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.
The following statement was released today by Douglas B. Fridsma, MD, PhD, FACP, FACMI, regarding a letter to ONC about information blocking:
Information blocking is the absence of interoperability, and there are numerous reasons why information may not flow as intended. Some of these reasons are technical, others for business […]
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submitted to the Food & Drug Administration (FDA) today, the American Medical Informatics Association (AMIA) said new draft guidance is well-timed to initiate a broad discussion over the future of clinical decision support (CDS) and patient decision support (PDS) software.
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 […]
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 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 […]
AMIA acknowledged NIST’s efforts to highlight the importance of usability testing for electronic health records (EHRs) through its issuance of the proposed guidance. AMIA expressed concerns about several aspects of the draft guidance including the following: a limited and narrow identification of EHR users; the need to consider more comprehensive […]
AMIA recently issued comments in response to a U.S. Food and Drug Administration (FDA) draft guidance on mobile medical applications. In the comments, AMIA president Ted Shortliffe noted, among other things, the need for additional clarification, definitions, terms, and terminology in the guidance. Click below to read AMIA's full comments.
AMIA comments to ONC on consumer’s privacy and security of Personal Health Records. AMIA discusses the benefits and risks to consumers of PHRs and other points.
AMIA comments on the interim final rule, which amends the enforcement regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to conform to the revisions made pursuant to the Health Information Technology for Economic and Clinical Health Act (HITECH) for which the Secretary may impose a […]
AMIA and AHIMA advocate empowering individuals to manage their healthcare through the use of a personal health record (PHR). The PHR is a tool for collecting, tracking and sharing important, up-to-date information about an individual’s health or the health of someone in their care. Using a PHR will help people […]