HIT stakeholders raise concerns with FDASIA framework

Several healthcare industry groups are raising concerns in new comments submitted this week to the U.S. Food and Drug Administration about the health IT risk-based regulatory framework it published in April in conjunction with the Office of the National Coordinator for Health IT and the Federal Communications Commission.

For instance, the American Hospital Association, in a letter to Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, remarks that the report only distinguishes various types of health IT based on "descriptions of the technology as it is currently used." The AHA also worries that the "functional approach" within the report fails to capture three important facets of health IT: interoperability of information across data sources; product usability; and accurate patient matching.

"We recommend that the final report include all three of these factors as considerations in the assessment of health IT by level of risk," the letter states.

Meanwhile, the College of Healthcare Information Management Executives and the Association of Medical Directors of Information Systems, in joint comments, call electronic health record certification a primary method to ensure patient safety through the use of health IT. The groups call for the ONC to "retool" the EHR certification program to focus on three areas: beta-testing, post-certified performance and standard adherence.

"The single biggest action federal regulators could take to improve patient safety is to identify clear standards and require strict adherence to those standards," CHIME CEO Russell Branzell says in a statement.

Health attorney Brad Thompson of Epstein Becker Green, representing five groups--including the CDS Coalition, the CDS Consortium, the Continua Health Alliance, the mHealth Regulatory Coalition and the Wireless-Life Sciences Alliance--specifically calls for less regulation of clinical decision support tools, saying that a distinction between man and machine must be made when assessing such risk.

"In our view, the need for FDA oversight of CDS depends entirely on whether the CDS is designed and marketed with an expectation that the user will be substantially dependent on the CDS in making a clinical decision," Thompson writes. "FDA should not regulate CDS that is not expected to create substantial user dependence."

The Bipartisan Policy Center generally agrees with the recommendations made in the FDA's Safety and Innovation Act report, calling it consistent with its own proposed health IT safety framework, published in February 2013.

The framework is "the right approach for protecting patient safety and continuing to promote innovation in the development, implementation and use of health IT," it says.

To learn more:
- here's the AHA letter (.pdf)
- check out the CHIME/AMDIS announcement
- read Thompson's letter (.pdf)
- here's the BPC letter (.pdf)