Lawmakers Introduce Bill To Ease FDA Oversight of EHRs, Health IT

On Thursday, Sens. Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) introduced a bill that would loosen FDA's oversight of certain electronic health records and other related health IT, Health Data Management reports (Goedert/Slabodkin, Health Data Management, 12/5).
Bill Details
The bill -- called the Medical Electronic Data Technology Enhancement for Consumers' Health, or MEDTECH, Act -- would revise the definition of medical devices in the Federal Food, Drug and Cosmetic Act to remove most clinical decision support software from regulatory oversight by FDA (iHealthBeat, 11/24).
According to Politico Pro, software would be regulated based on its level of transparency. For example, if a clinician can review the information on which decision-making software bases its suggestions, the software in most cases would not be regulated (Allen, Politico Pro, 12/4).
Other exempted software would include tools that are used to:

  • Analyze and support the display of patient data for diagnostics, prevention and treatment recommendations; and
  • Format, organize and present clinical lab test report data prior to analysis, as well as lab test report findings and related patient education data.

Further, the bill would exempt EHRs -- with the exception of diagnostic image data -- that are used by health care professionals as long as the EHRs' software was approved prior to marketing and is in line with federal premarket standards.
However, the bill would allow FDA to maintain its regulatory oversight of software associated with medical devices of medium or high risk (iHealthBeat, 11/24).
In addition, FDA would maintain oversight over diagnostic imaging software, such as programs that predict which areas of scans physicians should examine.
According to Politico Pro, the MEDTECH Act is a more focused health IT bill than others that have been introduced to limit FDA regulation to low-risk software.
Lawmakers who support the bill say there could be action on the legislation by January (Politico Pro, 12/4).
The bill has gained support from several health industry groups, including the Health IT Now Coalition.
Joel White, executive director of the Health IT Now Coalition, said, "It is time for our laws to reflect the technological advancements made in our healthcare system over the past four decades" (Health Data Management, 12/5).
Ken Wash, president of the Software & Information Industry Association, also praised the bill, saying it "will help advance the use of innovative [health IT] by providing regulatory clarity and certainty, without compromising safety" (SIIA release, 12/4).
Rep. Blackburn To Reintroduce SOFTWARE Act Next Legislative Session
In related news, Rep. Marsha Blackburn (R-Tenn.) on Wednesday at a Bipartisan Policy Center event announced that she will reintroduce a bipartisan bill that aims to develop a new regulatory framework for FDA's oversight of health IT, MobiHealthNews reports (Comstock, MobiHealthNews, 12/4).
Blackburn said she plans to reintroduce the SOFTWARE Act (HR 3303) in January 2015, predicting that it would pass Congress shortly after (Slabodkin, Health Data Management, 12/5). According to Modern Healthcare, incoming Senate Health, Education, Labor and Pension Committee Chair Lamar Alexander (R-Tenn.) will be the bill's Senate sponsor (Tahir, Modern Healthcare, 12/4).
The bill would divide health IT regulation into three categories based on whether tools are:

  • Low risk;
  • Medium risk; or
  • High risk.

FDA would maintain regulation over only the high-risk category, while the middle-risk category would be "subject to risk-based oversight," according to Blackburn. Low-risk health IT would be unregulated (MobiHealthNews, 12/4).
Congress To Consider Legislation for Networks, Medical Devices Regulation
Meanwhile, two Republican senators on Thursday said Congress during its next session will consider legislation regarding the regulation of networks and the medical devices that connect to them, FCW reports.
Sens. Kelly Ayotte (R-N.H.) and Deb Fischer (R-Neb.) at an event hosted by the Information Technology and Innovation Foundation said that current regulatory framework for such networks is outdated.
Fischer said, "New technologies shouldn't be tied to old red tape," noting that FDA's oversight of networks and medical devices relies on a 1976 definition of medical devices. She added that "it's entirely appropriate for the U.S. government to think about how to modernize its regulatory frameworks" (Hochmuth, FCW, 12/4).
Source: iHealthBeat, Friday, December 5, 2014

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