Mostly likely, some of your patients have downloaded a mobile app designed to monitor a health-related function. An estimated 21% of Americans use some form of technology to track their health, and 7% already use an app or other tool on their mobile devices.1 However, to date only about 3% of people with two or more chronic conditions currently use a mobile app, so there’s room for growth.
However, the newness of what the United Nations-sponsored Mobile Health Alliance has dubbed “MHealth” prompts understandable concerns about the accuracy and validity of mobile health apps. In fact, the first example of the process gone awry was a rheumatology calculator. In 2011, Pfizer pulled its rheumatology smart phone app off the market because it gave faulty results.2
Until now, the FDA has been reluctant to issue standardized regulations and no approval process or “Good App Seal of Approval” exists, though developers can seek approval for applications voluntarily.
That will change in a few days, however, if the FDA (as promised) delivers its final guidance document for MHealth apps on September 30.
A preliminary guidance document issued in 2011 said that apps intended to be used as medical devices for making clinical and diagnostic decisions (such as stethoscope, blood pressure cuff, and glucose meter apps) need FDA approval.3 It’s not clear whether such approval would be required for apps that require self-entry, such as symptom trackers.
In the meantime, developers of MHealth apps have been torn between waiting for the final guidance document before releasing their products to the market or taking the risk of sidestepping the process, with implications for patient care, safety, and privacy. Those opting to continue development have piled on disclaimers designed to protect themselves, but not necessarily patients.
A major problem with health-related apps is that, once downloaded, they keep working as originally designed unless users take active steps to update or remove them. Thus the onus is on users, not primarily on developers, to stay informed and update frequently. A malfunctioning app that remains active until the user remembers to update obviously has the potential to create serious problems.
One resource that can help make sense of this confusion is Happtique, a business subsidiary of the Greater New York Hospital Association that was established as an MHealth clearinghouse and app portal. Happtique has its own certification process based on a set of standards for assessing the quality of MHealth apps. It has a catalog of thousands of apps destined for evaluation. The organization also has a MyRx program, designed to encourage doctors to prescribe apps to patients electronically, to encourage treatment adherence.
Once the final FDA guidelines have been issued, the MHealth industry can move forward, but there may be some catch-up time. In the meantime, here are some apps from established developers that have generated favorable reviews online from physicians and other scientifically oriented sources.
1. MyRA (free, compatible with iPhone, iPod Touch, and iPad)
Developed and released in March 2013, MyRA allows patients to flag and make notes on various body parts where they are experiencing symptoms. The app also can generate reports for symptom tracking and sharing with physicians.
2. RxmindMe (free, compatible with iPhone, iPad, iPod Touch)
RxmindMe is a medicine reminder and pill tracker created by Walgreens. It includes the entire FDA drug database and its capabilities include taking pictures of prescriptions and emailing prescription history.
3. MyMeds ($9.99 per year, compatible with iPhone and Android)
MyMeds allows patients to create medication profiles for prescription and over-the-counter medications, vitamins, and herbal supplements. The app helps track taken and missed doses, and allows users to export this information for review by physicians.
4. My Pain Diary ($4.99, compatible with iPhone, iPod touch, iPad)
This app enables patients to track pain levels on a calendar in order to identify triggers and to email reports to physicians. It also has a built-in reminder system, and a camera feature to photograph affected areas.
5. MyMedSchedule (free, compatible with iPhone, iPod Touch, and iPad)
MyMedSchedule allows patients to input their medication regimens and set up text and email medication reminders. It contains pictures of pills and has an export functionality for physician review of medication schedules. Unlike the above apps, MedSchedule does not yet have the capability to track taken and missed doses.
1. RAVE (free, compatible with iPhone, iPod Touch, and iPad)
RAVE stands for Rheumatoid Arthritis Vital Education and was developed by the continuing medical education company DKBmed in collaboration with rheumatologists at Johns Hopkins. RAVE offers a single-screen patient chart view, which shows lab results, medications, side effects, and notes. There are also comorbidity checklists, as well as disease activity and diagnostic calculators using 2010 ACR/EULAR Classification Criteria, as well as a medication guide.
2. Mediquations ($4.99, available on iPod, iPod Touch, iPad, and Android)
Mediquations includes over 200 medical equations such as the one for calculating creatinine clearance. There are more specialized rheumatology calculators, including DAS scores, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the SLE Disease Activity Index (SLEDAI). The app also has scores and indices for assessing mental health and neurological conditions.
3. @Hand: Treatment Strategies in Rheumatology ($28.99 for iPhone and iPad, and Android)
Developed by physician-founded Medical Wizards, this app was designed specifically for mobile devices, and provides diagnostic and management decision-making support. The app works like a checklist, with information presented in the following categories: History & Physical, Tests, Differential Diagnosis, Management, Specific Therapy, Follow-Up, Complications and Prognosis.
4. RheumaHelper (free, compatible with iPhone, iPod Touch, iPad, and Android) (https://play.google.com/store/apps/details?id=si.modrajagoda.rheumahelper
This app provides a toolbox of classification criteria for rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, peripheral spondyloarthritis and inflammatory back pain. It also includes disease activity score calculators for DAS-28, the Clinical Disease Activity Index, the Simple Disease Activity Index and the Bath Ankylosing Spondylitis Disease Activity Index.
5. Lab Gear by Med Gears ($2.99, compatible with iPhone, iPod Touch, and iPad)
Lab Gear provides peer reviewed content and normal values for a range of lab tests, as well as background information, common symptoms and other information that can aid in differential diagnosis. It also has score calculators for around 130 medical formulas.
An ordinary search on ITunes delivers some newer apps specifically designed for rheumatology care. However, unlike the apps above, these have not been vetted by “experts”, and there's no assurance of quality aside from online reviews of the developers themselves or voluntary online reviews by non-clinicians. That's the problem: Lacking FDA regulation of these “devices,” it’s difficult to know whether they’re any good.
1. Rheumatrack (free, compatible with iPhone, iPad touch, and iPad)
This app developed by rheumatologists allows patients to create and export a personal RA diary to track their pain, morning stiffness, infections, and other symptoms. There is also a medication scheduler and reminders about doctor visits.
2. READY (RhEumAtic Disease ActivitY) ($9.99, compatible with iPad)
This app was developed for in-office use, to allow clinicians to collect patient data and track their clinical outcomes. It enables collection, storage, and trending over time of information on validated disease measures such as global pain, fatigue, and various disease activity indices.
3. Rheumatoid Arthritis Diagnosis and Management (free, compatible with iPhone and iPad)
This app provides point-of-care information on the diagnosis, updated ACR/EULAR classification, and management of RA. It includes disease activity scores like DAS-28, CDAI and SDAI as well astreatment algorithms and information on medication and surgical management. There is also a link to patient treatment resources.
1. Fox S and M Duggan. Tracking for Health. Pew Research Center, Jan. 28, 2013
2. US Food and Drug Administration. Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications, July 21, 2011
3. Pfizer Ltd. Pfizer rheumatology calculator. Iphone/Android application. Important information. 14 Oct 2011.