Federal bill to boost health IT innovation by exempting low-risk medical software and mobile apps from FDA regulation

Senators Bennet and Hatch reintroduced the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, to “cut red tape at the Food and Drug Administration (FDA) and help boost innovation in health IT.”

According to Senator Hatch’s press release:

The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act would exempt low-risk medical software and mobile apps from FDA regulation and provide greater certainty regarding what software will be regulated by the agency to protect consumers.

“As the possibilities for medical technology continue to defy expectations, we must provide innovators with clarity about the regulatory rules of the road,” Hatch said. “The MEDTECH Act is a commonsense approach to give medical software pioneers the certainty they need to continue developing new technology that will benefit both health-care professionals and consumers alike.”

“Medical innovation is helping our health care providers better take care of patients, and it’s putting tools into the hands of families to help them manage their own health,” Bennet said. “Some tools, whether a calorie counter or an activity tracker to monitor your exercise routines, are low risk and don’t require in-depth oversight by the government. Our bill provides certainty for innovators in the life sciences and the FDA by clarifying which devices and software should be monitored to keep consumers safe.”

Background

The MEDTECH Act takes a risk-based approach and builds upon a Food and Drug Administration Safety Innovation Act Workgroup report released earlier this year. The report was commissioned by Bennet and Hatch through an amendment to the 2012 FDA reform law.

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 health care providers in developing treatment recommendations for their patients. As the rate of innovation rapidly increases in the medical technology field, this bill provides greater clarity to ensure that businesses understand the rules of the road and safe and effective products reach consumers as soon as possible.

FDA has already provided Guidance on Low-Risk, General Wellness Products, and even in its Mobile Medical App Guidance has indicated a more hands-off regulatory approach to apps that do not diagnose or treat disease, and to clinical decision-making support software.

However, the proposed bill makes matters even clearer.

According to the press release the proposed legislation focuses on:

• administrative and financial software
• wellness and lifestyle products
• certain aspects of electronic health records
• software that aids health care providers in developing treatment recommendations for their patients

The bill proposes to amend Section 520 of the Federal Food, Drug, and Cosmetic Act by adding new subsection (O) REGULATION OF PATIENT RECORDS AND CERTAIN DECISION SUPPORT SOFTWARE so as to provide that the following are not medical devices subject to FDA medical device regulation:

• Software that is intended solely for administrative or operational support of a health care facility or the processing and maintenance of financial health care records within a health care setting;
• Products that are intended 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;
• Electronic patient records created, stored, transferred, or reviewed by health care professionals or individuals working under supervision of such professionals that functionally represent a medical chart, but excluding diagnostic image data, provided that software … is validated prior to marketing….
• Software that is intended to format, organize, or otherwise present clinical laboratory test report findings or data and related patient education information.
• Software that is 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 health care professionals to assist in patient care ….

With this legislation, among other things, Congress would clearly take clinical decision-making support software out of the FDA medical device arena, with a few caveats.

First, if the product is intended to diagnose or treat disease, or to transfer diagnostic image data (like an MDDS or PACS) would still fall within FDA medical device regulation.

Second, the bill also provides that it does not limit the authority of the Secretary of Health and Human Services from exercising enforcement discretion “as to any device subject to regulation under the Act.” This phrasing is a bit confusing but clearly a hat tip back to FDA with respect to rule-making and enforcement.

When bringing a consumer product to market that involves health and wellness, it’s still prudent to consult an experienced healthcare and FDA lawyer to assess whether the product is likely to be classified and a medical device and thereby subject to medical device regulation.