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FDA Begins to Regulate Smartphone Health Apps

Posted Sep 30 2013 12:00am

I have closely tracked the evolution of smartphones as devices that can be adapted, sometimes with plug-in gadgets, to monitor one's health status (see: New Definition for "Apps": The Smartphone Market for Medical SoftwareThe iPhone Effect: Smartphones and Their App Ecosystems Have Changed EverythingHealthcare in Developing Countries; Relationship to Smartphone Apps and DevicesSmartphone Otoscope: Diagnosing Middle Ear Disease at Home? ). As one might expect, the FDA intends to regulate some of these smartphone apps and gadgets, some of which are beginning to closely resemble medical devices (see: FDA lays out rules for some smartphone health apps . Below is an excerpt from the article:

Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy. Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to high-tech heart monitors.The FDA ...[has said] that the vast majority of these health care apps don't pose much of a risk to consumers if they malfunction, and will not be federally regulated. Instead, the agency will focus on a handful of apps that turn smartphones into devices, like a heart monitor, or medical attachments that plug into smartphones, like arm cuffs that measure blood pressure. "Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it," said Dr. Jeffrey Shuren, director of the FDA's medical device center....[A] growing number of companies are developing more complex apps and attachments that perform tests and functions once reserved for the doctor's office. These tools allow users to take photos of their eardrums, monitor irregular heartbeats and even measure lung function. Many of these tools can cost $100 or more....Last year the FDA approved the sale of a $199 heart monitor from AliveCor . The attachment snaps on like a smartphone case with finger electrodes that measure the users' heartbeat. Hold the device for 30 seconds and it delivers an approximate EKG reading, an essential medical test that checks for problems with the heart's electrical activity. Patients can e-mail the reading to their doctor for analysis.

As I have mentioned in previous notes, I think that some of these smartphone apps/gadgets will fundamentally change some aspects of healthcare delivery. For example and in the hands of physicians, smartphones will change the way patient are triaged (see:  Physicians Using an iPhone Application to Triage Their Patients ). On the patient side, smartphone apps and gadgets can diagnose disease, sometimes enabling patients to come to a physician appointment or seek emergency care with a diagnosis in hand (see:  "Check Engine Light" for Health Surveillance on Our Smart Phones ; Healthcare Consumers as Self-Trackers; Process Enabled by New Apps ). In developing countries, smartphone apps with gadgets may serve as a substitute for a scarcity of healthcare professionals (see: Healthcare in Developing Countries; Relationship to Smartphone Apps and Devices ).

In summary, smartphone apps and gadgets will be able to place actionable medical information in the hands of healthcare consumers. This is little different than the current custom of those who currently seek advice from "Dr. Google" when they have symptoms of a disease (see: Paging Dr. Google! We Are Waiting for a Second OpinionTeaching Consumers to Say "No" to Physicians' Recommendations ). I am in favor of the FDA regulating some of these apps/gadgets but I hope they do not launch this regulation in a heavy-handed way so that smartphone innovation becomes stifled.

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