Several prominent healthcare organizations have signed a letter to Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.) that calls for the passage of a bill that aims to boost innovation in health IT by exempting low-risk medical software and mobile apps from regulatory oversight.
Late in 2014, U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) originally introduced the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, S. 1101, that aims to cut red tape at the Food and Drug Administration (FDA) in terms of regulatory oversight of health IT software products. The bill would exempt low-risk medical software and mobile apps from the FDA regulation. It would also clarify which software would be regulated by the agency to protect consumers. The bill was then referred to the Senate Committee for Health Education Labor and Pensions (HELP).
Now, the letter to Alexander and Murray, Senate HELP Chairman and Ranking Member, respectively, penned by major vendors such as athenahealth, IBM, McKesson, and other healthcare companies, says, “Within the broad community of stakeholders, there is near universal agreement that regulatory certainty is essential for continued innovation and development of health IT. We are concerned, however, that significant confusion exists in the market place about what technologies may be regulated, by which agencies, and to what standard.”
It continues, “This uncertainty creates barriers to the development of promising technologies that can help clinicians access more evidence-based medicine, provide patient populations with specific needs more individualized care, and generate better patient-caregiver-provider engagement. The potential cost and delay created by current regulatory uncertainty may further deter software and system developers from creating products that have the ability to greatly benefit patients.”
The letter concludes, “We are pleased to see the bipartisan support for S. 1101 and we encourage the Committee to pass this crucial piece of legislation. Congressional action on this issue will allow the Administration to focus its limited resources, staff and expertise on ensuring the safety of new medical technologies that pose the highest potential risk to patients, and will promote a new era of medical innovation that will improve care and lower costs.”
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