from direct capture, devices, transcription, EHRs, or patient-reported outcome instruments) to an electronic case report form (eCRF) system, and several approaches have been proposed for trying to feed EHR data into our existing EDC-based processes. Last year the FDA even asked for demonstration projects to explore such approaches. 

	But a more recent draft Guidance on Use of EHR Data in Clinical Investigations offers another take entirely with explicit goals to “facilitate the use of EHR data in clinical investigations” and to “promote the interoperability of EHRs” with clinical research systems.  The guidance recognizes that the ONC Health IT Certification Program can indicate the readiness of EHRs to support research. And ONC’s Advancing Care Information initiative relies heavily on leveraging application program interfaces (APIs) to make health data more timely and accessible to patients and caregivers.

	This is where HL7’s FHIR platform standard comes in:

		FHIR’s Data Access Framework will provide a universal API to EHR systems that can be used to populate much of a casebook in a clinical database. 

		The Smart on FHIR specification demonstrates how patients can grant researchers access to their data through electronic informed consent, as well as input outcome data through smartphones and browsers-data that can be directed to an EHR or a trusted third-party cloud-based research repository simply by selecting the appropriate target FHIR server.

		Since EHR data is eSource, FHIR can also provide authorized access to remote study monitors.

		And since FHIR can update as well as read data, it can also support the processing of data clarification transactions, thus making it possible to synchronize EHR records with clinical databases, improving transparency and traceability for both monitors and regulatory inspectors.

		FHIR makes it possible for regulatory reviewers to delve into the full EHR database to explore, for example, serious adverse events, in more depth than was ever possible before.

	In the future, it may not be necessary to have an eCRF system in the middle of the process. That would enable using the EHR data directly to feed our analysis so that all health data could potentially be reused as research data. 

Wayne Kubick, is Chief Technology Officer, Health Level Seven International, and a member of Applied Clinical Trials’ Editorial Advisory Board 

Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.

EHR eSource: Sword of Change?

Recently I participated in a “Partners in Interoperability” workshop in Washington DC. The meeting brought together senior decision makers from the clinician, payer and biopharmaceutical communities to exchange ideas on how to make more progress toward a mutual, worthy goal of “an interoperable healthcare system that leads to better patient care and improved outcomes.” The focus of the meeting was on how to achieve this goal through the use of FHIR® - 

HL7’s Fast Healthcare Interoperability Resources standard

	 	FHIR (pronounced “fire”) is a new standards-based framework and platform that makes it possible to tap directly into Electronic Healthcare Record (EHR) systems to retrieve and even create protected healthcare and administrative data. It is based on a small set of ~100 core information resources, modular bundles of healthcare information, which can be tied to different databases and can be easily deployed for multiple purposes. In the USA, FHIR has attracted great interest from the 

 as a potential solution to the requirement for a general Applications Programming Interface (API) which is part of the next phase of Meaningful Use, and is also being used for the NIH 

 pilot. Though still an evolving standard, FHIR has already been adopted by many of the largest EHR vendors and other adopters for production uses, and is the focus of a major collaborative effort of more than 75 stakeholder organizations to conduct testing and produce implementation guides through 

. FHIR is based on the same modern technologies that drive web platforms like Facebook and Twitter, which makes it possible to rapidly develop 

 for browsers and mobile devices. And FHIR has developed a groundswell of excitement because it is both human readable and understandable by programmers, scientists and clinicians. Lastly, FHIR is free.	 	At the 

, there was great interest in exploring how FHIR could be used in biopharma to provide a standard API for evaluating the feasibility of eligibility criteria, supporting patient recruitment, and harvesting data from EHRs to support clinical studies, with additional interest in using it for ePRO apps and providing real world evidence.	 	The potential benefits to biopharma should be apparent. FHIR, by opening a window into the world of higher quality digital healthcare data, and a lens that presents it in a semantically consistent manner, can truly re-engineer how pharma collects evidence about how drugs are performing in the real world, and a new method for collecting data for clinical trials that truly involves a consistent and comprehensive solution to using the actual patient health record as the ultimate eSource.	 	In Jack London’s classic story 

, a man and his dog are wandering in a snowy wilderness during a period of extreme cold. He builds a fire for warmth to eat his lunch, and then continues his journey, but in his haste to reach his destination waits too long before building another fire, and ultimately dies of frostbite. In an industry of closed proprietary systems and silos of inconsistent data, with antiquated, complex processes that seem to endlessly transform and over-process data over and over again in the path from patient to analysis, it sometimes feels to me that biopharma is also wandering in a frigid wilderness of its own creation. It’s time we built a FHIR. 	 	Wayne Kubick is Chief Technology Officer of HL7. He can be reached at 

FHIR (pronounced "fire") is a new, free of cost, platform that has the ability to access and create data though EHR systems. Wayne Kubick writes that using such a platform could truly re-engineer how pharma collects data during clinical trials.

Wayne Kubick

Articles

Patients as Partners in the API Era

Searching for Innovation in Research

EHR eSource: Sword of Change?

Building on FHIR for Pharmaceutical Research