A new bill, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, has been introduced by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), with the aim to exempt low-risk medical software and mobile medical apps from regulation by the U.S. Food and Drug Administration. It was officially was introduced to Congress Dec. 4, 2014.
According to FierceHealthIT, the bill has been introduced as the “the beginning of a conversation” on the issue of health IT regulation. The bill will be re-introduced in January if it doesn’t move throughout the remainder of the 2014 lame duck session.
“Our bill attempts to create specific legal definitions around types of software to exempt them from FDA regulation,” Hatch told FierceHealthIT. “Specifically, the bill limits and clarifies the FDA’s role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records and software that aids healthcare providers in developing treatment recommendations for their patients.”
Hatch also said his bill, in conjunction with a repeal of the medical device tax, is important to protecting and enabling innovation in healthcare. “Since the tax took effect last year, it has been a drain on American innovation, job growth and our ability to provide groundbreaking medical technologies to patients in need,” he told FierceHealthIT.
According to HIMSS, the MEDTECH Act would allow the FDA to continue regulating EHR software that serves as an accessory to medical devices of medium or high risk, but would exclude EHR software considered lower risk from regulation in five specific areas:
• Software intended for administrative or operational support of a healthcare facility
• Products unrelated to clinical treatment of a disease or disorder,
• EHRs that “functionally represent a medical chart, including patient history records, but excluding diagnostic image data,” as long as the EHR system is “validated prior to marketing”,
• Software intended to format, organize or otherwise present clinical laboratory test report data prior to analysis;
• Software for analyzing and supporting the display or printing of patient or other medical information for supporting or providing prevention, diagnostic or treatment recommendations to clinicians.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is regulatory legislation that that provides the FDA with the authority to:
• Collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics,
• Promote innovation to speed patient access to safe and effective products,
• Increase stakeholder involvement in FDA processes;
• Enhance the safety of the drug supply chain.
FDASIA included the Medical Device User Fee Amendments of 2012, or MDUFA III.
The intent of MDUFA III was to encourage greater collaboration and efficiency of regulatory processes between the medical device industry and the FDA to reduce the time it takes to bring safe and effective medical devices to the U.S. market. EHRs were not clearly distinguished and may have led to over-regulation of medical software at the “expense of continued innovation.”
MEDTECH Act is a response to that.