The MEDTECH Act was one of seven bills passed by the Senate Health, Education, Labor and Pensions (HELP) Committee this week to further medical innovation.
During the markup of the bills Wednesday, Senate Health Committee Chairman Lamar Alexander (R-Tenn., pictured) said if the bipartisan biomedical innovation agenda is a success, "it will be the most important bill signed into law this year," according to an announcement.
The legislation would help authorize President Barack Obama's Precision Medicine and cancer moonshot initiatives and would be a companion to 21st Century Cures.
The revamped Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act that passed Wednesday was unveiled last April. It aims to exempt low-risk medical software and mobile apps from regulation by the U.S. Food and Drug Administration while clarifying which offerings fall under federal authority FierceHealthIT previously reported.
Both the American Medical Informatics Association (AMIA) and Health IT Now praised the committee for passing the legislation.
However, AMIA President and CEO Douglas Fridsma, M.D., Ph.D., also said in a statement there is more to be done on the MEDTECH Act, including a greater focus on ensuring health IT tools are safe and effective.
"As a way to address pre-market barriers to innovation, we agree with the approach taken by MEDTECH, but we are concerned the legislation is incomplete," he said. "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."
For its part, Health IT Now said in a statement that the legislation "is essential to ensuring that patients can benefit from the technology revolution occurring in other areas of the economy" and the group will work with Congress to get the bill to the president's desk before the year is out.
Bradley Merrill Thompson, an attorney with Epstein Becker Green who serves as general counsel for the CDS Coalition, told FierceHealthIT in an email that the coalition supports the bill. However, he added that there must be guidance from "someone" on clearance of medical software, especially when it comes to clinical decision support tools. Currently, the uncertainty has stifled innovation and caused projects to be shelved.
"Given the complexity of the issues, there will almost certainly be a need for FDA guidance, whether Congress legislates or not. Our goal is to see a line that is both clearly drawn and sensibly determined," Thompson said. "Either Congress or FDA needs to act soon."
The Senate currently faces obstacles on the overall medical innovation bill, including funding for the National Institutes of Health.
Senate Democrats have promised to block the bill if NIH doesn't receive new mandatory funding, according to The Hill.
However, in his opening remarks on Wednesday, Alexander said he will pledge to work with Sen. Patty Murray (D-Wash.) to try to achieve bipartisan consensus on the matter.
"We will work hard together to find a way to have a surge in mandatory funding for the National Institutes of Health. But I am willing to do that," he said.