WEBVTT

00:00:00.542 --> 00:00:03.962
What opportunities are available
to companies in digital health

00:00:04.004 --> 00:00:06.339
amid an evolving
regulatory environment?

00:00:12.887 --> 00:00:15.515
In digital health,
advancements in technology

00:00:15.515 --> 00:00:17.851
have far outpaced the regulations.

00:00:18.143 --> 00:00:21.187
For example, digital health
offerings, including AI,

00:00:21.354 --> 00:00:23.982
have the potential to
be regulated as medical devices

00:00:24.024 --> 00:00:28.361
by the FDA under a legal framework
established in the 1970s,

00:00:28.403 --> 00:00:31.114
well before the advent
of these technologies.

00:00:31.281 --> 00:00:34.617
This need for regulators
to catch up to innovation creates

00:00:34.659 --> 00:00:36.202
enormous opportunities

00:00:36.202 --> 00:00:39.205
for industry to play a role
in educating regulators

00:00:39.414 --> 00:00:42.584
and shaping regulatory frameworks
that apply to their offerings.

00:00:42.917 --> 00:00:45.295
With the backdrop
that the current administration

00:00:45.295 --> 00:00:47.630
has voiced support
for the advancement

00:00:47.630 --> 00:00:51.301
of digital health technologies
like wearables and AI systems.

00:00:56.681 --> 00:01:00.143
The biggest risk for new entrants
to digital health is the potential

00:01:00.185 --> 00:01:03.229
for the offering to be
subject to onerous regulation

00:01:03.271 --> 00:01:05.231
without knowing
until in the market.

00:01:05.815 --> 00:01:07.358
New entrants may not grasp

00:01:07.358 --> 00:01:09.486
regulatory requirements
applicable to them.

00:01:09.652 --> 00:01:13.364
And these requirements can impact
product development, functionality,

00:01:13.406 --> 00:01:16.785
timelines, commercial
potential, and market entry.

00:01:22.207 --> 00:01:24.959
Companies have an opportunity
to design their products

00:01:24.959 --> 00:01:27.712
to fit within their preferred
regulatory frameworks,

00:01:27.712 --> 00:01:31.591
even with small changes that don’t
materially impact the bottom line.

00:01:31.841 --> 00:01:34.469
It’s important to
seek the advice of experienced

00:01:34.469 --> 00:01:36.888
and commercial counsel
who can help guide.

00:01:37.180 --> 00:01:39.599
Latham handles
complex regulatory matters

00:01:39.599 --> 00:01:41.935
to help our clients
developing and offering

00:01:41.935 --> 00:01:45.522
digital health technologies
get to and stay on the market,

00:01:45.647 --> 00:01:48.691
and to advocate for a tailored
regulatory approach.

00:01:48.900 --> 00:01:50.944
I’m Liz Richards,
and I’ve been advising

00:01:50.944 --> 00:01:54.155
life sciences and technology
clients on complex FDA

00:01:54.197 --> 00:01:57.200
regulatory matters
for more than 15 years.