Bipartisan legislation drafted by Senators Orrin Hatch (R-Utah) and Michael Bennett (D-Colo.) looks to exempt electronic health records and clinical decision support software from FDA oversight. Introduced late last week, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act seeks to amend the definition of medical devices under the Federal Food, Drug and Cosmetic Act, exempting low-risk medical software and mobile apps from FDA regulation.
“Medical devices” are defined under the FD&C Act, which reflects statutory language from the 1970s. The MEDTECH Act would update the law governing what is covered by exempting low-risk software and medical apps that provide administrative support for healthcare facilities, the ability to create and share medical and patient information, certain “reminder” devices and lifestyle products, and software that aids healthcare providers (HCPs) in developing treatment recommendations for patients.
“New and innovative technology is helping our health care providers better take care of their patients, and it’s putting tools into the hands of families that help them manage their own health,” Rep. Bennet said. “Some of these tools, whether a new app to track your calorie intake or an activity tracker to help you while you exercise, are low risk and don’t require in-depth oversight by the government. This bill provides certainty for innovators in the life sciences and the FDA as to which devices and software should be monitored to keep consumers safe.”
“Advances in technology have allowed us to continuously improve the efficiency and quality of healthcare,” Rep. Hatch added. “This bill will give innovators the certainty they need about health IT regulation to continue pioneering medical software for consumers and health care professionals.”
“It is time for our laws to reflect the technological advancements made in our healthcare system over the past four decades,” said Joel White, executive director of the Health IT Now Coalition, an organization that promotes adopted and use of healthcare technology. “It is unacceptable that the laws currently governing health software, mobile apps and devices like cell phones and tablets were designed and passed when ABBA was popular and the Watergate scandal was just unfolding. The regulatory framework in place is ill-equipped to adapt to today’s advanced technologies and patients are losing out.” Health IT Now voiced their support of the MEDTECH Act.
Read the legislation: MEDTECH Act
The Act removes the following five innovations from covered devices:
- (A) Software intended solely for administrative or operational support of a health care facility or the processing and maintenance of financial records within a health care setting.
- (B) Products for use in activities unrelated to the clinical treatment of a disease or disorder and that are for the purpose of maintaining health and conditioning.
- (C) EHRs, including patient history records, but excluding diagnostic image data, provided that software designed for use in maintaining such patient records is validated prior to marketing.
- (D) Software intended to format, organize, or otherwise present clinical laboratory test report data prior to analysis
- (E) Software intended to analyze and support the display or printing of patient or other medical information for the purpose of supporting or providing prevention, diagnostic, or treatment recommendations for HCPs to assist in patient care, and that enables the HCP to independently review the information on which such recommendations are based such that the intended use of the software is for the health care professional to not rely solely on any specific recommendations or results provided by such software to make a clinical diagnosis or treatment decision, except to the extent that any such software or substantially equivalent product—
- ‘‘(i) is a component or accessory, or has the same function as a component or accessory, of a device subject to regulation under this Act; or
- ‘‘(ii) as of the date of enactment of this subsection, is regulated or subject to regulation as a device classified as a class II or class III device or has the same function as a component or accessory of a device subject to regulation under this Act.
This last section (E) highlights the bill’s desire to exempt only technology where the healthcare provider is able to independently review the software’s recommendations.
View the MEDTECH Act
View FDA’s Mobile Medical App Final Guidance, issued September 25, 2013