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 supported the use of real-world data and real-world evidence to support regulatory decision-making for medical devices.
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.
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On July 18, 2016, AMIA submitted comments to FDA regarding their draft guidance to industry on using EHR data in clinical investigations.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 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 […]
On January 6, 2016 AMIA submitted comments to HHS recommending ways to improve the Federal Policy for the Protection of Human Subjects, also known as the Common Rule. AMIA support many of the updates, and believes they will better enable a learning health system over current policies.