ONC Seek Input On mHealth Regulations

The ONC, FDA and Federal Communications Commission are seeking broad input from the healthcare and information technology industries on how the federal government should regulate health IT and mobile health technology in particular.

As directed by the Food and Drug Administration Safety and Innovation Act of 2012, the three agencies are jointly developing a proposal for “an appropriate, risk-based regulatory framework” covering health IT generally and mobile apps specifically, with the goal of promoting innovation, protecting patient safety and avoiding regulatory duplication.

Housed under the ONC’s Health IT Policy Committee, the 32-member FDASIA Workgroup has been working to create a mobile health regulatory framework — a difficult task, considering the pace of mobile health IT’s evolution. As Steve Posnack, the ONC’s director of federal policy, said at a recent meeting, some “people don’t think that the regulatory oversight or frameworks that we have today are prepared to handle what could come from an innovation standpoint” in even two or three years.

Now, with the regulatory strategy report due by January 2014, the three federal agencies have several broad and specific questions for the greater healthcare and tech communities, with comments open until the end of August.

For one thing, in terms of regulatory taxonomy, they’re asking: “What types of health IT should be addressed by the report developed by FDA, ONC, and FCC?”

In terms of balancing risk and innovation, the main Congressional directive in the law, the agencies are asking: “What are the risks to patient safety posed by health IT and what is the likelihood of these risks?” And, “What factors or approaches could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety?”

And on the issue of avoiding duplicative compliance and oversight, the agencies are soliciting feedback on whether or not industry leaders think there is currently regulatory overlap among the FDA, ONC and FCC, and if so, what can be done to minimize it.

The FDASIA Workgroup includes agency officials and representatives from groups and companies like Aetna, Cerner, Intel, IBM, Qualcomm, Happtique and Roche Diagnostics, as well as consumer groups and providers, like Partners Healthcare.

The Workgroup and agencies’ balancing act is among the complicated regulatory tasks for the federal government. As workgroup member Paul Tand, MD, the chief innovation and technology officer at the Palo Alto Medical Foundation, said at one meeting: “I think what you’re charging us to do is identify ways to think about risk and ways to think about innovation and then try to balance the two, because not always, but sometimes, they may be in conflict.

Somewhat related to the regulatory strategy report, the FDA is set to release guidance on mobile health apps by October, likely building on the agency’s tentative approach differentiating between wellness apps and quasi-diagnostic apps that should be treated as medical devices.

Recently the FDA warned the Indian software company Biosense Technologies Private Ltd. that its urinalysis app, which uses an iPhone camera to measure compounds like glucose and proteins on a dipstick, would need agency clearance as a device. “The uChek Urine analyzer appears to meet the definition of a device,” the FDA wrote.

A “company intending to promote their device for use in analyzing, reading, and/or interpreting (urinalysis) dipsticks need to obtain clearance for the entire urinalysis test system,” the agency wrote, while also offering the company the option of contesting whether or not the app qualifies as a device — a sign of the ambiguities permeating the effort to regulate mobile health apps. “If you do not believe that you are required to obtain FDA clearance for the uChek Urine analyzer, please provide us with the basis for that determination,” the agency told the company.

Although Biosense Technologies has not received the FDA’s device clearance for the app, the company noted on its website that it is registered with the agency as a class 1 medical device, classified as an automated urinalysis system.

Article written by Anthony Brino