- The FDA posted a job opportunity on Monday for its Digital Health Team.
- The position — Digital Health Advisor (Interdisciplinary Engineer) — is one of the first job opportunities posted as part of the agency's plan to build a new team solely focused on digital health.
- The position will be responsible for providing technical expertise in identified digital health focus areas as well as developing and implementing regulatory policy in those areas. Applications will be accepted until Sept. 18.
The job description gives a bit more insight into the areas the FDA is looking toward as it circles around the digital health market.
The identified focus areas include software lifecycle management processes, mobile medical apps, medical device interoperability, cybersecurity, wireless technologies, cloud-enabled software deployment, machine learning/artificial intelligence, Big Data, advanced analytics, digital health product development and program management.
In June, FDA Commissioner Scott Gottlieb laid out the agency's "Digital Health Innovation Plan" which is aimed at streamlining the path for digital medical devices to get to market. In addition, the FDA wants to clarify its position on health tools like mobile apps.
In August, the agency announced a voluntary pilot program opportunity for digital health companies to experiment with market innovation. "The challenge FDA faced in the past is determining how to best regulate these non-traditional medical tools with the traditional approach to medical product review," Gottlieb wrote in August. "We envision and seek to develop through the Pre-Cert for Software Pilot a new and pragmatic approach to digital health technology."
The agency is currently accepting applications for its Digital Health Entrepreneur-in-Residence program, which will support its Pre-Cert Pilot Program. Duties include analyzing software industry business processes and KPIs and identifying areas to imprves data sharing policies and processes.
The FDA provided more details on the action plan last month. Highlights included the goal to issue draft guidance on 21st Century Cures implementation by the end of 2017 and on clinical decision support software in early 2018.