AMIA News

AMIA Unveils 2017 Policy Priorities,
Defines Pillars of New Policy Domain

During the 2016 Annual Symposium, American Medical Informatics Association (AMIA) officials unveiled Public Policy Principles & Positions for 2016–2017. The first four precepts of Health Informatics Policy—a new realm of public policy—were developed by AMIA’s Public Policy Committee over the last several months, and endorsed by the AMIA Board of Directors in October. Officials hope this work will articulate to members, policymakers, and other stakeholders which issues and conversations are most critical to discovering health insights and accelerating health care transformation.

“These principles and positions reflect the values of our organization and represent the vast expertise of the AMIA membership,” said Thomas H. Payne, MD, FACP, FACMI, AMIA board chair and medical director of IT services at the University of Washington’s UW Medicine. “Whether we are discussing how to break down data silos and improve reproducibility in research, or empowering patients through access to their data, AMIA members are leading the way.”

In articulating a new realm of public policy, AMIA’s Public Policy Committee said, “Health Informatics Policy is a distinct policy domain which seeks to optimize care delivery and care experience, improve population and public health, and advance biomedical research through the collection, analysis, and application of data.” Not unlike Environmental Policy, Education Policy, and Fiscal Policy, Health Informatics Policy is dynamic and organized around key domains. The Public Policy Committee identified the following six initial pillars of Health Informatics Policy:

• patient empowerment;
• health IT safety;
• workforce and education;
• data sharing in research;
• standards and interoperability; and
• informatics-driven quality measurement.

Each priority begins with a series of statements describing what AMIA believes—principles that describe the values intrinsic to the pillar and viewed through an informatics lens. A series of policy positions result from these principles, and they are supported through evidence in peer-reviewed literature.

“These first six pillars help define an initial framework to help communicate the way informatics impacts research, care delivery, public health, and workforce issues,” said Paul Fu, Jr., MD, MPH, FAAP, AMIA Public Policy Committee chair and chief medical information officer at Harbor-UCLA Medical Center. “AMIA will build upon and leverage these principles to improve the regulatory and legislative landscape for health informatics policy.”

“This work is foundational to the ongoing evolution of our field,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI. “It will further enable policymakers to benefit not just from what AMIA members know, but from what they do.”

Over the next several months, the Public Policy Committee will continue its work to define the core of Health Informatics Policy, consistent with AMIA’s brand of evidence-based policy recommendations, supported by the latest research and reinforced through the literature. Principles focused on Standards & Interoperability and Informatics-Driven Quality Measurement are scheduled for release before the end of 2016, and AMIA’s Public Policy Committee will initiate a process of review to explore additional pillars and enhance existing pillars.

AMIA’s Annual Symposium is the premier educational event in the field. The symposium presents leading-edge scientific research on biomedical and health informatics and more than 100 scientific sessions. The symposium presents work from across the spectrum of the informatics field—translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.

— Source: AMIA

AMIA Joins FDA’s Network of Experts

The FDA has tapped AMIA to be part of a select group of technical advisors, officials announced at the AMIA 2016 Annual Symposium. Known as the Network of Experts, AMIA will provide rapid access to informatics expertise when needed by FDA officials within the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER).

“This further validates AMIA as a trusted source of evidence-based informatics expertise,” said Thomas H. Payne, MD, FACP, FACMI, AMIA board chair and medical director of IT services at the University of Washington’s UW Medicine. “We are proud to be part of FDA’s Network of Experts, and look forward to helping the FDA understand how informatics can be leveraged to address emerging medical devices and novel pharmaceuticals.”

The Network of Experts is a vetted network of partner organizations and their member scientists, clinicians, and engineers who can provide CDRH and CDER staff with access to expertise to supplement existing knowledge within the centers. In a description of the network, FDA notes that despite the tremendous internal cadre of scientific expertise within CDRH and CDER, it is unrealistic to expect staff to encompass all of the applicable expertise and experience necessary to fulfill its mission, given the rapidly growing variety and complexity of medical devices and pharmaceuticals. This is particularly true when it comes to new and emerging fields of science and pioneering technologies. In these areas, it is often necessary for staff to gain further scientific understanding from sources outside of the federal government. The Network of Experts facilitates this exchange.

“AMIA stands alone in this distinction among peer associations,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI. “The Network of Experts provides AMIA members a unique opportunity to improve health and health care on a national scale.”

2017 will be an important year for the FDA as medical device and prescription drug user fee agreements are debated and authorized by Congress. These agreements outline how FDA will spend billions in user fees collected from medical device and pharmaceutical companies to review products and drugs. Among the commitments made by FDA to industry are plans to use “real-world evidence” to evaluate the safety and effectiveness of devices and drugs, the use of advanced simulations for clinical trials and “model-informed drug development,” and creation of a Digital Health unit inside CDRH to review Software as a Medical Device and Software inside a Medical Device.

FDA officials have also discussed their vision for a National Evaluation System for health Technology, or NEST, which will include functional links across a range of systems and federal agencies, developed to capitalize on existing digital information collected in the course of health care delivery, such as EHRs, insurance claims, and data housed in clinical registries.

“As we look to the horizon, the impact that informatics can have in helping FDA balance the need to facilitate innovation while protecting public health and safety is enormous,” said Jeffery Smith, MPP, AMIA vice president for public policy. “During our 2016 AMIA Policy Invitational, FDA Commissioner Califf called informatics ‘a gateway to bring the two together, to facilitate innovation and regulation at the same time.’ We agree, and our members stand ready to assist FDA in this mission.”