Not good: FDA Easing Oversight of Medical Device Data Systems, mHealth

On Friday, Feb 6 2014, the FDA issued two final guidance documents that detail the agency's plans to loosen its regulation of medical device data systems and mobile applications, Health Data Management reports.

Final Guidance Details

In one final guidance document, FDA said it will not enforce regulations -- such as registration and listing, premarket review and postmarket reporting -- for medical device data systems that receive, store, send or display data from medical devices because they pose a low risk to patients (Goth, Health Data Management, 2/9).

According to Modern Healthcare, the guidance is similar to a proposal issued in June (Tahir, Modern Healthcare, 2/6).

The proposed guidance applied to medical device data systems, which do not aim to control or "alter the functions ... of any connected medical devices," but rather are intended to:

  • Facilitate electronic transfer or exchange of medical device data;
  • Store and retrieve medical device information, such as blood pressure data;
  • Convert medical device data from one format to another; and
  • Display medical device information (iHealthBeat, 6/23/14).

In the final guidance, FDA expanded the language to include image-based data (Modern Healthcare, 2/6).

Meanwhile, FDA in separate final guidance said 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 (Health Data Management, 2/9).

Further, FDA in the guidance footnotes more explicitly defined active monitoring devices as those that are "intended to be relied upon in deciding to take immediate clinical action" (Modern Healthcare, 2/6).


Bakul Patel, associate director for digital health in FDA's Center for Devices and Radiological Health, said the guidance will allow system developers to improve interoperability with other devices (Hall, FireceHealthIT, 2/6).

In a blog post accompanying the guidance, Patel and Jeffrey Shuren, director of digital health at the center, noted that the "finalization of this policy will create an impetus for the development of new technologies to better use and display ... data."

Meanwhile, Bradley Merrill Thompson -- general counsel for the mHealth Regulatory Coalition -- said, "The implications are profound, both for MDDS type software, but also for what it suggests about the future for health information technology generally." He added, "FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software" (Health Data Management, 2/9).

However, some stakeholders, such as Health IT Now Executive Director Joel White, say they still want to see legislation that would formally exempt certain health IT categories from FDA oversight (Gold et al., "Morning eHealth," Politico, 2/9).

Such language has been included in the 21st Century Cures initiative and the Medical Electronic Data Technology Enhancement for Consumers' Health Act, according to Modern Healthcare.

Dan Haley, vice president of government and regulatory affairs at athenahealth, said, "We are witnessing a jurisdictional tug-of-war between the branches" (Modern Healthcare, 2/6).

Source: iHealthBeat, Monday, February 9, 2015

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