BOSTON—Institutions responsible for regulating mobile health (mHealth) products are hustling to keep up with the pace of technological innovation. While mobile devices like smartphones and tablets have cleared new paths to providing healthcare and encouraging wellness, the current regulations guiding the development of mHealth tools can be burdensome and unclear, according to a July 25 panel discussion at the 4th annual mHealth World Congress.
The FDA considers mHealth tools promising for their potential to promote public health, but the regulatory agency is primarily concerned with safety and needs to ensure that patients are given the same level of confidence in mHealth tools as they are in other FDA-regulated medical devices, according to Bakul Patel, MS, MBA, a policy advisor with the FDA's Center for Devices and Radiological Devices.
The FDA’s most difficult challenge in terms of regulating mHealth tools is striking the appropriate balance between encouraging innovation, protecting public health and promoting public health, Patel said during the panel.
“It’s not just about making cool software or even useful applications,” he added. “It’s about understanding risk.”
The FDA issued a draft guidance for mobile medical applications and a request for comments in July 2011 to form specific regulations that may be finalized later this year, but the guidance is in need of clarification, according to co-panelist Brad Merrill Thompson, JD, the general counsel to the mHealth Regulatory Commission.
Thompson recognized the FDA’s concern with safety risks and agrees that mHealth tools should be regulated, but he said regulators should weigh potential tools’ health benefits against the costs their developers will incur should their products require FDA approval. There is a fine line, however, that differentiates a product that requires approval from one that doesn’t.
The FDA’s regulatory domain includes health-related products, or those used to treat or diagnose diseases, but not wellness-related products, or those that promote healthy living outside the context of a disease. The problem is that wellness-related products can be perceived as health-related products. For instance, a major food producer was once subjected to FDA scrutiny for claiming that one of its cereals could help lower cholesterol, as Thompson pointed out. Similarly, treadmills used to treat obesity or stroke patients in healthcare settings require FDA approval, but treadmills used in fitness centers don’t.
“It all comes down to how you promote your product,” said Thompson, illustrating his point by telling of the debate that occurred when he asked a Columbia University law class whether or not a tongue depressor was a medical device. “There are certain lines you can’t cross without dealing with the FDA.”
The FDA’s proposed regulations for mHealth tools may not be perfect, but the agency is working to clear the gray area and Patel agrees with Thompson that low-risk tools should not bear the full brunt of regulations reserved for medical devices.
“Even though certain tools mHealth tools may meet the definition of a medical device, they don’t pose great concern or patient risk,” he said. “At the end of the day, we are focused on a small portion of tools that actually mimic medical devices.”