An FDA program to streamline the regulatory process for digital health technologies like wearable devices is set for expansion but may not be enough to aid innovation, regulatory attorneys who assist industry said.

Comprehensive protocols and practices are essential and desperately needed in the digital health world, but can regulation be produced quick enough as not to stifle future innovations? The attorneys are skeptical.

“Startups have been the lifeblood of the medical technology industry for decades,” Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg Law. Current regulatory frameworks have let many startups down, Thompson said, and the proposed pilot program expansion may not be able to relieve regulatory confusion fast enough.

Planned Expansion

The pilot program, run by the Food and Drug Administration’s Center for Devices and Radiological Health, was started in July 2017 with the intention of easing the regulatory burdens for a select group of medical software developers who would become “pre-certified” and could essentially bypass some regulation procedures. Through the pilot program, the FDA seeks to understand how companies approach the development of health-care technologies so the FDA in turn can figure out what regulation processes are needed to verify an array of emerging technologies from insulin monitoring applications to virtual reality therapy programs.

Nine companies, including Apple Inc. and Johnson & Johnson, are already enrolled in the pilot program but the FDA seeks to add more.

“The goal of the pre-cert program will be eventually to pre-certify companies beyond the original pilot participants,” Stephanie Caccomo, FDA press officer, told Bloomberg Law in a written statement. Caccomo could not give timing for when more companies would be added and how many would join.

News of the expansion has been met with overall optimism. “Getting more companies involved will definitely help further the mission of the program,” Howard Look, CEO, president and founder of Tidepool, a California based digital diabetes monitoring software company and current participant in the pilot program, told Bloomberg Law.

The program “if properly implemented, it has the potential to reduce pre- and post-market burdens for both software developers and the FDA,” Zach Rothstein, associate vice president of technology and regulatory affairs at the Advanced Medical Technology Association, a medical device trade associated in Washington, told Bloomberg Law.

Good Intentions

The digital health technology industry is continually expanding, making the goal of the pre-certification program ever more important, Jean Frydman, an attorney at Fox Rothschild LLP specializing in FDA regulatory compliance matters in Princeton, N.J., told Bloomberg Law. With continual expansion, the pre-certification of software regulation allows the FDA to be aware of what’s out there and what types of new software are emerging, Frydman said. The program “is another layer of being able to be mindful of who has what in this arena,” she said.

A watchful eye in the continually evolving health tech space is essential to ensure consumer protection, Yuri Maricich, chief medical officer and head of clinical development at Pear Therapeutics, told Bloomberg Law. Pear Therapeutics, a current participant in the pilot program, creates digital therapies to treat addiction, post traumatic stress disorder, anxiety, and other conditions.

Health software apps have proven erroneous before. A 2015 study led by British researchers assessed the accuracy of 46 different insulin dose calculator apps and found that 67 percent of the apps contained risks that could provide patients with incorrect dosage recommendations. In February, the FDA recalled a diabetes management app developed by Roche Diabetes Care Inc., a participant in the pre-cert program, due to a technical glitch that produced incorrect insulin dosage amounts for patients.

“There should never be a presumption that just because it is a software that it is automatically safe,” Maricich said.

A Blurred Line

The FDA’s desire to improve the digital health technology pre-certification program is appreciated, Thompson said, but doesn’t address the most salient needs in the health tech space—establishing a firm understanding of which technologies are regulated and which are not.

“There are hundreds of companies out there with clinical decision support software, for example, who were expecting the FDA to define a risk-based line between what is regulated and what is not and the agency has completely let them down,” he said. Thompson is a member of the Bloomberg Law advisory board.

Current FDA regulations are rather unclear, Frydman said, because the FDA appears to be torn over what types of software applications to monitor and regulate and which ones to ignore. Applications that manipulate data to provide diagnostics are generally regulated, while other tech devices that are simply data monitoring tools aren’t typically considered a medical device, Frydman explained. “It is muddy, it is mucky, really mucky as to whether or not the FDA is going to regulate a tech software or not.”

This state of limbo, especially for entrepreneurs and startups without a structured compliance team, can create the risk of preventing innovative technologies from coming to market, Thompson said.

Before Pear Therapeutics joined the FDA pre-certification pilot program, the company spent over two years working with the FDA to understand how the company should approach the regulatory landscape. Eventually Pear filed a de novo request, a classification request for when there is no other legally marketed predicate device available for FDA clearances. “What we did required a lot of time and a lot of capital, " Maricich said.

Frydman and Maricich are optimistic of the pilot program and believe an FDA pre-certification program will lead to a faster regulation process that foster innovations that will eventually solve the current blurred lines between what software applications are regulated and which are not.

The end result needs to bring flexibility and transparency for all companies involved, Maricich said. “Expansion is inevitable and that is the goal, if we can’t make this work and allow it to expand so that there is clarity for companies writ large, then we failed.”