The FDA is searching for candidates with backgrounds in analytics, digital therapeutics and interoperability to join its "dynamic digital health team," FDA Associate Director for Digital Health Bakul Patel wrote in a LinkedIn blog post Nov. 2.
Mr. Patel described the digital health team as a "startup" within the FDA's Center for Devices and Radiological Health tasked with developing a regulatory pathway to evaluate the safety of digital health products. Digital health has been a growing area of concern at the FDA, and the agency has attempted to introduce various regulatory programs to oversee these types of emerging technologies in recent years.
Mr. Patel provided scarce details about the new positions, all listed under the banner of a "digital health adviser," but he said the FDA is "seeking candidates for multiple positions with a variety of expertise in delivering digital health technologies." He noted clinicians, health scientists and software engineers as potential candidates the team would benefit from.
He added that the agency is seeking candidates with experience related to medical apps, interoperability, healthcare cybersecurity, digital therapeutics, artificial intelligence, digital health product development, advanced analytics, software-as-a-medical-device, cloud storage or wireless communication.
"We are an interdisciplinary group of experts pooling our technology, business, scientific and public health expertise to promote and protect public health," Mr. Patel said of the digital health team. "We are looking for digital health experts to join us on this exciting and cutting-edge healthcare transformation journey and lead as agents of change at FDA for the digital health future."
The new hires would be tasked with partnering with business and technology subject matter experts to stay up-to-date on technological advances, health risks and best practices to inform the FDA's digital health policies. Other responsibilities would include reviewing emerging digital health technologies and participating in research in the field.
The FDA released its initial call for a digital health adviser in September 2017. At the time, an agency spokesperson confirmed to Becker's Hospital Review the position marked the first in a set of hires the FDA planned to add to its digital health team, pointing to the FDA's digital health innovation action plan, published in June of that year.
"Our goal is to build a cadre of experts with a deep understanding and experience with software development and its application to medical devices," the plan reads. "This new staff will work with reviewers, compliance officers and others within the FDA to improve the quality, predictability, consistency, timeliness and efficiency of decision making on individual products and firms."
For details on how to apply to join the FDA's digital health team, click here.