This episode's guest is Dave Navarro, Senior Director of Data Science for Harmony Healthcare IT, a data management and lifecycle solutions firm. Dave joins the Dish on Health IT host, Ken Kleinberg, and co-host, Jocelyn Keegan,to talk 21st Century Cures Act and the change in the definition of “EHI”, critical components of plans to purge, archive, or transition data to new platforms, and how to marry data in various formats and versions of CCDA and FHIR. 

Ken kicked off the episode by asking co-host, Jocelyn Keegan, to briefly introduce herself and to share what she's looking forward to learning from today’s guest.

Jocelyn responded by explaining that she is the payer-practice lead at POCP, devoted to positive change and building/getting stuff done. She went on to say that her focus is on interoperability, prior authorizations, and the convergence of tech, standards, and product strategy. She also serves as the program manager for the HL7 Da Vinci Project. Da Vinci started as a conceptual idea of emulating the great work produced by the argonaut project but with a focus on payers and providers, value-based care, and clinical data interoperability and has become likely the most expansive of the FHIR Accelerators to date, focused on payer-provider collaboration.

Ken then asked guest, Dave Navarro to briefly introduce himself and to include his professional background and journey to Harmony Health.

Dave reiterated that he is the Senior Director of Data Science at Harmony and that he started his career about 22 years ago in the health IT world. He explained that he started by configuring EHRs and building clinical integrations for financial systems and clinical systems for Cerner Corporation.

Dave explained that early on he had a lot of exposure to different data formats and files and that he’s been spending the last 17-plus years in the health information exchange world. He landed at Harmony Health to work on the interoperability of legacy data and the legacy data solutions Harmony provides.

Ken asked Dave to expound a little more on the work Harmony Health is doing.

Dave explained that Harmony helps their clients' archive data from a legacy system or in some cases transition data from a legacy system to a new system.  If data are archived, they must still be in a format that can be managed, accessed, and consumed to inform clinical decisions.

Harmony offers the Health Data Archivers solution, which includes extraction services. Clients can also earmark data that they’d like to have posted in their new system.

Ken then shifted the conversation by asking how the industry as a whole or different stakeholders in particular view 21st Century Cures differently and whether Dave wishes there was a perspective the industry would share about how they approach compliance.

Dave started by admitting that he hasn’t read the entire 21st Century's Cures Act but has familiarized himself with the portions related to interoperability. He shared that he believes this legislation is a good thing. Dave pointed out that while it was signed back in 2016, the industry is just now seeing the results.

He explained that he believes Cures has pushed the industry towards the adoption of content standards such as USCDI and transmission standards like HL7 CDA and now FHIR. Dave then went on to talk about the data blocking provision explaining that nobody wants to be a data blocker. This portion of the Act helps open the data stream and make data available where EHRs and ultimately patients can view it.

Concerning what perspective he wishes the industry would share, Dave explained that it’s about FHIR. He realizes that FHIR is a little bit scary to some, but that the industry should be starting with FHIR. Dave explains that one reason he believes this is the relative ease to understand and use FHIR compared to CDA, which has been a bit challenging to figure out. He went on to say that with FHIR, someone can study an implementation guide for an hour and pretty much figure it out. Dave also pointed out the FHIR US Core data set as being a good specification.

Dave then went on to explain that while FHIR isn’t an architecture guide it can be used to help make architecture decisions when an implementer is getting started. He added that FHIR builds on the work the industry has done on CDA and takes the lessons learned and fixes a lot of what the industry was frustrated by with CDA.

Ken asked Jocelyn to share her view of Cures based on her day-to-day work as program manager of Da Vinci Project focused on payer-provider data exchange. 

Jocelyn expressed that everything Dave said is so incredibly important. From the Da Vinci perspective, she explained that there is an ongoing dialogue about the intersection of and confusion about the year-end USCDI V3 and FHIR R4 capabilities along with everything in the electronic health information (EHI) requirement.  Joce expressed that this is a great example where folks are looking for additional guidance before making new investments. She explained that most EHRs have a big lift to meet that requirement in a meaningful way. 

Joce continued by saying that FHIR alone isn't necessarily going to get the industry to the semantic interoperability that it’s striving for but that if the industry would pick up the FHIR implementation guides in addition to the more advanced workflow guides, the industry would be making progress toward where it wants to be.

The group spoke briefly about the expansion of the definition of EHI to expand outside of USCDI V1 and that many stakeholders are not ready to meet the October deadline. Dave pointed out that ultimately every journey starts with one step, and everyone just needs to pick a place to start which ideally would probably be USCDI V3, and start the work.

Jocelyn pointed out that by nature stakeholders under regulation want to achieve certification She went on to say that investments were already made in CDA & CCDA and there’s lots of CCDA data moving around. She went on to add that the big question is how the industry is going to manage the collision and misalignment of data formats. And how will the industry decide what needs to be codified, and cleansed and what’s OK to remain unstructured? There are several stakeholders in the industry that have stood up to say that it’s important that data created today needs to be usable and shareable going forward.

Dave shared the experience he’s had working in the historical archive world. He explained that for the most part, he encounters more organizations simply interested in checking the regulatory and requirements box, but that Cures pushes toward data being structured and codified simply by setting the expectation that patients will be able to access all their data which means that data, even unstructured data isn’t going away. He went on to say that even if only minimum pieces of data or data from specific timeframes are migrated to a new system, archives must be able to be queried so a patient can access that data whether it’s in the current EHR system or not.  The perpetuity of data required by the info-blocking rule must change the industry’s mindset.

Ken asked Dave to share some of the surprising or challenging questions from Harmony clients or notable projects. 

Dave explained that sometimes clients can share their entire database at the start of a project and this is ideal so the Harmony team can go through everything, and it makes extraction a little easier. What is being seen in many of these projects is that as the team goes through and looks for NDC codes, signature lines, problem descriptions, or allergy lists, the data isn’t codified. This information will be there as text. For this data to be queried from any archive, it’s got to be codified.

Dave added that they use the specifications from USCDI and cross-reference them with FHIR US Core. Dave continued to explain in more complex detail some of the data types and mapping that occur to ensure the archived data can be queried effectively in the future. 

Dave pointed out that as painful as it sounds, he has been through every single element in the FHIR specification for US Core. He expressed how well put together US Core is and it’s critical to how they do their work.

Ken then asked about how consent is handled during these archiving projects. This led to a robust conversation with Dave sharing that consents get archived if they are found, however the most recent consent on record in the current EHR would likely be applied to how any data pulled from the archive would be shared.

The group went on to discuss the complexity of consent and the importance of establishing and maintaining eConsent in a scalable way. Jocelyn pointed out that through the discussions she’s had with stakeholders and through her personal experiences, the industry needs to solve this so that patients can manage their consents in a secure, central place so they can update and change their consents based on their changing lives.

Jocelyn then shifted the conversation toward the nature of adop