The American Medical Informatics Association has called for a national discussion about whether federal regulation of health information technology systems could help promote patient safety.
AMIA: Time to revisit government regulation of health IT
The association on Thursday stopped just short of calling for federal regulation of the health information technology industry in a five-page report endorsed by the AMIA's board of directors.
The report, "HIT Vendors, their customers and patients: New challenges in ethics, safety, best practices and oversight," was the product of a task force impaneled by the AMIA board in September 2009 and composed of eight representatives from academia and the IT industry.
The report was released at the association's annual symposium in Washington.
Task force members were mindful of the controversy surrounding possible government regulation of medical and health-related software but concluded that "some system of government oversight or regulation of health information technology needs to be given serious consideration," according to the report.
This latest declaration is almost an about-face from a 1997 recommendation that the AMIA made in conjunction with other healthcare organizations. That report urged the FDA to exempt most clinical software systems from regulation and instead focus regulatory efforts on those systems posing the highest clinical risk.
"The idea of additional regulation or oversight of HIT vendors continues to be a source of intense controversy,” the new report's authors wrote. But, the group noted that the FDA recently asked selected hospitals for reports on safety issues regarding health information technology systems. The task force also noted that Sen. Charles Grassley (R-Iowa), the ranking member of the Senate Finance Committee, asked hospitals about gag clauses in their IT contracts that bar them from talking about system glitches and providers' financial ties to IT vendors.
The report authors concluded that because there has been "extraordinarily rapid growth" in IT adoption since 1997—including the adoption of direct digital links between regulated patient monitoring devices and unregulated health IT systems—the AMIA should "join with other stakeholders to revisit the role of governmental and other formal regulation." The task force also recommended re-examining "governance of institutions that manufacture and use health information systems—including, but not limited to, electronic health records, personal health records, computerized provider order entry systems, electronic medicate administration record systems and laboratory systems."
The AMIA should either direct the existing task force or organize a new one to move forward with the new recommendations, as by defining a framework of best practices for addressing patient safety issues as they arise with health IT systems and creating an IT defect-and-hazard reporting mechanism.
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