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.
In response to a Request for Comment from the National Telecommunications and Information Administration, AMIA urged the administration to seek harmonization of federal data privacy policies, while also ensuring that consumer access to and control over his or her data be the baseline for its policies.
AMIA strongly encouraged the Trump administration to leverage an existing strategy on Artificial Intelligence Research and Development (AI R&D), rather than begin from scratch. It additionally emphasized a need for federal investments in areas of strong societal importance not aimed at consumer markets, especially related to human-AI collaboration and the […]
In comments submitted to the Office of the National Coordinator for Health IT (ONC), the AMIA questioned the constrained scope of the EHR Reporting Program, strongly recommending that it measure performance to improve CEHRT security, interoperability, and usability, and not be used simply to provide data for “acquisition decision makers.”
AMIA responded to an FDA request for input with a preliminary review of relevant research into the specific benefits and risks to health associated with software functions that the 21st Century Cures Act excluded from the definition of medical device. While some health IT applications to healthcare delivery have unambiguously […]
In comments submitted to the Food & Drug Administration (FDA) today, the American Medical Informatics Association (AMIA) said new draft guidance is well-timed to initiate a broad discussion over the future of clinical decision support (CDS) and patient decision support (PDS) software.
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 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 […]
On April 6, 2016, AMIA called proposed revisions to substance use disorder (SUD) regulations, also known as 42 CFR Part 2, well-intentioned, but ultimately insufficient. AMIA urged the Department of Health and Human Services (HHS) to lead a national effort to develop technical standards that would enable patients to have […]