U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently said digital health technology will be a priority focus during his tenure.
In a blog post for the agency, Gottlieb announced the creation of a “digital health innovation plan” that aims to provide streamlined updated policy guidance on how digital wellness and health software will be regulated under a Trump White House and FDA.
One of the main points that Gottlieb emphasized was that there will be an elimination of unneeded ambiguity in rule-making so that the private sector has more space for innovating and developing new technologies. Changes included a quicker approval process to be installed, as well.
“The FDA is exploring options under current authorities to more closely align our regulatory review with the software manufacturing industry’s innovation timelines,” Stephanie Caccomo, an FDA press officer, told Patient Daily on behalf of Gottlieb. “For these products, the development and modification timelines are often faster than other devices that the FDA regulates. The FDA is currently soliciting feedback from stakeholders to ensure a model that aligns with product development timelines, industry practices, and real-world experience while providing reasonable assurance of the safety and effectiveness of these devices.”
Caccomo said the new guidance will provide the agency’s Center for Devices and Radiological Health an opportunity to incorporate regulations that specifically touch on connectivity devices and personal, mobile phone applications.
Ultimately, the new focus is to empower software developers and designers to expand operations into industry verticals like mobile health applications for smart phones, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine, among other verticals.
“Patients and consumers can use digital health to better manage and track their health and wellness related activities,” Caccomo said. “The use of technologies such as smartphones, social networks and internet applications is not only changing the way we communicate, but is also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes.”
According to Bloomberg BNA’s coverage on the matter, FDA expects that the 165,000 health and wellness-centered mobile applications for Apple iOS and Android devices will be downloaded 1.7 billion times by the end of this year.
Growth for health IT is expected, too. Grand View Research, in an October 2015 report on the health care information technology industry’s projected growth by the year 2020, indicated that the health IT industry was valued at $41.2 billion in 2013. Unfettered growth was expected, as well.
