When Doctors and Patients Turn to Their Phones for Health Care
With nearly 100,000 health related apps available at the fingertips of smartphone or tablet users, consumers can capture their vitals without having to step into a hospital. Mobile health, or mHealth, involves using these smartphones or tablets for a medical purpose. Software applications, or apps, can provide diabetes management, track sleeping habits, and screen for depression. Azoi Mobile Technologies’ Wello is a case cover made for Androids or iPhones that allows users to track their heart rate, blood pressure, blood oxygen level, respiration, heart rate variability (stress levels), ECG, and temperature, all in one device. While connected to BlueTooth, users must place their fingers on the sensors of the case for a few seconds. A “snapshot” of the user’s vital readings is immediately displayed for any given time. It is so simply designed that the Thelma Harpers of the world can easily figure out how to navigate through the app.
Clinicians have raised concerns over these apps, some of which may need to operate under the “medical device” umbrella, and the FDA is working toward finding a solution to put these apps through an approval process. Well aware that consumers carry their health care in their pocket, Eric Topol – a cardiologist who holds positions at Scripps Translational Science Institute, Scripps Health and AT&T– understands this is a turbulent period. “These apps have no validated data compared with accepted reference standards and therefore are quite concerning.” In March of 2014, the FDA published guidelines for health care app developers; their complete listing of approved Mobile Medical Apps, or MMAs, have been approved through 2013. The approval process is sluggish and the pressure is on the FDA to meet the growing number of app submissions.
Researchers are also concerned that the FDA’s involvement may curb mHealth innovation. Nathan Cortez, Assistant Dean at SMU’s Dedman School of Law and lead author of an editorial in the New England Journal of Medicine, along with his colleagues point out that “FDA oversight will protect the public health, sustain consumer confidence in mHealth products, and encourage high-value innovation.” The barrage of mHealth products requiring FDA oversight, however, is growing faster than the FDA can process. The authors point out the FDA will require the capital and human resources to oversee the products. A mobile health industry without FDA oversight could create, what Cortez calls, “a Wild West” market. He also recognizes that many of the mHealth products are low-risk, but there are some which have caused harm to patients. In 2011, Pfizer reached out to its clinicians using the Rheumatology Calculator app, which created high and low scores for measuring swollen joints in patients with arthritis. A year later, Sanofi Aventis recalled their diabetes app because it miscalculated insulin doses.
Although most health-related apps pose low risks to consumers, some apps do not have the scientific support or evidence-based guidelines for the developers to substantiate their product. Software companies may have disclaimers indicating that their app is for entertainment purposes. If an app were the cause of an error, this opens a door to PHI and legal implications for patient harm. Currently, the FDA does not require software companies to report errors, making it difficult to obtain an accurate measurement of errors. The biggest risk is when consumers do not engage the health care system and instead rely on an app.
Have your patients shared any interesting health care apps with you? Share your second opinion with Claire at firstname.lastname@example.org.
Note: CHPSO does not endorse any of these applications. These apps have not been evaluated for medical accuracy by CHPSO and have not been approved by the U.S. Food and Drug Administration (FDA).