ONC & CMS Interoperability Regulations: Part 4 – Clinicians and Caregivers


By John D’Amore, MS, President and Chief Strategy Officer

This is Part Four of a four-part series that will cover major implications of the March 2020 ONC and CMS regulations for interoperability. Each segment of the series highlights the impact of the regulations on one stakeholder group, and here we discuss clinicians and caregivers.

Information Is Our Lifeblood

For those who work in healthcare and provide care for ill and vulnerable populations, there is a recognition of the hardships of the job. Long hours, intensive training and reams of regulatory requirements. The one thing that makes all this worthwhile is the care provided for the well-being of others. That care is fueled by information.  Back in 2010 the leader of the Office of the National Coordinator for Health IT (ONC) summarized it best:

“Information is the lifeblood of modern medicine. Health information technology is destined to be its circulatory system” – David Blumenthal, MD, MPP

The impetus for the recent regulations by ONC and CMS was the 21st Century Cures Act, which directed actions be taken to prevent “information blocking.” We defined this concept in Part Two of this series, and we will further explore how this impacts clinicians and caregivers.

The Revolution Will Be Read-Only

EHRs are the primary source and record of clinical information. The ONC and CMS regulations provide a host of actions to make sure that EHR can share more information using a newer standard between providers, payers and patients. The rules take unprecedented action by picking one standard, namely Fast Healthcare Interoperability Resource (FHIR) Release 4 (R4). Apps will access patient medical data using this standard, which will span across data requested from hospitals, ambulatory providers as well as payers. The types of data that will be encoded are outlined in the US Core Profile and the CARIN Alliance Profile based on this FHIR version as reviewed in prior parts of this series.

Having rich clinical data readily accessible has the potential to unleash massive innovation in healthcare. Researchers at Harvard Medical School outlined how medical applications could fundamentally change how clinical care is performed using specialized apps The problem is that many of these applications won’t work given the ONC and CMS regulations. The regulations only require EHRs to output data (read-only access); they do not need to create write capabilities. Do you have a great app that will help with medication reconciliation? Well, it will be able to listen but can’t speak back to your EHR. Do you have a new medical algorithm to predict patient risk? Well, it will be able fetch data to make predictions, but it won’t be able to flag the patient in the EHR or share clinical decision support. Since the EHR remains the legal medical record of care, providers will spend most of their time in front of the same (ugly) EHR interfaces for years to come.

The unfortunate truth is that the revolution in clinical data will be read-only. While this will be disappointing, the upside is that it will still empower patients. Patients will be able to get their information on their phone and laptops and use third-party applications to visualize and understand that data. While many app stores are already brimming with health applications, I expect that to increase significantly in the coming two years. Particularly in areas where those apps can help caregivers service others, like children helping their aged parents.

Is This Meaningful Use Stage 4?

Those working with providers and health systems over the past decade remember the program for EHR adoption, known as Meaningful Use, had three stages. Several of those stages were painful as new functionality was required and major testing and upgrades necessary. This new regulation, which stems from different legislation than Meaningful Use, will feel both familiar and different. Just like before, EHRs and Health IT modules will need to be certified using criteria developed by the ONC. Just like before, providers will need to endure upgrades with associated time requirements and costs. But unlike before, what providers get out is a lot different. They will have liberated access to data recorded in their system. They will find switching costs between EHRs to be reduced. And they will find patients can access most of their medical record with relative ease using their smartphone.

While this all requires work and time, the progression of EHR adoption has followed a predictable model. First, the government spent a lot of money to get clinicians off paper. Next, requirements were introduced around how data were structured and codified. Now, the priority is standards-based, web-friendly access to that information. This has happened before in other industries, such as finance, real estate and transportation. What will it look like eventually for healthcare?

Where Does This All End?

Once data can flow readily from EHRs to clinicians, caregivers and patients, we will begin to conquer the final interoperability frontier in changing healthcare: semantic interoperability. That means being able to effectively understand, incorporate and apply data from external systems to improve care quality and costs. Information technology has revolutionized other industries once this has been achieved. While some might believe that existing EHRs and federal regulation alone will achieve this, past experience points to a larger need. At HIMSS 2018, Eric Schmidt, former CEO of Google explained:

Diameter Health has been building this middle tier of data normalization, enrichment, reorganization and deduplication for the past seven years. We’ve processed data on over 50 million lives touching billions of different clinical data elements. We believe that interoperability will only be achieved when software translates clinical information recorded in any source into a lingua franca, making understanding universal (Read further here and here). After that, we will find that machine learning, artificial intelligence and other innovations will change healthcare in ways we cannot predict. It’s happened on your computer and your phone…it is now coming to your clinical record.

Your Next Step

This is the end of our four-part series on the new ONC and CMS regulations, but you may have other questions. We’ll continue to provide web conferences and online resources to help you plan for your future with FHIR and interoperability, but you don’t need to wait to get started. Now is the perfect time to get the conversation rolling given the importance of this rule. For more information, please reach out to Diameter Health at Also you can stay tuned to our Twitter and LinkedIn accounts here. Thanks for reading and I look forward to speaking with you soon.

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