HHS response to IOM's safety report may need some tweaking

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At long last, the U.S. Department of Health & Human Services has responded to the Institute of Medicine's Nov. 2011 report calling for more action to improve patient safety when providers use electronic health records and other forms of healthcare technology.

The HHS response, released Dec. 21, is an impressive document. It outlines a number of initiatives to reduce the chance of patient harm when technology is used. Proposed initiatives include:

  • Engaging health IT developers to "embrace their shared responsibility for patient safety" and promoting reporting of events and risks, including the development of a code of conduct
  • Requiring the Agency for Healthcare Research and Quality to issue guidance to provide support to patient safety organizations to identify, aggregate and analyze adverse events related to EHRs and other health IT
  • Monitoring health IT adverse reports through the U.S. Food and Drug Administration's manufacturers' medical device database
  • Using Meaningful Use to improve patient safety
  • Aligning health and safety standards from the Centers for Medicare & Medicaid Services with the safety of health IT, and training surveyors accordingly.

The 39-page plan reports that it "builds on IOM's recommendations" and even includes a handy crosswalk between the IOM's recommendations and the HHS' response to each of them.

However, note that this is a proposed plan; HHS is accepting comments on it through Feb. 4. And even with just one reading of the plan, several issues jump out, including:

  1. The IOM recommends that health IT developers be required to report health IT-related adverse events. The HHS report lets vendors off the hook, calling for them instead to create and adhere to a voluntary code of conduct, and stating that Office of the National Coordinator for Health IT certifying entities will be "encouraged" to conduct surveillance of complaints. To me that doesn't go far enough. Vendors have a shared responsibility for patient safety. A code of conduct sounds more suitable for the Boy Scouts.
  2. The IOM recommends that an independent federal entity be established to investigate adverse health IT-related patient safety events, as well as monitor events, analyze data and issue reports. ONC has opted to retain this authority. That's all well and good, except that ONC already has a lot on its plate implementing the Meaningful Use Incentive Program. It also could be argued that with ONC's championing of EHR adoption, it could run into a potential conflict of interest if patient safety issues impeded EHR adoption and the Meaningful Use program. Why put itself in such a quandary?
  3. ONC intends to monitor adverse patient safety events via the FDA's manufacturer medical device database. However, the FDA has stated before that it doesn't consider EHRs, personal health records, and other general IT products to be medical devices. If they're not medical devices, then would health IT adverse events even be reported to that database? Would there be anything relevant for ONC to monitor?

Readers, please take a few moments to review the HHS response and see if you believe it's adequate to address patient safety issues stemming from EHRs and other IT products. If not, please make your voice heard and submit comments to HHS. - Marla