New Vendor Coalition Seeks More FDA Regulation, Including EHRs

Laboratory information systems vendor Sunquest is spearheading development of a new coalition of vendors regulated and unregulated under the Food and Drug Administration to push for additional FDA regulation in the health information technology industry, including electronic health records vendors.

Sunquest has had preliminary discussions with six other regulated vendors whom it describes as medical device firms that have shown substantial interest in joining the coalition, called The HIT Group. Sunquest also is sending a letter to other vendors in the HIT community, including those not currently regulated, asking them to consider joining the group. The plan is to announce charter members and goals during the first quarter of 2014.

“Sunquest believes it is important to adopt a balanced approach to healthcare IT, one that supports continued innovation, assuring appropriate patient protections,” according to a cover letter and attachment with additional information being sent to HIT companies. “Sunquest wants to partner with other vendors and the federal agencies to help author clear, predictable and reasonable regulations with patient safety representing the top requirement. The related impact to product development practices must also be explicitly dictated.”

Electronic health records will be part of the debate, says Patrice Nedelec, vice president of client experience at Sunquest. He emphasizes that the goal is to avoid over-regulation, but to have a clear focus on patient safety and a balance for businesses to remain agile and efficient.

Any EHR function that impacts diagnosis, treatment and follow-up should be regulated, Nedelec said in an interview with Health Data Management. “That’s patient safety at its core.”

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