The announcement of Apple’s new health app means several things for consumers and the healthcare industry. Perhaps most important, the explosion of the personal health tech sector and the development of apps and devices that allow people to track their health and outcomes may mean the industry is getting closer to solving one of its stickiest wickets – patient engagement.
Long a bane for caregivers, and taken seriously enough that it’s been incorporated into meaningful use measures, patient engagement is more than a term. It’s a cultural and behavioral issue. Physicians have long lamented the fact that they have an especially difficult time getting their patients involved in their own care and managing their outcomes, especially as it relates to chronic conditions.
However, new apps like Apple’s, which is touted as “the new health app gives you an easy-to-read dashboard of your health and ﬁtness data” and provides “a new tool for developers called HealthKit, which allows all the incredible health and ﬁtness apps to work together, and work harder, for you. It just might be the beginning of a health revolution.” Not the beginning, of course, but the investment by Apple – a well-known and mainstream company – may push consumers and the healthcare community closer together through the use of such a tool.
In many ways, these devices and apps employ a gamification element. They allow users to track heart rate, calories burned, blood sugar, cholesterol, and collect all that data, putting it in one place, accessible with a tap to provide a clear and current overview of the user’s health. Additionally, users can create an emergency card with important health information — for example, their blood type or allergies -- that’s available when needed. Like a video game, the app essentially lets users play along, with themselves as the primary player in the game, reaching new levels of success, collecting “points” and leveling up, if you will.
With Apple’s HealthKit, developers can make their apps even more useful by allowing them to access an Apple user’s health data, choose what they want shared and allow the data to be automatically shared with their doctor, if requested. Additionally, for example, a user’s nutrition app can tell their fitness apps how many calories they consume each day. The theory is, according to Apple, “When your health and fitness apps work together, they become more powerful. And you might, too.”
Solutions such as this will breed new solutions, and build new industry, just as the development of the iPad did. According to Time magazine, new start-ups are focused on creating apps and solutions for Apple products. “Before Apple launched its apps environment for the iPhone and iPad, the PC software industry was in decline and the Internet software industry was mostly focused around creating websites for companies and e-commerce. Now, the creation of software for iOS, Android, Windows Phone, along with new versions of Windows and HTML 5 apps, is at an all-time high.
“The iPad is changing how people in every part of the world work, learn, play and use computers. This single product is redefining mobile computing, and it came from a company based in the U.S. Smartphones and tablets are the two fastest-growing categories in all of computing. If Apple hadn’t been in the picture to raise the bar in those two categories, I think you could make an extremely strong case that the devices of tomorrow would be imported instead of exported,” Time reported.
Additionally, the need for the number of software engineers and developers needed to fuel this insatiable demand for new apps and app-related services is unrelenting, which is good for those that work in the space. The same will likely be true of Apple’s renewed investment in healthcare.
This reinvigoration of the software-development world, which Apple is responsible for, has inevitably led to more jobs. There is an app economy for Android and will inevitably grow around Microsoft’s platforms in Windows 8 and Windows Phone. This reinvigoration is very good for the U.S., as well as other parts of the world.
Healthcare IT News recently reported that more than 95 million Americans are currently using mobile health technologies, citing a Manhattan Research Cybercitizen Health study. Thirty-eight percent of smartphone users deemed them "essential" for finding health and medical information, according to the report.
“Among the patient audiences who are most likely to be mobile health adopters are those with cystic fibrosis, growth hormone deficiency patients, acne patients, those with ADHD, and people with hepatitis C, researchers say. Patients with migraines or Crohn's disease are also high on the list for mHealth users,” Healthcare IT News reports.
“In five years, more than 3.4 billion smartphone and tablet users will have access to mHealth apps, officials say, with 50 percent of them actually downloading. Currently, the market has hit its commercialization phases, where a massive increase in solutions has occurred. However, missing regulations will prove to be a considerable barrier to entering the integrated phase, where mHealth becomes incorporated in physician treatment plans.”
The impact is huge and is not being taken lightly by the federal government, however. According to the U.S. Food and Drug Administration, the widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and healthcare delivery.
People are able to manage their own health and wellness, promote healthy living and gain access to useful information when and where they need it. “These tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a healthcare application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.
Even though the FDA encourages the development of these solutions, it also claims to have a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps. The agency even went so far as to issue the Mobile Medical Applications Guidance for Industry and Food and Drug Administration, a document explaining the agency’s oversight of mobile medical apps. The document outlines the agency’s plan to focus on apps that present a greater risk to patients if they don’t work as intended as well as apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.
The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices. The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device” and “are intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device.”
Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.
However, the FDA’s mobile medical apps policy does not require mobile medical app developers to seek agency re-evaluation for minor, iterative product changes. For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretion and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA.
This includes mobile medical apps that:
Help patients/users self-manage their disease or condition without providing specific treatment suggestions
Provide patients with simple tools to organize and track their health information
Provide easy access to information related to health conditions or treatments
Help patients document, show or communicate potential medical conditions to healthcare providers
Automate simple tasks for health care providers, or
Enable patients or providers to interact with personal health records (PHR) or electronic health record (EHR) systems.
FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers. FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.
Though the guidance provides some comfort and guidance for those developing the apps, it is meant to ensure that all apps used can be trusted by those using them. As the segment of the industry continues to evolve, likely too will guidance and oversight by organizations like the FDA.
However, the ever-present problem of getting patients even more involved in their health and outcomes will likely remain even as billions of dollars are invested in new projects, technologies and solutions. At its simplest, Apple’s app will engage patients more even if they don’t do so with their doctors, providing a much truer depiction of how patients are managing their conditions. Engaging technology rather than physicians, though, could create a whole new set of problems, but that’s yet to be determined.
Another problem with the explosion in use of the technology might be lack of patient privacy. Use of the technology means more data can be collected across a population and analyzed. This may put IT on alert. However, the benefits are overwhelming, for patients and for those in health IT. Developers now have thousands of new ways to add apps and develop new products. By giving them access to Apple's API, the company basically invited developers to collaborate, create and package more apps. Because of this they are able to design and produce apps quickly by cutting development time, simplifying the app development process and creating better user experiences. Through collaboration, developers can also reduce redundancies and errors that will make coding more reliable, safer, and should significantly increase the number of new developers using Apple.
With Apple’s backing, developers should have little trouble worrying about violating regulation, and consumers should expect a burgeoning of new products on the market that they can hopefully use to improve their overall health.