Beyond compliance with the 21st Century Cures Act Rule: a patient controlled electronic health information export application programming interface.

Objective: The 21st Century Cures Act Final Rule requires that certified electronic health records (EHRs) be able to export a patient's full set of electronic health information (EHI). This requirement becomes more powerful if EHI exports use interoperable application programming interfaces (APIs). We sought to advance the ecosystem, instantiating policy desiderata in a working reference implementation based on a consensus design.

The Patient Role in a Federal National-Scale Health Information Exchange.

The federal Trusted Exchange Framework and Common Agreement (TEFCA) aims to reduce fragmentation of patient records by expanding query-based health information exchange with nationwide connectivity for diverse purposes. TEFCA provides a common agreement and security framework allowing clinicians, and possibly insurance company staff, public health officials, and other authorized users, to query for health information about hundreds of millions of patients. TEFCA presents an opportunity to weave information exchange into the fabric of our national health information economy.

Patient-led data sharing for clinical bioinformatics research: USCDI and beyond.

The 21st Century Cures Act, passed in 2016, and the Final Rules it called for create a roadmap for enabling patient access to their electronic health information. The set of data to be made available, as determined by the Office of the National Coordinator for Health IT through the US Core Data for Interoperability expansion process, will impact the value creation of this improved data liquidity. In this commentary, we look at the potential for significant value creation from USCDI in the context of clinical bioinformatics research and advocate for the research community's involvement in the USCDI process to propel this value creation forward.

A landscape survey of planned SMART/HL7 bulk FHIR data access API implementations and tools.

The Office of National Coordinator for Health Information Technology final rule implementing the interoperability and information blocking provisions of the 21st Century Cures Act requires support for two SMART (Substitutable Medical Applications, Reusable Technologies) application programming interfaces (APIs) and instantiates Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR) as a lingua franca for health data. We sought to assess the current state and near-term plans for the SMART/HL7 Bulk FHIR Access API implementation across organizations including electronic health record vendors, cloud vendors, public health contractors, research institutions, payors, FHIR tooling developers, and other purveyors of health information technology platforms. We learned that many organizations not required through regulation to use standardized bulk data are rapidly implementing the API for a wide array of use cases.

A proposal for shoring up Federal Trade Commission protections for electronic health record-connected consumer apps under 21st Century Cures.

Under the 21st Century Cures Act and the Office of the National Coordinator for Health Information Technology (ONC) rule implementing its interoperability provisions, a patient's rights to easily request and obtain digital access to portions of their medical records are now supported by both technology and policy. Data, once directed by a patient to leave a Health Insurance Portability and Accountability Act-covered health entity and enter a consumer app, will usually fall under Federal Trade Commission oversight. Because the statutory authority of the ONC does not extend to health data protection, there is not yet regulation to specifically address privacy protections for consumer apps.

Push Button Population Health: The SMART/HL7 FHIR Bulk Data Access Application Programming Interface.

The 21st Century Cures Act requires that certified health information technology have an application programming interface (API) giving access to all data elements of a patient's electronic health record, "without special effort". In the spring of 2020, the Office of the National Coordinator of Health Information Technology (ONC) published a rule-21st Century Cures Act Interoperability, Information Blocking, and the ONC Health IT Certification Program-regulating the API requirement along with protections against information blocking. The rule specifies the SMART/HL7 FHIR Bulk Data Access API, which enables access to patient-level data across a patient population, supporting myriad use cases across healthcare, research, and public health ecosystems.

The effect of an electronic health record-based tool on abnormal pediatric blood pressure recognition.

Background: Recognition of high blood pressure (BP) in children is poor, partly due to the need to compute age-sex-height referenced percentiles. This study examined the change in abnormal BP recognition before versus after the introduction of an electronic health record (EHR) app designed to calculate BP percentiles with a training lecture.

Methods And Results: Clinical data were extracted on all ambulatory, non-urgent encounters for children 3-18 years old seen in primary care, endocrinology, cardiology, or nephrology clinics at an urban, academic hospital in the year before and the year after app introduction.

Modeling and validating HL7 FHIR profiles using semantic web Shape Expressions (ShEx).

Background: HL7 Fast Healthcare Interoperability Resources (FHIR) is an emerging open standard for the exchange of electronic healthcare information. FHIR resources are defined in a specialized modeling language. FHIR instances can currently be represented in either XML or JSON.

Opening the Duke electronic health record to apps: Implementing SMART on FHIR.

Objective: Recognizing a need for our EHR to be highly interoperable, our team at Duke Health enabled our Epic-based electronic health record to be compatible with the Boston Children's project called Substitutable Medical Apps and Reusable Technologies (SMART), which employed Health Level Seven International's (HL7) Fast Healthcare Interoperability Resources (FHIR), commonly known as SMART on FHIR.

Methods: We created a custom SMART on FHIR-compatible server infrastructure written in Node.js that served two primary functions.

SMART-on-FHIR implemented over i2b2.

We have developed an interface to serve patient data from Informatics for Integrating Biology and the Bedside (i2b2) repositories in the Fast Healthcare Interoperability Resources (FHIR) format, referred to as a SMART-on-FHIR cell. The cell serves FHIR resources on a per-patient basis, and supports the "substitutable" modular third-party applications (SMART) OAuth2 specification for authorization of client applications. It is implemented as an i2b2 server plug-in, consisting of 6 modules: authentication, REST, i2b2-to-FHIR converter, resource enrichment, query engine, and cache.

SMART precision cancer medicine: a FHIR-based app to provide genomic information at the point of care.

Background: Precision cancer medicine (PCM) will require ready access to genomic data within the clinical workflow and tools to assist clinical interpretation and enable decisions. Since most electronic health record (EHR) systems do not yet provide such functionality, we developed an EHR-agnostic, clinico-genomic mobile app to demonstrate several features that will be needed for point-of-care conversations.

Methods: Our prototype, called Substitutable Medical Applications and Reusable Technology (SMART)® PCM, visualizes genomic information in real time, comparing a patient's diagnosis-specific somatic gene mutations detected by PCR-based hotspot testing to a population-level set of comparable data.

SMART on FHIR: a standards-based, interoperable apps platform for electronic health records.

Objective: In early 2010, Harvard Medical School and Boston Children's Hospital began an interoperability project with the distinctive goal of developing a platform to enable medical applications to be written once and run unmodified across different healthcare IT systems. The project was called Substitutable Medical Applications and Reusable Technologies (SMART).

Methods: We adopted contemporary web standards for application programming interface transport, authorization, and user interface, and standard medical terminologies for coded data.

Driving Innovation in Health Systems through an Apps-Based Information Economy.

Healthcare data will soon be accessible using standard, open software interfaces. Here, we describe how these interfaces could lead to improved healthcare by facilitating the development of software applications (apps) that can be shared across physicians, health care organizations, translational researchers, and patients. We provide recommendations for next steps and resources for the myriad stakeholders.

Are Meaningful Use Stage 2 certified EHRs ready for interoperability? Findings from the SMART C-CDA Collaborative.

Background And Objective: Upgrades to electronic health record (EHR) systems scheduled to be introduced in the USA in 2014 will advance document interoperability between care providers. Specifically, the second stage of the federal incentive program for EHR adoption, known as Meaningful Use, requires use of the Consolidated Clinical Document Architecture (C-CDA) for document exchange. In an effort to examine and improve C-CDA based exchange, the SMART (Substitutable Medical Applications and Reusable Technology) C-CDA Collaborative brought together a group of certified EHR and other health information technology vendors.

The SMART Platform: early experience enabling substitutable applications for electronic health records.

Objective: The Substitutable Medical Applications, Reusable Technologies (SMART) Platforms project seeks to develop a health information technology platform with substitutable applications (apps) constructed around core services. The authors believe this is a promising approach to driving down healthcare costs, supporting standards evolution, accommodating differences in care workflow, fostering competition in the market, and accelerating innovation.

Materials And Methods: The Office of the National Coordinator for Health Information Technology, through the Strategic Health IT Advanced Research Projects (SHARP) Program, funds the project.