Imagine it’s 1970. You’re watching Star Trek when Dr. James McCoy scans a seriously injured crewmate with his tricorder—a handheld device that helps diagnose diseases and collect bodily information about a patient. Very high tech, right?
Fast-forward to 2013, and the tricorder is back—only this time, for real. It has been reincarnated in the form of the Scanadu Scout™, a portable device, about 2” in diameter, that promises to ignite a personal health revolution. Simply press the Scout against a patient’s temple and it measures temperature, heart rate, and hemoglobin levels in a mere 10 seconds. The information transmits via Bluetooth to a smartphone app, giving users the ability to send it elsewhere for analysis or to track and store vital signs in the phone virtually anywhere. The Scout gathers the data noninvasively and provides a safe warehouse of information on a smartphone. According to its manufacturer, it has a 99% accuracy rating.
Welcome to the world of mobile health, or mHealth. Scout is the latest iteration of mHealth apps that run on smartphones and other mobile communication devices. These apps have a short but vibrant history and many applications. The term mHealth describes the practice of medicine, nursing, and public health supported by mobile devices (cell phones, tablet computers, personal digital assistants, and other wireless technologies) to access information about health and healthcare services. The apps allow users to input patient-specific information and to access reference materials to automatically diagnose a disease or condition. They have various goals, including:
- providing increased access to health care and health-related information, particularly for hard-to-reach populations
- improving the ability to diagnose and track diseases
- offering timelier and more actionable public health information
- expanding access to ongoing medical education and training for healthcare workers.
First-generation mobile apps included arcade games, ringtone editors, calculators, calendars, and the like. In the health arena, they included electronic copies of medical textbooks and reference materials, as well as teaching aids to provide clinicians with training or reinforce training previously received. Examples of medical textbooks include the electronic Physician’s Desk Reference and similar reference materials used as part of course instruction and implemented as electronic books. Examples of teaching aids include flash cards and quizzes used for training purposes or as reference materials, slideshows of common medical conditions, lists of medical terminology, and review materials for use by medical students during training. (See the chart below.)
Useful mHealth apps
This chart lists helpful healthcare apps and describes some of their features. (Note: The chart isn’t intended to be all-inclusive or to indicate an endorsement of any product listed.)
Click here to download the chart
The promise of second-generation mHealth apps
Second-generation apps include suggestions for intervention—and more. As with other technologies, users expect medical apps to evolve rapidly from providing information to offering actual healthcare interventions and treatment. So far, the use of apps to treat disease is more a dream than a reality. In a November 12, 2012 Washington Post article, reporter Rochelle Sharpe wrote, “When the iTunes store began offering apps that used cellphone light to cure acne, federal investigators knew that hucksters had found a new spot in cyberspace… [Many health apps] offer quick fixes for everything from flabby abs to alcoholism, and they promise relief from pain, stress, stuttering and even ringing in the ears… In an examination of 1,500 health apps that cost money…more than one out of five claims to treat or cure medical problems. Of the 331 therapeutic apps, nearly 43% relied on cellphone sound for treatments. Another dozen used the light of the cellphone, and two others used phone vibrations. Virtually any app that claims it will cure someone of a disease, condition or mental health condition is bogus.” Diagnosis is one thing; intervention is another.
The extensive variety of actual and potential functions of mobile apps combined with rapid innovation in the mobile health marketplace offers both considerable benefits and tremendous risks to public health. And unlike nearly every other health-related intervention in the United States, the mobile health market is virtually unregulated. The Food and Drug Administration (FDA) recently published its app regulations. The FDA is applying its regulatory oversight only to certain mobile apps—a narrowly defined group that traditionally have been considered medical devices or that affect the performance or functionality of currently regulated medical devices. In that case, the FDA would be regulating only about 20% of apps in the healthcare marketplace.
Certification of mHealth apps
With the exponential increase in medical, health, and fitness apps in the marketplace (some experts estimate more than 50,000 mobile apps exist across all platforms), users are starting to question their safety and credibility. Proliferation of health social networking sites further complicates patient privacy and security in the mobile space. The bottom line: Not every mHealth app is a good app.
Before mHealth apps can be added to care management plans in a meaningful way, providers and consumers need tools to help identify trustworthy and reliable apps. Happtique, whose company mission is to integrate mHealth into patient care and daily life, has focused on the transformative potential of mHealth while respecting the need for privacy, security, and clinical validation demanded by the traditional healthcare system. In 2012, the company launched its Health App Certification Program (HACP) to provide oversight and verification for the privacy, security, operability, and content of mHealth apps. After an app successfully meets all HACP standards and associated performance requirements, it is granted certification for a 2-year period. Testing of the technical standards is conducted by Intertek, a global leader in software testing, certification, and auditing services. Content reviews are conducted by organizations with expertise in the field of the app under review. Content-review partners include the Association of American Medical Colleges and CGFNS International.
Health apps promise to transform our healthcare delivery system in many ways—from increasing access to medical services to providing better monitoring of chronic conditions to improving patient engagement and ultimately, outcomes. Properly developed, carefully certified, and judiciously used, these apps might be the best thing to happen to primary care since penicillin. With the right oversight and clinical guidance, they will allow patients to monitor their own health and report data to their healthcare providers with the same smartphones they carry around every day. Now that’s truly patient-centered care.
Franklin Shaffer is chief executive officer at CGFNS International in Philadelphia. Sandra Maliszewski is director of the HACP at Happtique Inc. in New York City.
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