Apple’s December FDA Meeting Addressed ‘Moral Obligation’ for Health, Sensor Innovation, and Regulation
Last December, several Apple executives led by Senior Vice President of Operations Jeff Williams traveled to Washington, DC to participate in a meeting with Commissioner Margaret Hamburg and other representatives of the U.S. Food and Drug Administration (FDA).
While the topic of the meeting was listed only as “Mobile Medical Applications”, speculation fueled in part by the presence of Michael O’Reilly had suggested that Apple might be laying some groundwork for the iWatch by having preliminary discussions with the FDA. At the time of the meeting, O’Reilly had only recently joined Apple after serving as Chief Medical Officer of pulse oximetry firm Masimo.
Following disclosure of the December meeting, AppleToolbox filed a Freedom of Information Act request with the FDA, asking for details on the meeting with Apple. After three months, the FDA has responded with a memo outlining the highlights of the meeting, and while the iWatch is unsurprisingly not addressed directly, it’s clear that Apple is indeed looking to maintain a dialogue with the FDA as the company seeks to make an impact in health monitoring.
With regard to Apple’s plans for health, company representatives thanked the FDA for guidance on mobile health apps and suggested that there may be a “moral obligation” to leverage this technology to improve human health but that care must be taken to make sure industry and regulators are on the same page.
Apple sees mobile technology platforms as an opportunity for people to learn more about themselves. With the potential for more sensors on mobile devices, Apple believes there is the opportunity to do more with devices, and that there may be a moral obligation to do more.
Sensors already exist on medical devices. For instance, Apple’s devices have cameras and accelerometers. There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA.
Discussions also centered around what aspects of health monitoring technology the FDA would regulate, with the FDA noting an emphasis on software being used to receive and calculate data rather than the more general hardware that would sense or display the data. Emphasis is also placed on how such health information is used, with uses considered educational or informational not being regulated while those considered diagnostic would be subject to FDA review.
Using the glucometer example, the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition. If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device. FDA looks at how devices are actually used.
Apple’s “Health” app for iOS 8, briefly introduced at WWDC last week, is Apple’s first major step into this area, serving as a single location for users to either manually or automatically input various types of health data for tracking purposes.
While the lack of significant stage time for the feature at WWDC has led to some discussion of just how serious Apple is about its health initiative, the company may simply be waiting until it is ready to introduce the iWatch before making a bigger push with Health. With rumors of several types of biometric sensors being included the iWatch, it will likely serve as the core of Apple’s health tracking initiative, with other accessories from third-party companies plugging into the system for more specialized tracking.
With iOS 8 installed on thousands of developer devices, details about the operating system continue to leak out. We covered quite a few new iOS 8 features listed during the keynote by Apple, including battery usage by app, and then followed that up with even more iOS 8 tweaks and changes, such as time-lapse mode, Messages improvements, WiFi calling, and grayscale mode.
Pulling from an extensive list maintained by our forum members and other iOS 8 users on Twitter and the web, we’ve catalogued even more improvements to the operating system below.
Randomized MAC addresses – iOS randomizes the MAC addresses of iOS devices when scanning for WiFi networks, which makes it more difficult for companies to track and gather location data on a customer. Each iOS device has a unique MAC address, which could previously be used for location tracking and data collection via WiFi scanning. iOS 8 will use random, locally administered MAC addresses that “may not always be the device’s real (universal) address.”
Safari credit card scanning – In iOS 8, Safari can utilize the camera to scan in credit card numbers when making online purchases, a faster alternative than manually entering a credit card number. Currently, this scanning function is available in the App Store to scan in iTunes Cards, and the credit card scan functions in the same way.
Photos in the Notes app – Photos can be inserted into the Notes app from the Photos app for the first time in iOS 8.
Hide images from Photos app – Images in the Photos app can now be hidden from the Moments, Collections, and Years view in the Photos app. Holding a finger on a photo will bring up an options menu and selecting “Hide” will keep it from being visible in those sections. Hidden photos are still visible in the albums view, however, in new “Hidden” album.
Background location notifications – iOS 8 has new popups that will notify users of apps that access Location information while running in the background. The popup asks users if they want to continue to allow the apps to access the information or turn it off, giving users more information on apps that could potentially be using a lot of battery life. There are also more Location Services options in the Settings menu and more options per app, for more control over how Location is used.
iTunes Radio Control Center – When playing a song on iTunes Radio, the Control Center will now offer a “Buy” button to give users a quick way to purchase a song.
Indoor Mapping – iOS 8 adds the M7 processor and iPhone motion sensors to the CoreLocation API, allowing venue owners to create indoor positioning systems. In use at San Francisco’s California Academy of Sciences, the Westfield Center in San Francisco, and the San Jose Airport, the system can be used to display floor number or direct users to points of interest.
Keep up with all of the new changes introduced in iOS 8 on our forums, where our readers are discussing and sharing feature enhancements and tweaks in the “iOS 8, All The Little Things” thread.
Apple’s split-screen multitasking feature for iOS 8 did not make it into the company’s Worldwide Developers Conference or the first release of iOS 8, but it is still in the works. As noted by developer Steven Troughton-Smith, iOS 8′s internal SpringBoard includes code that allows apps to run side-by-side in multiple sizes: 1/4, 1/2, or 3/4. Apps that are running side-by-side are displayed as a single app in the App Switcher.
First hinted at in May, split-screen multitasking will allow two apps to be displayed on a single screen on the iPad Air, Apple’s largest tablet. The feature, which reportedly only works in landscape mode, will allow iPad owners to use two apps simultaneously and it may also allow users to share information like links, images, and text between two apps.
Previous concept for split-screen multitasking (not based on specific rumors)
The iPad’s inability to display two apps at once is a lack that Microsoft has used to advertise its Surface tablet, which does have the ability to display multiple apps on the screen at one time.
It appears that split-screen multitasking may initially be limited to the iPad Air, with support for the iPhone and the Retina iPad mini possibly coming at a later date. Split-screen multitasking could also be slated for Apple’s rumored 12.9-inch “iPad Pro” that may or may not be in development.
Ahead of the Worldwide Developers Conference, Brian Chen of The New York Times confirmed that split-screen multitasking is still a work in progress. It may see a debut during one of the many updates Apple is likely to release as it refines iOS 8 ahead of a public release, or it may be a feature the company is saving for a later iOS 8.1 update.
It is hard to believe that Google announced Google Glass nearly 2 years ago at Google I/O 2012. It took a little while for the early adopting “Explorers” to start getting their kits in the mail, but that didn’t bother any of them. Since they started shipping more and more people have been jumping on the proverbial bandwagon. Sadly though, the whole Google Glass experience has been met with hit and miss approval. There have been multiple instances of run ins with the law, public places banning them out right and stereotyping of wearers, Glassholes. It is still such a new idea and concept that it is natural for the general public that doesn’t have access to some things to be afraid of it. Education is the single best approach that is viable, but while many Glass Explorers educate to the best of their ability, there just aren’t enough people walking around, or physical locations, for people get a real look at what is going on.
While Google Glass is available for public consumption, it still isn’t in a physical location for people to really get a good look at. We know that will change and according to @evleaks, AT&T is supposedly on board to be one of the first physical retailers to carry Glass.
Personally I think is going to be great. It will bring physical Glass to physical locations across the US and should help the general public get a better look at, and better understanding of, Google Glass. The leak is just that, a set of words pushed out on twitter with no physical proof. @evleaks has a pretty solid track record, so we believe it is at least something that AT&T and Google are talking about. AT&T will surely package it with phones and hopefully let you pay it off over time. We can only assume at this point that the price tag will remain the same, or very similar, when ever this happens.
Via @Evleaks G+
img via – TCD
UPDATE: Seems a Google rep reached out to Phandroid and said “We have no plans to sell Glass in AT&T stores.” It is expected that they would deny it. Even with a denial, it is still a 50/50 chance. We have seen and heard plenty of denials of things that were actually true. As with all things, it is just a leak/rumor still.
Android’s best selling App/Game is about to get better. Mojang the creator of the very successful game Minecraft, needs beta testers for their mobile version 9.0 update. If you have an Android device, a Google+ account, and have purchased Minecraft PE you can follow the links below to sign up. All new features have been added on their site and it is huge. Here is a snippet of just a few of the things that are being packet inside the 9.0 update:
- Unlimited worlds!
- New culling algorithm
- New culling of clouds
- Tile entities are saved differently
- New falling mechanics for gravel and sand
- New insta ticking of water and lava
This Minecraft PE update is so far the biggest yet. This would adds plenty of features that are only available on PC and console version. However, the only downside is that you must play the game on a compatible device to enjoy all the new features. These features can be turned off if the game runs to slow to enjoy. Now go out there and start punching wood!
The mad scientists at DARPA are encouraged to come up with crazy schemes to provide the US with an edge in future military campaigns. It looks as if the Z-Man Program, presumably subtitled “project make soldiers climb walls like Spider-man,” has come to a successful conclusion. Copying the physical structure of a Gecko’s toe, a team at Draper Laboratory, Cambridge, Mass., has constructed a pair of paddles that enable a 218-pound human to scale a wall with a 50-pound load strapped to their back. Naturally, it’ll be a while until we see snipers scaling enemy buildings with this sort of tech, but it’s a damn sight more useful than suction cups or a strong rope and a lot of pulling.
Filed under: Science
Electronic Arts is one of the largest third-party publishers in the video game industry, and if you aren’t in LA you’ll probably want a way to watch their E3 press briefing, right? Well you can do that right here. What’s on tap? We’re expecting news and footage of the next Battlefield game, lots of sports and even some Star Wars. And that’s not all: Mirror’s Edge 2, more on Dragon Age: Inquisition have been promised as well as a surprise from Criterion games — the developer perhaps best known for the crashtacular Burnout racing series. The show starts at 3 pm Eastern or noon Pacific and you can catch it below!
Right before Microsoft kicked off its E3 event, Graeme Boyd told us to expect games, games and… more games. True to his word, Redmond spent the full presentation talking about the new generation’s latest games, including titles from the Call of Duty, Forza and Halo franchises. It was a massive list of announcements, and a huge day for any Xbox One owner. Did you miss all the fun? You can go back and read our liveblog right here, or simply read on for a full rundown of Microsoft’s big E3 announcements.
Call of Duty: Advanced Warfare
Is Titanfall’s world too far-flung into the future for you? Then pay attention to Call of Duty: Advanced Warfare, the long-running franchise’s new future-looking series. Microsoft’s E3 briefing didn’t nail down a specific year for the title, but it has all the hallmarks of an imagined future war: holographic gun readouts, magic flying grenades, mech suits, future tanks and augmented soldier armor.
Forza Horizon 2
Been playing Forza 5? You’ve already got wheels on Forza Horizon 2′s tracks. This Xbox exclusive racer hits September 30th, and promises more cars, more tracks and a social experience that plays nice with your existing Forza 5 profile.
Been looking forward to Evolve, the futuristic team-shooter from the minds that spawned the original Left 4 Dead? Looks like Xbox One owners will get first crack at the beta this fall, not to mention exclusive DLC. Not familiar with it? Read this and catch up, man!
Assassin’s Creed: Unity
Find playing the part of a deadly Assassin a little too solitary? This is the game for you. Staged during the French revolution, Assassin’s Creed: Unity lets you team up with three friends for co-op
murder liberation activities.
Dragon Age: Inquisition
Giant reptiles, spiders and fantasy landscapes are coming in Dragon Age: Inquisition. Microsoft showed off a gorgeous trailer teasing plenty of environments, tons of detail and, of course, dragons. Oh, and its DLC is hitting the Xbox first, naturally.
Looking for an action packed cautionary tale about the contents of your favorite energy drink? That’s Sunset Overdrive: Insomniac’s brightly colored, free-running horde shooter with eight-player co-op support. This quirky action game is an attitude-heavy, completely silly, over-the-top monster romp, and we have to admit, it looks pretty fun. Oh, and it’s an Xbox One exclusive.
Super Ultra Dead Rising 3 Arcade Remix Hyper Edition EX Plus Alpha
And the award for the most excessive video game title of the decade goes to Super Ultra Dead Rising 3 Arcade Remix Hyper Edition EX Plus Alpha, an Xbox Live exclusive based on Capcom’s zombie apocalypse series. Dead Rising has always been a silly series, but this Arcade-style remix takes it to a new level, outfitting players with silly costumes sourced from all of Capcom’s franchises. Not enough? Don’t worry — the more humbly named Dead Rising 3 will be getting new DLC later this year, too.
Fantasia: Music Evolved and Dance Central:Spotlight
Pick up an Xbox One before Microsoft axed its Kinect requirement? Put on your dance shoes: Harmonix just announced Dance Central: Spotlight. Harmonix head-honcho Alex Rigopulos bounced back and forth between teasing the title’s downloadable return and reminding us that Disney’s Fantasia: Music Evolved is on the way, too. Plenty on the way for the rhythmically inclined.
Miss the land of Albion? Don’t fret: it’s back. The franchise’s latest adventure features a multiplayer bent, highly stylized visuals and even the ability to play as the villain (in an isometric view, no less!) The game’s multiplayer beta launches this fall: check out FableLegends.com to sign up.
No, Project Spark isn’t a new game announcement but Microsoft found a reason to sneak it into its E3 presser anyway: Conker. For the unfamiliar, this quirky squirrel was the rude protagonist of Conker’s Bad Fur Day – a charming, if crude platformer from Rare’s N64 days. Now the alcoholic anti-hero has found an exclusive home on Project Spark. Super weird, we know.
Ori and the Blind Forest
Not interested in making your own 3D, free-roaming video game? That’s okay, Microsoft is showing off simpler games, too: Ori and the Blind Forest is a gorgeous, watercolored 2D platformer. It’s cute, dark and potentially creepy — everything we want out of the indie scene.
Halo: The Master Chief Collection
If you read Engadget, you knew this was coming — but Microsoft thought it’d be a good idea to make it official, too. Halo: The Master Chief Collection remasters the first four Halo games, but still keeps each game plugging along on their original engines. Meaning that you can get the exact same experience you had when each title was new, but with better graphics. It also has over 100 multiplayer maps and, wouldn’t you know, exclusive access to Halo 5′s multiplayer beta.
Dig the atmospheric wonderland of Playdead’s Limbo? Then pay attention to Inside, the company’s upcoming 2.5D puzzle platformer. The team didn’t reveal much about this game, but it’ll bring a creepy, dystopian prison experience to your Xbox One sometime next year.
Rise of the Tomb Raider
Apparently Lara Croft’s last adventure was pretty traumatizing, because the reboot’s sequel starts with the hero in a therapy session. Don’t worry though, she overcomes (or embraces?) her issues and charges right back into action: this game teases plenty of bow-slinging, tomb raiding action — but it won’t be in your livingroom until holiday 2015.
The Witcher III: Wild Hunt
Geralt is back, and now he’s wandering through a huge, open-ish landscape. Oh, and taking down huge mythical creatures, of course. This demo was overloaded with action, but it did stutter a bit in the heat of battle. Hopefully that framerate drop will pick back up before it launches next spring.
Here’s a franchise revival we didn’t expect: Phantom Dust. This title was an action / strategy game for the original Xbox, and a bit of a cult classic. Unfortunately, Ken Lobb gave us few details to go on for the new game — just a piano-backed battle between two magically glowing mages.
Tom Clancy’s The Division
Looking for a tactics-laden realistic shooter? The Tom Clancy brand has always delivered on that front. The franchise’s latest game, The Division, teased us plenty last year, but it’s back again with a desolate looking train station, a holographic map overlay and a pretty well destroyed Times Square. We were never much for kitschy tourism anyway.
If Dragon Age doesn’t have quite enough mythical beasts for you, here’s another game shock-full of ‘em: Scalebound. Platinum Games’ latest action series features a dragon-slaying archer who sports scaled armor, swords and a pair of Beats-style headphones. Makes sense — the ancient craft of killing monsters had to come into the modern era eventually, right?
Fully destructible environments, cell-shaded weapons and lots and lots of explosions: Crackdown is back. There aren’t a lot of details just yet, but the series revival seems to have player-controlled aircraft, remote explosives and the ability to destroy entire skyscrapers. Neat.
Not every game during Microsoft’s presser got its own dedicated summery, but that doesn’t mean we didn’t get peek. The outfit’s ID@Xbox trailer (as seen above) teased a slew of indie titles, including Aztez, Forced, Knigh Squad, White Night, Spectra, Cuphead, Hyper Light Drifter, Divekick, Habitat, Hellraid and tons more. It’s a serious overload.
Two weeks ago, hackers hijacked several iOS and Mac devices in Australia, remotely locking them via iCloud and demanding a ransom from the owner to get the device unlocked.
“Device locked by Oleg Pliss,” read the hijacker’s message, along with a demand for $50 to $100. Quite a few users were affected and while early speculation suggested iCloud may have been hacked, Apple confirmed that iCloud was not compromised, and that hackers had instead gained access to Apple IDs and passwords, likely through other site breaches where they used similar credentials.
The two hackers behind the attacks have now been detained by Russian authorities, reports The Sydney Morning Herald.
The hackers – aged 17 and 23 – were detained in the course of “operational activities” by the Russian Interior Ministry, Russia’s Ministry of Internal Affairs said. They are both residents of the Southern Administrative District of Moscow and one has already been tried before, it said.
According to Russian site MKRU [Google Translate), the two hackers were caught after appearing on camera withdrawing a victim’s ransom money from an ATM. The site also confirms the hackers gained access to Apple IDs and passwords via phishing pages and social engineering techniques, then used that information to lock devices. Russian users were also affected, which led to the investigation.
One method of obtaining login information involved a pre-owned account filled with movies and music that was sold to an unsuspecting victim. Once the person linked their own details with the account, it was vulnerable to being hijacked.
During the attacks, users who had passcodes enabled on their devices were able to bypass the hack, but those who had not previously set a passcode were out of luck, requiring a full reinstall of iOS. Apple recommends using a passcode with iOS devices, as well as two-step authentication, which can help thwart attacks like this one.