Source: Flickr, ilamont.com
If predictions that the U.S. mobile health (mHealth) market will continue to grow exponentially in the next few years hold true, consumers will more often be able to fill in for their doctors in certain scenarios, according to a recent report by Transparency Market Research.
The more popular health apps generally are ones that consumers can use to track weight, diet and exercise, such as Map MyRun or Calorie Counter. In more recent years, however, app developers have become increasingly interested in creating tools that people can use to track blood pressure, sleep patterns, chronic pain and serious medical conditions.
No question that the ability of patients to track and store key medical information on their smartphones can bring more convenience and health benefits to their lives. However, the medical app market, though gaining popularity, is still relatively new, and consumers and patients, along with health care professionals, app manufacturers and policy makers, have raised questions about how safe and accurate these apps are, what health risks they may pose and if and how they will be regulated.
Patients can expect more safety and innovation
A lack of standardized regulations or oversight has thus far made it difficult to determine whether mobile medical apps function accurately, which can raise issues about patient safety.
Of particular concern is the safety and accuracy of “mobile medical apps,” which the U.S. Food and Drug Administration (FDA) defined in its preliminary 2011 draft guidance as apps that are either used as an accessory to, or transform a mobile platform into, a regulated medical device – essentially, any app that serves the same purpose as a traditional medical device.
Examples of mobile medical apps include those that serve as blood glucose meters, blood pressure monitors or X-Ray machines. Some existing mobile medical apps also allow doctors to turn smartphones into a stethoscope, ECG heart monitor, blood pressure cuff and a glucose meter.
These mobile medical apps are considered high-risk, as they can greatly affect a medical patient’s care and treatment when the apps don’t work as intended.
App manufacturers are going to need to have specific guidelines by which they can abide and be held accountable for the safety of their medical devices, according to federal government agencies. The FDA has set its deadline for publishing its final guidance on mobile medical application (app) regulation for the end of the 2013 fiscal year (September 30), according to FDA’s Christy Foreman, who serves as the Director of the Office of Device Evaluation at the Center for Devices and Radiological Health.
One of the FDA’s biggest challenges is figuring out how to balance patient safety with technological innovation, according to Bakul Patel, who is an FDA policy advisor and the primary author of the FDA’s 2011 draft guidance. The FDA says it hopes that setting clear definitions and regulations could have a domino effect in allowing app manufacturers to demonstrate more innovations that are beneficial to patients. In turn, patients may benefit from increased safety.