News

SMART Health IT Comments on CMS National Directory of Healthcare Providers and Services RFI

By DAN GOTTLIEB, MPA, JOSHUA MANDEL, MD, and KENNETH D. MANDL, MD, MPH

November 29, 2022

We applaud CMS’s vision for expanding availability and improving accuracy of healthcare directory information while reducing the provider burden associated with keeping directory listings up to date.

There is an opportunity to build on the existing, widely used, National Provider Plan and Enumeration System (NPPES) directory infrastructure to incrementally address these challenges. Crucially, improvements in incentives, user experience, and federation are needed to unlock the full potential of NPPES.

Overview. We propose that rather than developing a new centralized directory, enhanced NPPES listings could serve as a “primary key” for healthcare directory information, maintaining the unique id used to tie together data from multiple organizations and storing links to flat files in FHIR format with additional, frequently-updated, information maintained by payor and provider organizations (e.g., details about services, hours, plan participation, and facilities). The term “API” sometimes refers to fine-grained interfaces (e.g., supporting queries like “at which locations does Dr. Smith practice,” or “What time is Dr. Smith’s clinic open next Tuesday”), but we believe a simpler API might be a better starting point — beginning with the ability to host a set of “flat files” at a well-known URL. Hosting flat files that are updated on a frequent basis would satisfy many consumption use cases. Leveraging SMART/HL7 FHIR Bulk Data standards would take advantage of tools and infrastructure designed for working with FHIR data. Third-party aggregators could use the data in NPPES and the referenced flat files to create applications targeted at specific use cases (e.g., a user-friendly, patient-facing application for people to find new healthcare providers).

Incentives. The RFI notes that provider data in the NPPES directory is frequently inaccurate. Without strong incentives for providers to keep the data up to date, technology changes are unlikely to improve data quality. One approach to addressing this challenge would be attestation requirements, such as mandating that providers participating in CMS payment programs periodically attest to the accuracy of their information in the NPPES directory. Additionally, the more the NPPES data are actively used in CMS operations, the more likely providers are to keep it up to date, suggesting another avenue for incentives. For example, the contact information in the directory could be used for all communications around provider payment, necessitating up-to-date information and ongoing engagement with the system.

Improving User Experience. Anecdotally, we’ve heard from users that updating their information on the NPPES website can be cumbersome, particularly when managing listings for multiple providers. It seems common for organizations to be listed multiple times in NPPES, perhaps because creating a new entry is easier than gaining administrative control over a previous entry. CMS should launch a user centered design effort to understand how the site is being used and redesign it to better accommodate common use cases. For example, a simplified interface may be useful for solo practitioners, functionality to create or update listing by uploading a spreadsheet may be beneficial for users at mid-sized organizations, and the ability to integrate through an API may be preferred by users at large institutions.

Federation (hub and spoke). While a single repository for all healthcare directory data is an attractive notion, it would be costly to build and maintain, and would also risk a single point of failure for a system that has high uptime requirements. Furthermore, a single directory with multiple constituencies, varied data granularity, and a range of update frequencies for different data elements introduces substantial complexity in the data model. In a hub-and-spoke federated model, core metadata would be centrally hosted by NPPES while auxiliary information such as a provider’s hours at an institution and whether they are accepting new patients would be maintained in a file directly on the relevant organization’s website, and easily updated when the data changes. To aggregate this data, consuming systems would follow URLs to the files from the NPPES directory. Similarly, payer organizations could publish files listing plan information and participating providers, and the locations of the payer files could be published in a new section of the NPPES directory. By using providers’ NPPES ids to join the data in these files with those on provider sites, third parties can build up comprehensive databases to power specific apps without the need for novel, centrally maintained infrastructure. A similar approach has been successfully adopted with the SMART Scheduling Links project; working with the US Digital Service, participants enabled distributed discovery of COVID-19 immunization appointments across major pharmacies and healthcare providers (https://github.com/smart-on-fhir/smart-scheduling-links).

RFI: https://www.federalregister.gov/documents/2022/10/07/2022-21904/request-for-information-national-directory-of-healthcare-providers-and-services

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

Patient Controlled Health Data: Balancing Regulated Protections with Patient Autonomy

By KENNETH D. MANDL, MD, MPH, DAN GOTTLIEB, MPA, and JOSHUA MANDEL, MD

September 3, 2019

Cross Posted on The Health Care Blog

A patient can, under the Health Insurance Portability and Accountability Act (HIPAA), request a copy of her medical records in a “form and format” of her choice “if it is readily producible.” However, patient advocates have long complained about a process which is onerous, inefficient, at times expensive, and almost always on paper. The patient-driven healthcare movement advocates for turnkey electronic provisioning of medical record data to improve care and accelerate cures.

There is recent progress. The 21st Century Cures Act requires that certified health information technology provide access to all data elements of a patient’s record, via published digital connection points, known as application programming interfaces (APIs), that enable healthcare information “to be accessed, exchanged, and used without special effort.”  The Office of the National Coordinator of Health Information Technology (ONC) has proposed a rule that will facilitate a standard way for any patient to connect an app of her choice to her provider’s electronic health record (EHR).  With these easily added or deleted (“substitutable”) apps, she should be able to obtain a copy of her data, share it with health care providers and apps that help her make decisions and navigate her care journeys, or contribute data to research. Because the rule mandates the ”SMART on FHIR” API (an open standard for launching apps now part of the Fast Healthcare Interoperability Resources ANSI Standard), these apps will run anywhere in the health system.

Apple recently advanced an apps-based information economy, by connecting its native “Health app” via SMART on FHIR, to hundreds of health systems, so patients can download copies of their data to their iPhones. The impending rule will no doubt spark the development of a substantial number of additional apps.

Policymakers are grappling with concerns that data crossing the API and leaving a HIPAA covered entity are no longer governed by HIPAA. Instead, consumer apps and the data therein fall under oversight of the Federal Trade Commission (FTC). When a patient obtains her data via an app, she will likely have agreed to the terms and the privacy policy for that app, or at least clicked through an agreement no matter how lengthy or opaque the language.  For commercial apps in particular, these are often poorly protective. As with consumer behavior in the non-healthcare apps and services marketplace, we expect that many patients will broadly share their data with apps, unwittingly giving up control over the uses of those data by third parties.

Some patients may wish to explore the nascent emerging marketplace offering options to monetize their data. “Information altruists” and self-assembling patient groups will donate data to speed social and direct benefit through innovation and research. Notably, the monetary value of an individual record is generally low, with exceptions for patients having rare or complex conditions and histories.

How do we support a patient’s autonomy to use tools of her choice to improve her health and contribute to research, provide her with options to share in the monetary value from downstream uses of her data, while also protecting her from predatory practices?

HIPAA does not adequately address the issue. While it does allow an app developer to become a business associate of a covered entity (such as a provider or healthcare institution) this arrangement only applies when an app is managing health information on behalf of the covered entity — whereas in a consumer-centric ecosystem, many apps will choose to have a relationship with a consumer directly.  Importantly, the covered entity itself may be a conflicted party when the patient wishes to use an app that either (1) shares data with a competing health care provider or (2) competes with the functionality of the entity’s EHR. These conflicts could limit data flow across institutions, and raise the barrier to entry for new, innovative apps.

Further, the HIPAA business associate framework does not prevent commercial use of patient’s data without consent. Patient data in de-identified format are already shared widely in healthcare on hundreds of millions of patients, generally in ways that are opaque and not reported to the patients whose data have oft times been aggregated sold, and used for profit, and sometimes in ways that enable downstream re-identification.

A federal taskforce recognized that enabling patient autonomy to share data comes with inherent risk, and largely left these trade-offs in the patient’s hands. We propose strengthening the federal role in protecting health data under patient-mediated data exchange, while maintaining patient choice.

  • Require the EHR, upon exposing data across the API to a patient, to provide a standardized summary, at a sixth-grade reading level, of an app’s privacy policy and terms of service, highlighting risks for consumers (such as the ONC model privacy notice), and summarizing with an indication of whether they meet some specific bar (such as the CARIN code of conduct or a professional society or patient organization endorsement).
  • Establish best practices and federal standards for privacy policies and terms and conditions, relying on user-centered design as in large-scale federally funded research studies. Consider multimedia and semi-structured questionnaires (quizzes) to promote and confirm comprehension. Methods used to de-identify or aggregate data and their re-identification risk should be transparent, as should be intentions to commercialize the data.
  • Define a robust auditing process with oversight authority by either the Department of Health and Human Office for Civil Rights (OCR) or the FTC regardless of how the data are obtained.
  • Define penalties for violation of the terms of service and demonstrate strong and public federal enforcement.
  • Develop a consumer hotline and website for complaints to the OCR or the FTC, and publicize those complaints.
  • Introduce legislation to protect patients from predatory uses of their health data. Consider as model the Genetic Information Nondiscrimination Act of 2008, which prevents discrimination on the basis of genetic information in both health insurance and employment.

There are promising approaches available to protect a patient’s health data without limiting choice or creating a bottleneck to innovation by new and smaller entrants into the Health IT ecosystem. Now is the time to consider these carefully.

Kenneth D. Mandl, MD, MPH is director of the Computational Health Informatics Program at Boston Children’s Hospital and the Donald A.B. Lindberg Professor of Pediatrics and Professor of Biomedical Informatics at Harvard Medical School. He can be found on Twitter @mandl

Dan Gottlieb, MPAis a clinical informaticist and software consultant working with the Harvard Medical School Department of Biomedical Informatics and Boston Children’s Hospital Computational Health Informatics Program on tools to empower patients and researchers. He can be found on Twitter @gotdan

Joshua C. Mandel, MDis a physician and software developer working to fuel an ecosystem of health apps with access to clinical and research data. He can be found on Twitter @joshcmandel

Comments on the 21st Century Cures Act Proposed Interoperability Rule

May 20, 2019

Dear SMART Community:

10 years ago, the SMART project launched with a New England Journal of Medicine article proposing that EHRs could serve as a platform with a universal API supporting substitutable apps. Now, the 21st Century Cures Act requires the very API we envisioned and the draft rule, by the Office of the National Coordinator of Health Information Technology, following from Cures, is open for public comment.

The rule specifies that the SMART on FHIR API will be 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.

Getting the details right could not be more important to realizing a future healthcare system underpinned by a robust health information economy, driven by apps and real world information.

We post a copy of our public comment here.

The input is from our perspective as founders and members of the SMART on FHIR team that developed the SMART API, defined with HL7 and ONC the Bulk Data Export API specification, and launched the CDS Hooks project.

For our final version we have integrated several insightful edits and suggestions from the community.

Thank you for engaging with us on this.

Ken Mandl


Public comments on the Proposed Rule for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program 

Dan Gottlieb, Josh Mandel, Kenneth Mandl

@gotdan @joshcmandel @mandl

Overview. Our first and overarching comment is that the ONC’s drafting of this rule reflects clear thought, responsiveness to the community, attention to detail, and tremendous skill in expressing critical desiderata for a robust health IT ecosystem. The product of these efforts, the Proposed Rule, is extraordinarily impressive to us. The Rule addresses and reinforces virtually all of the major underpinnings which are currently feasible and needed to produce an interoperable apps-based ecosystem.

We state clearly and emphatically that the Rule should be largely left intact in its spirit and in most of its details.

Priority Goals

1. Improve App Connectivity for Patients and Providers

Connectivity. We cannot overemphasize the importance of standardizing the capability for a SMART on FHIR app written one time, to run unmodified anywhere in the healthcare system, regardless of the EHR or database vendor or version, accessing all of a patient’s electronic health data.  The app should be substitutable–easily added to or deleted from an EHR or related database, as easily as apps are added to iPhones and Android mobile devices.  The ONC has taken an enormous step forward with the certification requirement for the SMART application launch framework with the declaration of FHIR as a foundational standard, constrained by the Argonaut- or US Core-defined profiles. 

Weakening of any of the API requirements or information blocking provisions would potentially interfere with this objective.

Affordability. A patient’s access to all elements of her electronic medical record, across the SMART API, without cost, is well-supported in the Rule. The power of the provision is illustrated by the ease and speed with which Apple connected its Health App to more than 500 health systems across the SMART API, enabling patients at those institutions to download their data to iPhones for subsequent use in iOS apps. Under the Proposed Rule, any other app can connect to the same systems across the same SMART API.

Equally important, however, is that when a data provider (e.g., a practice or a healthcare system) also acts as an API user, they must be able to connect any app of their choice to their EHR. This ability is well-supported in the Rule, including important guardrails around what an API Technology Supplier can charge for cost recovery and on a per API call basis. It is essential that the proposed fee structures are such that providers can afford to connect third-party applications to their EHRs via APIs, opening up the interoperability that is a core property of any modern software system. There is a risk that the economics of paying for API calls to enable API Technology Supplier cost recovery will be limiting.

In an API/Apps model, the EHR and related IT serve as a platform for multi-sided business. It will take some time to understand and support the economics underpinning a nascent apps-based economy. Getting it right will strongly promote American business innovation, job creation and improved infrastructure to deliver value-based healthcare.

Evaluation. We recommend two evaluations. One concerns the real-world costs of APIs being used by health systems. The other concerns the actual patient experience of successfully obtaining their own electronic health information from specific providers.

With regard to the costs of APIs, we understand that ONC may be pursuing the cost-based pricing program out of necessity, but not that API Technology Supplier will not have an incentive to drive down their own costs. Additionally, current levels of revenue for API providers are not necessarily maintainable for a health system seeking value and growth in the diversity of app developers. API pricing structures should ideally level the playing field between first-party EHR functionality and third-party app functionality for a modular, extensible IT infrastructure.

Therefore, we propose that within six to twelve months after the implementation of the information blocking provisions of the Rule, ONC conduct a study to evaluate the real-world cost of APIs being used by health systems for areas such as clinical decision support, payments, machine learning, and precision medicine, and use the results to drive future policy. Benchmarking these costs will be difficult, but potentially useful metrics could include:

  • Comparing the cost of accessing data via APIs to that of accessing the same data with traditional EHR front end interfaces by amortized EHR licensing costs and adjusting for expected use. 
  • Comparing the cost of accessing data via EHR APIs to that of similar APIs, including those from cloud providers such as Microsoft Azure API for FHIR[1] or Google Cloud for Healthcare[2] and those provided as part of software solutions in other industries.
  • Examining the business models being used. For example, are API providers charging for system upgrades only, or are there substantial ongoing fees that limit app usage?

With regard to evaluating patient access, consumers continue to express tremendous variability in the ability and ease of gaining access to their own data. We therefore further propose that within twelve months after the API provisions of the Rule take effect, ONC conduct a study on patient access to their medical records, across the SMART on FHIR API without special effort.

2. Embrace Community Driven API Standards

Population API Access. We are extremely pleased to see that the Rule supports Population API Access (including https://www.federalregister.gov/d/2019-02224/p-447 and https://www.federalregister.gov/d/2019-02224/p-837). This requirement should specifically mandate the use of the FHIR Bulk Data Access Standard for all USCDI elements, including $export operations at the population level and including SMART Backend Services for authorizations. These specifications are currently being standardized through HL7 (http://hl7.org/fhir/us/bulkdata/ ).

Provide API Access for Data Exports. On the subject of full EHI access, we are concerned about the gap between the Proposed Rule for EHI Export and the regulatory intent of the 21st Century Cures Act to achieve interoperability with APIs that provide “access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws.” In ONC’s proposal for certified API access, “all data elements” has been interpreted to mean “a limited set of data elements.” While not all data have been standardized, ONC should still include a functional requirement that the EHI Export capabilities must be available through a documented (if potentially vendor-specific) API, and accessible to patients. Specifically, to provide a usable consumer experience, the EHI Export capability must be:

  • Accessible directly to a patient (or authorized representative), rather than (or in addition to) being built as a feature for clinic staff. This is to ensure that patients don’t need to make a request by, e.g., phoning the medical records department, and waiting while the departmental staff hits the “export” button in response to a request — a friction-laden process.
  • Exposed end-to-end through an API, rather than being implemented exclusively as a button hidden deep within a patient portal experience, or being crippled by the exchange of physical media like CD-ROMs. This is critical because:
  • Portal experiences vary, making features difficult to find and correctly describe (e.g., if a third party is trying to guide patients toward the export functionality in a variety of portals). This was a clear challenge for anyone trying to identify the “Transmit to a third party” features of a patient portal in the MU2 timeframe.
  • Managing physical media, e.g., CDs, would take access outside the realm of modern, convenient consumer experiences, and would violate the without special effort requirement.
  • Managing files may be challenging on many patient devices (e.g., mobile phones), and some files may be best suited for off-device storage (e.g., in the cloud).

Our key recommendation on EHI Export is that ONC should require certified EHRs to support full EHI export at the patient level via patient-accessible API, and at the population level via data-provider-accessible API, even without standardizing the API or the data payloads. This will meet the Cures intent for API access.

API connectivity will provide patients with a seamless experience for accessing all of their health data, not just a core data set, and will ensure that healthcare providers can connect apps to data that is not currently available through the USCDI dataset. Providing access through open APIs, even for data that are not structured in open formats, will further this goal.

We have heard concerns about the overall scope of EHI access in a variety of exceptional circumstances (e.g., for data not stored in the EHR itself, or for data that represent purely internal system implementation details). As a baseline, we recommend that the data to be included in EHI Export should encompass the complete set of information that an EHR vendor currently makes available through their widely adopted data warehouse products, through their user interfaces, or through their reporting infrastructure.

SMART on FHIR.  The Rule should Specify which SMART on FHIR capabilities an API provider will need to support, at a minimum. The Proposed Rule requires mandatory support for “refresh tokens,” “Standalone Launch,” and “EHR Launch” requirements. However, to ensure consistent implementation the Rule should also specify mandatory support for the following ten SMART capabilities: sso-openid-connect, launch-standalone, launch-ehr, client-public, client-confidential-symmetric, context-ehr-patient, context-standalone-patient, permission-patient, permission-user, permission-offline.

USCDI. The USCDI is a strong successor to the Common Clinical Dataset. To cover an expanded set of app use cases, we recommend the addition of data elements that cover clinical encounters and clinical imaging metadata.

In addition to considering data elements for read API access, ONC should look ahead to a future-state USCDI definition that includes some write API requirements, as well. Each element of the USCDI should include a list of required operations; today, these would all be “read access,” but this would provide a clear placeholder for future expansion of functionality (rather than just a list of data elements).

FHIR R4. The need to support multiple versions of standards can hinder interoperability.  ONC should adopt FHIR R4 as the only allowed version for standard API access moving forward, with an advancement process as described in the Proposed Rule.

Backend Services Access. To ensure that API Data Providers have the flexibility to innovate on top of the APIs provided by API Technology Suppliers, ONC should introduce a condition of certification ensuring that API Data Providers can obtain automated system-level access to all API calls from the API servers offered by API Technology Suppliers (e.g., via the SMART Backend Services authorization guide), with “system/*.*” scopes. This condition would enable API Data Providers to create additional services (e.g., API proxy or gateway functionality) on top of the APIs offered by API Technology Suppliers — an important “escape valve” for introducing new functionality or policies on top of existing data services.

Token Introspection. Again, to ensure that API Data Providers have the flexibility to innovate on top of the APIs provided by API Technology Suppliers, ONC should introduce a condition of certification ensuring that API Data Providers can perform token introspection using services enabled by API Technology Suppliers. This will ensure that additional resource servers (e.g., PACS systems that might expose FHIR imaging resources) can work with the same access tokens and authorization policies as the resource servers built directly by API Technology Suppliers.

ARCH. The ONC proposes the “API Resource Collection in Health” (ARCH) Version 1 implementation specification in § 170.215(a)(2), which would list a set of base FHIR resources that Health IT Modules certified to the proposed API criterion (§ 170.315(g)(10)) would need to support. While we see value in providing a catalog, we strongly recommend that ONC populate it using community-developed standards by groups like Argonaut and HL7, who can take functional requirements from USCDI versions, and produce Implementation guides. If ONC maintains an ARCH definition, this definition should be limited to referencing implementation guidance from community-developed processes; ONC should not “get out ahead” of the community process. For example, the ARCH should not make unilateral determinations about which FHIR resource or data elements are needed to meet a given USCDI requirement. Instead, that determination should be made through a community-driven, iterative process with real world testing of use cases.

Immature Standards. The vast majority of referenced standards in the Rule are mature, in real world use, and widely embraced by the community.  Two standards, however, strike us as “not ready for prime time:” Data segmentation for privacy (DS4P) and Consent2Share. While we recognize privacy maintenance and consenting as essential functions in health care, we are very concerned that a premature push for adoption of these immature standards would have unintended negative effects. ONC should omit these from the certification criteria (including voluntary certification) and focus on driving real-world implementation experience before pursuing regulations.

3. Move Beyond EHR Data

Clinical Imaging. We are concerned that sharing of images, an essential data type for patient care, may slip through the cracks. EHR systems often contain metadata around the available imaging studies, however, the imaging studies themselves are frequently stored in separate systems known as picture archiving and communication system (PACS). Providers should be responsible for sharing this imaging data, regardless of the technology supplier they choose. We recommend making PACS vendors subject to EHR certification rules, specifically for API access requirements.

Laboratory Data. While some clinical laboratory result data are accessible to patients through EHR APIs, historical data may not be comprehensive. Recently, national laboratory companies have begun to make these data available through API access for select apps. To promote a robust ecosystem of clinical applications, guidance should be provided on how this access should be expanded to an open ecosystem of apps to comply with the information blocking restrictions in the Rule.


[1]
https://azure.microsoft.com/is-is/pricing/details/azure-api-for-fhir/

[2] https://cloud.google.com/healthcare/docs/pricing

The SMART Team Comments on the 21st Century Cures Act Interoperability Rule

Dear SMART Community:

10 years ago, the SMART project launched with a New England Journal of Medicine article proposing that EHRs could serve as a platform with a universal API supporting substitutable apps. Now, the 21st Century Cures Act requires the very API we envisioned and the draft rule, by the Office of the National Coordinator of Health Information Technology, following from Cures, is open for public comment.

The rule specifies that the SMART on FHIR API will be 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.

Getting the details right could not be more important to realizing a future healthcare system underpinned by a robust health information economy, driven by apps and real world information.

In advance of posting our public comments, we post a draft here for community feedback.

The input is from our perspective as founders and members of the SMART on FHIR team that developed the SMART API, defined with HL7 and ONC the Bulk Data Export API specification, and launched the CDS Hooks project.

Thank you for engaging with us on this.

Ken Mandl


Draft 

Public comments on the Proposed Rule for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program

Dan Gottlieb, Josh Mandel, Kenneth Mandl

@gotdan @joshcmandel @mandl

Overview. Our first and overarching comment is that the ONC’s drafting of this rule reflects clear thought, responsiveness to the community, attention to detail, and tremendous skill in expressing critical desiderata for a robust health IT ecosystem. The product of these efforts, the Proposed Rule, is extraordinarily impressive to us. The Rule addresses and reinforces virtually all of the major underpinnings which are currently feasible and needed to produce an interoperable apps-based ecosystem.

We state clearly and emphatically that the Rule should be largely left intact in its spirit and in most of its details.

Priority Goals

1. Improve App Connectivity for Patients and Providers

Connectivity. We cannot overemphasize the importance of standardizing the capability for a SMART on FHIR app written one time, to run unmodified anywhere in the healthcare system, regardless of the EHR or database vendor or version, accessing all of a patient’s electronic health data.  The app should be substitutable–easily added to or deleted from an EHR or related database, as easily as apps are added to iPhones and Android mobile devices. The ONC has taken an enormous step forward with the certification requirement for the SMART application launch framework with the declaration of FHIR as a foundational standard, constrained by the Argonaut- or US Core-defined profiles.  

Weakening of any of the API requirements or information blocking provisions would potentially interfere with this objective.

Affordability. A patient’s access to all elements of her electronic medical record, across the SMART API, without cost, is well-supported in the Rule. The power of the provision is illustrated by the ease and speed with which Apple connected its Health App to more than 500 health systems across the SMART API, enabling patients at those institutions to download their data to iPhones for subsequent use in iOS apps. Under the proposed rule, any other app can connect to the same systems across the same API.

Equally important, however, is that when a data provider (e.g., a practice or a healthcare system) also acts as an API user, they must be able to connect any app of their choice to their EHR. This ability is well-supported in the Rule, including important guardrails around what an API provider can charge for cost recovery and on a per API call basis.  Affordability of this capability is essential. Data providers must be able to afford the enhanced health IT systems that have APIs to permit the fundamental interoperability that many believe should be native properties of any modern software system. The data providers must also be able to afford the cost of API access resulting from the use of apps that connect and provide value. There is a risk that the economics of paying for API calls to enable API provider cost recovery will be limiting.

In the API/Apps model, the EHR and related IT serve as a platform for multi-sided business. It will take some time to understand and support the economics underpinning a nascent apps-based economy. Getting it right will strongly promote American business innovation, job creation and improved infrastructure to deliver value-based healthcare.

Evaluation. We understand that ONC may be pursuing the cost-based pricing program out of necessity, but not that API Providers will not have an incentive to drive down their own costs. Additionally, current levels of revenue for API providers are not necessarily maintainable for a health system seeking value and growth in the diversity of app developers. API pricing structures should ideally level the playing field between first-party EHR functionality and third party app functionality for a modular, extensible IT infrastructure.

Therefore, we propose that a year after the implementation of the Rule, O NC conduct a study to evaluate the real-world cost of APIs being used by health systems for areas such as clinical decision support, payments, machine learning, and precision medicine, and use the results to drive future policy. Benchmarking these costs will be difficult, but potentially useful metrics could include:

  • Comparing the cost of accessing data via APIs to that of accessing the same data with traditional EHR front end interfaces by amortized EHR licensing costs and adjusting for expected use.  
  • Comparing the cost of accessing data via EHR APIs to that of similar APIs, including those from cloud providers such as Microsoft Azure API for FHIR or Google Cloud for Healthcare and those provided as part of software solutions in other industries.
  • Examining the business models being used. For example, are API providers charging for system upgrades only, or are there substantial ongoing fees that limit app usage?

2. Embrace Community Driven API Standards

Population API Access. We are extremely pleased to see that the Rule supports Population API Access (including https://www.federalregister.gov/d/2019-02224/p-447 and https://www.federalregister.gov/d/2019-02224/p-837). This requirement should specifically mandate the  use of the FHIR Bulk Data Access Standard, currently being balloted through the HL7 standards organization (http://docs.smarthealthit.org/flat-fhir/ ).

Provide API Access for  Data Exports. On the subject of full EHI access, we are concerned about the gap between the proposed rule for EHI Export and the regulatory intent of the 21st Century Cures Act to achieve interoperability with APIs that provide “access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws.” In ONC’s proposal for certified API access, “all data elements” has been interpreted to mean “a limited set of data elements.” While not all data have been standardized, ONC should still include a functional requirement that the EHI Export capabilities must be available through a documented (if potentially vendor-specific) API, and accessible to patients. Specifically, to provide a usable consumer experience, the EHI Export capability must be:

  1. Accessible directly to a patient (or authorized representative), rather than (or in addition to) being built as a feature for clinic staff. This is to ensure that patients don’t need to make a request by, e.g., phoning the medical records department, and waiting while the departmental staff hits the “export” button in response to a request — a friction-laden process.
  2. Exposed end-to-end through an API, rather than being implemented exclusively as a button hidden deep within a patient portal experience, or being crippled by the exchange of physical media like CD-ROMs. This is critical because:
    • Portal experiences vary, making features difficult to find and correctly describe (e.g., if a third party is trying to guide patients toward the export functionality in a variety of portals). This was a clear challenge for anyone trying to identify the “Transmit to a third party” features of a patient portal in the MU2 timeframe.
    • Managing physical media, e.g., CDs,  would take access outside the realm of modern, convenient consumer experiences, and would violate the without special effort requirement.
    • Managing files may be challenging on many patient devices (e.g., mobile phones), and some files may be best suited for off-device storage (e.g., in the cloud). API connectivity ensures that patients can have a seamless experience for accessing all of their health data, not just a core data set.

Our key recommendation on EHI Export is that ONC should require certified EHRs to support full EHI export via patient-accessible API, even without standardizing the API or the data payloads. This will meet the Cures intent for API access.

API connectivity will ensure that patients can have a seamless experience for accessing all of their health data, not just a core data set and healthcare providers have the option to connect apps to data that is not currently available through the USCDI dataset. Providing access through open APIs, even for data that are not structured in open formats, will further this goal.

We have heard concerns about the overall scope of EHI access in a variety of exceptional circumstances (e.g., for data not stored in the EHR itself, or for data that represent purely internal system implementation details). As a baseline, we recommend that the data to be included in EHI Export should encompass the complete set of information that an EHR vendor currently makes available through their widely adopted data warehouse products, through their user interfaces, or through their reporting infrastructure.

SMART on FHIR.  The Rule should Specify which SMART on FHIR capabilities an API provider will need to support, at a minimum. The proposed rule requires mandatory support for “refresh tokens,” “Standalone Launch,” and “EHR Launch” requirements. However to ensure consistent implementation the Rule should also specify mandatory support for the following ten SMART capabilities: sso-openid-connect, launch-standalone, launch-ehr, client-public, client-confidential-symmetric, context-ehr-patient, context-standalone-patient, permission-patient, permission-user, permission-offline.

USCDI. The USCDI is a strong successor to the Common Clinical Dataset. To cover an expanded set of app use cases, we recommend the addition of data elements that cover  clinical encounters and clinical imaging metadata.

FHIR R4. The need to support multiple versions of standards can hinder interoperability.  ONC should adopt FHIR R4 as the only allowed version for standard API access moving forward, with an advancement process as described in the Proposed Rule.

ARCH. The ONC proposes the “API Resource Collection in Health” (ARCH) Version 1 implementation specification in § 170.215(a)(2), which would list a set of base FHIR resources that Health IT Modules certified to the proposed API criterion (§ 170.315(g)(10)) would need to support.  While we see value in providing a catalog, we strongly recommend that ONC populate it using community-developed standards by groups like Argonaut and HL7, who can take functional requirements from USCDI versions, and produce Implementation guides. If ONC maintains an ARCH definition, this definition should be limited to referencing implementation guidance from community-developed processes; ONC should not “get out ahead” of the community process. For example, the ARCH should not make unilateral determinations about which FHIR resource or data elements are needed to meet a given USCDI requirement. Instead, that determination should be made through a community-driven, iterative process with real world testing of use cases.

Immature Standards. The vast majority of referenced standards in the Rule are mature, in real world use, and widely embraced by the community.  Two standards, however, strike us as “not ready for prime time:” Data segmentation for privacy (DS4P) and Consent2Share.  While we recognize privacy maintenance and consenting as essential functions in health care, we are very concerned that a premature push for adoption of these immature standards would have unintended negative effects. ONC should omit these from the certification criteria (including voluntary certification) and focus on driving real-world implementation experience before pursuing regulations.

3. Move Beyond EHR Data

Clinical Imaging. We are concerned that sharing of images, an essential data type for patient care, may slip through the cracks. EHR systems often contain metadata around the available imaging studies, however, the imaging studies themselves are frequently stored in separate systems known as picture archiving and communication system (PACS).  Providers should be responsible for sharing this imaging data, regardless of the technology supplier they choose. We recommend making PACS vendors subject to EHR certification rules, specifically for API access requirements.

Laboratory Data. While some clinical laboratory result data are accessible to patients through EHR APIs, historical data may not be comprehensive. Recently, national laboratory companies have begun to make these data available through API access for select apps. To promote a robust ecosystem of clinical applications, guidance should be provided on how this access should be expanded to an open ecosystem of apps to comply with the information blocking restrictions in the Rule.


Ensuring that the 21st Century Cures Act Health IT Provisions Promote Interoperability and Data Exchange

Kenneth D. Mandl, MD, MPH,1,2 Dan Gottlieb, MPA,2 Josh Mandel, MD,1,2,3

1. Computational Health Informatics Program, Boston Children’s Hospital, Boston, MA

2. Department of Biomedical Informatics, Harvard Medical School, Boston, MA

3. Microsoft Healthcare, Redmond, WA

The opportunity has never been greater to, at long last, develop a flourishing health information economy based on apps which have full access to health system data–for both patients and populations–and liquid data that travels to where it is needed for care, management and population and public health. A provision in the 21st Century Cures Act could transform how patients and providers use health information technology. The 2016 law requires that certified health information technology products have an application programming interface (API) that allows health information to be accessed, exchanged, and used “without special effort” and that provides “access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws.”

After nearly two years of regulatory work, an important rule on this issue is now pending at the Office of Management and Budget (OMB), typically a late stop before a proposed rule is issued for public comment. It is our hope that this rule will contain provisions to create capabilities for patients to obtain complete copies of their EHR data and for providers and patients to easily integrate apps (web, iOS and Android) with EHRs and other clinical systems.

Modern software systems use APIs to interact with each other and exchange data. APIs are fundamental to software made familiar to all consumers by Google, Apple, Microsoft, Facebook, and Amazon. APIs could also offer turnkey access to population health data in a standard format, and interoperable approaches to exchange and aggregate data across sites of care.

The Office of the National Coordinator of Health IT (ONC)-funded SMART on FHIR API specification enables apps to connect with EHRs in a standards-based way, giving users a frictionless way to choose their favorite apps. This property of substitutability defines a new form of interoperability. SMART leverages the Health Level Seven (HL7) Fast Health Interoperability Resources (FHIR) standard and has been implemented by the major EHR products. The SMART app gallery, and EHR-specific app stores such as Epic’s App Orchard and Cerner’s code App gallery host scores of app that connect to EHRs.

Two particularly intriguing uses of SMART are (1) Apple’s use of the API to connect its health app to hundreds of health systems enabling users to download copies of their health records to their smartphones; and (2) the Centers for Medicare and Medicaid’s implementation of “Blue Button 2.0”, enabling beneficiaries to connect apps to their healthcare financial data.

Because the specifics of the final rule matter greatly, we strongly encourage policy makers to attend carefully to a few key requirements which derive from the phrases “without special effort” and “all data elements.”

Expanded data access. ONC has proposed a set of standardized clinical data that will grow over time from the 2015-era “Common Clinical Data Set” to a forward-looking “US Core Data for Interoperability”. This kind of consistent, standards-based data set holds tremendous promise for the ecosystem. At the same time, standards can lag behind clinical practice and cutting-edge technology development, so the Cures Act goal of “all data elements” would be challenging to achieve through detailed clinical modeling standards alone. We should not allow the perfect to be the enemy of the good. We propose a three-pronged approach to meeting the Cures provisions for “all data elements”:

  1. Use standards that exist today. For example, FHIR “US Core” profiles cover the 2015 era Common Clinical Data Set, providing a common basis for communicating patient demographics, medidcations, conditions, lab results, vital signs, and more. These core data should be made available through APIs to provider- and patient-facing apps.
  2. Continue developing these standards over time. For example, efforts like HL7’s Argonaut Project are driving common support for new data types like clinical notes as a fast-moving 2018 roadmap. We should start building a community-maintained “profile backlog” to articulate and prioritize the most valuable data that haven’t yet been standardized.
  3. Enable flexible approaches to cover the gap between our well-standardized-and-growing “core data” definitions and the long tail implied by the Cures provision for “all data elements.” As one example to illustrate how EHR vendors could ensure that innovators have programmatic access to all of the clinical data accessible in the system: similar to the way vendors publicly document a subset of APIs today, they might expand this documentation to include database schema, tables, columns, and enumerations used to store complete clinical records.

This approach (use standards, develop standards, and cover the gap) would empower early adopters to develop cutting edge clinical integrations ahead of the standardization process, building experience to guide the standards process that follows.

Standard and ubiquitous APIs for patient facing apps, provider facing apps and population analytics. Our vision is that an app written once should run anywhere in the healthcare system. The availability of standardized APIs, ubiquitously implemented across care settings, is essential to driving down the “special effort” that is still typically required to create, distribute and use health apps.

  1. Standardize APIs for apps. The SMART Health IT (a.k.a. SMART on FHIR) specification is sufficiently mature to be considered as an industry standard for launching and authorizing apps in an EHR or patient portal. It is in widespread use in clinical settings, has achieved consensus through the Argonaut process, is implemented in EHR products, and its core elements are being incorporated into the next release of the FHIR standard.

While the SMART-based app integration focuses on one‐patent‐at‐a‐time access to health system data, population level data export is critical for value‐based care, postmarket surveillance, quality improvement, and clinical research. The API should enable a user or an app to specify export of all EHR data or EHR data on defined cohorts at the discretion of the data owner. Under ONC funding, a standard for bulk data export in a FHIR‐formatted flat file has been proposed and the Argonaut implementation group is working to pilot it in 2018.

  1. Allow multiple pathways to register apps for connection to EHRs and other HIT. As more EHR vendors build support for standards-based apps, developers are discovering that they need to independently register each new app with each vendor and complete a set of on-boarding, review, or “vetting” steps before users are able to install the app and authorize a data connection. The app registration and vetting landscape is evolving quickly as vendors create developer programs, launch partnerships, and build out their own app marketplaces. App vetting procedures review and assess critical aspects of integration including security, usability, and business/privacy practices and offer value to end-users, who expect a clean, safe, experience of choosing, installing, and running apps.

Nonetheless, we have observed that these vetting practices can cause friction for some use cases and believe it is too early to define a “one size fits all” standardized app vetting process.  As such, we propose an “escape hatch” in the form of an at your own risk principle, by which provider organizations and individual patients should be able to accept the risk of connecting an un-vetted app to their own data without vendor review. While many apps will follow a conventional path of registration and vetting, this option provides a route to ensure that all apps, even small-scale apps (e.g., one-offs produced by individual tinkerers, open-source developers, research efforts) can reach visibility and commercial viability within the real-world clinical landscape, and that providers have the opportunity to select any apps of their choice.

  1. Ownership terms. App developers should have the option of retaining all intellectual property related to the app, regardless of how the app connects to the EHR and which underlying EHR APIs the app consumes.
  2. Maintain free registration of apps for patients. As required now under Meaningful Use Stage 3, patients should always be able to connect apps of their choice, without cost.
  3. App connections should be long lasting, when desired. In other words, the user should not need to reauthorize the app to the system each time data is accessed. This property will enable apps to perform functions on behalf of patients and providers, without special effort (for example, checking periodically for new lab results).

Summary. We are so pleased that ONC has and the OMB have gotten to the is stage in which a proposed rule is pending at OMB. We are on the precipice of creating a national-scale apps model for health, based on an API that promotes interoperability and data exchange via substitutable apps. The simple imperatives we enumerate above, could reshape the health IT industry by providing a channel for innovators to distribute and/or sell their software applications by enabling customers to select and integrate EHR-connected apps as easily as they do for smartphones. As the final proposed language implementing the 21st Century Cures Act API provisions is reviewed and prepared for release is decided, we encourage policy-makers to keep all eyes on this prize.

This blog has been cross posted at The Health Care Blog.

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!

SMART at HIMSS 2018!

All times are PST. Session schedule may change – check back for updates.

  • Tuesday (3/6)

    • FHIR for Bulk Data
      Dan Gottlieb, Senior Technical Lead, SMART Health IT Project
      Learn about an exciting new effort by SMART and HL7 to bring the FHIR standard to bear on the challenges of bulk-data export.
      1:00 – 1:30pm | HL7 – Booth 5623
    • Sync for Science and the CMS Blue Button on FHIR API: Claims Data for Research
      Josh Mandel, Health IT Ecosystem Lead, Verily; David Kreda, Healthcare IT Designer and Consultant; Carly Medosch, Program Analyst, CMS
      2:00 – 3:00pm | CMS Booth #10110
    • SMART on FHIR: Building apps that integrate with clinical systems through open standards
      Dan Gottlieb, Senior Technical Lead, SMART Health IT Project; Josh Mandel, Health IT Ecosystem Lead, Verily
      Learn how SMART Health IT’s open source, standards-based technology platform enables innovators to create apps that run seamlessly and securely across the healthcare ecosystem.
      3:30 – 4:15pm | HIMSS Developer Innovation Lab (Hall G, Booth 9900-DL)
  • Wednesday (3/7)

    • Sync For Science Scientific Session
      Josh Mandel, Health IT Ecosystem Lead, Verily; David Kreda, Healthcare IT Designer and Consultant; Teresa Zayas Caban, Chief Scientist, ONC
      In this session, the Sync for Science team will sit down with the research community to talk through use cases, challenges, wish lists, and pragmatics of working with EHR data.
      10:00 – 10:45am | The Venetian, Room Zeno 4601
    • Argonaut Project Town Hall Meeting
      Micky Tripathi, President & CEO, MAeHC; Aneesh Chopra, President, CareJourney; Ryan Howells, Principal, Leavitt Partners; Josh Mandel, Health IT Ecosystem Lead, Verily; Dan Gottlieb, Senior Technical Lead, SMART Health IT Project
      The town hall will cover 1) Argonaut Project 2017 deliverables and 2018 work plan, 2) CARIN Alliance consumer directed exchange trust framework updates and TEFCA alignment, 3) SMART and ONC efforts to accelerate bulk data access via FHIR APIs.
      5:30pm – 6:30pm | Hall G, Booth 11955ET | RSVP Here
  • Thursday (3/8)

    • Sync For Science Demonstration
      Josh Mandel, Health IT Ecosystem Lead, Verily; David Kreda, Healthcare IT Designer and Consultant; Teresa Zayas Caban, Chief Scientist, ONC
      In this session we’ll review the consumer workflow, the underlying technologies and the regulatory environment that support Sync for Science, and describe upcoming extensions to support new data types.
      10:00 – 10:45am | The Venetian, Room Zeno 4601
    • CDS Hooks: Integrating decision support at the point of care
      Josh Mandel, Health IT Ecosystem Lead, Verily; David McCallie, Senior Vice President for Medical Informatics, Cerner
      We’ll review the technology, clinical use cases, standards development, and real-world implementation experience for the emerging CDS Hooks specification.
      11:40am – 12:10pm | HL7 – Booth 5623
    • FHIR for Bulk Data
      Dan Gottlieb, Senior Technical Lead, SMART Health IT Project
      Learn about an exciting new effort by SMART and HL7 to bring the FHIR standard to bear on the challenges of bulk-data export.
      1:00 – 1:30pm | Hall G, Booth 9900-DL

Response to ONC’s proposed Trusted Exchange Framework and Common Agreement

Next week is the final opportunity for public comment on the ONC’s proposed Trusted Exchange Framework and Common Agreement. I’ve prepared a set of comments and recommendations that focus on the scope and mechanics of individual access, including technical standards, security requirements, identity proofing, authentication, and authorization.

Given the importance of health data exchange to the SMART Health IT community, I’m sharing the full letter and 15 recommendations here in PDF.