January 26, 2021
Source: PEW
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Policymakers can further accelerate and improve API use
Congress, CMS, and ONC have accelerated some uses for APIs, including patient access. The ONC regulations requiring FHIR, associated implementation guides, and additional standardized data will aid the implementation of APIs in health care. However, these new rules should not be the final effort on APIs. Given the expected increased use of these tools and their future promise, gaps that policymakers should address include privacy, write capabilities, data exchange among providers, and costs.
Although some changes may require Congress to pass new legislation, ONC and CMS could also accelerate additional use cases and their related benefits through policymaking. For example, Congress required ONC to develop the Trusted Exchange Framework and Common Agreement (TEFCA), a program created through the Cures Act to support nationwide data exchange. Similarly, CMS maintains the Promoting Interoperability Programs, through which the agency offers financial incentives for hospitals to use technology in ways that improve patient care. And the private sector—including app developers and EHR vendors—can also take steps to advance the use of third-party applications integrated within EHRs and ensure provider access to data at the point of care and within workflows.
"We want those apps to have the same privacy and security standards that we have."Hospital quote
To further accelerate API use, policymakers should consider regulations, legislation, or other policies that:
Improve privacy and security. Given provider concerns about unauthorized access to patient data and the effect of this hesitation on offering consumer and patient-facing applications access to patient data via APIs, policymakers should prioritize solutions for privacy and security gaps. Congress, ONC, other offices within the Department of Health and Human Services, the Federal Trade Commission (which has jurisdiction when companies violate their own terms and conditions), state attorneys general, and other policymakers should ensure that third-party applications both provide information about and confirm adherence to disclosures on how they use data and respect patient preferences. Given concerns that consumers do not often review terms and conditions of software applications, which are often designed to be difficult to understand, policymakers should ensure that appropriate privacy and security safeguards are in place and that consumers can understand and make meaningful choices about how their data is used. Meanwhile, technology developers and health care providers should commit to disclose how they use data and make certain that patients are able to meaningfully understand and agree to policies governing their data. Emerging industry-led codes of conduct—such as one developed by the CARIN Alliance, a multisector coalition that advances patient access to data—can provide guidance on best practices.17
Build out the ability to enter data into records. Although currently most APIs can only read information from EHRs, several opportunities remain to promote write access functions—both for CDS to offer additional capabilities and benefits to clinicians and to enable patients to contribute to their records, such as changing an address or updating symptoms. First, health stakeholders—including EHR vendors—should develop and refine write access implementation guidance to address, among other things, how to record the provenance of information. Once developed, ONC should consider expanding its requirements for EHR certification to include write access. ONC could build on its existing provisions for read access APIs and focus on the USCDI. CMS can also advance this approach through its Promoting Interoperability Programs.
Increase API use for data exchange among providers. Although government policies have prioritized patient access to data, vendor participants noted there are few technical barriers to using FHIR APIs for provider exchange. To more effectively and efficiently treat patients, hospitals and health care providers should be able to both retrieve the relevant data from their own copies of patients’ records and access information stored in other providers’ EHRs. Standard APIs have the potential to improve how providers connect via APIs to hospitals and other ambulatory sites where they share patients. New pilots for evaluating enhanced data sharing among clinicians could offer insights on the benefits and potential challenges of using FHIR for cross-provider data exchange. Benefits include, for example, ensuring that clinicians receive only the information they need—both reducing the quantity of data reviewed and preserving privacy. Going forward, federal agencies should encourage the use of APIs for cross-provider data exchange. For example, ONC can incorporate this method for data exchange in TEFCA, and CMS could tie provider interoperability to reimbursement. Other use cases should be explored, including APIs for population health, public health, clinical care delivery, analytics, and reporting.
Include more data elements for exchange. ONC has already taken steps to add more data to APIs by expanding the information made available in the USCDI. However, Congress required that EHRs make “all data elements” available via APIs, and some notable gaps remain. For example, the USCDI does not currently include images, genomic data, social determinants of health, cost information, and other, more granular, information. More data will give patients a comprehensive view of their health, enable the development of additional decision support tools (such as those that analyze images or genomic data), and ease communication between providers. Additional data accessibility via the USCDI and APIs will also benefit providers and other stakeholders. ONC has indicated plans to expand USCDI regularly and cyclically and should aggressively act to expand the available data elements.18
Monitor costs. In the Cures Act, Congress instructed the Department of Health and Human Services, the agency that oversees both ONC and CMS, to ensure that EHR-based APIs can be used “without special effort.” In implementing that requirement, ONC indicated that exorbitant costs would represent special effort. Therefore, the agency determined that, aside from patient access APIs that must remain free to use, EHR vendors can only charge reasonable fees to generally recoup their expenses. ONC did not require technology developers to follow specific cost structures, such as through call-based or tiered systems. To ensure that API use remains affordable and accessible without special effort, ONC should aggressively monitor costs charged for their use and take appropriate enforcement actions in the event that EHR developers violate the regulatory provisions. As EHR developers make the USCDI available via FHIR-based APIs, ONC should also issue sub-regulatory clarification based on real-world examples of cost structures. Additionally, ONC should work with researchers to generate anticipated reasonable costs based on those charged in other industries that use APIs.
Guard against health inequities with CDS tools. ONC regulations will usher in a new era for CDS that use APIs, which will increasingly help guide medical decisions on medications, treatment plans, and a range of other interventions. However, some decision support tools may exacerbate or fail to address inequities in care, increasing disparities for disadvantaged populations. For example, researchers have questioned whether forthcoming CDS tools for melanoma will appropriately support diagnoses for patients of varying skin complexions.19 The federal government, health care providers, and the industry should monitor the creation of CDS tools to ensure they are developed with data on diverse populations and do not increase disparities once deployed.
In addition, FHIR-based APIs may also offer promise in improving the public health infrastructure, such as in responding to future pandemics by making data exchange easier with state and local health departments to obviate the need for faxes. This research occurred prior to the novel coronavirus pandemic of 2020, and therefore that issue was not explicitly investigated or proactively raised by interviewees.
Conclusion
Increased use of APIs—particularly those based on common adopted and consistently deployed standards—has the potential to make health care more efficient, lead to better care coordination, and give providers and patients additional tools to access information and ensure high-quality, efficient, safe, and value-based care. Yet obstacles remain, such as some hospital hesitation to grant patient access to data, lack of bidirectional data exchange, confusion around the process of implementing APIs, and potentially prohibitive fee structures.
Despite that hesitation, recent rule-making will further integrate APIs into health care. With that, clinicians and patients alike can have access to comprehensive data and use third-party applications to aggregate information, make better decisions, and manage care more effectively.
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