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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).  Below, AMIA responses are arranged by Federal Agency and Congressional Committee.

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AMIA Supports, Encourages Further Refinement of FDA AI/Machine Learning Regulatory Framework

June 5, 2019

In comments submitted this week to the U.S. Food and Drug Administration (FDA), the nation’s informatics professionals applauded the agency for developing a regulatory Modification Framework for Artificial Intelligence (AI)/Machine Learning (ML)-based software as a medical device (SaMD). The American Medical Informatics Association (AMIA) offered additional observations and recommendations for […]

AMIA Recommends ‘Phased Approach’ to Payer API Requirements

June 4, 2019

In comments submitted to the Centers for Medicare & Medicaid Services (CMS), AMIA recommended a phased approach for making payer and insurance plan data available through open application programming interfaces (APIs) to beneficiaries. AMIA also called on the CMS Innovation Center (CMMI) to develop new models to provide structural funding […]

AMIA Urges Feds to Think Beyond Traditional Care Boundaries for ‘Future Vision’ of Interoperability

March 15, 2019

In comments submitted to the National Science Foundation’s (NSF) Networking and Information Technology Research and Development Program (NITRD), AMIA supported their future vision for interoperability among medical devices, electronic health records, and other systems within the healthcare ecosystem. In doing so, AMIA observed that the future of interoperability will undoubtedly […]

HIPAA Must Better Promote Information Sharing, Urges AMIA

February 12, 2019

In comments submitted to the Department of Health & Human Services (HHS) Office of Civil Rights (OCR), AMIA recommended that the Office ensure that HIPAA both requires and permits information-sharing upon patient and clinician request, as well as robust penalties for failing to deliver data pursuant to the patient “right […]

AMIA Calls on HHS to Decouple Clinical Documentation and Administrative Requirements

January 29, 2019

In comments submitted to ONC and CMS, AMIA recommended that the Department of Health and Human Services orient its documentation burden reduction strategy towards a long-term goal of decoupling clinical documentation from billing, regulatory, and administrative compliance requirements. AMIA highlighted the unique opportunity to leverage informatics tools and methodologies to […]

AMIA Weighs-In on NIST Remote Patient Monitoring Project

December 21, 2018

In response to a Request for Information from the National Institute for Standards and Technology, AMIA recommended that a planned project to develop a reference architecture for remote patient monitoring utilize existing mobile infrastructures and available health IT standards, such as FHIR, to improve the likelihood of success.

AMIA Supports National Testing Collaborative for Health IT

December 20, 2018

In response to a Request for Information from the Centers for Disease Control and Prevention, AMIA urged HHS officials to focus on narrow use cases, such as CDS or eCQMs, when conceptualizing a national collaborative for health IT testing. AMIA also outlined the pros/cons of focusing on CDS versus eCQMs […]

AMIA Supports New NIH Data Policy, Encourages Phased Implementation

December 8, 2018

In comments submitted to the NIH, AMIA supported an expansive update to its 2003 data sharing policy, recommending a phased approach to implement new data management and sharing requirements for NIH-funded research. It also noted that quality data management and sharing plans are prerequisite to the NIH’s goals of making […]

HIPAA Modernization Needed, Experts Say

December 5, 2018

Partnering with AHIMA, AMIA recommended that policymakers modernize HIPAA by either establishing a new term, “Health Data Set,” which includes all clinical, biomedical, and claims data maintained by a Covered Entity or Business Associate, or by revising the existing HIPAA “Designated Record Set” definition and require Certified Health IT to […]