The U.S. Senate Committee for Health, Education, Labor and Pensions (HELP) this week passed the MEDTECH Act, along with six other bipartisan healthcare-related bills, that are part of an effort to advance medical innovation.
The MEDTECH bill 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 seven bills that passed the committee this week are part of a larger biomedical innovation agenda that also includes the Improving Health Information Technology (Health IT) Act as well as six other biomedical innovation bills that passed the committee last month.
In a Senate HELP committee press release announcing the passage of the bills this week, Senate health committee Chairman Lamar Alexander (R-Tenn.) said if the biomedical innovation package is a success, “it will be the most important bill signed into law this year.”
“The committee has worked on a bipartisan basis for more than a year to develop pieces of legislation that will together form legislation authorizing the president’s Precision Medicine and cancer moonshot initiatives and serve as a companion to the House-passed 21st Century Cures legislation,” Alexander stated in the press release.
And, Alexander also said the committee would continue to work in a bipartisan manner to reach agreement on a short-term surge of mandatory funding to boost high-priority research projects at the National Institutes of Health.
According to Politico, disagreement about NIH funding appears to be the main obstacle to passage of the HELP committee’s innovation package.
Alexander also stated, “Because of our budget deficit, we need to fund that new surge in mandatory funding by reducing existing mandatory funding. We can discuss these ideas in committee, but everything we’ve done in committee has had bipartisan support and we do not have a bipartisan consensus on how to do this,” he stated.
Health IT Now praised the committee’s passage of the MEDTECH Act and in a statement the organization said, “The MEDTECH Act provides greater clarity to the FDA’s role in regulating health IT which is essential to ensuring that patients can benefit from the technology revolution occurring in other areas of the economy. We are pleased to see the bipartisan support for S. 1101 and we encourage the Senate to consider this integral piece of legislation.”
Doug Fridsma, M.D., president and CEO of the American Medical Informatics Association (AMIA), praised the legislation as well, noting that it is intended to provide “regulatory stability and assurance to the growing ecosystem of health IT not considered a medical device,” yet he also said the legislation is “incomplete” and does not address the issue of how to ensure the safety and effectiveness of health IT.
“The legislation is silent on how the safety and effectiveness of health IT should be managed absent regulatory oversight, despite our growing awareness of how even benign functionality can harm patients,” he stated.
In a report about health IT and patient safety, the Office of the National Coordinator for Health IT (ONC) recommended the development of a national center on health IT patient safety.
In the AMIA statement, board chair Thomas Payne, M.D., said, "While this legislation is needed to help ensure innovative products can more easily come to market, we must have additional support from the federal government to tackle this mounting challenge. Now is the time to get serious about health IT patient safety. Now is the time to fully fund a collaborative, national center for health IT safety."
As previously reported by Healthcare Informatics’ Managing Editor Rajiv Leventhal, several prominent healthcare organizations have pushed for the MEDTECH Act’s passage. In a letter to Alexander and Senate committee ranking member Patty Murray (D-Wash.), major vendors such as athenahealth, IBM, McKesson and other healthcare companies voiced support for the bill, saying current regulatory uncertainty creates barriers to the development of promising technologies that have the ability to benefit patients.
The letter from major vendors also stated, “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.”