Many health care professionals are excited about the idea of prescribing mobile health applications, but the health care industry still is struggling with how to ensure quality and safety of such apps, the New York Times reports.
About the Use of Health Apps
Health apps often collect data to help patients make decisions about their health. For example, the DiabetesManager app collects data on the diet, blood sugar level and medications of a patient with diabetes, and then offers suggestions to help the user normalize his or her blood sugar levels.
Lee Perlman -- managing director of Happtique, a subsidiary of the business arm of the Greater New York Hospital Association -- said physicians soon will be able to prescribe clinically tested apps and more basic apps that perform functions like reminding patients to take pills (Brustein, New York Times, 8/19).
Plans for FDA Regulation
Last year, FDA issued draft guidance on its plans to regulate mobile medical apps. The agency could release the final regulations later this year (iHealthBeat, 7/27).
Although it is unclear how far FDA's regulation of medical apps will extend, Bakul Patel -- an FDA policy advisor -- said the agency only will regulate apps that act as medical devices by making diagnostic or clinical decisions.
To date, fewer than 10 apps have received FDA approval.
Challenges of Ensuring Quality, Safety
Some apps already on the market violate FDA regulations because they make untested medical claims. In addition, some mobile health app developers are attempting to skirt FDA regulation by adding disclaimers about their products.
Unlike apps from other industries, apps dealing with medical issues cannot be introduced to the public with problems that will be fixed later, the Times reports.
In response to such challenges, some organizations -- such as Happtique -- are establishing their own guidelines to evaluate the quality of medical apps (New York Times, 8/19).