AMIA Advises CDC to Start with Limited Pilot for Health IT Testing in the Field

Jan. 9, 2019
The American Medical Informatics Association (AMIA) is urging the Centers for Disease Control and Prevention (CDC) to initially use a limited scope for testing health IT in the field to ensure the future success of the CDC’s National Test Collaborative (NTC).

The American Medical Informatics Association (AMIA) supports health IT testing in the field, but is urging the Centers for Disease Control and Prevention (CDC) to initially use a limited scope for in the field testing to ensure the future success of the CDC’s National Test Collaborative (NTC).

AMIA submitted written comments to the CDC in response to the agency’s request for information (RFI) on its National Test Collaborative initiative. According to the CDC’s RFI, the agency is seeking input on the development of a national testbed (the National Test Collaborative) for real-world testing of health IT that enables improved delivery of best evidence to health care providers at the point of care as well as facilitates data created in the course of care provision to be available for appropriate research and public health purposes (e.g., clinical decision support (CDS), electronic clinical quality measures (eCQMs) and electronic health record (EHR) data extraction tools.)

The CDC also is asking for input on approaches for creating a sustainable infrastructure that can be leveraged to meet robust clinical testing needs in public and private sectors.

The RFI is born from work the CDC undertook earlier in 2018 called “Adapting Clinical Guidelines for the Digital Age,” in which the agency was looking to develop clinical guidelines to be easily adopted by EHRs for clinical decision support.

In the RFI, CDC officials note that the agency has not been able to identify an existing network of organizations ready to test health IT in real-world settings. “There has been a previous attempt at setting up such a network by the Centers for Medicare and Medicaid Services (CMS) with respect to testing eCQMs, but the effort was not able to be realized. As such, setting up such a network would help provide a ready path for clinical testing for a variety of health IT. In particular, there is a need to expand on the sandbox idea to test true interoperability across EHR platforms as well as different clinical organizations in situ,” the CDC stated.

In its comments, Doug Fridsma, AMIA president and CEO, says AMIA supports such an endpoint, but advises the CDC to begin with a narrow scope that is initially developed for a single purpose, for example, either eCQMs, CDS or other clinical testing. “Starting with a limited pilot will enable the NTC to learn how to establish and coordinate relationships among various stakeholders, including health IT developers, clinician users, clinical informatics experts, healthcare organizational leaders, standards developers, measure stewards, and others,” Fridsma wrote. A limited scope will also improve the sustainability of the NTC by increasing the likelihood of tangible outputs and outcomes from which to incorporate into future focus areas, according to AMIA.

AMIA notes that eCQMs are an obvious starting point, as a focus on eCQMs would benefit from existing organizations, processes, and address a high-priority need.

“Establishing the NTC based on the use case of eCQMs may be relatively easy and quick given the existing environment. For example, were the NTC to focus on testing eCQMs in situ it would benefit from a socio-technical infrastructure of processes to endorse eCQMs and encourage widespread use of measures through regulation,” Fridsma wrote, noting, however, these same organizations and processes have various associated constraints that could hinder the NTC’s impact and long-term sustainability.

A focus on CDS use cases would fill existing gaps in testing infrastructure, AMIA says, as well as serve to convene various stakeholders to establish processes. However, it is likely that a focus on testing CDS in situ would require a longer timeline to see such impact given the currently disparate stakeholders and lack of established structures, according to AMIA.

As it relates to “other clinical testing,” AMIA says it supports helping the CDC and other federal agencies operationalize in situ health IT testing. “Specifically, interoperability testing of specific kinds of transactions that utilize Certified EHR Technology (CEHRT) would greatly improve the usability and utility of clinical data. We view ONC’s work in this area as essential, yet incomplete, since the Certification Program only tests conformance to a standard, not interoperability of that standard,” AMIA wrote.

Fridsma also notes that new requirements from the 21st Century Cures Act will require CEHRT to have successfully tested the real-world use of the technology for interoperability as part of new conditions and maintenance of certification. “We envision that once an NTC is established, such testing could represent an important set of use cases,” he wrote.

Fridsma also offered a word of caution regarding testing real-world, EHR-derived health IT scenarios, which involves organizational and legal structures that lab-based testing does not.

“These additional dimensions will likely mean that only the most motivated individuals and organizations will engage with the NTC on a voluntary basis, given the difficulty and uncertainty of in situ testing,” he wrote. In that regard, AMA suggest that CDC officials consider various incentives that sister agencies within HHS can provide to testing participants, such as CMS payment policy and ONC Surveillance capacity.