Samsung Galaxy heart-rate sensor ignites regulatory review

By Judy Mottl, for FierceMobileHealthcare

Government health officials in South Korea want to take a closer look at the heart-rate sensor built into Samsung's impending Galaxy S5, but the regulatory review likely won't impact the smartphone's scheduled debut on April 11.

The handset's sensor technology may lead to the smartphone being designated as medical equipment, according to a report from Yonhap News. Such a designation requires approval from the South Korea Ministry of Food and Drug Safety before it can be put into market.

"Even if it is designated as a medical device, the procedure for testing its safety and functions is not complicated," states a spokesperson in the news report.

The news comes as a wave of mobile healthcare software, smartphone health features and health-focused devices, such as Samsung's Get Fit smartwatch, are being launched by a growing number of tech vendors.

The S5's heart rate monitor works by placing a finger on a sensor underneath the phone's camera flash and takes up to eight seconds to take a reading. The new smartphone also features the vendor's S-Health 3.0 personal tracker app that can help users 'manage behavior' with tools including a pedometer, diet and exercise records.

The Galaxy S5 sensor monitor is the latest mobile healthcare device strategy move by Samsung. In August, 2013 Samsung launched a health app designed for its Android-based Galaxy S4 smartphone. The app, which is free on the Google Play Store and currently only available in Samsung's home market, calculates how the user is doing in terms of calories based on recorded food intake, hours of exercise, and the user's initial input of height and weight.

A few months later, in October, Samsung signed a multi-year deal with global health service company Cigna to co-develop health and wellness related features built into Samsung's S Health platform on the company's major smart mobile devices.

The regulatory review requested by South Korea comes as U.S. federal agencies, lawmakers, healthcare mobile device makers and services vendors continue to debate how to regulate mobile healthcare innovations.

Last week the mHealth Regulatory Coalition again announced its opposition to a proposed law to eliminate U.S. Food and Drug Administration oversight on mobile healthcare software poses serious risks to patients. "The rush to avoid expert reviews of complex technologies with far-reaching health ramifications ignores the fact that we cannot separate the high risk from the low risk apps using broad terms in legislation," Bradley Merrill Thompson, MRC general counsel, said in a statement.

For more info:
- read the Yonhap News report