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 NIH, AMIA called for change to its Data Sharing policy in order to ensure that research data can be systematically and strategically collected, managed and shared. Specifically, AMIA recommended that Data Sharing Plans be subject to peer-review and made scorable elements of applicable grants.
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 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On July 18, 2016, AMIA submitted comments to FDA regarding their draft guidance to industry on using EHR data in clinical investigations.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 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 […]
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.