U.S. Department of Health and Human Services announced the long-awaited final rules on information-blocking and interoperability

March 9, 2020

This morning, the U.S. Department of Health and Human Services Secretary Alex Azar, National Coordinator of Health IT Don Rucker, Centers for Medicare and Medicaid Services Administrator Seema Verma, and Matthew Lira from the White House Office of American Innovation jointly announced the long-awaited final rules on information-blocking and interoperability, part of a national strategy to transform medicine into a data-driven enterprise. The new rule from the Office of the National Coordinator for Health Information Technology (ONC) promotes nationwide secure, standardized, and interoperable health information technology, as called for under the 21st Century Cures Act.  

Over a decade has passed since the 2009 New England Journal of Medicine article, in which researchers at the Boston Children’s Hospital Computational Health Informatics Program introduced the idea of an application programming interface (API) to promote an apps-based health information economy and an “app store” model for health.

The ONC granted funds for the development of the SMART on FHIR API in 2010. Now, ten years later, the SMART on FHIR API is universally required so that an app written once can run anywhere in the healthcare system, and gain access to all of the elements of a patient’s electronic data, without special effort.

The Final Rule from the ONC supports seamless and secure access, exchange, and use of electronic health information, requiring standardized APIs to enable patients to securely access computable copies of their health records via smartphones.

The Final Rule also requires, for certified HIT, SMART/HL7 Bulk Data Export/Flat FHIR API, which will enable ready and secure access to population level data sets from electronic health records. Boston Children’s Hospital worked with HL7 to enable push-button population health, which should make it turnkey to extract data from EHR systems. Streamlined aggregation and analysis of data at a population level will lead to improved population health management, value-based care delivery, and opportunities for discovery science.

New Report Available: Push Button Health: Advancing SMART/HL7 Bulk Data Export/FLAT FHIR

The universal health data application programming interfaces called for in the 21st Century Cures Act present an opportunity to create the learning healthcare system that has been long envisioned. A learning healthcare system must be able to do more than conduct individual queries on one patient; it requires the ability to aggregate and analyze data at a population level. Activities such as managing population health, delivering value-based care, and conducting discovery science requires access to large population data sets. Population level data combined with new technologies such as machine learning and AI has extraordinary potential to improve the health and lives of Americans.

To address this need, the SMART team and HL7 have jointly developed the SMART/HL7 Bulk Data/Flat FHIR standard and associated tools.

Building on the momentum our 2017 Population Level Data Export / FLAT FHIR Meeting, the Office of the National Coordinator for Health Information Technology asked the Computational Health Informatics Program (CHIP) and SMART Health IT team to host a second meeting to measure interval progress on use and uptake of the SMART/HL7 Bulk Data/Flat FHIR standard and tools, understand where the rough edges are, explore federal use cases, and drive toward effective regulation.

The 2019 SMART Flat FHIR / Bulk Data meeting was held on November 6th at the Harvard Medical School Countway Library. Sixty stakeholders from across the healthcare ecosystem gathered to talk about bulk data use cases and experience, and plan next steps for the standard and its use. 

Key Takeaways:

  • Demand for standardized bulk data export in the Flat FHIR format is growing rapidly. 
    • Within eight months of the 2017 meeting, the Centers for Medicare and Medicaid Services (CMS) were already using the standard in pilots to provision data to ACOs. 
    • An astounding 105,000 providers have requested access to Flat FHIR data via the CMS Data at Point of Care Project.
  • The substantial efforts, via the Argonaut project, to implement the SMART on FHIR API advances us significantly toward implementing the bulk data API at scale. Notably, the Argonaut process was one year long and can serve as a yardstick for the length of time required for implementation of bulk data capabilities. 
  • More than 20 health systems and health plans have committed to move the HL7 balloted standard into real-world testing. 
  • The community has access to a suite of free and open-source products to facilitate FHIR bulk data implementation, including the SMART reference implementation, SMART sample client, and the SMART bulk data testing tool to verify server compliance. 

An early release of the detailed report is now available Here

Push Button Population Health Data: Extending the HL7 FHIR Standard to Support Bulk Data Export

Activities such as managing population health, delivering value-based care, and conducting discovery science require access to large population data sets. The existing FHIR and SMART APIs work well for accessing small amounts of data, but large exports perform poorly, requiring an impractical number of API requests to be issued serially. By adding asynchronous primitives to FHIR and defining an export operation, the Bulk Data API enables secure integration of third-party, externally-hosted applications into diverse EHR and data warehouse environments.

On behalf of the ONC, The Boston Children’s Hospital Computational Health Informatics Program and SMART hosted a meeting in December 2017 to discuss standardizing bulk data exports from EHR systems and data warehouse environments. This meeting brought together key stakeholders from across health care, including the Director of the Office of the National Coordinator for Health Information Technology (ONC) and other members of the ONC staff, as well as representatives from payers, health systems, EHR vendors, and other health technology innovators.

A summary report is now available:

Also, get involved in the ongoing, early stage, FHIR Bulk Data API Project by reviewing the draft specification and joining the discussion group!

New Report On Connected Apps in Healthcare

In an evaluation developed in partnership with SMART and funded by the Office of the National Coordinator for Health Information Technology (ONC), KLAS Research spoke with clinical leaders at nearly 50 healthcare organizations about how they select and use clinical apps today, what they would like to see in the future, and the concerns they have around adopting apps.

Findings include:

  • Around half of the healthcare organizations interviewed use apps at the point-of-care.
  • Looking forward, many providers are interested in purchasing or developing apps around patient engagement, followed by EHR data visualization, diagnostic tools and decision support tools.
  • Usability is the most important factor healthcare organizations consider when purchasing an app, followed by cost, clinical impact and integration with existing systems.
  • Pilot programs and demos represent providers preferred way to evaluate apps, with peer recommendations, web content and video demonstrations also being popular.
  • Privacy and security is by far the biggest concern around adopting apps, although app credibility, concerns regarding ongoing maintenance, and the need for integration with existing systems are also high on the list.

The role of apps in healthcare is growing, with many organizations looking to third-party vendors to supply niche solutions that improve patient care and organizational efficiency.

Increasing adoption of the SMART and FHIR application programming interfaces (APIs) by EHR vendors and health systems is streamlining the process of connecting these apps to clinical systems, and strong regulatory support requiring APIs in certified health IT is expected to continue driving this trend. With app discovery tools, such as the SMART App Gallery, making it easier for healthcare providers to find and evaluate apps, there is a bright future for connected apps in healthcare.

View the full report, “Connected Apps in Healthcare 2017: A Look at Trends and Provider Attitudes in a Growing Market”

21st Century Cures Act makes APIs in EHRs the law


One aim of the 21st Century Cures Act recently passed by Congress is to make digital health data more accessible, emphasizing the use of APIs in healthcare to increase EHR interoperability and improve patient records matching. Aligning closely with the SMART Health IT focus on creating a app ecosystem for healthcare, the act states that a year from now, open APIs will be necessary for EHR system certification.

“… that the entity has in place data sharing programs or capabilities based on common data elements through such mechanisms as application programming interfaces without the requirement for vendor-specific interfaces;

[…] publish application programming interfaces and associated documentation, with respect to health information within such records, for search and indexing, semantic harmonization and vocabulary translation, and user interface applications; and

[…] demonstrate to the satisfaction of the Secretary that health information from such records are able to be exchanged, accessed, and used through the use of application programming interfaces without special effort, as authorized under applicable law.”

Read the full document at 21st Century Cures Act