FDA Launches Digital Health Center of Excellence

Technology and digital platforms are driving a revolution in health care. In a step towards advancing and realizing the potential of digital health technology, the U.S. Food and Drug Administration (FDA) recently launched its Digital Health Center of Excellence (DHCoE.)  In this blog post, Cindy Elko-Simms, M.D., senior vice president of pharmacovigilance, regulatory affairs and medical writing; and Niklas Morton, senior vice president of PPD Digital, discuss the FDA’s newly launched DHCoE and its potential impact for stakeholders in clinical development.

Health care stakeholders around the world are adapting to evolving patient needs by modernizing regulatory approaches and adopting policies that incorporate and encourage the use of digital technologies to decentralize research. The September 2020 launch of the FDA’s DHCoE is an important milestone in the agency’s planned evolution of its digital health program, which is helping to advance innovative digital health technology to benefit patients.

FDA Digital Health Center of Excellence

The DHCoE is housed within the agency’s Center for Devices and Radiological Health (CDRH) and led by Bakul Patel, former agency lead for regulatory and scientific efforts for digital health devices. Its mission is to protect and advance public health by helping to speed innovations that provide the American public with safe and effective digital health technologies.¹

The center aligns all FDA digital health activities, spanning a broad spectrum of categories, including telehealth, telemedicine, wearable devices, mobile health (mHealth), health information technology (IT) and personalized medicine.²

While the DHCoE is intended to coordinate digital health activities across the FDA, it will also support efforts to modernize digital health policies and regulatory approaches within the industry. The center will also provide technological expertise and tools to support external stakeholders interested in digital health activities and innovation, including the public, patients and health care workers. In addition, it will also be a resource for the device industry and mobile application developers who may or may not have health care experience.

Roadmap to implementation

The FDA move towards digital health innovation has been underway for some time. After the 21^st Century Cures Act required the FDA to issue guidance to clarify requirements for software as a medical device, the “Digital Health Innovation Action Plan” of 2017³  added the aim to implement a software precertification program for medical software and to build “bench strength” and expertise in the digital health unit.

The Digital Health Software Precertification (Pre-Cert) Program was launched in 2019, and in September 2020 the FDA published highlights and lessons learned on this topic.⁴

In a 22 September announcement, the FDA acknowledged the DHCoE is still a work in progress,⁵ and in stakeholder listening sessions in October and November outlined the following three-phase implementation plan:

• Phase I (Fall 2020) involves raising awareness and engaging stakeholders through a range of stakeholder listening sessions, as well as operationalizing the DHCoE and increasing existing FDA digital Health work.
  • Phase II (Fall/Winter 2020) will focus on building strategic partnerships for policy and regulatory science, establishing FDA and CDRH advisory groups and a digital health community of practice.
  • Phase III (Winter 2020 onwards) will focus on building and sustaining capacity though continued strategic partnering, updating and implementing the regulatory framework for digital health as well as aligning with other regulators.

During these listening sessions, 13 areas of current focus were highlighted, including software as a medical device (SaMD), artificial Intelligence/machine learning, wearables and medical device cybersecurity.⁶

Interested in learning more?

Stakeholders interested in learning more about the DHCoE can access the FDA’s 16 October and 12 November virtual listening sessions, in which its purpose, operations and services are outlined.

Additionally, the FDA is currently seeking software, artificial intelligence and machine learning engineers, security researchers, designers and product managers to join the DHCoE as digital health advisors.⁷

What is the impact?

While the COVID-19 pandemic can be blamed for nearly half of all trial disruptions in the first half of 2020, we believe, with hindsight, the pandemic will be viewed as a catalyst for some positive advances in clinical development. In recent months, PPD has designed and deployed decentralized offerings for sponsors around the world, including eConsent, televisits, direct-to/from-patient structures, eCOA, home health care, and remote monitoring, which in many cases meant the difference between damaging trial disruption and enabling study continuity. We, like the FDA, are learning from this experience and optimizing digital solutions for the future.

The launch of the FDA’s DHCoE is another milestone demonstrating the benefits of these solutions and the agency’s commitment to advancing digital health innovation and re-imagining digital health care. Our expectation is that once fully operational, the DHCoE will be a beneficial resource for patients, healthcare workers, industry developers and regulators. We welcome this announcement and will monitor progress with interest.