The US Food and Drug Administration (FDA) has permitted marketing of a new device that uses Apple Watch to reduce sleep disturbance related to nightmares.
The device targets adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD), the FDA said on Friday.
It provides gentle vibration through touch based on an analysis of heart rate and motion during sleep.
The device, called Nightware, is a digital therapeutic that uses an Apple Watch and an Apple iPhone that are configured and logged into a software application and the Nightware server.
Throughout the night, Apple Watch sensors monitor body movement and heart rate during sleep.
These data are sent to the Nightware server and, using a proprietary algorithm, the device creates a unique sleep profile for the patient.
When Nightware detects that a patient is experiencing a nightmare based on its analysis of heart rate and body movement, the device provides vibrations through the Apple Watch while the product is in use.
Nightware is available by prescription only and is intended for home use, the FDA said.
“Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need,” Carlos Pena, Director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.
“Today’s authorisation offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares.”
PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event.
People may experience a range of reactions after trauma, and most will recover from their symptoms over time.
Nightware is not a standalone therapy for PTSD. The device should be used in conjunction with prescribed medications for PTSD and other recommended therapies for PTSD-associated nightmares and nightmare disorder, the FDA said.
In an email to WhatsApp head Will Cathcart, the nation’s IT ministry said the upcoming update to the app’s data-sharing policy has raised “grave concerns regarding the implications for the choice and autonomy of Indian citizens… Therefore, you are called upon to withdraw the proposed changes.”
“Such a differential treatment is prejudicial to the interests of Indian users and is viewed with serious concern by the government,” the ministry wrote in the email, a copy of which was obtained by TechCrunch. “The government of India owes a sovereign responsibility to its citizens to ensure that their interests are not compromised and therefore it calls upon WhatsApp to respond to concerns raised in this letter.”
Through an in-app alert earlier this month, WhatsApp had asked users to agree to new terms of conditions that grants the app the consent to share with Facebook some personal data about them, such as their phone number and location. Users were initially provided until February 8 to comply with the new policy if they wished to continue using the service.
“This ‘all-or-nothing’ approach takes away any meaningful choice from Indian users. This approach leverages the social significance of WhatsApp to force users into a bargain, which may infringe on their interests in relation to informational privacy and information security,” the ministry said in the email.
The notification from WhatsApp prompted a lot of confusion — and in some cases, anger and frustration — among its users, many of which have explored alternative messaging apps such as Telegram and Signal in recent weeks.
In a statement on Tuesday, a WhatsApp spokesperson said, “We wish to reinforce that this update does not expand our ability to share data with Facebook. Our aim is to provide transparency and new options available to engage with businesses so they can serve their customers and grow. WhatsApp will always protect personal messages with end-to-end encryption so that neither WhatsApp nor Facebook can see them. We are working to address misinformation and remain available to answer any questions.”
WhatsApp, which Facebook bought for $19 billion in 2014, has been sharing some limited information about its users with the social giant since 2016 — and for a period allowed users to opt-out of this. Responding to the backlash last week, the Facebook-owned app, which serves more than 2 billion users worldwide, said it was deferring the enforcement of the planned policy to May 15.
WhatsApp also ran front-page ads on several newspapers in India last week, where it has amassed over 450 million users, to explain the changes and debunk some rumors.
New Delhi also shared disappointment with the timing of this update, which, to be fair, WhatsApp unveiled last year. The ministry said that it was reviewing the Personal Data Protection Bill, a monumental privacy bill that is meant to oversee how data of users are shared with the world.
“Since the Parliament is seized of the issue, making such a momentous change for Indian users at this time puts the cart before the horse. Since the Personal Data Protection Bill strongly follows the principle of ‘purpose limitation,’ these changes may lead to significant implementational challenges for WhatsApp should the Bill become an Act,” the letter said.
On Tuesday, India’s IT and Law Minister Ravi Shankar Prasad also offered loud advice to Facebook. “Be it WhatsApp, be it Facebook, be it any digital platform. You are free to do business in India but do it in a manner without impinging upon the rights of Indians who operate there.”