FDA Taking 'Very Light Touch' To Overseeing mHealth Apps

Bakul Patel, associate director for digital health at FDA's Center for Devices and Radiological Health, in an interview said the agency plans to take a light approach to regulating most mobile health applications, Bloomberg reports (Satariano, Bloomberg, 3/30).


FDA in February issued final guidance stating that it plans to regulate mobile health apps based on functionality, rather than their sale.

Specifically, FDA oversight will apply to apps that perform medical device functions and are therefore mobile medical apps. For example, FDA would regulate apps that:

  • Analyze patient data from a connected device or are being used in active patient monitoring;
  • Connect to an existing device with the purpose of controlling its operation, function or energy source; or
  • Transform a mobile platform into a regulated medical device.

Meanwhile, FDA would take a "hands off" approach for apps that are not considered to have a medical function, such as those used to:

  • Automate simple tasks for providers;
  • Interact with providers via electronic health record systems;
  • Self-manage conditions, without offering specific treatment suggestions; and
  • Organize or track health information (iHealthBeat, 2/9).

Patel's Comments

Patel said that FDA would not "want to be engaged in" regulating a "technology that's going to motivate a person to stay healthy."

Specifically, Patel clarified that the agency is focused on the regulation of apps that attempt to mirror a medical device's functions, rather than apps that track certain health metrics, such as heart rate or steps taken.

Patel also said that product marketing would play a role in whether FDA would seek to regulate a product. For example, he said that an app that claims it can help physicians to make medical decisions would warrant additional FDA scrutiny, as would products that are intended to offer treatment recommendations or diagnose diseases.

Patel added that companies with devices that host apps, such as Google and Apple, should contribute to ensuring that health apps accurately state their potential benefits.

Stakeholders Weigh In

Rock Health Managing Director Malay Gandhi questioned whether FDA and other federal agencies have the necessary staff and funding to adequately oversee the mobile health industry. He said, "We have to see the enforcement, otherwise it creates a very uneven playing field between companies that are acting ethically and those that aren't."

Similarly, Derek Newell, CEO of health care startup Jiff, said that "FDA isn't built to handle new [product] categories" such as mobile apps and wearables. He said that it can take the agency awhile to be able to adequately regulate new product categories.

Further, some industry stakeholders, including Patel, have noted a disconnect between FDA and startup companies, which list FDA regulation as a main business risk.

To address the gap, Patel said the agency is looking to hire a new senior staff member to help improve relations with technology companies (Bloomberg, 3/30).

Source: iHealthBeat, Wednesday, April 1, 2015