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Policy News

Mobile Health Industry Faces Safety and Security Challenges

By Vera Gruessner

- The mobile health industry has a variety of legal implications that must be addressed by mHealth application manufacturers and healthcare providers who take part in utilizing mobile devices and apps during work hours. Federal regulatory agencies such as the Food and Drug Administration (FDA) work toward improving laws that would further strengthen the mobile health industry.

mHealth Legal Challenges

In 2015, the FDA has regulated more mobile health apps than ever before and has approved the use of approximately 100 products over the last ten years, according to a pwc report.

Mobile health apps can offer more convenience to patients and consumers throughout the healthcare spectrum. Telemedicine services also offer a simpler way for patients to connect with their physicians via video-based consultations instead of needing to take time off to drive to the doctor’s office.

Currently, mobile health apps play an important part in improving consumer health through four main factors including healthy eating tips, weight loss and dieting advice, fitness guidelines, and health education.

With more products coming out of the mobile health industry and the number of users increasing every day, digital health companies will need to focus their efforts on meeting regulatory requirements as set forward by federal agencies.

The FDA is currently working toward approving mHealth apps and devices “whose functionality could pose a risk to a patient’s safety if the mobile app were to not work as intended.”

The FDA is constantly revamping and clarifying its stance on regulating the mobile health industry. A successful organization should be able to understand the ongoing oversight of mobile health apps and devices in order to effectively use these new technologies to improve patient care.

“The FDA review process can be costly and time-consuming. Products that don’t need regulatory approval may enter the market with greater ease and at a lower cost. Awaiting agency approval also can lock in a product too early in the innovation process, hampering ‘release and revise’ strategies that have worked well in the tech world to update and improve products after their initial launch,” the pwc report stated.

“But regulatory approval also may lend legitimacy to products and prove valuable for building successful, sustainable revenue models.”

To gain greater understanding of the legal challenges surrounding the mobile health industry, the Robert Wood Johnson Foundation granted funds to the American Association for the Advancement of Science in order to conduct a project on legislation within the mHealth field.

There are currently 6.3 billion mobile devices being used by consumers around the globe. With this rise in the amount of mobile devices and apps, there are more risks and challenges related to legal standards that much be addressed by manufacturers and healthcare providers.

Privacy, security, and patient safety are some of the key issues that federal agencies are deciding upon when regulating this field. The American Association for the Advancement of Science will be holding three two-day workshops to address some of the legal challenges of the mobile health industry. The topics will revolve around liability, privacy/security, regulation, and patient safety.

“As health care moves from paper to wirelessly transmitted electronic records, from face-to-face encounters between patients and their doctors to digital encounters, and between devices at the bedside to devices implanted in the body, questions arise regarding safety, reliability, privacy, security, and responsibility. Each of these questions raises issues at the intersection of science, technology, health, and law. These issues need to be addressed more fully in order for the potential of mHealth to be achieved in a safe and responsible manner,” according to AAAS. 


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