The Standard

Clinical Trial Matching...Room for Improvement 

Clinical trials are essential to the advancement of patient care. The outcomes of a trial directly enable the future development of new treatment options for patients. Participants also benefit during the trial – they are provided access to potential treatments that may not be otherwise available to them – sometimes improving their overall prognosis.

Trial sponsors (the party responsible for the clinical trial) make significant investments, including procurement of products and services supporting the clinical trial workflow. According to the Tufts Center for the Study of Drug Development (CSDD), the mean direct cost to conduct a clinical trial per day is approximately $40,000 for Phase II and Phase III trials, and delays to launching a product can cost $800,000 per day.

With a very high percentage of trials delayed due to enrollment, there is much work to do to ensure clinical trials are sustainable and new therapies reach patients faster. Efficiencies gained in clinical trial matching benefit patients and their caregivers, sponsors and service providers.

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For a patient to be matched with the right trial, that patient’s medical history is compared with multiple trials’ criteria.   In concept, this is a simple process, but more information is often needed than is available in the patient’s record (in Part 1 we tell the story of Dr. Smith’s inability to easily obtain her patient’s medication history from his previous health care provider.) If, after a first evaluation, a patient isn’t disqualified, they must often undergo additional screening by their care team or more involved procedures required by the protocol sponsor to fully determine eligibility.

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Introduction

  Questions to Address:

• How can we build interoperability into this process with HL7 Fast Healthcare Interoperability Resources (FHIR®) – automating trial matching by fitting patient data and clinical trial criteria together like puzzle pieces?  

• Two separate-but-related teams within one of the world’s leading health data standards organizations are independently addressing aspects of this complicated puzzle.  Through more standardized patient medical records and machine-readable, digital clinical trial protocols, we can make progress toward a future state where trial matching is more accurate and seamless. You can be part of the journey!  

A Closer Look at the 26th Virtual HL7 FHIR Connectathon Held January 13-15, 2021

Despite adjusting almost everything in life to a pandemic-driven “new normal” these past ten months, most of us have discovered a few unexpected benefits from the upheaval. Such is the case for the HL7 FHIR Connectathons, which migrated from in-person to virtual beginning with the May 2020 Connectathon. The January Connectathon #26, occurring last week, carries the distinction of being the largest Connectathon yet – with over 800 participants!

The in-person, face-to-face Connectathons of the past provided a rare (and delightful) opportunity to join developers, implementers, clinicians and interested stakeholders in testing and development of FHIR standards. Moving to the virtual format, however, has allowed more people to participate without having to travel to the event.

What Happens at a FHIR Connectathon?

If you are still fuzzy on the detailed activities of Connectathons—and whether you should attend one, there are many avenues where you can learn more. FHIR Connectathons serve as events that are centered upon developing the FHIR specification; including resources, profiles, and implementation guides (IG). The first Connectathon occurred in September 2012 and readily set the stage for future Connectathons that typically occur in the days ahead of an HL7 Working Group Meeting, thereby encouraging members to participate in both.

Much Progress Made on This and Other Da Vinci Project Use Cases During Recent FHIR Connectathon

The HL7 Da Vinci Project’s Gaps in Care use case continues to make rapid progress in developing a Fast Healthcare Interoperability Resources (FHIR®)-based solution to help payers, providers and patients improve care quality under value-based care scenarios.

Several issues were addressed during last month’s Virtual FHIR Connectathon, and the hope is that an implementation guide update for the standard will be balloted in September stated Viet Nguyen, MD and Yan Heras, who are leading the work on the use case. The progress and work on the Gaps in Care use case exemplifies work done on several Da Vinci Project use cases during the Connectathon.

Due to COVID-19, most of the in-person conferences have been changed to virtual events. I recently attended my first-ever fully online technology conference, the Virtual HL7 FHIR Connectathon. This article details my experience and recommendations, in general, for all future conferences post-COVID-19.

Introduction

First, let me give my kudos to HL7 Fast Healthcare Interoperability Resources (FHIR) Product Director Grahame Grieve, the planning team, track leads, FHIR community and HL7 for the  excellent execution of  the Virtual FHIR Connectathon. The conference includes healthcare data interoperability topics with different tracks, expertise and both technical non-technical skills.

I have attended many in-person conferences in the past. Over time, I realized people attend conferences for primarily for two reasons:

1. Learning new skills
2. Networking

Let me share my thoughts based on my first Virtual FHIR Connectathon experience.

The next Consolidated Clinical Document Architecture (C-CDA) Implementation-A-Thon (IAT) is scheduled this September 14-15  in Atlanta, Georgia. It will be held as a track within the HL7 FHIR Connectathon, allowing attendees to optimize participation across CDA and FHIR-related tracks. 

 Boston is on FHIR!

HL7^® FHIR^® DevDays in Boston just concluded. This first US Edition of HL7 FHIR DevDays exceeded expectations in all respects. Attendance eclipsed all previous HL7 FHIR DevDays events and there was a waiting list. The content was stellar and was a window into the rapidly changing future of healthcare data liquidity and secure data access that is starting to become reality. Furthermore, the State Room venue on the 33^rd floor above downtown Boston was spectacular.  

Caption: View of downtown Boston from the State Room on the 33rd floor. 

 The HL7® FHIR® Connectathon Consumer Centered Data Exchange Track

Covered entities face an ever-growing demand to enable digital health apps to access Protected Health Information (PHI). The technical and legal requirements to enable this are the focus areas for the Consumer Centered Data Exchange (CCDE) track at the HL7 FHIR Connectathon. This track initiated at the San Diego Connectathon (September 2017), and it made more progress recently (January 27-28) at the New Orleans Connectathon. Track participation may have been piqued by Apple’s recent announcement that it will provide patients an “effortless solution bringing health records to iPhone”, and that Apple will use FHIR services to enable this.

Caption: Participants at the HL7 FHIR Connectathon 17 in New Orleans, LA. Image credit: Kai Heitmann.

Apple’s announcement couldn’t be more closely tied to the work of the enthusiastic CCDE track participants, representing the entire healthcare industry including providers, payers, government, academia and app developers. Apple could benefit a lot from this track’s work if iPhone users are to access PHI from covered entities beyond the initial 12 participants of the iOS 11.3 beta.

Why? Mainly because the CCDE track focuses on 3 key requirements:

1. It should be technically simple for a covered entity to verify that an app requesting access to a patient’s PHI is indeed controlled by that particular patient;
2. The way an app accesses PHI should be compliant with data governance and privacy policies of the covered entity, as well as HIPAA guidelines, and;
3. The experience of an app user should be simple enough so that they clearly understand and acknowledge what they are sharing with the app. 

 The HL7® FHIR® Connectathon at HL7's 31st Annual Plenary & Working Group Meeting

I don’t know what you were doing on Saturday, September 9, but I was in a San Diego hotel ballroom watching a little history being made.

HL7 held the 16^th FHIR Connectathon on September 9 & 10 and it was another great success. Over 200 people happily gathered together at 9:00 am (with lots of coffee) to work in the 19 tracks developing FHIR solutions.

Clinical Research Track

The Clinical Research track, co-sponsored by TransCelerate, filled three large tables. This was a huge jump in participation. We had seven participants at the January Connectathon in San Antonio and two at the May Connectathon in Madrid.

Read more about how TransCelerate BioPharma Inc. generated use cases for the Clinical Research track and supported the event here.

 The HL7® FHIR® Connectathon Consumer Centered Data Exchange Track

In my previous article, Patient Consent Forms: Redundant in the World of OAuth, Part 1, I suggested providers to design their OAuth2 authorization challenge as a patient consent form so that patient consent can be digitally recorded during the OAuth dance. This would allow providers to share patient health records with the patient health apps much more efficiently without requiring separate paper/PDF consent forms, while still meeting the policy and regulatory requirements.

In this post, I will walk through a specific example of how to do this, and also discuss the differences in providers and patients’ perspectives on consent.

OAuth2 Authorization Challenge as a Patient Consent Form

First, let’s consider the scenarios from the Consumer Centered Data Exchange track at the FHIR Connectathon 16 in San Diego where a patient app can pull their health records from all of their providers in one place, or cause their EMR data to be sent from provider A to provider B. In both these scenarios, the provider may need an explicit patient consent or authorization form (often paper-based) signed by patient. So, how can we use OAuth2 challenge instead to capture patient consent?