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.
Time to regulate health IT?
AMIA seeks to foment serious consideration of topic
The association stopped short of calling for federal regulation of the health IT industry in a five-page report that was released Nov. 11 and endorsed by the AMIA’s board of directors. The report, Challenges in Ethics, Safety, Best Practices and Oversight Regarding HIT Vendors, Their Customers and Patients: A Report of an AMIA Special Task Force, was the product of an eight-member task force impaneled by the AMIA board in September 2009.
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.
The declaration is almost an about-face from a 1997 recommendation that the AMIA made in conjunction with other healthcare organizations. The groups urged the FDA to exempt most clinical software systems from regulation and instead focus regulatory efforts on those systems posing the highest clinical risk.
In the new report the task force also noted that Sen. Chuck Grassley (R-Iowa), the ranking member of the Senate Finance Committee, has requested information from hospitals and IT vendors. Specifically, Grassley asked hospitals about gag clauses in their IT contracts that might bar them from talking about system glitches and about 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 organization proposes doing that through the existing task force or a new one.
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 medication-administration record systems and laboratory systems.”
Task force Chairman Kenneth Goodman said the group also made recommendations to eliminate the “hold harmless” clauses vendors often insert in contracts with providers and the gag clauses that prevent providers from discussing systemic errors with other providers.
“The latter was the source of some pretty intense debate,” said Goodman, a professor of medicine and the director of the bioethics program at the University of Miami.
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