Robert D. Belfort, Manatt, Phelps & Phillips, LLP, Project HealthDesign Regulatory and Assurance Advisory Group
Just before the holidays, on December 21, 2012, the Office of the National Coordinator for Health IT (ONC) released its draft “Health IT Patient Safety Action and Surveillance Plan.” ONC released the Plan in response to a November 2011 Institute of Medicine (IOM) report called, “Health IT and Patient Safety, Building Safer Systems for Better Care.” I wrote a blog about the IOM’s report, which you can read here.
IOM released its November 2011 report in response to a request by 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.
ONC stopped short of taking the IOM’s recommendation. Instead, in its draft Plan, ONC proposed to leverage existing federal agencies’ authorities and private sector safety programs to increase knowledge about health IT safety among health care professionals and improve how health IT makes care safer. The draft Plan prescribes a list of actions that are organized under three strategies: (i) Learn: increase the quantity and quality of data and knowledge about health IT safety; (ii) Improve: target resources and corrective actions to improve health IT safety and patient safety; (iii) Lead: promote a culture of safety related to health IT.
Below are some highlights from the draft Plan:
- ONC will work with developers on a code of conduct that commits developers to (i) work with Patient Safety Organizations or similar entities to report, aggregate, and analyze health IT-related safety events; (ii) support providers in reporting safety events; and (iii) collaborate with private sector efforts to make comparative user experience with different EHR systems more available.
- ONC will leverage ONC-ACB surveillance and live testing to ensure EHR safety features are functional in live environments and that developers address safety complaints. ONC will continue to incorporate safety into its standards and certification criteria.
- ONC will monitor health IT adverse event reports to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
- The Agency for Healthcare Research and Quality (AHRQ) and ONC will work with providers and PSOs to incorporate AHRQ Common Formats into providers’ health IT and reporting systems. AHRQ Common Formats allow for easy, real-time reporting and aggregation of patient safety events and risks.
- AHRQ, in collaboration with ONC, will work with PSOs, providers, and developers to add a focus of health IT to their collection, aggregation, analysis, and mitigation of providers’ adverse event reports. AHRQ will also provide guidance to PSOs on how they can work with providers to use health IT to improve reporting and mitigate health IT risks.
- The Centers for Medicare & Medicaid Services will align its safety standards for health care facilities, its interpretive guidance, and surveyor trainings to add a focus on health IT and patient safety.
Reactions to ONC’s proposed Plan are only beginning to trickle in. Some stakeholders are suggesting it doesn’t go far enough while others are calling the proposal a necessary step in the right direction. We thought it was interesting that, while the IOM’s report included an entire 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”), ONC’s proposed Plan includes no such references. The IOM report specifically noted patients’ ability to use personal health records (PHRs) and other tools to record and share “activities of daily living.” It did not offer up a silver bullet for avoiding patient safety risks created by PHRs and other patient engagement tools but it noted 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.”
Do you think that ONC’s proposed Plan should include more of a focus on the unique patient safety challenges associated with PHRs and other health IT tools that enable patients to generate and share health information? You have until February 4th to provide public comments, which can be submitted to ONC.Policy@hhs.gov.
You can read the draft Patient Safety Plan here: http://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf