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 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 to the FDA, AMIA said it supports FDA’s efforts to develop modern, flexible and adaptive regulatory approaches to the oversight of NGS-based tests as part of the Precision Medicine Initiative (PMI). This support notwithstanding, AMIA noted a lack of standards – for ontologies, metadata and other technical […]
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 HIMSS and 36 other organizations, AMIA submitted recommendations on how the Office of Management & Budget should update the Standard Occupational Classification codes, which help Federal statistical agencies understand and forecast national data on occupations. The groups strongly recommended separate codes for Health Informatics, Health IT and […]
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.