The Department of Health and Human Services has released the “Health IT Patient Safety Action and Surveillance Plan” for public comment. The comment period closes Feb. 4, at 11:59 pm EST.

The patient safety action plan is the response by the Office of the National Coordinator for Health Information Technology about the growing potential of health I.T. to be a contributor to medical errors. The ONC commissioned a study by the Institute of Medicine about how to identify and mitigate those risks; the action plan is based on that study and its recommendations.

The action plan outlines goals, strategies and actions to get stakeholders to coordinate efforts to improve health I.T. safety, some of which could have significant impacts on the HIT regulatory environment.

For example:

* One goal is to make it easier for clinicians to report patient safety events and risks using EHR technology. To do so, ONC intends to propose using certification criteria to ensure EHRs can facilitate reporting patient safety events in the Common Formats developed by the AHRQ. The forms are a reporting tool that standardizes and promotes increased reporting of adverse events, near misses and unsafe conditions. The most recent version of the Common Formats includes a “Device with Health IT” format that allows collection of standardized information about I.T.-related adverse events as well as events where health IT may be a contributing factor.

* The ONC plans to, within 12 months of the release of the safety plan, develop a code of conduct for health I.T. vendors to enable them to “embrace their shared responsibility for patient safety and promote reporting of patient safety events and risks.” The ONC wants health I.T. developers to work with patient safety organizations, or similar entities, to report, aggregate, and analyze health I.T.-related safety events. Developers would be required to provide safety information related to their product for the purposes of improving patient safety. “Currently, the patient safety work product (PSWP) protections do not extend to developers reporting events to PSOs. However, HHS believes there may be ways developers can mitigate risks of reporting. HHS will monitor this and would consider suggestions on how to expand PSWP protections,” the proposed safety plan states.

* Another proposal is to incorporate health I.T. safety in post-market surveillance of certified EHR technology through ONC-Authorized Certification Bodies (ONC-ACBs). ONC will work with ONC-ACBs and the ONC-Approved Accreditor to provide guidance on: 1) developers keeping a record of complaints; 2) making complaint records available to the certification body upon re­quest; 3) taking appropriate action with respect to com­plaints; and 4) documenting actions taken. The ONC, the report states, expects that ONC-ACBs will conduct surveillance to ensure that the capabilities of certified EHR technology work in operational settings (in the field or in a live environment) to the same extent as when they were certified, and ONC-ACBs could review and validate a sample of the complaints EHR technology developers receive.

The entire Health IT Safety Plan may be viewed here.

Comments should be sent to ONC.Policy@hhs.gov

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