Setting health IT standards could promote innovation – report

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Congress should require the federal government to establish standards for health information technology, according to an analysis released Friday by the nonprofit Bipartisan Policy Center in Washington.

The recommendation was one of several in a report that examined how Congress could make the process for approving drugs and medical devices more efficient and less expensive. Members of the BPC committee who wrote the report based it on “extensive research and interviews with industry, patient groups, academia, government, and legislators.”

According to the report, Congress should establish standards for a range of issues, including patient data, provider identification and security.

Most of the recommendations centered on bolstering the Food and Drug Administration, the agency that evaluates medical products. Indeed, according to the report, $1 out of every $4 consumers spend is on an FDA-approved product — drugs, devices, food and tobacco.

“Americans cannot afford to rely on 20th century methodologies for treatments when the world is on the cutting edge of new medical technologies,” former Senate Majority Leader Bill Frist, a co-chair of the group that developed the report, said in a release. “Federal agencies must be equipped to keep the U.S. at the forefront of medical innovation.”

Authors said Congress should also encourage FDA to provide its IT infrastructure so it better supports communications between reviews, centers and sponsors. The report also said that Congress should establish a working group on precision medicine.

Several of the recommendations are integrated into the 21st Century Cures Act, which cleared the house earlier this month. In the release, Director of Health Innovation Janet Marchibroda said the recommendations would offer the FDA the tools to succeed in a fast-changing field.

“The policy recommendations in this report will accelerate the delivery of much-needed, safe and effective cures to patients,” she said.

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Department of Health and Human Services (HHS), Departments, Food and Drug Administration, Health IT, Tech
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