Latest Health IT Policy Developments

Deven McGraw, Proje­ct HealthDesign Regulatory and Assurance Advisory Group, Center for Democracy & Technology

A new year has started — year two of the incentive program to encourage the meaningful use of certified electronic health record technology to improve individual and population health. It’s a good time to get caught up on policy developments from the end of a very busy 2011 and provide an update on expected developments in early 2012.

On November 7, the Institute of Medicine issued a report and recommendations intended to assure the safety of EHRs. The report identifies some safety risks associated with EHRs and acknowledges the potential for safety benefits. The report also recommends the establishment of a new entity to investigate EHR safety risks and urges HHS to establish a mechanism for vendors and others to report safety-related incidents. In response to the report, ONC noted it is already in the process of developing an EHR safety and surveillance plan.

In December, the Department of Health & Human Services (HHS) announced that providers who started participating in the  meaningful use incentive program in the first year (2011) will have an additional year (until 2014) before being required to meet the more robust meaningful use Stage 2 requirements. This change, which was initially recommended by the Health IT Policy Committee, is intended to give providers a longer period of time to adjust to and implement the earliest stage of meaningful use before being required to demonstrate more robust use and exchange of health information in Stage 2.

Speaking of meaningful use, the proposed meaningful use requirements for Stage 2 are still expected to be released early in 2012. In addition, the Health IT Policy Committee has begun discussions about requirements for Stage 3, and incorporation of patient-generated data into EHRs continues to be a priority.

ONC unveiled its consumer engagement program in September, and the office is continuing to roll out initiatives to promote consumers’ use of e-health tools to improve their health:

• Earlier this month, ONC announced the Healthy New Year video challenge intended to collect short (up to two minutes) videos from consumers sharing their new year’s resolutions for the use of e-health tools to improve their health or the health of their families. The deadline to submit a video is February 16, at 5 p.m. EST. Cash prizes will be awarded to the top videos.

• On December 6, the Office of the Surgeon General and ONC launched a Healthy Apps Challenge to encourage the development and submission of technology apps that tailor health information to the needs of the consumer user and empower the public to regularly engage in and enjoy health-promoting behaviors. The deadline for entry was December 31, 2011. Winners will be announced on January 31, 2012 and finalist apps will be featured on an HHS website.

ONC also has launched efforts to gather more information about consumer concerns about e-health privacy and security. Specifically, ONC is surveying consumers (and conducting focus groups) about attitudes and preferences regarding the communication of personal health information using mobile devices. In addition, ONC will conduct annual, nationwide surveys to assess the percentage of individuals who are concerned about the privacy and security of EHRs, who report having kept any part of their medical history from their doctors due to privacy concerns, and who are concerned that an unauthorized person would see their medical information if it is sent electronically, among other key measures. ONC will assess trends in consumer privacy and security views between 2012 and 2016 and intends to compile the results into a final report.

Stay tuned for further updates.

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Institute of Medicine Weighs In On Health IT and Patient Safety

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.

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