By some estimates, there are now more than a million healthcare-related applications (apps) available to users of mobile technology. With healthcare becoming increasingly patient-centric and mobile-enabled, physician practices appear to be moving along with that trend by engaging with their patients leveraging the technology that patients use every day for social media, games, travel and many other purposes.
With so many options, it can be a challenge for both patients and providers to identify the apps most appropriate to the patient’s health conditions and interests, that provide the most functionality and which apps serve to enhance the patient-provider relationship. At the same time, policymakers have the challenge of determining what role the government should play in helping to ensure the efficacy and safety of these apps.
While many of these smartphone or tablet healthcare apps are related to diet and fitness, some physicians appear to be “prescribing” apps with the expectation of receiving follow-up data from the patient.
An Aug. 8 MGMA Stat poll that included more than 1,200 respondents found that 19% of respondents said their physicians recommended health-related mobile apps to their patients. More than half (53%) said they did not, and a further 28% indicated they were not sure. Of those that did recommend apps to patients, condition-specific apps received the most responses (34%) with meal tracking at 14% and fitness at 9%. An additional 33% responded “others” while another 10% responded unsure.
The 2016 QuantiaMD research involving 1,500 physicians found that 42% of physicians will not prescribe apps because there is no regulatory oversight of them, and 21% never recommend apps to patients. Another 21% will not prescribe apps because there is no longitudinal data on their effectiveness, and 21% will not prescribe apps because an overwhelming amount of patient data would result. In another 2016 study, the Commonwealth Fund reviewed 946 iOS apps and 1,173 Android apps and evaluated them on their merits regarding patient engagement. Only 161 (43%) of iOS apps and 152 (27%) of Android apps were assessed as “possibly useful,” of which 126 apps existed on both platforms.
Practices typically will leverage mobile apps to improve patient access to care, better monitor chronic illnesses, improve the efficiency of the care delivery process and (perhaps most importantly for patients) make the healthcare interaction with the practice more personalized. Those physicians who do recommend apps may suggest specific ones to their patients or be more generic in their suggestions. Those particularly tech-savvy, younger physicians may be more likely to prescribe and suggest a particular app to a patient.
With the mobile healthcare app environment being somewhat of a “Wild West,” the need for government oversight in this new healthcare environment has been raised. However, the bipartisan 21st Century Cures Act, passed in late 2016, clarified that the Food and Drug Administration (FDA) has only limited responsibility for regulating healthcare apps. Specifically, the Cures Act excluded several categories of apps from FDA oversight, including a variety of consumer-focused apps intended to:
- Organize and present information for health or wellness education or for use in maintaining a healthy lifestyle, including medication adherence and health management tools
- Serve as an electronic patient record
- Transfer, store, convert formats, or display clinical laboratory test or other device data and results and certain other related information
- Provide recommendations to healthcare professionals for clinical decisions, where the user can independently review the basis of the recommendation.
At the same time, the Cures Act does permit the FDA to step in and regulate an area of health information technology if the agency finds it would be “reasonably likely to have serious adverse health consequences.”
In response to this legislation, the FDA released its Digital Health Innovation Action Plan, where it outlined its intention to issue new draft guidance with draft interpretations of several of the medical software provisions in the Cures Act and, explain their effect on pre-existing FDA policy, including policy on “mobile medical applications.” In a recent blog post, FDA Administrator Scott Gottlieb, MD, acknowledged that the challenge the FDA faces is determining how best to regulate these non-traditional medical tools with the traditional approach to medical product review. Through its Pre-Cert for Software Pilot, the FDA will adopt a new approach to digital health technology by recognizing the unique characteristics of digital health products and the marketplace for these tools, while seeking to promote the innovation of high-quality, safe and effective digital health devices.
Many anticipate that the one in five physicians figure recommending healthcare apps to their patients will increase in coming years. If used correctly, these apps can provide actionable data to physicians and assist in diagnosing and treating patients. However, with little government oversight over the quality, effectiveness and security of these apps, the onus is on both medical groups and their patients to work collaboratively to identify high-value apps that improve the care delivery process.
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