As we physicians know, health IT is a field that is rapidly expanding and promises to continue its speedy evolution. Health professionals are starting to realize that increased oversight of these technologies, specifically with regard to patient safety, is crucial.
As part of the Food and Drug Administration (FDA) Safety and Innovation Act, the FDA, the Federal Communications Commission and the U.S. Department of Health & Human Services’ Office of the National Coordinator for Health Information Technology (ONC) collaborated to produce a proposed risk-based regulatory framework for health IT. The proposed plan would create oversight of health IT and establish a safety center to monitor any patient safety problems with electronic health records (EHR) and other health IT.
I’m a proponent for using technology smartly and safely, so I’m proud that the AMA supports this collaborative effort. While health IT has the potential to help improve patient safety, it also can cause unintended harm. Developing and implementing a patient safety infrastructure is urgently needed.
The AMA weighed in on the FDA’s proposed framework last week, encouraging a comprehensive and integrated approach to patient safety and health IT.
For example, we support the creation of a multi-stakeholder safety center that includes practicing physicians who use and understand EHRs and other health IT. A center that focuses on promoting health IT innovation by building on evidence would provide more formal industry oversight and contribute to improved patient safety.
The FDA strategy proposes using successful safety models, such as those used by the Aviation Safety Information Analysis and Sharing and patient safety organizations, as a basis for identifying and diminishing adverse events. The AMA agrees, and we’re pushing for a framework that is cooperative between the government and the health IT industry.
Our comments also highlighted that more attention should be paid to health IT in the ambulatory setting. Research is currently lacking in this area, but we need to consider how processes and systems can differ across care settings. This will help us to make smart decisions about how health IT is employed and how patient safety can be protected.
Additionally, we’re asking for increased focus on mobile health apps. Growing evidence suggests that many consumer- and physician-targeted apps are misleading at best and dangerous at their worst. The agencies involved in this proposal should continue exploring collaborations with technology vendors to learn more about these apps and their uses.
The AMA has made it a priority to ensure health IT is implemented in a way that is most beneficial for physicians and their patients. We’re working to improve the usability of EHR systems, reduce burdens placed on physicians by programs like meaningful use and develop tools that will equip physicians to be better EHR users.
Overall, we’re on the right track in moving toward more efficient, safety-driven regulation of health IT. The collaborative efforts between these government agencies are a huge step forward. Taking a unified approach will ensure widespread deployment of well-developed and safe technology that better serves our practices and our patients.
