One year ago, CMS Administrator Seema Verma announced the MyHealthEData initiative that endeavored to empower patients by giving them control of their healthcare data, and allowing their health data to follow them through their healthcare journey. Recently, CMS and ONC each released a Notice of Proposed Rulemaking (NPRM) to improve the access and interoperability of health information:


The CMS NPRM requires any payer that CMS administers through Medicare Advantage, Medicaid Fee for Service, Medicaid Managed Care, CHIP Managed Care entities, and qualified health plans sold on the federal marketplace to make specific data available to the patient: Claims and encounter information, plan coverage and medical formulary information, provider directories, lab results, and other clinical information that the payer may maintain. The CMS NPRM requires this information to be made available using the data standards that ONC lays out in its concurrent NPRM, primarily via the HL7 FHIR standard.

The ONC NPRM is separate from the CMS NPRM, but a part of it is relied upon by the CMS regulation. The ONC NPRM is making a deliberate move to mandate the use of the FHIR standard for the transmission of health data. The ONC NPRM specifies FHIR using version 2 as a minimum, with room for vendors to implement version 3 and 4. It is noteworthy that with FHIR, ONC is in the process of developing a FHIR testing tool called Inferno. Inferno is a set of testing tools to help health IT developers make sure the FHIR standard is consistently implemented.

ONC’s rule will address information blockingpayment for the use of APIs on the part of patients and other 3rdparty vendors, and processes for the required use and cortication of software system that support the U.S. Core Data for Interoperability (USCDI) as it relates to the clinical sections that are called out.

Throughout the ONC rule is the concept of Electronic Health Information (EHI). This concept of EHI complements the concept of Protected Health Information (PHI). What ONC is trying to highlight with the concept of EHI is that the information will be computable. So, EHI is (most likely) PHI… but not all PHI is EHI. This term might be very important to define as data is not only in a digital format but also interoperable.

The ONC rule also touches upon the certification of bulk exports of EHI data from systems. The fact that it mentions bulk export is interesting in that this would serve use cases that are not just limited to one patient or encounter.

Taken together, the two proposed rules begin to forge a path forward for patient (and their providers) access to health data that provides a more comprehensive picture of the whole patient. There is opportunity here for innovators to bring applications and technology to the table that can distill this data into meaningful, actionable information for all parties involved.

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Rob McCready, M.S.

Senior Principal Healthcare Systems Engineer - MITRE

Rob McCready, M.S., advises across multiple federal agencies, including the Centers for Medicare & Medicaid Se... Read Bio


Kathy Mikk

Health Policy Analyst - MITRE

Ms. Mikk applies her knowledge of health law, policy, and compliance to a broad range of projects in support o... Read Bio


Pace Ricciardelli

Healthcare Software Systems Engineer - MITRE

Pace Ricciardelli is a healthcare software systems engineer supporting the Office of the National Coordinator ... Read Bio

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