Brian Dolan

The current state of health gaming By Jonah Comstock As Games for Health organizer and DigitalMill cofounder Ben Sawyer pointed out at the 2014 Games for Health conference, health gaming had some big milestones in the past year -- events that may not represent a breakthrough for the category but show it steadily building in importance. Health games made the cover of Nature when a study showed that a game called NeuroRacer could improve neuroplasticity in older adults, leading to a potential therapy for ADHD, depression, and autism spectrum disorders. A spin-off company, called Akili Labs, has since partnered with Pfizer to develop a game for Alzheimer's. And Facebook made two acquisitions with potential gaming consequences -- Oculus Rift, whose CEO keynoted last year's Games for Health conference and Moves, an app that puts the company into the increasingly gamified activity tracking space. Health games are a subcategory of "serious games," a growing movement to use games and gamification in areas like education, healthcare, science or defense. It's an area of mobile health that has grown up right along side other kinds of health apps. One of the largest areas where gaming, or at least gamification, is being used is in corporate wellness, where game mechanics like points, rewards and competitions are used to motivate employees to move more or eat better, often in combination with an activity tracker. Similar efforts have been employed to get kids moving more, through game platforms like Zamzee or GeoPalz. There are also plenty of exergames (or exercise games) in the direct to consumer market, including console platforms like Wii Fit and apps like Zombies, Run! This is a space that Sawyer and others think will explode as tracking and wearables become more and more ubiquitous over the next few years. Games can also be used in the treatment of diseases, like the aforementioned Akili Labs. A study is underway right now at The Ohio State University testing Jane McGonigal's SuperBetter game on populations recovering from traumatic brain injuries. Many startups are working on using motion sensing game platforms like the Microsoft Kinect to treat patients who need physical therapy, as well as children on the autism spectrum. A game by HopeLab called Re-Mission helps educate kids with cancer about their disease and treatment, and has even been shown to improve their prognosis by giving them a sense of agency in their care. Simulation games have a lot of potential in various areas of healthcare, whether as training games for mental health professionals and counselors (the province of Kognito), simulations for surgeons in training, or even public health education, such as dating simulations for teenagers that promote good sexual health or other positive health choices. One such game, PlayForward, recently completed a randomized control trial. Large-scale simulation games can be used to educate people about health risks in their environment in an effort to decrease their pollution or other kinds of waste. Games certainly have a lot of healthcare potential. But does healthcare need full-fledged games, or is it better to add innovations from the gaming world on top of existing systems? Currently one of the big debates in the industry is around the term "gamification" -- what it means, what it should mean, and how it differs from full-fledged games. Games vs gamification Over the last few years, gamification has been used to refer to taking elements of games -- especially rewards, points, leaderboards, and social competitions -- and inserting them into apps geared at behavior change for fitness, wellness, or medication adherence. Gamification is increasingly popular among groups like payers and corporate wellness program vendors. But prominent voices in the gaming community have decried it, saying it uses game elements in an out-of-context and ultimately ineffective way. "Bribery is not a game,” Ayogo CEO Michael Fergussen said at the 2012 mHealth Summit. “It’s not enough just to give people rewards for doing the right thing. Points and badges are to games what page heading and chapter numbers are to books. I can put page numbers and chapter headings on my VCR manual, but that doesn’t make it ‘War and Peace’.” The concern is that those sorts of game mechanics work only so long as they are novel, and won't produce long term, sustainable behavior change the way an immersive game experience does. Additionally, at the 2014 Games for Health conference, attendees talked about gamification as primarily a way to sell games to enterprise buyers that might be shy about incorporating them. "I think much of the attraction to gamification comes from the acknowledgement that games are very significant right now," John Ferrara, Creative Director of Megazoid Games said at the event. "But there’s a timidity about their professional legitimacy. People are nervous to say 'I’m working on a game.' Gamification is comforting in that way." Another speaker at the conference, FIX CEO Mike Tinney said that his corporate wellness game company uses the term "gamification" in its sales copy, but "it’s a door opener and we immediately start to reposition when we get them on board." What is it about games that works so much better than gamification? Well, Ferrara has a theory that effective games are constructed in layers, and that a successful game will address each layer before moving onto the next one up. At the base of that tower is motivation -- making sure that the player will want to play the game. Players play games for different reasons: for fun or recreation, as a channel for social interaction with friends, to establish and prove their skill, because it gives them a chance to be creative, or because it provides catharsis of some kind.  Because the makers of health games have another goal, like getting people to move more or eat better, they can fall into a trap if they neglect to build a game users will be intrinsically motivated to play. Above motivation is meaningful choice -- an engaging game has to give the player some agency in the outcome, which allows for tactics and strategy to exist in the game. Other layers go on top of that, like balance and usability. Aesthetics, the superficial design elements of the UI, are at the top of Ferrara's pyramid. In his talk at Games For Health, Ferrara looked at a number of health games he felt failed at their intended purpose. Some of them fail because they are meant to be educational games, but the game elements muddle the educational message. For instance, Ferrara talked about a financial planning game by Charles Schwabb wherein the highest score is attained by choosing to not start a family, to prioritize work over everything else, and to "die alone with lots of money and no one to leave it to." In a less extreme example, a toothbrushing tablet game for the Leap Frog system imposes a 30-second time limit for kids to clean all the virtual plaque off a set of teeth. Not only is it very hard to win, but the message is not aligned with healthy habits -- most dentists recommend brushing your teeth for two minutes, and that's by no means a maximum someone should be punished for exceeding. The takeaway from these examples is that there's a dual challenge in healthcare: Games for health have to be worthwhile in themselves, with an intrinsic motivation for people to play, but that motivation cannot conflict with the health messages and lessons the game is meant to convey. Who will pay for health games? As health gaming looks to move forward, the industry faces challenges when it comes to monetizing their products. When companies sell directly to consumers, the money can be very good -- for instance, many people credit Wii Fit with saving the Wii platform by bringing in a wider demographic than most other games. The problem, according to Ferrara and Stephen Yang, a physical education professor at SUNY-Cortland who also spoke at Games For Health 2014, is that mass appeal direct-to-consumer games don't really need to be concerned with increasing movement -- only with convincing people they increase movement to sell some games. But a 2012 study in Pediatrics suggested that those games didn't really contribute to increased activity among players. Game developers working on things like physical therapy games find themselves selling to clinics and providers rather than directly to patients or consumers. This has its own problems, of course, as getting games approved for reimbursement is a slow process, and game developers aren't used to the strenuous level of efficacy data insurers are looking for. Getting providers to pay for something that isn't covered by reimbursement is often a challenge as well. Pharma is a space with some interest in games, which could be used to improve medication adherence or educate patients about things like proper inhaler use. But the large pharma companies are so risk-averse and have so many regulations, they're often not nimble enough to work with game companies, according to Sawyer and Steffen Walz, a professor at RMIT University in Melbourne, Australia. Correction: A previous version of this article identified Walz as a professor atthe University of Melbourne. "Pharma, and we're talking about big pharma, are large organizations, they have core products they want to keep selling, and they’re very very conservative," Walz said. "That means you have to educate them. ... The real problem we’ve been facing is we have to explain to them what the use is and can be. Behavior change? They can’t use that in a certification process. They have to have a biometric marker." The saving grace has been the increase of pharma companies like Merck, Roche, and Pfizer adding innovation groups that can pilot things the larger arm of the company won't touch. "This will become the only model by which pharma plays a role in games and apps," Sawyer said. What's next in games for health? Just as Apple, Google, and Samsung have now shaken up the tracking space with their near-simultaneous entrances, the niche, startup-filled field of health gaming is also waiting to be shaken up by big entrances. As those plays bring health tracking to a larger group of people, it opens the way for games built around health tracking to have a wider appeal, and a more well-established base of standards for developers. Sawyer mentioned that Apple's mysterious iWatch product could prove to be a new platform for game designers, with a lot of potential for health gaming. Google Glass also offers potential for augmented reality health games, that could reward users for the healthy choices they make in day to day life while wearing glass. One large company that has been involved in health gaming for a long time is Nintendo, and they announced a major shift into health in January, though the company has been very quiet about the details. All we know right now is the launch date is April 2015 and CEO Satoru Iwata told the Wall Street Journal that “the new product wouldn’t be wearable, that it wasn’t an extension or version of the Wii Balance Board — which players can use to measure their weight or posture while playing on a Nintendo exercise game — and that it wouldn’t be used in the living room.” But in many ways, games for health are still waiting to take off. The killer health game Sawyer was searching for at 2013's conference has still not emerged. What's changed is that the Games for Health project isn't sitting around waiting for that game, but instead taking steps to bring it about. Sawyer announced a new toolkit for prototyping games about nutrition, because the existing ones on the market leave so much to be desired. When Sawyer was brainstorming ideas for a nutrition game kit he was building, his friend told him something that resonated — “I don’t think about nutrition, I think about food. Make stuff about food.” So Sawyer developed a kit to help inspire other game developers to come up with meaningful games that help kids learn about healthy food. Some of the ideas Sawyer brainstormed when creating the kit included how to simplify the ideas behind nutrition yet add diversity of topics, such as exploring beyond calories and binary choices like fruit versus pizza. He also wanted to figure out how to engage developers and non-developers, keep the goals set on good outcomes, identify issues around food that improves health and health outcomes, and identify areas where games could offer deeper content. In addition, DigitalMill is working on an open-source gaming platform called Meili, named after the Norse god of travel. The system would help facilitate the creation of games that used the smartphone's built in activity tracker or other sensors in combination with an interface that is either audio-based or requires only glancing at the screen. These would be games that, in Sawyer's words, "turn people into human joysticks" who can control the game just by moving. A timeline of health gaming By Aditi Pai Digital health games have been gaining popularity in recent years and some bigger players are even starting to get involved, but six years ago far fewer digital health games were making headlines. MobiHealthNews has compiled a timeline that starts in 2009 when Corventis and the University of Southern California created an iPhone app game called Beating Heart and leads us all the way to just a few months ago when the Journal of the American Medical Association (JAMA) Pediatrics published an article that found overweight and obese children lost weight and demonstrated a significant increase in physical activity after using a 16-week weight management program that incorporates active video gaming. Along the way, other researchers published studies showing the efficacy of gaming and more startups began creating their own apps, instead of just bigger companies. This is not a comprehensive list of events in digital health gaming, but rather a splash of some of the biggest health gaming headlines over the last five years. October 2009: Corventis, USC create concept Beating Heart mobile game Wireless health company Corventis demoed a concept iPhone app called Beating Heart. The app is a game that leverages Corventis’ wireless “band-aid” sensor to transmit the player's heart rate to the iPhone, which then can broadcast the heart rate over Twitter and Facebook or via text message or email. By using Bluetooth, the concept app also demonstrates that players can get a snapshot of nearby players’ heart rates in real-time. The concept app aimed to demonstrate the ability for mobile health to become interactive and fun through a social game, and could create social incentives to becoming healthier. Read More April 2010: Bayer, Nintendo bring blood glucose meter integration to US Bayer brought the Nintendo DS enabled blood glucose meter, Didget, to the US. Inventor and entrepreneur Paul Wessel wanted his diabetic 4-year-old son, Luke, to stop hiding his glucose meter, so he found a way to pair one of Luke’s treasured possessions, his Nintendo DS, with his least favorite. German healthcare company Bayer purchased Wessel’s idea for a Nintendo DS game paired with a glucose meter and branded it Didget back in 2009. Read More June 2010: Humana launches mobile games for health Humana, a US health insurance company with more than 10 million members, announced that its games for health team had launched the first of several iPhone apps that use gaming to help people engage in healthy activities. According to Humana, Colorfall offers customers an amusing way to exercise their brains and bodies as they interact with the game as players must arrange cascading colored tokens in the order of the colors of the rainbow. In order to get the colors, the player needs to take a picture of something that has that color on it. Read More July 2010: Mobile apps for Obama’s Apps for Healthy Kids First Lady Michelle Obama’s Apps for Healthy Kids competition website posted 95 apps that aim to encourage kids (or encourage their parents) to make healthier decisions and help curb childhood obesity. The competition, which is part of the First Lady’s Let’s Move campaign, aims to drive the country closer to achieving Obama’s stated goal of eliminating childhood obesity within one generation. Of the 95 entrants, half-dozen or so were specifically created for mobile platforms (iPhone and Android mostly). Some mobile apps included Rhythmatics Kids, a Guitar Hero for running, and Work It Off!, an app that teaches children the correlation between the calories they eat and the calories they burn. Read More April 2011: JAMA argues it's time to take mobile health games seriously The Journal of the American Medical Association (JAMA) published a paper that argued health-focused video games, including those for mobile platforms, now deserve “serious attention.” Dr. Leighton Read of Alloy Ventures and Seriosity and Dr. Stephen M. Shortell said while people doing jumping jacks in front of their Xbox may prove entertaining, the real news is how Read and Shortell see mobile devices playing a big role in the healthy gaming world. Read More July 2011: Diabetes Hands Foundation launches mobile game HealthSeeker, a free mobile app that uses gamification for diabetes management and health improvement, launched for the iPhone and Android platforms. HealthSeeker was created by the Diabetes Hands Foundation (DHF) in collaboration with the Joslin Diabetes Center. It was developed by Ayogo Games. HealthSeeker began life as a Facebook application, where it currently has more than 8,000 users. The game allows players to complete specific “missions” that encourage exercise and healthy activities. Successful completion of the missions earns players points and “kudos” from fellow players and Facebook friends. Read More July 2011: PHR provider Dossia adds games, incentives, social networking Dossia unveiled the latest version of its Dossia Health Manager software. It will be available to existing customers in the third quarter of 2011. According to the non-profit consortium, the Health Manager now “integrates game and social dynamics, incentives and messaging to foster sustained user engagement and behavior change, thereby offering long-term value to employers, employees and their families.” Read More July 2011: Humana developing game for students Raja Rajamannar, SVP and Chief Innovation and Marketing Officer at Humana explained a project Humana was working on called the Humana Horsepower Challenge. The project involved giving pedometers to students in 60 different schools across the US. Humana developed an “aquarium” game where the students’ pedometer logged activity data was represented by fish avatars of various sizes. (Humana has its own branded pedometer device as part of its Humana Gear offerings.) Students who exercised more appeared in the “aquarium” as larger fish. Rajamannar said that the students in the program did six times as much physical activity as they did before the program started. He said activity levels for the group were still higher on average than they were before the program. Read More March 2012: Medical device and design company develop asthma inhaler game Medical device design and development consultancy Cambridge Consultants showed off its latest creation, an asthma inhaler training device called the T-Haler. According to the company the concept device “more than doubles patient compliance.” According to Cambridge Consultants, the device offers interactive software, linked to a wireless training inhaler that monitors how a patient uses the device and provides real-time feedback via an interactive video game. T-Haler provided visual feedback to the user on their performance and the areas that need improvement. Read More March 2012: Cancer-fighting video game may positively impact behavior HopeLab Vice President of Strategic Partnerships Ellen LaPointe wrote in the company's blog that a researcher at Stanford Business School found an hour of playing the company's cancer-fighting video game Re-Mission, created in 2006, could cause shifts in emotion, knowledge, and perceptions of chemotherapy that might potentially influence downstream behavioral impacts. Since then, HopeLab has launched a second version of Re-Mission that is a collection of online games. Read More November 2012: Study finds virtual avatars improve fitness motivation A study from the University of Missouri found social engagement with avatars can improve self-image and engagement in a health context. Elizabeth Behm-Morawitz, study author and Assistant Professor of Communication at U of M, looked at self-reported data from 279 users of the game Second Life, where players create virtual avatars and interact in an online, social context with other players. Behm-Morawitz found that in general, Second Life players used their avatars to test out new looks or styles in a low risk environment. She also believes the social nature of Second Life enhances the sense of identification users have with their avatar. She said the real market for this might be engaging a group of people, gamers, who often aren’t already invested in fitness. Read More January 2013: UnitedHealthcare, Konami bring health games to schools In partnership with UnitedHealthcare (a division of UnitedHealth Group), Konami, a Japanese company that is one of the pioneers of the video game industry, entered the field of public health. The company offered their DanceDanceRevolution Classroom Edition as a pilot in three schools in Florida, Georgia, and Texas. Read More February 2013: SuperBetter graduated from Rock Health's fourth class The game is available online and on iOS app and helps people dealing with a range of challenges turn their life into a game in order to better face that challenge. In March, SuperBetter founder Jane McGonigal said the game has more than 250,000 users. She added the Ohio State University was conducting a clinical trial of 40 patients to test the efficacy of SuperBetter for helping patients recover from traumatic brain injuries. Read More May 2013: Cigna explains gaming is one of its key area of focus for company's consumer engagement strategy Cigna’s Director of IT Strategy and Innovation Willis Gee  said that historically healthcare has not been leveraging games to engage customers, but it's ubiquitous. He added that something like 70 percent of mobile phone owners are playing games on them and a large percentage of households have game consoles in them. Gee pointed to Cigna’s longtime work on healthy gaming with HopeLab, where it has helped to develop games for people with cancer and the exergaming system Zamzee, which is fighting childhood obesity and inactivity. Read More June 2013: Miami Children’s CIO interested in adding gaming feature to discharge process  While still a far off prospect, Miami Children’s Hospital Senior Vice President and Chief Information Officer Edward Martinez and his team are interested in adding a gaming feature to the discharge process to help obese kids stick to a healthy schedule and remember to exercise. The process would entail introducing the kids to a game that would include a fitness component so advancing in the game is a direct effect of getting exercise. With many products on the market that offer these kinds of services already, Martinez sees an opportunity to either purchase, partner or build it in-house. Read More June 2013: Ayogo is building an adherence game for big pharma Health gaming company Ayogo’s CEO Michael Fergusson hinted at the Games for Health conference in Boston that the company is working on a new game for a major pharmaceutical company. The game, which is played partly online and partly on a mobile device, is a social game designed to be played like an alternative reality game. It integrates a broad prescription compliance program along with a diet and exercise program. Read More June 2013: Sparx game combats depression among youth New Zealand-based Sparx is a video game to help youth cope with depression that was created by University of Auckland Associate Professor Sally Merry. The object of Sparx is for the player to rid him or herself of negative thoughts and aim to reach ‘hope’. Within the game, the avatars that a patient can play as have New Zealand accents, which Burt believes will add to the fantasy of the game for an American audience. Burt also sees this is a possible treatment option for the influx of patients that hospitals will receive after the Affordable Care Act fully takes effect. Read More June 2013: Zombies, Run! makers to launch spy-themed walking app London, UK-based Six to Start, the creators of runaway hit fitness game Zombies, Run! announced that they are creating a new game that will use the same gamified, story-centric approach as Zombies, Run! but without the zombies — or the running. The game, called The Walk, is a spy thriller and it will be focused on getting people to move more and generally be more active. It’s being sponsored by the British Department of Health and the National Health Service (NHS) in London. Six to Start launched the game in December 2013. Read More August 2013: Mobile motion camera launches with fitness game Israel-based Extreme Reality has developed a motion sensor technology using a 2D camera, allowing the motion sensor to be used with mobile devices like tablets and laptops. Indie Hero, a British game company, is launching the first fitness game for this platform. Indie Hero’s game, called Beatboxer+, is a music-based shadowboxing game that instructs users to use one of six different punching motions in time with the music. Players can use the $15.49 game on its own, or take advantage of a partnership with Shadowboxer, an Australian company that makes a resistance-producing waistband. Read More September 2013: Study finds racing game can improve brain functions A new study from the University of California, San Francisco shows that a specially designed mobile video game could improve neural plasticity in older adults, improving their ability to multitask and to filter out distractions. A spin-off company is currently testing a version of the game for the possible treatment of ADHD, depression, or autism spectrum disorders. The study, published in the September issue of Nature, included three different experiments with a car racing game, called Neuroracer, played on a laptop with a video game controller attached. Read More September 2013: As Wii U sales flag, Nintendo sets sights on Fitbit crowd Video game maker Nintendo seems to be putting its energies into fitness in an effort to save its floundering Wii U console, including launching an activity meter that could compete with the likes of the Misfit Shine or the Fitbit One. The company announced that Wii Fit U, the new version of the company’s successful fitness game Wii Fit, will finally launch November 1. It was no surprise that the company is turning to Wii Fit U to revitalize the struggling system, given that the original Wii Fit was one of the best-selling console games ever. The software will be bundled with a clip-on activity meter worn at the hip called the Fit Meter. Read More October 2013: App to help children handle anxiety may add games SmartCAT, an app to help children handle anxiety, supplements brief therapy, eight or fewer sessions, with a set of cues to remind young people of skills taught in the sessions. The team plans to add a gaming feature. The first game they have developed, called Thought Buster, has thoughts that people might think floating across the screen like though bubbles and the kids are instructed to pop the bubbles of thoughts that make them anxious. An example thought would be ‘People are going to laugh at me’ or ‘Somebody’s going to get hurt’ or ‘I’m not going to know how to do this.' Read More November 2013: DanceDanceRevolution goes mobile with iOS app Popular exercise videogame DanceDanceRevolution may find new life in an unlikely place: the smartphone. Developer Konami released DanceDanceRevolution: Pocket Edition, which allows iPhone, iPad, or iPod touch users to play the dancing game without the need for large hardware like external dance pads. Read More December 2013: Guitar Hero inventors launch exergame Blue Goji Blue Goji, co-founded by Guitar Hero inventors Charles Huang and Kai Huang, launched an exergame called Goji Play, available for $99 online. The game is meant to be played at the gym on exercise machines such as treadmills, elliptical machines and stationary bikes. Blue Goji has three components. The app, available only on iOS devices, a set of wireless controllers that can be attached to any fitness machine, and an activity tracker to wear while exercising. On the app, users can play a variety of games, 12 total, designed for Goji Play. When users play the games, an activity tracker on the user sends data to the app. Read More January 2014: Video game maker partners with Pfizer for Alzheimer’s clinical trial Boston-based Akili Interactive Labs partnered with Pfizer to conduct a study of Akili’s iOS-based game, Project Evo, in the hopes of using the game to detect indications of Alzheimer’s in healthy individuals. The month-long study of 100 participants includes a mix of some who have risk markers of potentially developing Alzheimer’s and some who do not. All participants will take the game home and play it daily while researchers test whether the algorithms within the game can distinguish the group with risk markers. Read More January 2014: GlassesOff aims to eliminate reading glasses with brain training Israeli neuroscience technology company GlassesOff has announced its first iPad app, just a month after the company launched its iOS app for iPhones and iPods. The apps help users eliminate dependency on reading glasses by “enhancing the image processing function in the visual cortex of the brain,” according to the company. Within the app, users can play intensive visual stimulation games comprised of the 12-minute game sessions and reading evaluations. Read More February 2014: Virtual pet game targets kids asthma management Boston-based LifeGuard Games is gearing up to launch a mobile game to teach children to manage their asthma. Wellapets, which is due to launch at the end of February, follows the mold of recently popular virtual pet games like Club Penguin or Moshi Monsters, but with an extra element of chronic disease management. In the Android and iOS game, kids in the game will adopt a virtual pet and take care of it, but in addition to feeding and playing with the virtual pet, they’ll also administer the pet’s inhaler, look out for and clean up potential asthma triggers, and play unlockable minigames. The game will cost about $4 and the company will primarily seek to distribute and market it via pediatricians and other business-to-consumer channels. Read More March 2014: Researchers found playing certain mobile games for 25 minutes can reduce anxiety After just 25 minutes of playing a game, which is based on a cognitive treatment for anxiety called attention-bias modification training (ABMT), researchers found a reduction of anxiety levels in stressed people, according to a study of 75 adults published in Clinical Psychological Science. In the game, which researchers have not given a name to, users try to avoid “threatening stimulus” such as an angry face, and instead focus on happy and neutral faces. Read More March 2014: Study finds children exercise 7.5 minutes more per day with Kinect than without it Overweight and obese children lost weight and demonstrated a significant increase in physical activity after using a 16-week weight management program that incorporates active video gaming, according to a study which will be published in the May issue of the Journal of the American Medical Association (JAMA) Pediatrics. Seventy five children, ages eight to 12, participated in the trial at their local YMCAs and schools in Massachusetts, Rhode Island, and Texas. Fifty five percent were female. The study used UnitedHealth Group’s pediatric weight-management program, Join for Me. Read More

Apple has filed for a handful of new patents related to biometric sensing and tracking, according to a report over at AppleInsider.

Last week the Senate Finance Committee sent letters (PDF) to a wide assortment of healthcare stakeholders to source input on how the federal government could improve "the availability and utility of health care data" so that patients could more easily shop for doctors that suit their needs, providers could deliver higher quality care, and payers could design more effective care delivery models.

On Sunday giant medical device company Medtronic entered into a definitive agreement to acquire another big medical device company, Covidien, for $42.

As MobiHealthNews noted last week in the introduction to our In-Depth report on Apple's Health app feature set, the FDA made a rare move on Wednesday by adding a new description for a type of mobile medical app that it would not regulate as a medical device.

On Wednesday the U.S. Food and Drug Administration quietly updated its list of mobile medical applications that it would not regulate. It added a description of an app that fairly well describes Apple's recently announced Health app. The addition comes just a day after the FDA responded to a three-month old Freedom of Information Act request from a tech publication about its meeting with Apple last year and revealed a summary of their discussion. Here's the app that the FDA added to its list of those that might meet the legal definition of a medical device, but that it would choose to exercise regulatory discretion over: "Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014]." Apple's HealthKit and Health app followed a somewhat similar unveiling by Samsung a few weeks ago for its SAMI fitness data tracking platform. Just last night Forbes reported that it learned from an anonymous source that Google has designs on launching its own fitness tracking platform, called Google Fit -- not to be confused with the company's shuttered personal health record platform Google Health. The health and fitness tracking platform race appears to be on, and of the three big technology companies that have stepped on the field, Apple has shared the most about its platform so far. In the pages to follow, MobiHealthNews has outlined what kinds of health and fitness data Apple's Health app aggregates. Keep in mind this is an app that is a part of a beta iOS8, so it is likely that Apple will improve the app's capabilities before it's real launch later this fall. Apple missed at least a couple of important data fields that will disappoint some users and will leave out a considerable number of digital health companies' data sets. Read on for MobiHealthNews' breakdown of Apple's Health app.  Diagnostics: Diagnostics measured on the Health app so far include number of times fallen, galvanic skin response, and body heat flux. Galvanic skin response is a method of measuring the electrical conductance of the skin through sweat, which can indicate a change in someone's psychological or physical state. Galvanic, a Dublin-based startup, tracks this metric exclusively. Its device, a Bluetooth-enabled galvanic skin response sensor, is also a game controller. The product, called the PIP sensor, is designed to help users learn to reduce their own stress through gamified biofeedback. The company completed a successful Kickstarter campaign in July 2013. The product has yet to launch, but is available for preorder on the company's website. Basis Band, which was acquired by Intel in March, also tracks galvanic skin response, along with other metrics including blood flow, activity, and ambient temperature of the skin. Apple has had body heat flux tracking on the mind since at least 2010. Body heat flux, like galvanic skin response, measures activity through heat change. In 2010, MobiHealthNews rounded up a few patent applications that Apple submitted. One of the applications, for earbuds tracking biometrics includes heat flux as a potential metric. The patent has not been granted, and since then Apple submitted another patent for health sensing earbuds. While the second patent was granted, it did not include heat flux as a metric. Jawbone-owned BodyMedia, on the other hand, has an FDA-cleared armband available that does offer heat flux tracking. The final category in this section, number of times fallen, is a key one for the aging population whose risk of falling is much higher. Many startups have launched mobile personal response systems (mPERS) and smartphone apps so that an elderly person can alert loved ones and care providers if they fell down and need help. Some of these include GreatCall's Splash, a one-button mobile personal emergency response system powered by GreatCall’s 5Star mPERS offering, Philips Lifeline's HomeSafe, a help button worn as a pendant, and Amulyte's senior monitoring system, an on-the-go device connected to a companion app. Other companies are trying different approaches. In November 2013, The University of California at Los Angeles Wireless Health Institute teamed up with smart cane startup Isowalk to create a sensor-laden cane that could be used to predict falls or help speed up recovery for injured athletes. Last January, an Israeli company crowdfunded a “smart shoe”, the B-shoe. This shoe has a motor in it that will roll an elderly person’s foot backward to catch them if they start to fall. Finally, at a recent AARP Life@50+ event, a startup named Sway Medical announced its cost effective offering for fall-risk assessment.  The balance screening tool they offer is available as an app for smartphones and has been clinically validated and FDA cleared. The test is also reimbursable so patients would have to pay just $32 per test. Fitness: In its Fitness category, Health has a long list of metrics, some of which are a little inscrutable. Given Apple's these could be mistakes in the beta. Or they could be new metrics Apple plans to track. Apple's metrics in the fitness category fall broadly into two categories: weight-related metrics that would be measured by a smart scale of some kind, and activity metrics, measured either through the phone's built-in accelerometer or via one of the many fitness wearables on the market. On the scale side, interestingly, the fitness section includes a module for height, but not weight. Height is an odd metric to track since only children, teens, and the very old will see that metric change over time. But it might be included because it's part of the formula for calculating body mass index (BMI) along with weight. Weight itself is not included on the list, but body mass is. The only difference between weight and mass is that weight accounts for gravity, so unless Apple is trying to make the app more consistent and accurate for astronauts, it's an odd choice of wording, too.  Weight and BMI could be imported from a number of smart scales on the market, the most prominent of which are the Fitbit Aria, the Withings Smart Body Analyzer and Withings Wireless Scale, and the iHealth Wireless Scale. Additionally, Apple gives options for tracking body fat percentage and lean body mass, two tracking metrics offered by all of the previously listed scales except for the stripped-down Withings Wireless Scale. The activity metrics are also interesting. Of course, Apple includes the big three: steps taken, calories burned, and distance traveled. These metrics could be imported from any one of the major fitness trackers: the three Fitbit devices, Withings Pulse, iHealth's Wireless Activity and Sleep Tracker, the (possibly soon-to-be-discontinued) Nike+ Fuelband and Fuelband SE, the Jawbone UP and UP24, the Misfit Shine, or the Basis Band, as well as less expensive devices like the Fitbug or the Fitlinxx Pebble. They could also be tracked with the phone's built-in accelerometer and imported via an app like ProtoGeo's Moves, RunKeeper, MyFitnessPal, MapMyFitness, Endomondo or Azumio's Argus. The new LifeBand from LG tracks all these metrics, as does Sony's new SmartBand, but the latter isn't likely to integrate with Health: the wearable is Android-only. The next step up from those three standard tracking metrics is "flights climbed" a measure for stairs (and possibly other altitude changes like slopes). Of the major trackers, only a few are equipped with an altimeter to actually track steps right now. The Fitbit One does it (as did the now-recalled Fitbit Force), and so do Withings Pulse and the new LG LifeBand. Endomondo and Moves claim to track stair climbing as well. Beyond that, there's a metric called "Activity Count" which could refer to a number of possible things including active minutes or a number of activities completed toward a pre-set goal. Without knowing the meaning of that metric, it's hard to say exactly which devices Health could import tracking information from. That leaves just two more fitness metrics in Apple's slate. One, basal calories, is a measure of the calories your body burns at rest, without moving at all. It's hard to actually track basal calories, but they can be calculated based on weight, height, age, and sex, and they can be used to more accurately estimate how many calories your body is burning during exercise. Currently, only a few apps, including Argus and MyFitnessPal, track basal calories. Finally, Apple included a tracking module for Nike+ Fuel points, the measure of activity that RunKeeper CEO Jason Jacobs once described as "a Nike-branded calorie." Although Nike made efforts when it launched its accelerator to get other developers starting to think about Fuel, the only devices that really track it right now are from Nike: The FuelBand and FuelBand SE, the Nike+ Move App, the Nike+ SportWatch GPS, the Nike+ Running App, and Nike+ Kinect Training, a video game on the Xbox. Lab results: The lab results tab in the Health app includes blood glucose, blood alcohol content, and perfusion index. Several devices offer connected apps that record blood glucose, which is used by people with diabetes to adjust their diet and to determine how much insulin they need to give themselves. At the end of 2011, Sanofi announced that the iBGStar, the company's smartphone-enabled blood glucose monitor, was the first to receive an 510(k) clearance from the FDA. Just six months later, Apple announced that people could buy the iBGStar in its stores. LabStyle, a connected glucometer company based in Israel has been taking steps to launch its product Dario in the US.  In December 2013, the company said it had filed for FDA 510(k). Another company, Glooko, helps people with diabetes connect their glucometers to their smartphones with a cable. While Glooko could potentially connect devices to Health, the company has a relationship with Samsung, which might affect Apple's willingness to integrate with Glooko. Quite a few startups have also tackled blood alcohol content tracking, which helps people understand how much they've had to drink. The most high profile company, in part because of its screen time on ABC show Shark Tank, is Breathometer, a peripheral device that connects to a smartphone t0 display the user's blood alcohol content data. The company’s pitch on the show resulted in an unprecedented $1 million investment from all five investors. Since then, Breathometer topped $1 million in sales. MobiHealthNews has previously rounded up six companies in this space including an iPod-connected breathalyzer that was available as early as 2009. Perfusion index is a measure of arterial pulse strength. At least one company, Masimo, currently has a product on the market that offers perfusion index tracking. Masimo's commercially-available iOS-enabled pulse oximeter, called the iSpO2, tracks blood oxygenation but also tracks the perfusion index using the same pulse oximetry technology as Masimo’s medical products. Masimo c-level executive Michael O'Reilly also left the company to join Apple as its head of medical products. Medications: We anticipated that the medications section would be similar to a medication reminder app, offering users a list of all medications that they are currently taking, reminders for refills, and alerts if there's a possibility users will be taking medications that might react differently when taken together. That's still a possible future for the app, and even a likely one. For now, though, the medications section sports a single tab: "Inhaler Usage." Both Gecko Cap and Propeller Health have developed sensors that connect to asthma or COPD rescue inhalers and collect data when the inhaler is used. In addition, pharmaceutical company Opko Health recently acquired an Israeli smart inhaler company, Inspiro Medical, and will begin to offer its inhaler bundled with particular Opko drugs. Any of those sensors could potentially integrate with the Health app down the line.  Outside of inhalers, there are a lot of medication adherence apps and connected smart pill bottles or boxes that could be integrated with the app, including Johnson & Johnson's Care4Today app, Mango Health, GlowCaps, and AdhereTech. While the Health App isn't well-equipped for issuing reminders, it could integrate data from an adherence app to help the user keep track of medications taken and doses missed. Nutrition: The Health app's nutrition section can keep track of total fat, polyunsaturated fat, monounsaturated fat, saturated fat, cholesterol, sodium, carbohydrates, fiber, sugar, calories, protein, vitamin (A, B6, B12, C, D, E, K), and calcium. There are countless nutrition tracking apps and devices available to users. This year, MobiHealthNews made a list of 27 nutrition tracking tools that have either been around, been discontinued, or are coming soon. Many of these tools require users to manually enter their meals and snacks into an app, and the app will act as a food diary that can provide users with graphs and other views of their data. A few examples of this type of tracking include MyFitnessPal, which recently acquired fitness coaching startup Sessions, and FatSecret, which partnered with glucose tracker company LabStyle. Lark Life Other companies have tried another food tracking route, for example tracking nutrition through pictures the user takes of meals. One company in this space, Rise Labs, not only asks people to take pictures of their food, but also offers personal coaching including daily feedback and tips to stay healthy. Another alternative method of food tracking, which is arguably similar to manual entry, is using a weight scale to weigh meals, so that users can get a more exact nutrition count. Former Apple employee Michael Grothaus launched a Kickstarter campaign for a smart food scale, called Situ. Users place their food on the scale, and then enter the name of the food into the companion app. The app then displays the food’s weight as well as other nutritional information like total fat, cholesterol, protein, total carbs, and sodium. Sleep: Apple also includes a section for sleep, something else increasingly included in consumer fitness trackers on the market. The sleep section in the Health app has only one metric under it, "Sleep Analysis." But this could potentially be a placeholder for any number of sleep-related metrics. For instance, Basis Band's new advanced sleep analytics track REM sleep, deep sleep, light sleep, toss-and-turn, interruptions and duration. In addition to Basis, sleep is currently tracked by Fitbit Flex, Fitbit One, Withings Pulse, Jawbone UP and UP24, and dedicated sleep tracker Lark, although the Lark wearable may not be available for purchase anymore. Recent devices in the sleep space have not been wearable, but have been attached to the bed or set down next to it, but these devices could also conceivably integrate with Health. Beddit, a company tracking sleep with sensors that strap to the user’s bed, had a successful Indiegogo campaign and began selling its product in December. Another company, IntelliClinic, raised $400,000 for a smart sleep mask called NeuroOn, meant to measure and improve the user’s sleep. In January, SleepRate launched an app-based sleep system using cognitive behavioral strategies licensed from Stanford University’s School of Medicine, Psychiatry, and Behavioral Sciences. Sleep tracker maker Bam Labs teamed up with smart bed maker Sleep Number to create an $8,000 bed with a tablet interface. Finally, at CES this year, Withings announced a whole new multi-device system, called Aura, for tracking sleep and facilitating sleep behavior change. Vital signs: Vital signs that the app tracks include heart rate, oxygen saturation, blood pressure, respiratory rate, body temperature, and RR interval. The RR interval measures the interval between heart beats. Devices track heart rate for several non-medical purposes: sports training, fitness metrics, stress, and sleep analysis. Recently, Samsung added a built-in optical heart rate sensor to its newest smartphone, the Samsung Galaxy S5. The Galaxy S5′s heart rate sensor requires the user to put their fingertip on the back of the phone in order to take a reading. A few months later, Samsung updated the S5's software so that now users can track their stress levels using the heart rate sensor. One company, Azumio, has been using the smartphone to track heart rate for a while. Its app, Instant Heart Rate, tracks heart rate by leveraging a smartphone camera, which tracks color changes in the light that passes through the user's finger. Both of these apps require users to be standing still when they are recording heart rate measurements. On activity tracker developer Basis' website, the company explains that although their fitness tracking armband is portable, it also cannot measure measure heart rate if the user is moving. Their device, Basis adds, cannot replace a chest strap that monitors heart rate during workouts as well. One such chest strap that offers continuous heart rate tracking is Covidien's Zephyr BioHarness, which not only measures heart rate, but also breathing rate, ECG, and posture. Sports tracking companies Polar and Garmin also have chest strap offerings for heart rate tracking. In May, LG launched heart rate sensing earbuds with its Lifeband Touch fitness tracker. Oxygen saturation is a measure of the amount of oxygen in the blood. A common way to measure oxygen saturation is through pulse oximetry. Some devices that do this include Masimo's commercially available iPhone-enabled pulse ox for climbers and pilots, Azoi's smartphone case that measures blood pressure, electrocardiogram (ECG), heart rate, blood oxygen, and temperature, and iHealth's pulse oximeter device that continuously monitors blood oxygen saturation and pulse rate via a fingertip sensor that connects to a wristband, which has it’s own dedicated screen. Nonin is working on a device that measures oxygen saturation in the brain, called regional oximetry. The company's device connects directly to an iPhone 4 or iPod touch via a sleeve containing a Nonin SenSmart Regional Oximetry sensor, a similar form factor to AliveCor’s iPhone Heart Monitor. A few blood pressure devices on the market include blood pressure wrist cuffs from iHealth and Withings. iHealth's blood pressure cuff launched in 2012. Withings launched a second blood pressure cuff this year that is similar to the one Withings released in 2011, but adds Bluetooth connectivity and Android support (the previous device connected via the phone’s 16-pin connector). When the user presses the button to inflate the cuff on his or her upper arm, the Withings Health Mate app opens automatically, displaying instructions and saving data right on the phone. The cuff runs on four triple A batteries, similar to its predecessor. If Health Mate connects integrates with Apple's Health app, the blood pressure cuff would be one of many devices that could integrate with the app. Another device called  QardioArm is working on developing a wireless blood pressure monitor that fits into a small colorful case that looks like it could carry a smartphone, notebook, or even a wallet. Two smartphone-connected temperature monitors on the market currently include Kinsa Health's FDA 510(k) cleared smart thermometer, which is likely to be sold for $15, and Raiing's peel-and-stick contact thermometer sensor that continuously transmits body temperature readings to a companion iPhone app, which is already available in the iOS AppStore. Finally, health tracker company Scanadu has yet to ship their product, but Scanadu's device, called Scout, aims to track temperature, blood pressure, heart rate, heart rate variability, pulse oximetry, ECG, and stress.  Here's what Apple's Health app is missing. Lab results, diagnostics Apple included an entire card in its Health app for lab results, but the only metrics it specifies for that category are blood glucose, blood alcohol content, and perfusion index, which is a pulse oximeter data point. There are many more types of lab results that Apple could include in this category. While all the data aggregated by HealthKit is data that is generated by the consumer – either tracked manually or using a device that is under the own control – increasingly labs are making the results of blood tests available to patients directly. There are even entire companies like Segterra who offer services like InsideTracker, which is direct-to-consumer blood test packages that include some light coaching on how to improve certain blood constituents. Again, while the initial form that Health and HealthKit have taken is as a platform and app that collect data to make it easier for users to share it with their care providers, some data – like lab results – are now much easier for patients to get their hands on directly. A recent HHS mandate for all HIPAA-covered labs made clear that they need to make lab results -- no matter what state they are in -- available directly to consumers. Similarly, Apple only lists out number of times fallen, galvanic skin response, and body heat flux as the three types of "diagnostics" it aggregates in its Health app. While it's not entirely clear what this category name means -- times fallen and body heat flux seem to be rather different types of health data -- Apple could be collecting many more diagnostic-related data points than these three. Home diagnostics is a growing category for digital health, but a slower growing one since the devices that enable it require FDA clearance. Medication AdhereTech's smart pill bottle. While the Health app does include a card for medication, it is incredibly underdeveloped. This section of Health app really tips Apple’s hand – this beta version of iOS8 appears to include a very much unfinished Apple Health app. The only type of information that Health tracks related to medication is inhaler use. That's an obvious nod to high profile asthma and COPD tracking company Propeller Health, but few medications are inhaled. What's more, there is a number of companies working on smart pillboxes and pillbox caps that track adherence for ingestible medications. It seems like aggregating data from those more widely relevant devices would be an obvious addition to Apple's Health app. Ovulation, fertility When rumors of the then-codenamed Healthbook first surfaced and (what turned out to be fairly close) descriptions of the app’s feature set leaked out, MobiHealthNews was quick to point out that Apple appeared to be ignoring women’s health issues. Arguably, ovulation tracking is one of the earliest health tracking habits in existence, and there are countless apps in the AppStore that offer it as a core functionality. It’s a huge oversight on Apple’s part not to include some kind of tracker specifically for women who'd like to keep track of their cycle. Along the same lines, there is a growing number of companies focused on helping couples conceive and those groups typically offer tracking apps with personalized coaching tips. Some even include smartphone-enabled thermometers that help users optimize conception by using a woman’s body temperature as a guide. Mood, stress, and mental health A case could be made that Apple should add three new categories for mood, stress, and mental health, but the three could also be components of one card in the Health app. Mood tracking apps are abundant in the AppStore. They often employ a multiple-choice series of emoticons to help the user choose how their feeling without putting a label on it, but others do or are free form. Almost every disease or health condition has a mental health component. Depression is a common companion for those going through a serious illness or those recovering from a procedure. ORCAS' MoodHacker app is a good example of an app focused on depression tracking that also considers anxiety and stress as part of the mix too. Stress, in general, is a pervasive problem in this country, and one that many consumers have expressed an interest in fixing. There are a handful of companies that are working on quantifying and tracking mental health issues and stress, including Boston-based Neumitra, which is leveraging a wearable device that determines the user’s stress level by analyzing a couple of biometrics. It then creates stress maps to help public health departments better understand their communities, employers better understand their workplaces, and consumer better navigate their environment. The four missing data fields and categories above are glaring oversights of Apple’s Health and HealthKit team, but there are also a number of other data streams that Apple decided or forgot to include. These may not be as important or as relevant to as large a swath of users as the ones discussed above, but they do all have at least a few corresponding tracker apps and devices in the market today. Here are a few more health tracking fields Apple’s Health app does not include: posture, skin health, oral hygiene, and cognition.  Posture Like stress, back pain is an incredibly common ailment today. Companies like Lumo Body Tech have been designing wearable devices worn around the waist or clipped on to shirt lapels to help users become more aware of their posture. The devices connect to a companion app on the wearer’s smartphone and keeps track of when the user slouches or hunches, and vibrates their phone to nudge them to straighten up. Zephyr Technologies, which was recently acquired by Covidien, also offers a posture sensor on its more advanced BioHarness device. Skin health No type of health-related app has been pilloried in the press more often than mole check apps, which aim to help users keep tabs on whether their skin lesions are changing by saving images of them for comparison to images in the future. Some of the earlier versions of mole check apps got into trouble for over-selling their screening abilities for skin cancer, but similar efforts are still being developed and are mostly still in the research phases currently. Tracking has long been a practice for those at risk of skin cancer to do self-checks for moles and other lesions by marking the locations of these spots on a paper-based body map. The digitized version of these maps can include images of the moles as they looked at each body check – and that information can help dermatologists with diagnoses or preventive care. Oral hygiene There are a growing number of connected toothbrushes available today that transmit brushing frequency and other metrics to an app on the user’s smartphone. Many of these are intended to help parents keep tabs on nonadherent children who are just beginning to brush on their own. The Beam Brush was the first smartphone-enabled toothbrush to get FDA clearance back in 2012, but since then there have been others, including Oral-B's, which included a partnership with Disney. Cognition Online programs or mobile apps that offer “brain training” programs and cognition tests, like those offered by Lumosity, have for many years been a favorite tracking tool among many dedicated self quantifiers who use a morning test to determine whether cognition is trending up or down perhaps in part to another change to their routine. For example: Does eating copious amounts of butter make you smarter? These daily cognition tests can also be used by older people who want to keep their minds sharp – a baseline test each morning could be a motivator to start a program to improve memory, for example. Cognitive tests like these could also be helpful to patients and caretakers of people at-risk for developing Alzheimer's.

The University of Pittsburgh Medical Center has committed to deploy at least 2,000 Microsoft Surface Pro 3 tablets throughout its healthcare system.

Palo Alto, California-based G-Tech Medical, which is developing a wearable, disposable sensor patch for patients with gastrointestinal problems, has received funding from investor Peter Thiel's nonprofit fund, Breakout Labs.

Lehi, Utah-based VoIP communications service for dentists, Weave, has raised $5 million led by A Capital, with participation from Homebrew, Fuel Capital, SV Angel, Initialized Capital, and Y Combinator, according to a report in TechCrunch.

When we first learned that a small team of Apple executives met with FDA officials last December to discuss mobile medical applications, it seemed likely that the discussion was intended to help Apple better avoid FDA regulation for its rumored health products.