April 4, 2014 | 3
Health information technologies such as smartphone-based ultrasound and electronic health records should be regulated according to the risk they present to patients, per a proposed strategy rolled out Thursday by three federal agencies. The report, which is still subject to public comment, did not call for an extension of regulatory power for the agencies. Instead it emphasized the need for voluntary collaboration and planning by public-private partners. “Nongovernmental, independent programs to perform conformity assessments should be developed to fill current gaps,” it recommended. “The Agencies view this strategy rather than a formal regulatory approach as the appropriate method for advancing conformity assessments.”
The recommendations from the Food and Drug Administration, the Federal Communications Commission and the Dept. of Health & Human Services’ Office of the National Coordinator for Health IT (ONC) were largely aligned with those that were issued by an advisory committee last year that sought to strike a balance between innovation and safety monitoring. The agencies state in the report that instead of regulating these technologies by their platform, say a mobile phone versus a computer, their level of regulation should be determined by their functionality and the threat they pose to patients.
The report fell short of providing needed safety mechanisms to capture errors in electronic medical records, a vulnerability which Scientific American pointed out in an editorial in the October edition of the magazine. (Read it here). Scientific American editors wrote that this congressionally-mandated action would have been the perfect opportunity to call for setting up a system much-like the National Transportation Safety Board only for electronic health records – designed to catch and fix medical mistakes such as misreported lab tests or incorrect prescriptions.
The plans included in the draft report today instead suggested setting up a general Health IT Safety Center, a public-private entity created by multiple federal agencies and health IT private partners to “serve as a trusted convener of health IT stakeholders” that would “focus on activities that promote health IT as an integral part of patient safety with the ultimate goal of assisting in the creation of a sustainable, integrated health IT learning system.” It was very vague on details, however, and did not lay out any specific plans for how such a system would cull information on EHR errors, or fix them.
The congressionally-mandated report lays out plans to help ensure there were “better analytics to help address some of those safety issues,” Jodi Daniel, director of the Office of Planning and Policy at ONC, told Scientific American when it asked about this issue. The report is not yet in its final form. It will still be subject to a public meeting in May and a 90-day comment period, both of which will help solidify details about what such a safety infrastructure could look like.