Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP
All of us working in health care are keenly aware of the importance of ensuring that health IT improves the quality of health care without creating a new set of patient safety risks. With the release of a new report titled “Health IT and Patient Safety: Building Safer Systems for Better Care” by the Institute of Medicine (IOM), the issue of health IT safety is now on the radar screen as a major policy challenge.
IOM released the report in response to a request by the Office of the National Coordinator for Health IT (ONC) for recommendations about what a comprehensive health IT safety policy should look like. Among other recommendations, IOM suggested that the federal government create a new independent watchdog agency, along the lines of the National Transportation Safety Board, to accept reports on patient deaths, serious injuries or potentially unsafe conditions associated with health IT. IOM skirted the issue of whether the U.S. Food and Drug Administration should have immediate responsibility for overseeing health IT safety.
While the entire report is worth reviewing, I want to call special attention to the fact that the report includes a chapter devoted to the safety of health IT tools “designed to engage and support patients in health-related decision making and management of their own personal health information” (see chapter 5 “Patients and Families Use of Health IT: Concerns about Safety”). The chapter specifically references patients’ ability to use personal health records (PHRs) and other tools to record and share “activities of daily living.” It also cites “Project HealthDesign: Rethinking the Power and Potential of Personal Health Records” by Patricia Flatley Brennan, Steve Downs and Gail Casper.
The report doesn’t offer up a silver bullet for avoiding patient safety risks created by PHRs and other patient engagement tools. Rather, it highlights that health IT is one component in a larger sociotechnical system that includes technology, processes, organizational practices and the external environment, and that adding patients into the mix inserts an additional layer of complexity when it comes to patient safety.
The report’s key point about PHRs is summed up in the following quote: “Given the importance of clear patient-provider communications, special attention may have to be devoted to ensuring that computer-mediated interactions are not used inappropriately.” It goes on to note that one important way to ensure patient safety is for health care providers to manage patient expectations about how information they include in a PHR or other patient engagement tool will be used. According to IOM, health professionals, patients and their families need to develop “a shared understanding of appropriate use of patient-centered, validated data.”
Sound familiar? It should, because it’s consistent with the discussions we’ve been having with the current Project HealthDesign grantee teams about how to minimize health care providers’ medical malpractice liability when incorporating ODLs into clinical care assessments and decisions. In April 2010, the grantees raised a number of concerns, such as how to ensure the accuracy of patient-generated health data and whether health care providers are expected to review every piece of information that patients provide on a round–the-clock basis. These concerns are driving Manatt and CDT’s work on a set of recommendations to develop a shared set of expectations among patients and health care providers about the role of patient-generated data in clinical care.
Although we are formulating these recommendations with a focus on reducing health care providers’ legal liability — a cross-cutting policy issue that could stymie the incorporation of ODLs into clinical practice if not addressed — IOM reminds us that, at the end of the day, managing patients’ expectations about the incorporation of their ODLs into their care is also a patient safety issue.
The IOM report makes a total of 10 patient-safety related recommendations. I encourage everyone to review the recommendations and to read Chapter 5 of the report.