literature in depth and solicited examples of harm from the public. We also specifically sought and received input from the vendor community on numerous occasions. We found that specific types of health IT can improve patient safety under the right conditions, but those conditions cannot be replicated easily and require continual effort to achieve. We tried to balance the findings in the literature with anecdotes from the field but came to the realization that the information needed for an objective analysis and assessment of the safety of health IT and its use was not available. This realization was eye-opening and drove the committee to consider ways to make information about the magnitude of the harm discoverable.

The committee offers a vision for how the discipline of safety science can be better integrated into a health IT-enabled world. Early on we concluded that safety is the product of the larger sociotechnical system and emerges from the interaction between different parts of this larger system. This finding is not new. It is apparent in many other industries and has been introduced in health care before, but it needs to be underscored.

Building on the concept of a sociotechnical system, the committee concluded that safer systems require efforts to be made by all stakeholders. A coordinated effort will be needed from the private sector. However, the public sector must also be part of a solution to protect patient safety for two reasons: (1) patient safety is a public good and (2) with the government’s large investment in this area, it has a fiduciary responsibility to ensure the value of its investment.

Definitive evidence was not available in many areas, such as determining what the roles of specific private- and public-sector actors should be and how regulation would impact innovation in this area. Where evidence was not available, the committee—broad in its expertise and beliefs—relied on its expert opinion. While the entire committee believes the current state of safety of health IT must not be permitted to continue, individual approaches differed on how to best move forward and the speed for doing so. Over the course of many conversations, the committee designed recommendations that balance these approaches and strike common ground, outlining a private-public framework for improving patient safety without constraining innovation.

Unfortunately, we were unable to resolve the issues raised by one committee member. In his statement of dissent in Appendix E, he calls for health IT to be regulated as a Class III device under the Food and Drug Administration’s (FDA’s) medical device classification scheme. The dissent makes no mention of FDA’s capacity or the very serious implications that regulation of health IT by FDA as a Class III device could have on innovation. We deliberated about these issues over the course of the entire study and tried at length to understand each other’s perspectives toward reaching consensus



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