Last month, the U.S. Department of Health and Human Services (HHS) released proposed rules to improve the interoperability of health information. Rules issued by the Office of the National Coordinator for Health Information Technology (ONC), and further rules presented by the Centers for Medicare and Medicaid Services (CMS), put the 21st Century Cures Act into law. The rules are parallel and interconnected. We spoke with Micky Tripathi, president and CEO of the Massachusetts eHealth Collaborative (MAeHC) and a nationally recognized leader in health information technology, to get a better understanding of what these proposed rules mean and how they may impact OpenNotes.
Can you tell us about these rules, and how they will improve interoperability?
These rules aim to make health information more readily available to patients, providers and payers by defining policies to discourage “information blocking” and defining standardized technology mechanisms to make health care data available in a manner that is more consistent with the ways consumers use the internet in their everyday lives. The rules define a set of data that need to be made available to patients. And for the first time, access to clinical notes is a requirement.
The ONC rule speaks specifically to interoperability among providers and between providers and patients, and focuses on three things:
- APIs: Make health information more accessible using the same types of mechanisms – called APIs (application programming interfaces) — that we use to shop on Amazon, or to make a reservation with OpenTable, or to use an app on an iPhone or Android phone. APIs offer a way for two systems to communicate securely with each other electronically. They enable apps like ones you find at the Apple or Google Play stores. The idea is to spur the creation of an ecosystem where apps could, with appropriate security and permission, easily plug into different electronic health record systems to get usable clinical information. For example, a patient would be able to go to an Epic, or Cerner, or other site and download clinical data and opennotes using an app that allows them to focus on a specific illness like diabetes. They could gather all data and notes on that topic, rather than their entire medical record.
- Information Blocking: The 21st Century Cures act says that “information blocking” serves to “prevent or materially discourage the access, exchange, or use of electronic health information; and the actor knows or should know are likely to interfere with the access, exchange, or use of electronic health information.” The ONC rule starts with the assumption that clinical information should be shared and then defines seven legitimate exceptions to such sharing. Software developers or providers found to prevent information sharing in ways not allowed by the rule will face fines if found guilty.
- TEFCA: ONC will create a Trusted Exchange Framework and Common Agreement (TEFCA) —governance and oversight guidelines on how information is exchanged among providers, and with patients. TEFCA aims to establish a legal and governance framework for networks to connect with each other on fair terms. This would be like when cell phone companies AT&T, Verizon and Sprint allow users to talk with one another without worrying about what service the other user has because they are all connected. The goal is to create a way to do similar sharing of health info across networks.
What the CMS rule does:
It requires that any health plan associated with the federal government (such as Medicare, Medicaid, Medicare Advantage, health plans offered through the ACA, etc) make available a standardized API (according to the same specifications required of providers in the ONC rule). This is so that a patient can take an app and get their claims, benefits, payments, deductibles, and other data from their health plan. Requiring that health plans use the same API specification as providers would allow the patient to get all of their information – medical record and claims-related – in a single app, and manage the data according to their own needs. For example, they could focus on their diabetes. The ONC and CMS rules hope to incentivize a rich app market in health care with apps that are not tied to a patient’s provider or payer. In fact, vendors like Epic and Cerner have already set up app stores, and using the APIs that are already in place in many vendor systems, many patients can already download their medical records onto their Apple iPhone.
The name of the API specifications implemented by the majority of major EHR vendors and other technology companies, such as Apple and Microsoft, is HL7 FHIR. A voluntary private sector collaboration of technology companies and providers – called the Argonaut Project, for which I am the project manager – developed openly available guides to make the HL7 FHIR specifications easier to adopt. The rapid adoption of FHIR APIs, which are now available in 87% of hospitals and 70% of physician offices, as well as the Apple iPhone, demonstrates the power of modern internet standards and collaboration among technology vendors. The ONC and CMS rules add wind to the sails of these efforts by making FHIR-based APIs a cornerstone of interoperability.
The government has asked for public feedback on the proposed rule, what happens next?
There is a 60-day response period. Then it takes about six months for the comments to be reviewed before the rule becomes finalized. I expect this to happen before the end of 2019.
How does this all relate to OpenNotes?
The proposed rules require that providers and health plans exchange a basic amount of data, called the U.S. Core Data for Interoperability (USCDI). It defines the set of data that you have to make available among providers, health plans, and patients, and it now includes clinical notes. Previously, it focused on lab results and other structured data, but this time if providers do not make notes available as specified in the rule they can be reported and found guilty of information blocking and could be fined. This is a huge boost to the OpenNotes goal of making clinical notes accessible to all patients who want to see them. Though the current rule is still a draft, I expect the clinical notes requirement to make it to the final rule. Indeed, the Argonaut Project is just about to publish a guide to assist with the implementation of a FHIR API for clinical notes, and the ONC and CMS rules will be a great boost to adoption!