Mobile healthcare, telemedicine, telehealth, BYOD

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FDA Patient Engagement Committee Fosters mHealth Innovation

By Sara Heath

Although it is clear that the use of mHealth devices can help increase patient engagement, that relationship may rely on the development of good and effective applications and devices which benefit consumers. In an effort to ensure that happens, the Food and Drug Administration (FDA) has announced its Patient Engagement Advisory Committee, which will oversee the adoption of mHealth services as they apply to the patient.

mhealth apps will be overseen by FDA committees for patient engagement

The purpose of the Committee is to advise the FDA Commissioner, as well as the designer of the device or application, on issues regarding the development of certain mHealth devices.

“The Patient Engagement Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective devices for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility,” the Committee Charter states.

The committee is also in charge of advising the Commissioner of the way in which the apps are used by consumers and how they affect those consumers’ lives.

“The Committee will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices,” the FDA website states.

According to the Committee Charter, the Committee will be composed of nine members, including the Committee Chair. These members will be selected by the Commissioner of the FDA based on the member’s knowledge and expertise of, among other things, clinical research, primary care patient experience, or various healthcare needs of certain patient populations.

The implementation of the Patient Engagement Advisory Committee adds to the oversight the FDA has been creating in the realm of mHealth devices. As reported by, FDA oversight is on the rise, and it can often be perceived as controversial.

According to the article, both Congress and healthcare professionals are concerned that the increased oversight the FDA is implementing could hamper innovation and device development throughout the industry.

However, many stakeholders maintain that proper FDA regulation of the mHealth industry is critical for maintaining patient safety. Increased oversight allows both physicians and consumers to understand the risks and benefits involved in using a certain device.

In an effort to strike a careful balance between innovation-limiting oversight and creating a safe market for consumers, the FDA has stated it will prioritize certain devices that directly affect patient health over others. As reported by, this will be determined by whether or not they “pose a risk” to patients.

Furthermore, the FDA stated it would not place regulations on applications that serve as tools to promote general wellness, such as step counters or fitness bands. The FDA states that these relaxed regulations are intended to foster innovation and growth of “low-risk” mHealth devices.

The FDA continues to take these measures to ensure that the mHealth market is not only prosperous, but safe and beneficial for patients. As the Patient Engagement Advisory Committee joins these efforts to foster mHealth device development, the FDA expects continued growth in the industry.


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