EHR Association supports FDA plans

July 8, 2014 in Medical Technology

The EHR Association, with its nearly 40 EHR vendor members, largely supports the proposals for regulation of health IT put forth in a draft report from the Food and Drug Administration and other agencies, according to a July 7 letter to FDA Commissioner Margaret Hamburg, MD.

The letter, signed by EHR Association Chair Mark J. Segal of GE Healthcare, as well as the association’s vice president and executive committee, is in response to the report on health IT safety released by the FDA this past April.

[See also: FDA goes for ‘light touch’ on health IT.]

“EHRA supports the approach proposed in the draft report that categorizes health IT based on the level and nature of risk, then applying appropriate oversight mechanisms,” the letter states. “We have promoted such an approach for some time.”

However, the association cautions that the limited number of examples of applications in each category provided in the FDA report is not sufficient to determine the risk categories for the many existing and new applications being developed.

On the issue of interoperability, the association said, “yes,” interoperability should be tested, adding that it is important that  a common test is agreed upon for a given standard.

The Office of the National Coordinator for Health IT and the Federal Communications Commission joined the FDA in drafting the report, which was mandated under the Food and Drug Administration Safety Innovation Act of 2012, often referred to as FDASIA. The report now goes on to Congress.

When it was released in April, it was generally well received by industry insiders.

“By stating that FDA will not actively oversee what the report calls ‘Administrative HIT products’ and ‘Health Management HIT,’ even if they meet the FDA’s definition of a medical device – this could be pretty huge,” Robert Jarrin, senior director for government affairs for Qualcomm and a member of the FDASIA External Working Group, said at the time.

“I found the line on the executive summary quite telling,” he added. “‘We believe a limited, narrowly-tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities is prudent. We also recommend that no new or additional areas of FDA oversight are needed.’”

[See also: Take-aways from the FDASIA meeting.]

The EHR Association was also pleased with this approach to administrative health IT.

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