A commentary published in the Journal of the American Medical Association (JAMA) by three cardiologists at Scripps Translational Science Institute (Eric Topol, the institute’s director, Steven R. Steinhubl, director of digital medicine for Scripps Health, and Evan D. Muse, a clinical scholar and cardiovascular fellow) which performs clinical trials of mobile health applications and devices says that mobile healthcare applications and home monitoring will eventually make patients see their doctors far less often for minor acute problems and follow-up visits. However, they stress that a real-world clinical trial evidence is necessary to confirm the benefits of mobile health apps for patients, clinicians and payers.
According to the Scripps researchers, mobile health apps are advantageous in the following ways.
- Mobile health apps provide an opportunity for patients to diagnose their acute symptoms and manage their chronic conditions better, which would improve patient engagement and partnership in health care. For example, a smartphone-based otoscope can be used to check the presence of otitis media. The researchers also cite the example of a thermometer-enabled smartphone which can send physicians data that specifies whether a patient might have an upper respiratory tract infection. Besides monitoring temperature and relevant symptoms, this smartphone connects with the patient’s digital community to find out how many people at work or at school are affected.
- The apps allow more rapid diagnosis of acute problems and reduce the unnecessary visits to doctorsâ€™ office or emergency departments which would be a greater convenience to patients and decrease their cost of care. The home monitoring facility with the apps can be used to check blood pressure and send the relevant data to the physicians. As per the researchers, one in every three adults has hypertension and that condition impels them to make around 40 million visits in a year. Using digital blood pressure cuffs at home can largely reduce the number and costs of these visits.
- The researchers noted that more than a third of visits to physician office are associated with an acute condition, and health care services providing for up to a quarter of patients at emergency departments could have been managed in the ambulatory-care setting. They point out that creative mobile health devices are available for most common acute conditions and that such devices have the potential to free patients of dependence on the physicianâ€™s office or emergency department by allowing safe, effective and informed management from home.
Why Clinical Trial Evidence is Necessary
- Even though there is lot of evidence that monitoring blood pressure and glucose level at home is reliable, very few rigorous trials of mobile health apps have been performed. The meager published evidence is largely based on pilot studies.
- Without strong evidence, it is very difficult for physicians or consumers to know which app can be trusted. Of the 20,000 to 90,000 mobile health apps available on the market, the JAMA commentary points out that only 100 or so are approved by the Food and Drug Administration (FDA).
- The FDA’s final rule on the regulation of mobile medical applications states that approval is needed for the apps that claim to be medical devices or that are add-ons to the regulated medical devices.
- Steinhubl points out that there has been much hype in mobile health space. Though Toronto researchers announced they had invented a wristband device that can analyze the nutrients in the bloodstream of a person after taking food, Steinhubl is quite skeptical about the capability of the device.
Steinhubl adds that the iTunes store now requires the references to be included in the listing of medical apps and it is very hard for somebody to find a study to support their app with 10,000 papers published every week.
Apart from untried nature of mobile health apps, there are several barriers to the extensive use of these apps for acute and chronic conditions such as the financial incentives for providers to bring patients into the office, apprehensions of physicians about the weakening relationships with the patients, and so on. So companies providing mobile application development services for the healthcare sector could focus on mobile apps for which the FDA intends to exercise enforcement discretion which includes apps that:
- Help patients/users self-manage their disease or condition without providing specific treatment suggestions
- Provide simple tools that allow patients to organize and track their health information
- Allow easy access to information related to health conditions or treatments
- Assist patients in documenting, showing or communicating potential medical conditions to health care providers
- Automate simple tasks for health care providers
- Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems
In the words of Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation.”