When Does Mobile App Data Become Medical Data?

The EU’s privacy watchdog, The Working Party, has set guidelines for when information gathered by mobile phone/tablet applications shades into medical data.

“When conclusions are drawn about someone’s health, regardless of their reliability, these conclusions are to be treated as health data,” it said. “There has to be a demonstrable relationship between the raw data set and the capacity to determine a health aspect of a person, based on the raw data itself or on the data in combination with data from other sources.”

(Read the whole article here.)

In the U.S., the FDA issued their final guidelines on mobile medical apps in 2013, saying that they were “tailored” to support innovation without compromising patient safety and privacy.

In a press release issued in September of that year, they said they focused on medical apps that:

  • are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
  • transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

The FDA said that more than 130 comments were received during the commenting period and that opinion was overwhelming in favor of the tailored approach.

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

(Read the FDA’s finalized guidelines here.)

As a consumer of medical services with a concern over the easy availability of ‘private’ information on the internet, I will be giving the guidelines a close reading.


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