We’ve talked the talk about Health Information Technology (HIT) interoperability for a long time, but progress has been slow. The 21st Century Cures Act legislates that diligent work on interoperability get started. Signed into law with bipartisan support in December 2016, 21st Century Cures legislates changes for the Discovery, Development, and Delivery of new healthcare treatments and cures.
Key aspects of 21st Century Cures
The section of the law under Title II is “Discovery.” This part of the law funds NIH initiatives, including Precision Medicine and BRAIN, Brain Research through Advancing Innovative Neurotechnologies.
Title III of 21st Century Cures is all about “Development” of new treatments. This part of the legislation streamlines the structure of clinical trials and requires modernization of regulatory oversight of new drugs and devices by the FDA.
Of interest to EHR developers and users are the 21st Century Cures Act Title IV mandates around “Delivery.” This section of the law includes specific requirements for activities that support EHR interoperability by “…developing or supporting a voluntary model framework and common agreement for the secure exchange of health information to help foster bridging between networks.” In other words, trusted exchange frameworks will be used to support seamless interoperability.
The current HIT ecosystem includes many EHRs that collect and protect information within their own system. In 2013 ONCHIT published a white paper outlining trust principles to create a framework for information sharing among EHR entities. Some key trust issues include:
- How is access to the system controlled?
- How are users authenticated?
- How is authorization to access specific data granted or denied?
The ultimate goal is to enable one healthcare entity with an EHR in place to share information with an unaffiliated healthcare entity that uses another EHR. Sounds pretty straightforward, right?
Is it possible to achieve interoperability?
I asked Eddie Hedrick, a Vice President in the Fresenius Information Technology Group, about the reality of interoperability and trusted exchange frameworks in the real world and found out that a lot is happening today. Using Fresenius Medical Care North America (FMCNA) as an example, here is what Eddie is working on:
Today it takes a hodge-podge of connections to provide any degree of interoperability reach. That is somewhat of a surprise given how long ago the HITECH act gave healthcare organizations a roadmap for creating a health IT ecosystem in which health information could be readily exchanged (2009).
- More than conveying giant C-CDA documents from one EHR to another
- More than potential, theoretical connections between systems that are prevented from connecting in practice
- More than combining clinical data with more clinical data
Our goal is to develop infrastructure that would provide the broadest reach, both geographically and in the number of healthcare providers and entities we can connect to for data exchange.
Our objectives are to:
- Develop an interoperability strategy with the broadest reach to ease access to “actionable” data from across the care continuum and provide clinicians with information at the point of care to improve quality of care
- Improve patient access to their electronic HI
- Minimize special effort on the part of the clinician
- Serve workflows and use cases of everyone in the enterprise
- Facilitate secure, electronic movement and use of health information according to nationally recognized standards
- Minimize point-to-point connections and exchange agreements
- Address state laws mandating HIE participation
- Avoid “Information Blocking”
Building trusted exchange networks
In July the Office of the National Coordinator (ONC) held a kick-off meeting to discuss interoperability and trusted exchange networks. Eight trusted exchange framework groups presented at this meeting including Carequality, CARIN Alliance, CommonWell Health Alliance, Digital Bridge, Direct Trust, eHealth Exchange, National Association of Trusted Exchange, and the Strategic HIE Collaborative. This meeting was the start of creating consensus and a path forward to true interoperability for the national HIT community.
But, as Eddie notes, even these 8 exchange entities supporting trusted exchange of health information do not have the same standard functionality:
Each of the connections we need to make, including CommonWell, requires different technology, different standards, different protocols, different legal agreements, different governance processes, different policies, etc. And in some cases, there are conflicts across these differences. How can a healthcare entity like FMCNA agree to conflicting rules of the road across the various networks?
It is important to note that in the past year CommonWell members agreed to also implement the Carequality framework. This is great news in that Carequality would then represent a unified, common framework across all the major EHR vendors and networks.
What can trusted exchange frameworks do for you?
The current National Coordinator for HIT, Dr. Don Rucker, expects trusted exchange of HIT will give patients access to their health information without burdening them with extra effort to gather it. Patient-centeredness is a theme in the 21st Century Cures legislation, so rulemaking to implement the law will support patients’ ease of access to data, ability to easily see data from various healthcare entities, and opportunity to share health data as needed. The government is also interested in aggregating data to help providers better manage patient populations and improve public health initiatives.
Creating trust is complicated in general, so it’s no surprise that creating trust among healthcare networks to enable seamless information sharing is very complex. 21st Century Cures now requires this to happen, so rulemaking with specific actions for EHR vendors will follow. Trusted framework entities like Carequality are likely to be in the HIT news for bringing the network together. Eddie’s going to be busy!
Dugan Maddux, MD, FACP, is the Vice President for CKD Initiatives for FMC-NA. Before her foray into the business side of medicine, Dr. Maddux spent 18 years practicing nephrology in Danville, Virginia. During this time, she and her husband, Dr. Frank Maddux, developed a nephrology-focused Electronic Health Record. She and Frank also developed Voice Expeditions, which features the Nephrology Oral History project, a collection of interviews of the early dialysis pioneers.
Eddie Hedrick has more than 30 years of experience in the fields of information technology systems and health care. Hedrick provides strategic leadership and management for short and long-term goals related to Health IT aligned with Fresenius Medical Care enterprise strategy. He previously served as Vice President, Product Development for Acumen Physician Solutions.
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