The HIT Policy Committee, a federal advisory board, has approved a number of recommendations for increasing oversight of the safety of electronic health records.

The recommendations come amid debate of whether the Food and Drug Administration should regulate EHRs. The committee on April 21 adopted recommendations from its Adoption-Certification workgroup that stop short of endorsing regulation but acknowledge the FDA has expertise that the Office of the National Coordinator for Health Information Technology should tap into. "We recommend that the ONC work with the FDA and representatives of patient, clinician, vendor and health care organizations to determine the role that FDA should play to improve the safe use of Certified EHR Technology."

National Coordinator David Blumenthal, M.D., emphasized at the committee meeting that his office and the FDA already are in continuous communication with each other.

Other recommendations to increase the safety of EHRs include:

* Create a national, transparent oversight process and information system, similar to a Patient Safety Organization, to confidentially collect, investigate and disseminate reports of unsafe conditions caused by health information technology systems.

* ONC should commission a formal study to thoroughly evaluate HIT patient safety concerns and actions to address those concerns.

* Stage 2 of meaningful use criteria should include a requirement that providers report HIT-related patient safety issues to a HIT safety organization, with copies sent to affected vendors.

* EHR certification criteria should include functionality, such as a "feedback button," to make it easy for users to immediately report problems or concerns with information that appears on screens to appropriate staff who can take corrective action.

* Regional extension centers should provide HIT-related patient safety reporting training.

* Stage 2 EHR certification criteria should require vendors to maintain records of all customer-reported patient safety concerns, and have processes to promptly notify all affected customers.

* The HIT Standards Committee should consider requiring the use of audit trails or logs of interface transactions to ease the tracing and analyzing of sources of problems.

* ONC should work with regional extension centers, the American Medical Informatics Association and other organizations to create a set of best safety practices for selecting, installing, using and maintaining HIT systems.

* ONC should discuss HIT patient safety concepts with accreditation organizations to determine, for example, if they are examining whether large institutions have a patient safety review committee and whether processes are in place that encourage reporting of problems.

* For Stages 2 and 3 of EHR certification, the criteria should be available at least 18 months prior to the beginning of the eligibility period to ensure adequate testing of the software.

The complete letter of recommendations, minus several minor amendments--such as making certification criteria "available" rather than "finalized" 18 months before the eligibility period--is available here. Click on Certification/Adoption Workgroup Letter. The final version should be available within days at http://healthit.hhs.gov.

--Joseph Goedert

 

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