Good day.
My name is Bakul Patel.
I am the Director for the FDA's Digital Health
Center of Excellence and the Director for the
Division of Digital Health at FDA's Center for
Devices and Radiological Health; Today I will be
providing an overview of the FDA's Digital Health
Program and activities.
To start, I wanted to highlight that the goal
for the digital health efforts has been to foster
responsible digital health innovation that will:
Enhance patients' access to high-quality
evidence-based digital health products; Enable
manufacturers to rapidly improve their products
while addressing emerging issues; and Ensure a least
burdensome approach to maintaining a reasonable
assurance of safety and effectiveness.
As you all are aware, Digital Health Technology
is at the cutting edge of consumer and patient
health.
It is paving the way for empowering patients to
become informed participants in their
health care decision making.
This convergence of connectivity, health data,
and computing power is making possible the
potential for Moving health care from clinic to
patients; Novel insights in understanding the
patients "in the wild"; and Focusing on prevention
for early smaller interventions.
Digital health technologies are also
providing new options for facilitating prevention,
early diagnosis of life-threatening diseases,
and management of chronic conditions outside of
traditional care settings.
Not all digital health technologies fall within
the scope of the FDA's authority.
Technologies that do fall within the FDA's scope
include those that are intended to be: used as a
medical device; incorporated into a
medical product; used to manufacture medical
products or to study a medical product, including
in a clinical trial; or used as a companion or
adjunct with a therapeutic or a diagnostic medical
product.
CDRH has been making progress on many of these
areas for a long time-to name a few, software as a
medical device, Software in a Medical device,
wearables, medical device cybersecurity, and
interoperability.
As this work continued, it was important for industry
and the FDA to commit to this emerging field--there
were many opportunities as well as challenges that
needed to be addressed.
As part of the MDUFA IV commitments, FDA and
industry jointly agreed to continue building on
existing digital health work to address the needs
of this rapidly evolving field.
FDA committed to enhance this existing work by:
Providing continued regulatory clarity;
Building centralized digital health expertise;
Staying current with advancements and
supporting regulatory programs; Enhancing
coordination and consistency; and
Maintaining international harmonization.
In the fall of 2017, the FDA released an integrated
approach - the Digital Health Innovation Action
Plan - that mapped out the commitments and a plan to
build bench strength and expertise to support
internal and for external stakeholders, refine
policies and provide guidances in light of the
21st Century Cures Act, collaborate and partner
with stakeholders, and develop a learning
regulatory system that is tailored and aligned
globally.
The Digital Health Innovation Action Plan
aligns nicely with the MDUFA IV commitments as
denoted by the numbers on this slide.
I'm going to walk you through each of these
programmatic components and share with you some of
the accomplishments over the last few years.
I'll start with "building bench strength and
expertise" In 2017, CDRH formally established a
centralized Digital Health unit and subsequently
formalized that unit into a division giving
permanency within the organization.
As we continue to foster responsible digital health
innovation, recently we announced the launch of
the Digital Health Center of Excellence - This
launch will further FDA's ability to drive synergy
and coordinate digital health related efforts at
the FDA.
In addition to creating this infrastructure,
several systematic efforts continue to build and
supplement technical expertise across CDRH
Through the experiential learning program, 220 CDRH
staff visited 17 digital health manufacturers'
facilities to get hands-on knowledge.
In 2018 and 2019, we brought in seasoned
individuals with practical experience through our
entrepreneurs in residence program and presidential
innovation fellows program.
We also have a standing job opening for candidates
to join FDA in its digital health mission.
Next, I'll discuss how the FDA is supporting internal
and external stakeholders: The FDA's goal here is to
expand policy knowledge on digital health
technologies and to maintain consistency in
application of those policies.
The digital health division also provides
inquiry support to all stakeholders internal and
external, and provides submission support through
consults.
CDRH established the focal point program - designed
to maintain consistency and knowledge to resolve
unique submission issues across CDRH's Offices of
Health Technologies or OHTs.
The program is structured to include representatives
from all review areas along with the digital
health team.
This structure enables the Digital health program to
understand opportunities and needs for the center.
Addressing one of the needs the program
developed software 101 training for reviewers to
have a basic understanding of the software
development process.
In addition, this group is also in the process of
developing aids and tools for reviewers that will
help staff navigate different policy
documents.
Starting with FY 2018, we implemented a "Digital
Health" flag to mark submissions with digital
health content.
Looking at trends in submission -- For the last
few years the submissions volume has been rising
year-over-year, however the average submission
timelines are comparable to other submissions and
within our goals.
In addition to regulatory submissions, the digital
health team also provides support to stakeholders
inquiring about policies for solutions or products.
We have been receiving more than 600 inquiries
per year.
About 80% of those are from external
stakeholders.
The volume of these inquiries has increased
over the last two years.
Prior to 2017 we used to receive approximately 30
inquiries per month.
For the last three years our volume has more than
doubled to approximately 60 to 80 inquiries per
month.
Even with this increased volume, on an average we
respond in FY2020 within 14 days for 80% of these
inquiries - which is our internal target.
In FY2020 we continue to exceed our goals with a
median response time of about 5 days.
As part of the MDUFA IV - specifically, digital
health commitments 2 and 3 - it was important for the
FDA to revise and publish new and relevant guidance
documents to provide clarity to stakeholders.
Specifically, commitment 2 called for finalizing the
software modifications guidance 18 months after
the comment period ended on the draft guidance.
In this case, the FDA finalized the guidance
well before the commitment timeframe.
As I noted earlier, this emerging area yields
emerging issues and risks, which require ongoing
clarity on policies, approaches, and guidance
for stakeholders and staff.
Since the beginning of FY2018 the digital health
program has published 11 guidances--this is a
phenomenal achievement for this program.
I want to highlight that in the field of cyber
security we continue to make progress.
FDA issued a draft guidance for Content of
Premarket Submissions for Management of
Cybersecurity in Medical Devices.
We also established internal collaborations to
drive consistency in the premarket review.
As I mentioned earlier a special focal point
program was established for cybersecurity.
This focal point team along with the
cybersecurity team created tools and templates for
reviewers to look at cybersecurity in medical
devices.
This is just one of example where continued
clarity and a learning environment needs to be in
place.
In addition to providing ongoing clarity, MDUFA IV
committed the FDA to engage and build
partnerships with stakeholders.
The FDA continues to collaborate in many ways,
building upon the work item at the International
Medical Device Regulators Forum (or IMDRF).
Our engagement there led to the book of work on
Software as a Medical Device.
FDA is adapting and using these principles, as
appropriate, in its guidance documents and in
programs the FDA is building such as the
Software Precertification Pilot Program.
Citing 2 specific collaborations at IMDRF:
FDA Co-chaired the medical device cybersecurity
working group to develop principles and practices
for medical devices.
This document was finalized in March of
2020.
In addition, the FDA is currently participating in
the artificial intelligence (or AI) in
medical devices workgroup.
This group's charter is to develop guidance to align
and harmonize on key definitions and
terminology for AI in medical devices.
This work is led by the South Korean regulatory
body.
In addition to collaborating with other
regulators The FDA is participating in two
collaborative communities on artificial intelligence
and machine learning.
Over the last three years the digital health team
has participated in 90 plus speaking engagements,
established a network of experts specifically for
Digital Health to have access to 35 experts in
this area, we've conducted boot camps with academic
institutions and conducted at least three in-person
public workshops.
Collaborations in the field of Cybersecurity
include: FDA is currently co-chairing a group on
Legacy Device issues underneath the Healthcare
Sector Coordinating Council to explore
potential paths forward.
FDA is currently co-chairing a group on
Vulnerability Communications to advance
the state of sector communications with
stakeholders regarding cybersecurity
vulnerabilities.
FDA participated in the National
Telecommunications and Information
Administration, which is developing best practices
for software transparency (and software bill of
materials) Within the Digital Health space, FDA
continues not only to meet our MDUFA IV commitments,
but to exceed them.
As part of MDUFA IV, we committed to exploring
opportunities to establish premarket pathways that
were tailored to digital health technologies.
Building on that commitment, CDRH has made
significant progress in exploring a novel agile
regulatory paradigm that would be tailored and
aligned globally with the harmonized principles.
The digital health software precertification
program or Pre-Cert Program - was envisioned
in 2017.
Since the inception of the program the FDA has been
transparent and engaging stakeholders in the
process of building, testing, and iterating
this concept.
To name a few major milestones, in 2018 we
continued to build the concept with 9 pilot
participants and other volunteers to develop a
program working model.
In 2019 we published version 1.0 of the program
working model along with a test plan.
The digital health team continues to test, build,
and iterate the concepts of Pre-Cert to better
understand without compromising our standard
of reasonable assurance of safety and effectiveness.
This program envisions moving from an episodic
oversight to continuous oversight that enables
trust in the organization using a pragmatic check-in
with real-world performance data.
Most recently we provided an update on the ongoing
work in building this program.
in 2019 building upon the concept of the
precertification pilot program The FDA proposed a
novel approach to artificial intelligence
and machine-learning or AI-ML.
The goal of this framework is to create an innovative
pathway for these technologies that improves
overtime and has a potential for advancing
the standard of care.
For both of these regulatory innovation
efforts, the FDA has engaged stakeholders to
begin building this new paradigm.
We have engaged in public meetings and through
publishing documents.
We have also engaged with stakeholders and received
many useful comments from the public through the
Federal Register docket.
All these efforts at collaboration, building
expertise, clarifying policies, has led to
important public health outcomes.
Here are some notable examples that realized the
potential of digital health: As of September
2020, there are three major manufacturers of
consumer wearables who are pioneers in providing ECG
to individuals.
These products are reaching millions and
helping individuals engage in their heart health.
Earlier this year, the FDA permitted marketing of a
novel game-based therapy for children with ADHD.
And in the field of digital therapeutics,
we're seeing an increased use of software that
provides coaching and cognitive behavior therapy
for many conditions.
As we continue this journey of digital health
- we recently announced the launch of the digital
health center of excellence, which sets the
stage to enhance coordination, further
build and access expertise to help digital health
innovators and FDA staff.
Our goal for the center is to empower all
stakeholders to advance healthcare with
high-quality digital health technology.
Before I close my talk, I want to note that the
digital health program has accomplished and exceeded
most of the commitments in MDUFA IV.
To recap the digital health program has: Served
more than 2000+ customers through the Digital health
email inbox, and engaged with more than 100
stakeholders Met 510(k) Goals Digital health
submission timelines are comparable to other
submissions Created access to more than 35 experts in
addition to inhouse expertise as we continue
to build capacity Published 22 public
documents that embraces ongoing clarity and
transparency But our work is not done: The Digital
health market size is projected to grow at a
compounded rate of 25% in the next five years.
And it is anticipated that in light of COVID-19
digital health technologies will have
increased adoption beyond the current projections.
FDA and industry must continue to build, evolve
and adapt in order to keep pace with this
exponentially growing field, so that the
potential benefits of digital health are
realized for all individuals and patients.
Thank you!