Electronic Health Reporter

Q&A with Lyniate’s chief strategy officer, Drew Ivan.

While interoperability has always been one of healthcare’s greatest pain points, the last year or so has emphasized these challenges with the rising demand for data integration and information sharing. The pandemic has required high volumes of data integration, and it’s been difficult for organizations to adapt and respond in an effective and efficient way.

These challenges were further compounded this year with the impending ONC/CMS information blocking rules. With the previous administration’s focus on improving interoperability coinciding with a global health emergency, healthcare organizations had more on their plate than ever. As we look to the future of healthcare in a post-COVID environment, and to the new administration and its healthcare goals, what can healthcare organizations expect?

Healthcare organizations must remain flexible and optimize the organization to be as adaptable as possible. In our interview with Ivan, we explore what healthcare organizations should know about the information blocking rules and the new administration, what is really at the root of the healthcare interoperability problem, and best practices healthcare leaders can employ to set their organizations up for success now and in the future.

How would you define the healthcare interoperability problem?

Interoperability is an evergreen problem across the healthcare industry. As we continue to innovate new capabilities and concepts, we are also constantly expanding our interoperability needs. In a way, interoperability isn’t a problem to be solved. It’s an ongoing practice that has to evolve alongside our other capabilities. For example, there was a time not long ago when social determinants of health (SDoH) were not on anyone’s radar, but as SDoH became more important to healthcare practitioners, it was clear we needed not only to track and store SDoH-related data but also exchange that data across different software systems and organizations. The goal of HL7’s Gravity Project is to build out the standards for exchanging SDOH data using FHIR.

2020 was a tough year in healthcare. The demand for data integration was up, exposing the dire need for better data integration across the healthcare ecosystem. In a world where interoperability wasn’t an issue, how could the pandemic have looked different? 

The bad news is that we live in a world where the most reliable COVID vaccination records are stored on paper cards and interoperability is achieved by the patient themselves carrying the card from place to place. In an ideal world, the vaccination would come with an electronic record that the patient could capture on their mobile device and upload to their doctor’s EHR system, their employer’s HR system, and any other third party that needed to see proof of vaccination.

Although we’ve fallen far short of the ideal state, there are some interoperability bright spots to be happy about. For example, we’ve been able to onboard many new sources of lab result data and integrate that into public health departments. This has not always been easy, but because of the ONC’s prior work on the Promoting Interoperability program, we already had agreed-upon standards and an infrastructure in place to move the data from location to location.

The ONC/CMS information blocking rules have also been pending since the start of the pandemic. What are the biggest barriers to healthcare organizations in meeting these compliance regulations? 

In my view the biggest barriers healthcare organizations face in hitting these federal regulations comes down to who they choose as a vendor partner. Outside of that critical decision, there are two significant technical challenges facing healthcare organizations that we hear repeatedly:

How do I get my organization’s healthcare data from multiple internal data silos into a centralized place and how do I execute and manage complex mappings between my organization’s current healthcare data standards and the mandated FHIR R4.0.1 format?

Additionally, authorization and authentication are extremely thorny issues, as payers and providers are simultaneously tasked with freely sharing PHI upon request but have hefty penalties for improper sharing of healthcare data. As a result, the authorization and authentication of these patient requests are going to be critical to protecting organizations from liability, while meeting the required compliance deadlines.

Is this different for payer and provider organizations? 

There are many differences between the actions these rules mandate for payers and the actions providers need to execute. In short, the key difference is that payers must facilitate the bulk of data exchange between payers, and create and manage a provider directory API, while providers need to integrate compliant ADT feeds.

What should payers and providers know about the ONC and CMS rules as they prepare for compliance? 

The entire leadership teams at both payer and provider sites should know three key things about the ONC/CMS patient access rules.

These rules are prioritizing a change in the stewardship of patient data from payers/providers to the patient.  This may have repercussions across organizations impacting multiple teams and revenue streams.

These rules are extremely technical and complex. Organizations need to be sure they are partnering with a vendor who has deep experience in healthcare data exchange, in addition to experience navigating state/federal compliance issues.

These rules are here to stay and will probably expand in scope. Though many are hoping the Biden administration will be changing tack on implementing these onerous rules, all indications suggest a continued focus on patient access from the Biden team. Additionally, we’re expecting the re-submission of expanded criteria that payers and providers will need to serve up to patients in the coming years, ensuring this federal effort continues to impact organizations well into the future. Signs that these regulations will be expanding in scope also further emphasizes the need to partner with a vendor that’s fully committed to the interoperability space.

Amid all of these changes and challenges for healthcare organizations, we transitioned into a new presidential administration. How do you see the Biden administration’s role in addressing the barriers of healthcare interoperability? 

One of the most challenging elements of working in a heavily regulated industry is that we often see state/federal government’s priorities change as the political winds change. This makes long term planning extremely difficult as changes in administration can often dramatically alter priorities which impact businesses.

The Biden administration has signaled that there shouldn’t be any large course corrections as it relates to vision, but the administration may review the details of some proposed rules and potentially evolve their implementation moving forward. Most notably, I’m interested to see how ONC Leader Tripathi handles TEFCA implementation/enforcement as Tripathi has made national networks & TEFCA an early focus of his public comments.

What do you think healthcare interoperability and healthcare in general, will look like under the Biden administration? 

All indications point positively to the Biden administration’s impact on interoperability in general looking quite similar to that of the previous administration. Early indicators and investments give hope in a few areas. I think there will be progress made around interoperability infrastructure modernization, data standardization, and continued efforts to reduce the burden of health IT on clinicians and, fingers crossed – meaningful progress in patient ownership and stewardship of their clinical data.

What are successful organizations doing to prepare for the upcoming rules, and continue responding to the pandemic? 

As payers and providers look to address these consequential regulations there are several common pitfalls we’ve seen organizations fall into when looking to fast-track compliance.  Both payers and providers should be considering a few key questions, to ensure a smooth and productive implementation of compliant products and services.

Do we have the technical infrastructure to implement and maintain a secure, standards-based Patient Access API that allows patients to easily access their claims and encounter information, including cost, as well as a defined subset of their clinical information through third-party applications of their choice?

Do we have a plan for authentication and authorization of the patients accessing their data, stored at our organization? How are we planning on validating that the patient/member making the data access request meets the minimum security and compliance thresholds?

Do we have an interoperability solution that integrates easily with existing systems? This can be critical to gaining operational benefits from implementing API enablement tools, rather than siloed solutions that don’t support bi-directional integration with other key healthcare systems.

Do we have the infrastructure to build, manage, maintain, expose, and govern FHIR APIs? This requires API management, and FHIR normalization, neither of which are trivial problems to solve.

Can our vendor partners enable use cases outside of the CMS requirements, such as those outlined by the DaVinci Project and SMART on FHIR? Additionally, is our vendor/solution planning to support the proposed regulations that are likely to expand the scope of the healthcare data our organization will have to provide to patients in the future.