AMIA’s goal is to improve the legislative and regulatory environment for health informatics research, practice and education through AMIA member expertise. The primary pathway through which AMIA achieves this goal is by engaging Federal Agencies and Congress on public calls for input, such as Notices of Proposed Rulemakings (NPRMs) or Request for Information (RFIs).
Learn more about the comment process
AMIA responses are arranged by Federal Agency and Congressional Committee.
In comments submitted to the FDA, AMIA voiced supported for several aspects of MDUFA IV meant to enhance use of consensus standards; develop patient engagement strategies and improve the science of patient input; utilize real world evidence (RWE) to improve regulatory decision-making; and development of a policy framework for Digital […]
In comments submitted to the FDA, AMIA said it supports FDA’s efforts to develop modern, flexible and adaptive regulatory approaches to the oversight of NGS-based tests as part of the Precision Medicine Initiative (PMI). This support notwithstanding, AMIA noted a lack of standards – for ontologies, metadata and other technical […]
In comments submitted September 29, AMIA recommend several ways the NIH could assess the value of biomedical digital repositories and knowledgebases. The metrics span categories related to "utilization" and "impact" to "service quality" and "governance." AMIA recommended another category be included relate to data quality and data completeness.
In comments submitted to CMS, AMIA recommend CMS proceed with proposals for a 90-day reporting period for hospitals in 2016, and it supported policies that are meant to align requirements for hospitals participating in MU with requirements for clinicians participating in MIPS.
In comments submitted to CMS, AMIA supported continued policymaking to implement the Medicare AUC Program as part of the 2017 Physician Fee Schedule. The organization strongly recommended CMS target a 2019 implementation deadline, rather than the proposed 2018 start.
On July 18, 2016, AMIA submitted comments to FDA regarding their draft guidance to industry on using EHR data in clinical investigations. AMIA was supportive of the guidance, but challenged the assertion that EHR data was readily usable for prospective randomized controlled trials.
On June 27, 2016 AMIA submitted comments to CMS regarding proposed policies related to the new Medicare Quality Payments Program, which replaces the Sustainable Growth Rate and reforms how nearly 1.3 million clinicians are paid through Medicare. AMIA described a set of principles and recommendations CMS should consider during implementation […]
On January 26, 2016, AMIA submitted a letter of support for the Office of the National Coordinator for Health Information Technology (ONC) “Private Sector Interoperability Commitments Pledge,” which seeks to bolster interoperability in healthcare by enabling consumer access to their data, improving transparency and encouraging widespread adoption of […]
The following statement was released today by Douglas B. Fridsma, M.D., PhD., FACP, FACMI, President and CEO, American Medical Informatics Association (AMIA).
AMIA appreciates the work and bipartisanship demonstrated by Chairman Alexander, Ranking Member Murray and the entire HELP Committee in crafting the Improving Health Information Technology Act of 2015 […]
On January 8, 2016, AMIA submitted comments to the National Center for Advancing Translational Sciences (NCATS) on priority areas the Center should consider when developing its strategic plan. AMIA believes NCATS should focus on (1) developing ways to measure and convey how their programs impact patients and institutions; (2) defining […]