Policy Panel Endorses Proposal for Greater Oversight of EHRs

On Wednesday, the Health IT Policy Committee adopted recommendations from its adoption and certification work group that call for the creation of a national database to track errors and safety issues associated with electronic health records, Government Health IT reports.

The recommendations also call for the establishment of a patient safety organization to analyze and investigate the error reports.

Should FDA Play a Role?

The Policy Committee also discussed whether FDA should play a role in regulating EHR safety.

Jeffrey Shuren -- director of FDA's Center for Devices and Radiological Health -- said FDA has the authority to regulate health IT tools but has refrained from doing so because EHRs often are interconnected with other products.

Some panel members expressed hesitation about FDA regulation, saying it potentially could inhibit innovation (Mosquera, Government Health IT, 4/22).

Paul Egerman and Marc Probst, co-chairs of the adoption and certification work group, said their recommendations focus on the creation of an oversight system without specifying which agencies should run the system or how it should be structured (Guerra, InformationWeek, 4/22).

In its adopted recommendations, the Policy Committee said the Office of the National Coordinator for Health IT should work with FDA and other stakeholders to determine what role FDA should play in regulating and certifying EHR safety.

National Coordinator for Health IT David Blumenthal said his office already is communicating with FDA about the issue.

Other Safety-Related Recommendations

Some additional safety recommendations adopted by the Policy Committee call for:

  • Health IT systems to include a feedback button to make it easier for health care providers to report problems;
  • EHR vendors to maintain records of all safety concerns and establish processes to notify affected customers;
  • ONC to sponsor a study evaluating health IT-related safety concerns and corrective actions;
  • Regional extension centers to provide training on reporting health IT-related safety events; and
  • The Health IT Standards Committee to consider mandating the use of audit trails to make it easier to identify the source of EHR malfunctions (Goedert, Health Data Management, 4/21).

Moving Forward

The Policy Committee will present its recommendations to ONC, which will decide whether to adopt the proposals and how to implement any new patient safety measures (Government Health IT, 4/22).

Bobby Lee
This area has been somewhat glossed over in the past and I'm glad it is starting to bubble up. One thing to note is that EMR/EHR will highlight paper based safety issues that existed before (which is good) as well as new issues because of it (which we must do something about).
Gurdev Singh
This is, altogetther, a very necessary and wise endorsement.

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