HHS' OIG to review efficacy of FDA's oversight of medical devices linked to EHR

The Office of Inspector General for HHS released its Work Plan for fiscal year 2016, outlining new and continuous reviews of HHS programs and operations the agency plans to carry out.

New to this year's work plan is a review of the U.S. Food and Drug Administration's oversight of medical devices that integrate with EHRs.

"We will examine whether FDA's oversight of hospitals' networked medical devices is sufficient to effectively protect associated electronic protected health information and ensure beneficiary safety," according to the work plan, naming devices such as dialysis machines, radiology systems and medication dispensing systems.

Though not new to this year's work plan, the OIG will continue to review Medicare and Medicaid incentive payments for the EHR meaningful use program, as well as conduct audits gauging the security of certified EHR technology being used in the meaningful use programs.

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