Achieving the Interoperability Promise of 21st Century Cures

Don Rucker M.D. | June 19, 2018

Over the past decade, hospitals and physician offices have made tremendous gains in shifting their record-keeping from paper to computerized systems. This transition to electronic health records (EHRs) has engendered frustration among clinicians who expected computers to make their care more efficient, and among their patients who expected timely access to their information and seamlessly coordinated care.

To address these challenges, a bipartisan majority of Congress passed the 21st Century Cures Act of 2016 (Cures Act). In part, the law requires the US Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC) to improve the interoperability of health information. These efforts are foundational for HHS Secretary Alex Azar’s priority of building a health system that delivers value, for which he has identified maximizing the promise of health information technology (health IT) as a key area of emphasis. Implementing these provisions are central to the Trump administration-wide MyHealthEData Initiative.

Over the next few years, ONC will continue to work with stakeholders and federal agencies to implement key provisions of the Cures Act. Specifically:

  • ONC will engage in rulemaking to drive patient, clinician, and payer access to clinical data by advancing proposals related to application programming interfaces (APIs).
  • Rulemaking will also identify behaviors not considered information blocking which will assist the HHS Office of Inspector General (OIG) in their enforcement of Cures Act’s provisions that prohibit information blocking.
  • We will advance a Trusted Exchange Framework and Common Agreement to improve data sharing across disparate health information networks.
  • Additionally, we will develop a strategy with the Centers for Medicare & Medicaid Services (CMS) to reduce administrative and reporting burden among clinicians.

Our guiding principle is to make policy choices that will give consumers, clinicians, and innovators more options for getting to and using health information.

Open APIs “Without Special Effort”

Our primary focus is to accelerate individuals’ ability to access and send their health information via their smartphones or other electronic devices, so they can shop for and coordinate care. This is an important piece of delivering value throughout our health care system: As Secretary Azar has said, “To bring down costs and increase quality, we have to put patients in charge of their own data.”

The Cures Act builds on the 2015 Edition of ONC’s health IT certification criteria by calling for the development of modern APIs that do not require “special effort” to access and use. APIs are technology that allow one software program to access the services provided by another software program. As I described in a prior blog post, APIs need to be standardized, transparent, and pro-competitive. Open and accessible APIs have transformed many industries. We think they can transform health care as well.

Now a word about the technology that finally makes this transformation possible. The modern internet app economy thrives on an open API software environment. Part of the health care API evolution is incorporating many of the current protocols from leading standards development organizations with the newer FHIR (Fast Healthcare Interoperability Resources) web developer-friendly way of representing clinical data.

ONC also supports the ongoing work to extend this open API technology to population-level data transfer. (This ability to query for more than one patient at a time goes by a number of names including population-level data transfer, flat FHIR, and batch data transfer.) Currently, we work off a narrow worldview of interoperability where the task is to move one patient’s medical record from one doctor or hospital to another. Central to a value-based health system is expanding the ability to find and move data for more than one patient at a time. Modern networks should offer a vastly richer set of data movements and activities.

In addition, payers cannot effectively represent their members if they lack computational visibility into which providers offer the highest quality care at the lowest cost. Today, payers and employers who purchase care have little information on health outcomes. Often times, contracts between providers and payers are negotiated on reputation of the provider rather than on quality care. Providers should compete on the entire scope of the quality and value of care they provide, not on how exclusively they can craft their networks. Outcome data will allow payers to apply machine learning and artificial intelligence to have better insight on the value of the care they purchase. Population-level data transfer that is aligned with HIPAA is also central to having a learning health care system, advancing many research priorities and use cases, and modernizing public health reporting.

Trusted Exchange Framework And Common Agreement

There are more than 100 regional health information exchanges and multiple national level organizations that support exchange of health information. While these organizations expanded the flow of health information within their particular communities and spheres, there is still limited connectivity across networks due to variations in the participation agreements that govern exchange. This limits the health information to which a patient, provider, or health system has access, unless they join multiple networks or build multiple, costly, and burdensome point-to-point interfaces.

The Cures Act calls on ONC to develop or support a trusted exchange framework and common agreement to address policies and practices between health information networks. The final Trusted Exchange Framework will set common principles, terms, and conditions that facilitate trust between disparate health information networks. It will seek to scale interoperability nationwide and enable participating networks to work together to provide an on-ramp to electronic health information regardless of what health IT developer a provider uses, health information exchange or network a provider contracts with, or how far across the country the patients’ medical records are located. This means patients who have received care from multiple doctors and hospitals should have their medical history electronically accessible on demand by any other treating provider in a network that signed the Common Agreement.

 

On January 5, 2018, ONC released the draft Trusted Exchange Frameworkfor comment. We are incredibly grateful for the public’s interest and the more than 200 comments that were submitted. Our team has been carefully reviewing all of the comments to ensure we understand concerns and suggestions and expect to update the next version of the Trusted Exchange Framework to reflect that feedback.

Information Blocking

All of our efforts under the Cures Act will be for naught if we do not recognize and confront certain anti-competitive practices that impact the access and exchange of electronic health information. Health care providers and technology developers may have powerful economic incentives not to share electronic health information and to slow progress towards greater data liquidity. The nature and extent of these practices have come into sharp focus in recent years. In a 2015 report to Congress, ONC reported that the state of health IT—combined with the structure and conditions of health care markets—creates powerful incentives for some actors to pursue and exercise control over information in ways that significantly limit its availability and use.

Our experience since then—as well as a growing body of economic and empirical research—confirms those findings and underscores the severity and intractability of the information blocking problem. The Cures Act confronts information blocking by providing a comprehensive response to these concerns. The information blocking provision addresses actions that can impede the flow of electronic health information, or its use to improve health and the delivery of care. The prohibition against information blocking applies to health care providers, health IT developers, exchanges, and networks. Further, the Cures Act permits the establishment of disincentives and the imposition of substantial penalties for information blocking.

To ensure that practices that are innocuous, or even beneficial, do not implicate the information blocking provision, the Cures Act charges the Secretary with identifying reasonable and necessary activities that do not constitute information blocking. ONC has met with patients and patient advocates, providers, technology developers, and other stakeholders to understand their experiences and perspectives on information blocking. We will use our understanding of the day-to-day impact of the information blocking problem as part of our rulemaking around practices that should not be considered information blocking.

Looking Ahead

These collective steps to promote interoperability will help make sure that patients can get their data where and when they need it and in the most usable format. We need to reinject market competition to get economic value from modern health care. Greater and more efficient access to clinical data by patients and payers will be a valuable tool in restoring transparency to the American health care business and system.

Greater and more efficient access to clinical data by patients and payers will be a valuable tool in restoring transparency to the American health care business and system.

To achieve these goals, we need all stakeholders to get involved and provide input during our public comment periods. In the coming months, ONC will issue a Request for Information to solicit public input on reporting criteria for an EHR Reporting Program, which will inform the work of an upcoming stakeholder convening. The EHR Reporting Program, required by Cures, will provide publicly available, comparative information about certified health IT products. This fall, HHS plans to release for public comment a draft strategy to reduce provider burden. We will also issue a notice of proposed rulemaking to update the ONC Health IT Certification Program and implement certain provisions of the Cures Act. As a part of our coordination role in the Executive Branch, we will continue to collaborate with CMS and other federal agencies to promote interoperability throughout the health care system.

We look forward to hearing from you as we take these important steps on the nation’s path to the interoperability of electronic health information. Together, we can accelerate information flow and better capture the benefits of modern computing for health care.

This post is also available at the Health Affairs Blog.