ONC/CMS Compliance: How FHIR and the MyHealthEData Initiative Are Changing Access to Patient Data

May 22, 2020
ONC/CMS Compliance: How FHIR and the MyHealthEData Initiative Are Changing Access to Patient Data

Patient data is at the foundation of any well-functioning healthcare system. Physicians cannot make well-informed diagnoses, patients can’t choose the right care, and payers can’t make strategic financial decisions without the right information.

The last decade or so has seen an explosion in the use of health information technology (health IT) to store patient data. In 2008, 9 percent of hospitals could demonstrate meaningful use of electronic health records (EHR). In 2018 this had risen to 96 percent.

However, a key barrier preventing full use of this data within the healthcare ecosystem has been a lack of consistency and rigor in data format. This has, in turn, meant a lack of data ‘interoperability’: An inability for different IT systems to exchange and make use of the data.

Thankfully, this is beginning to change.

Here we look at two key initiatives, the Fast Healthcare Interoperability Resources (FHIR)specification, and the federal government’s MyHealthEData initiative. Both these initiatives, especially through the new Interoperability and Patient Access final rule, are transforming the ways in which health data can be used by patients, providers, and payers.

What is FHIR?

In order to advance the interoperability of healthcare data, Health Level 7 introduced the FIHR (pronounced ‘fire’) specification. In recent years it has become one of the most popular protocols for promoting the free exchange of health data.

In simple terms, FHIR is a framework which sets common standards for the exchange of healthcare information via Application Programming Interfaces (APIs). It determines both the way in which data is shared, as well as what that data looks like. The current release of FHIR defines 145 APIs, and ensures common definitions of core healthcare concepts such as patient and practitioner, clinical observational data, diagnostics, and healthcare financials.

What are the potential benefits of FHIR?

FHIR enables data interoperability, but why is this so important? Key benefits of FHIR include:

  • Empowering patients. FHIR promotes standardized health information which can improve clinical diagnostics, and improve the basis on which patients make their own healthcare decisions;
  • Reducing the financial/economic burden of healthcare. The United States has the highest health care costs per person in the world. Our annual health insurance premiums average $19,616 per family (according to the Kaiser Family Foundation). Transparency of cost information means a more competitive market and, eventually, lower costs for all of us;
  • Unlocking the power of data. FHIR means healthcare datasets which are suitable for data analytics and AI applications. Enormous datasets can be analyzed to predict conditions based on common symptoms, recommend medications or procedures, or identify where resources are being mis-used.

What is the MyHealthEData initiative?

FHIR provides a key tool for building healthcare data solutions. But it does not, in itself, require any actor in the healthcare ecosystem to do anything. This is where various government initiatives come into play.

The 21st Century Cures Act became law in December 2016. Through this law, the Office of the National Coordinator for Health IT (ONC) and the Center for Medicare & Medicaid Services (CMS) were directed to develop policies that support and encourage interoperability in data exchange, and prohibit blocking of patient data access.

In March 2018, the Trump government demonstrated that it, in turn, supported interoperable patient data with the MyHealthEData initiative: An initiative with the stated aim of promoting data interoperability in order to:

  • empower patients through access to their own data;
  • increase competition; and
  • encourage innovation.  

Initially, the focus was on encouraging private actors to adopt data interoperability voluntarily. Note also that the initiative was specification-agnostic: It did not mandate the use of FHIR.

The sole compulsory data sharing policy, to date, has been Blue Button 2.0 .An API, utilizing FHIR, which contains four years of healthcare data for Medicare beneficiaries.

What is the Interoperability and Patient Access final rule?

CMS confirmed on April 21 that it is expanding data interoperability through the Interoperability and Patient Access final rule (CMS-9115-F, ‘the rule’). This rule regulates the Medicare Advantage (MA), Medicaid, CHIP, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). That is, it regulates the activity of CMS-regulated payers.

The rule contains a range of policies that improve data accessibility and interoperability within the healthcare system. We consider each policy in turn:

  • The Patient Access API (applies from January 1, 2021): This requires CMS-regulated payers to share claims, cost, clinical and identification data, with patients. Through this API, the patient can transfer their data to other parties via a third party application of their choice. Patients could utilize this data in changing their healthcare plans or changing providers;
  • The Provider directory API (applies from January 1, 2021). This requires CMS-regulated payers to make their provider information publicly available;
  • Payer-to-Payer Data Exchange (applies from January 1, 2022). This means that CMS-regulated payers are required to exchange core healthcare data with other payers, where requested to do so by the patient;
  • Digital Contact Information (applies from late 2020). Under this provision, any providers that do not update their contact information (including FHIR API information), in the specified national registry, will be publicly reported;
  • Admission, Discharge, and Transfer Event Notifications (applies from fall 2020). This requires that patient event notifications (admission, discharge, and transfer information) be shared by Medicare and Medicaid participating hospitals with primary care providers and certain other specified parties.

You can read more about the new rule here ONC/CMS Compliance: How FHIR and the MyHealthEData Initiative Are Changing Access to Patient Data. Note, as explained on the CMS site, the enforcement of these new policies has been delayed for six months due to the impact of COVID-19.

In Conclusion

Unlocking data through interoperability standards, such as FHIR, has the potential to transform the healthcare system, both in terms of health outcomes and the financial burden of healthcare. Both the current and previous federal administrations have promoted this outcome via the 21st Century Cures Act and the MyHealthEData initiative respectively. With implementation of the Interoperability and Patient Access final rule over the next two years, we should expect to see a proliferation of new FHIR solutions enabling better patient, provider, and payer, data use.