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Electronic Health Record Systems Will Require 'Some Form of Oversight,' Government Advisor Says

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By Turna Ray

WASHINGTON, DC — As more healthcare providers move to implement electronic health records by 2011, the technologies for storing and managing these vast data sets will need to be regulated, an advisor to the federal government said at a conference here this week.

“There is some form of oversight necessary,” John Glaser, senior advisor of the Office of the National Coordinator for Health Information Technology, said at a colloquium on personalized medicine hosted by the American Association for the Advancement of Science. He acknowledged that a regulatory process would be necessary to handle the limitations of EHR systems and managing malfunction issues.

Glaser noted that ONC met with FDA this week to discuss regulation of EHR-related technologies. “Is it a formal device or not? I don’t know,” Glaser said, adding that he wasn’t sure whether regulation of EHR systems would necessarily fall under FDA oversight.

“However, to a large extent human aptitude plays a huge part in how well the software works,” said Glaser, who is also the chief information officer of Partners HealthCare System.

EHRs have been proposed as a key component of personalized healthcare, and Glaser noted at the meeting that they could be a powerful tool for picking up post-marketing drug risk information and relative risk data. At the meeting, other officials from government and academia outlined several efforts to use EHR systems to look for genes associated with disease predisposition and drug response (see related article, this issue).

The Certification Commission for Healthcare Information Technology, a private organization, conducts one-day testing of EHR systems. But currently no federal oversight of EHR systems exists.

Earlier this year, an article titled "Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems," published in the Harvard Journal of Law and Technology, advocated for federal oversight of EHR systems. Although the authors did not feel that oversight responsibilities should necessarily rest at the FDA, they recommended that EHR systems should be monitored for as long as they are operational so technical problems are detected and the system is continually improved.

The regulatory oversight for EHR systems is a looming question as hordes of healthcare providers will be moving to electronic record systems in the next five years, urged by the promise of federal funding. The stimulus package offers incentives to hospitals and physicians for the “meaningful” implementation of electronic health records. Glaser is helping the federal government implement its programs.

Physicians who accept Medicare and use EMRs can receive up to $44,000 over a five-year period between 2011 and 2016. Doctors who see more than 30 percent of patients receiving Medicaid benefits are eligible for up to $64,000 beginning in 2011 if they adopt the technology.

Furthermore, there are penalties proposed for non-adopters. Healthcare providers who have not shown “meaningful use” of a certified EHR system by 2014 can see a decrease of up to 1 percent in the Medicare fee schedule for 2015. The Medicare fee payment reductions will continue for every year of non-compliance. The deduction rate can go up to a maximum of 5 percent if total EHR adoption is under 75 percent of eligible providers by 2018.

In a recent study, researchers from the Harvard School of Public Health, Massachusetts General Hospital, and George Washington University found that less than 2 percent of hospitals had implemented comprehensive EHRs; and less than 8 percent had basic EHRs in place.

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