Digital Health: ‘Connecting the Dots’ Across FDA Centers

Regulatory NewsRegulatory News | 24 April 2019 |  By 

The US Food and Drug Administration’s (FDA) creation of a Digital Health Center of Excellence is in the works, although details offered Wednesday did not shed much light on when it’s coming or its envisioned role.
There are “lots of details to be ironed out,” said Bakul Patel, director for digital health at FDA’s Center for Devices and Radiological Health (CDRH), during a session on Wednesday at the AAMI/BSI/FDA International Conference on Medical Device Standards and Regulations. This includes the timeline on the development and establishment of the Digital Health Center of Excellence. The center will come in the next few months or the next few years, Patel estimated.
He also explained that challenges in creating the center partly stem from efforts already underway within FDA centers that are not necessarily at the same level as CDRH in terms of harnessing digital health’s potential.
Cross-center alignment has increasingly become an imperative for the drug and device sectors.
The initiative will start at CDRH before moving on to other FDA centers over time, Patel said. It will serve as a mechanism for creating agency-wide consistency around digital health as it’s less about centralizing resources and more about “connecting the dots, providing knowledge and making sure that knowledge sharing” is taking place across centers.
The Digital Health Center of Excellence will also play an important role in fostering existing connections and creating additional ones with agencies and other industry stakeholders.
Another detail the initiative explores involves the center’s fit in how FDA works with the Office of the National Coordinator for Health IT (ONC), which primarily focuses on electronic health record systems.
There is a lot going on at HHS around digital health outside of just ONC and HHS is looking to work together with FDA on the path forward, Patel said. He added that FDA’s contribution will be not only the creation of the Digital Health Center of Excellence, but also leveraging this new center to create more connections and a consistent way of working in collaboration with ONC.
Former FDA Commissioner Scott Gottlieb continued to highlight the digital health center during the past few months, following the center’s proposed creation as part of FDA’s Fiscal Year 2019 budget request.
“This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices,” Gottlieb said last September.
“We’re building our Digital Health Center of Excellence to develop more efficient ways to ensure the safety and effectiveness of technologies like smart watches with medical apps,” Gottlieb added before stepping down as FDA commissioner earlier this month.
Clarifications in FDA thinking on digital health came in response to asks from industry and Congress. The new center will also advance the PreCert model—an effort chaired by Patel. PreCert is still in the pilot phase, with some audience members expressing angst in the delay to moving beyond a pilot.


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