A recent survey of healthcare professionals with 2,291 healthcare respondents, including 649 physicians, conducted by eClinicalWorks, revealed that physicians believe that mobile health apps (mHealth) can improve a patient’s health outcome, but mHealth app developers are worried that FDA overregulation could stifle innovation.
Ninety-three-percent of physicians believe that mobile health apps can improve a patient’s health outcome and they find value having a mobile health app connected to Electronic Health Records (EHRs). Eighty-nine-percent of the physicians surveyed said they are likely to recommend a mobile health app to a patient.
Physicians, overall indicated that a mobile health application linked to an EHR could make an immediate impact on medication compliance, diabetes care and preventative care. Providers want their patients engaged, and they see clear benefits in health outcomes with this connection.
“In order to transform healthcare, patients need to be engaged,” said Girish Kumar Navani, CEO and co-founder of eClinicalWorks. “People are invested in and want to be engaged in their health as long as they trust the source of the information.”
Mobile health (mHealth) has mad a significant impact globally on the delivery of care but most regulators around the world are still uncertain how to address the technology. While regulatory bodies in the United States and the European Union are beginning to increase scrutiny over mHealth, over 150 countries have yet to develop regulatory frameworks or guidance.
Recently, Samsung released the latest model of its Galaxy smartphone, the S4 which is the first smartphone to fully embrace the integrated value of medical sensors, applications, and accessories that are supportive and not stand-alone or separate. The launch of a mHealth application within a smartphone by a global manufacturer could spark further discussions regarding regulatory controls at the US Food and Drug Administration.
Medical apps like the recently launched, uChek, an iPhone urinalysis device, will remain readily accessible through mobile application download services, such as Apple’s App Store until FDA and other agencies release new regulations. US Rep. Mike Honda (D-CA) plans to reintroduce a measure in Congress that would seek to establish a new Office of Mobile Health at the FDA dedicated to the development and oversight of mobile health technologies. Many of these mobile medical applications walk a fine line and are marketed to the public in a gray area.
The FDA stated its intent to regulate apps as medical devices under the Federal Food, Drug and Cosmetic Act when it issued a draft guidance in July 2011.
Last week, Health Subcommittee members of the House Committee of Energy and Commerce (CEC) heard healthcare professionals on potential regulations and taxes of mHealth devices during the “Health Information Technologies” hearing.”There must be a role for the FDA to determine what’s safe and effective,”
Congressman Frank Pallone (D-New Jersey) said during the hearing. “The reality is, the future of mobile health is very bright.”
Healthcare professionals are concerned that mHealth devices will be classified as medical devices, and sought to point out the differences between apps and devices during the hearings. They encouraged Congress that regulations should be drafted carefully to avoid overregulation.
“We need a new regulatory framework that is risk-based and specific to health information technologies,” said Jacqueline Mitus, MD, McKesson Health Solutions Senior Vice President of Clinical Development and Strategy. “Health IT doesn’t replace physician judgment, but rather provides guidance and support.”
A recent concern raised is the 2.3% medical device excise tax that device manufacturers are subject to under the Affordable Care Act. App developers feel that mHealth apps should be exempt from the tax.
The Oversight and Investigations subcommittee met with FDA and the Department of Health and Human Services during a hearing about their perspectives on innovation and regulation on March 21.
According to Christy Foreman, Director of the FDA Device Evaluation Division, a mobile app deemed to be a medical device would be subject to the medical device tax unless it is sold to consumers through retail stores, in which case it would be exempt. However FDA did not clearly explain to the public which mobile apps will be considered medical devices, though it intends to release the long-anticipated final guidance in October.
The market for mobile health services will likely reach $26 billion globally by 2017, according to a report published this month by research2guidance, a research and consulting firm. The report indicates that there are 97,000 mHealth applications in app stores. Fifteen percent of the mHealth apps on the market today are designed for the healthcare profession, including continued medical education, remote monitoring and healthcare management applications.
App stores, such as the Apple App Store determine whether to approve apps for market based on current draft guidance. If an app appears to require concurrence on a 510(K) PreMarket Notification, the approval is postponed until clearance is obtained. Foreman says that the 510(K) review and clearance process for mobile apps takes an average of 67 days, except for higher-risk devices that may require clinical data.