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).
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AMIA responses are arranged by Federal Agency and Congressional Committee.
Under the 21st Century Cures Act, the Office of the National Coordinator for Health IT (ONC) is supposed to implement an EHR reporting program. However, recent budget proposals would cut ONC’s funding – something ONC officials have said would prevent them from fully implementing this safety provision. The Cures Act […]
In response to a CMS Innovation Center request for information (RFI) on its potential new direction, AMIA offered several suggestions focusing on the interdependency of payment and delivery reforms, supported by health IT and health informatics. AMIA suggested additional guiding principles with which to approach new Innovation Center model design […]
AMIA provided comments to a VA proposed rule that would allow its providers to furnish telehealth services, regardless of the state or location where they or the beneficiary is physically located. AMIA supported the proposal, while emphasizing that any telehealth applications use nationally recognized health IT standards and enable use […]
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 supported the use of real-world data and real-world evidence to support regulatory decision-making for medical devices.
In conjunction with a public meeting held by the FDA August 15, 2016, AMIA submitted public comments supporting the direction of the its Prescription Drug User Fee Agreement Commitment Letter. Specifically, AMIA supports FDA’s work to utilize Real World Evidence in regulatory decision-making, incorporating the patient’s voice in drug development […]
On April 27, 2016, AMIA submitted comments to the Office of the National Coordinator supporting their proposed authority to conduct direct review of certified health IT products. AMIA said that reviews should be limited to instances when health IT posed a potential or real threat to patient safety, or was […]
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 11, 2016, AMIA submitted comments to the National Qualify Forum’s Health IT Safety Committee, supporting the framework and newly-developed domains to measure the safety and safe use of health IT. Numerous AMIA members participated in this effort, and AMIA believes these measures should serve as a foundation for […]